Trial Outcomes & Findings for Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) (NCT NCT04928287)

Results Overview

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of the following 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Results posted on

2025-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	HB-adMSCs Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	Placebo Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.
Overall Study STARTED	15	9
Overall Study COMPLETED	15	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HB-adMSCs n=15 Participants Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	Placebo n=9 Participants Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 11.29 • n=5 Participants	61.1 years STANDARD_DEVIATION 8.99 • n=7 Participants	60.6 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants
Height	174.41 centimeter STANDARD_DEVIATION 8.572 • n=5 Participants	173.57 centimeter STANDARD_DEVIATION 10.239 • n=7 Participants	174.09 centimeter STANDARD_DEVIATION 9.020 • n=5 Participants
Weight	79.56 kilograms STANDARD_DEVIATION 23.389 • n=5 Participants	78.94 kilograms STANDARD_DEVIATION 21.280 • n=7 Participants	79.33 kilograms STANDARD_DEVIATION 22.149 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of the following 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in MDS-UPDRS Part II. Baseline	10.00 score on a scale (52 points total) Standard Deviation 6.99	7.33 score on a scale (52 points total) Standard Deviation 5.15
Change From Baseline in MDS-UPDRS Part II. Week 4	-1.87 score on a scale (52 points total) Standard Deviation 2.83	0.11 score on a scale (52 points total) Standard Deviation 2.71
Change From Baseline in MDS-UPDRS Part II. Week 8	-2.07 score on a scale (52 points total) Standard Deviation 3.67	-1.56 score on a scale (52 points total) Standard Deviation 3.61
Change From Baseline in MDS-UPDRS Part II. Week 16	-2.00 score on a scale (52 points total) Standard Deviation 3.23	-0.67 score on a scale (52 points total) Standard Deviation 3.24
Change From Baseline in MDS-UPDRS Part II. Week 24	-1.33 score on a scale (52 points total) Standard Deviation 3.79	-1.44 score on a scale (52 points total) Standard Deviation 3.00
Change From Baseline in MDS-UPDRS Part II. Week 32	-0.73 score on a scale (52 points total) Standard Deviation 3.84	-0.44 score on a scale (52 points total) Standard Deviation 2.96
Change From Baseline in MDS-UPDRS Part II. Week 42	-0.33 score on a scale (52 points total) Standard Deviation 4.19	0.56 score on a scale (52 points total) Standard Deviation 2.46
Change From Baseline in MDS-UPDRS Part II. Week 52	1.20 score on a scale (52 points total) Standard Deviation 6.61	1.11 score on a scale (52 points total) Standard Deviation 4.37

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of % of white blood cell count.

Outcome measures

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with units of 10\^9 cells/L (Leukocytes, Platelets)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (10^9 Cells/L) Platelets (10^9 cells/L) Baseline Value	243.3 10^9 cells/L Standard Deviation 52.38	209.4 10^9 cells/L Standard Deviation 44.46
Laboratory Values. CBC (10^9 Cells/L) Platelets (10^9 cells/L) Week 24	9.1 10^9 cells/L Standard Deviation 32.96	-12.1 10^9 cells/L Standard Deviation 12.94
Laboratory Values. CBC (10^9 Cells/L) Platelets (10^9 cells/L) Week 52	8.1 10^9 cells/L Standard Deviation 23.48	0.8 10^9 cells/L Standard Deviation 7.24
Laboratory Values. CBC (10^9 Cells/L) Leukocytes (10^9 cells/L) Baseline Value	5.83 10^9 cells/L Standard Deviation 1.891	5.47 10^9 cells/L Standard Deviation 1.267
Laboratory Values. CBC (10^9 Cells/L) Leukocytes (10^9 cells/L) Week 24	-0.36 10^9 cells/L Standard Deviation 1.640	-0.08 10^9 cells/L Standard Deviation 1.335
Laboratory Values. CBC (10^9 Cells/L) Leukocytes (10^9 cells/L) Week 52	0.09 10^9 cells/L Standard Deviation 1.615	-0.11 10^9 cells/L Standard Deviation 0.885

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with units of 10\^12 cells/L.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (10^12 Cells/L) Erythrocytes (10^12 cells /L) Baseline Value	4.425 10^12 cells/L Standard Deviation 0.5909	4.723 10^12 cells/L Standard Deviation 0.4661
Laboratory Values. CBC (10^12 Cells/L) Erythrocytes (10^12 cells/L ) Week 24	0.021 10^12 cells/L Standard Deviation 0.2671	0.129 10^12 cells/L Standard Deviation 0.2073
Laboratory Values. CBC (10^12 Cells/L) Erythrocytes (10^12 cells/L ) Week 52	0.109 10^12 cells/L Standard Deviation 0.3503	0.024 10^12 cells/L Standard Deviation 0.1843

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of pg.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (pg) Ery. Mean Corpuscular Hemoglobin Baseline Value	30.80 pg Standard Deviation 1.838	30.08 pg Standard Deviation 1.949
Laboratory Values. CBC (pg) Ery. Mean Corpuscular Hemoglobin Week 24	0.01 pg Standard Deviation 0.816	-0.12 pg Standard Deviation 0.616
Laboratory Values. CBC (pg) Ery. Mean Corpuscular Hemoglobin Week 52	-0.06 pg Standard Deviation 1.005	-0.32 pg Standard Deviation 0.874

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of fL.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (fL) Ery. Mean Corpuscular Volume (fL) Baseline value	90.83 fL Standard Deviation 4.404	88.30 fL Standard Deviation 3.508
Laboratory Values. CBC (fL) Ery. Mean Corpuscular Volume (fL) Week 24	-0.85 fL Standard Deviation 1.968	-0.46 fL Standard Deviation 1.074
Laboratory Values. CBC (fL) Ery. Mean Corpuscular Volume (fL) Week 52	0.12 fL Standard Deviation 2.034	0.53 fL Standard Deviation 1.111

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of g/dL.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (g/dL) Ery. Mean Corpuscular HGB Concentration (g/dL) Baseline Value	33.89 g/dL Standard Deviation 0.718	34.03 g/dL Standard Deviation 0.930
Laboratory Values. CBC (g/dL) Ery. Mean Corpuscular HGB Concentration (g/dL) Week 24	0.34 g/dL Standard Deviation 0.741	0.06 g/dL Standard Deviation 0.781
Laboratory Values. CBC (g/dL) Ery. Mean Corpuscular HGB Concentration (g/dL) Week 52	-0.07 g/dL Standard Deviation 1.306	-0.54 g/dL Standard Deviation 1.242
Laboratory Values. CBC (g/dL) Hemoglobin (g/dL) Baseline Value	13.57 g/dL Standard Deviation 1.435	14.16 g/dL Standard Deviation 1.041
Laboratory Values. CBC (g/dL) Hemoglobin (g/dL) Week 24	0.09 g/dL Standard Deviation 0.798	0.33 g/dL Standard Deviation 0.561
Laboratory Values. CBC (g/dL) Hemoglobin (g/dL) Week 52	0.33 g/dL Standard Deviation 0.893	-0.06 g/dL Standard Deviation 0.652

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (% Difference in Volume and Size of RBC) Erythrocytes Distribution Width (%) Week 24	0.33 % difference in volume and size of RBC Standard Deviation 0.339	0.68 % difference in volume and size of RBC Standard Deviation 1.394
Laboratory Values. CBC (% Difference in Volume and Size of RBC) Erythrocytes Distribution Width (%) Baseline Value	12.39 % difference in volume and size of RBC Standard Deviation 0.491	12.64 % difference in volume and size of RBC Standard Deviation 0.590
Laboratory Values. CBC (% Difference in Volume and Size of RBC) Erythrocytes Distribution Width (%) Week 52	0.16 % difference in volume and size of RBC Standard Deviation 0.364	0.22 % difference in volume and size of RBC Standard Deviation 0.233

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CBC laboratory values with unit of % of total blood cell count.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (% of Total Blood Cell Count) Hematocrit (%) Baseline Value	40.01 % of total blood cell count Standard Deviation 4.348	41.63 % of total blood cell count Standard Deviation 3.403
Laboratory Values. CBC (% of Total Blood Cell Count) Hematocrit (%) Week 24	-0.15 % of total blood cell count Standard Deviation 2.143	0.91 % of total blood cell count Standard Deviation 1.900
Laboratory Values. CBC (% of Total Blood Cell Count) Hematocrit (%) Week 52	1.13 % of total blood cell count Standard Deviation 3.297	0.44 % of total blood cell count Standard Deviation 1.519

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Change from baseline in Blood Pressure.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Vital Signs. - Blood Pressure (mmHg) Systolic Baseline Value	129.0 mmHg Standard Deviation 14.63	135.6 mmHg Standard Deviation 9.53
Vital Signs. - Blood Pressure (mmHg) Systolic Week 4	-1.9 mmHg Standard Deviation 11.78	-8.7 mmHg Standard Deviation 6.22
Vital Signs. - Blood Pressure (mmHg) Systolic Week 8	-5.9 mmHg Standard Deviation 10.82	-6.3 mmHg Standard Deviation 7.12
Vital Signs. - Blood Pressure (mmHg) Systolic Week 16	-3.9 mmHg Standard Deviation 15.76	-9.2 mmHg Standard Deviation 5.93
Vital Signs. - Blood Pressure (mmHg) Systolic Week 24	-5.1 mmHg Standard Deviation 17.33	-6.0 mmHg Standard Deviation 11.90
Vital Signs. - Blood Pressure (mmHg) Systolic Week 32	-5.8 mmHg Standard Deviation 12.01	-8.0 mmHg Standard Deviation 11.11
Vital Signs. - Blood Pressure (mmHg) Systolic Week 42	-4.3 mmHg Standard Deviation 18.52	-11.6 mmHg Standard Deviation 11.70
Vital Signs. - Blood Pressure (mmHg) Systolic Week 52	-5.9 mmHg Standard Deviation 14.19	-7.0 mmHg Standard Deviation 11.27
Vital Signs. - Blood Pressure (mmHg) Diastolic Baseline Value	79.7 mmHg Standard Deviation 10.73	79.8 mmHg Standard Deviation 5.74
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 4	-1.3 mmHg Standard Deviation 8.38	-2.3 mmHg Standard Deviation 5.34
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 8	-2.5 mmHg Standard Deviation 7.59	-1.0 mmHg Standard Deviation 6.84
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 16	-2.3 mmHg Standard Deviation 9.42	-3.8 mmHg Standard Deviation 6.67
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 24	-3.1 mmHg Standard Deviation 8.56	-3.6 mmHg Standard Deviation 8.31
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 32	-1.9 mmHg Standard Deviation 7.80	-1.1 mmHg Standard Deviation 6.05
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 42	-1.2 mmHg Standard Deviation 11.48	-4.0 mmHg Standard Deviation 6.30
Vital Signs. - Blood Pressure (mmHg) Diastolic Week 52	0.3 mmHg Standard Deviation 8.09	-0.7 mmHg Standard Deviation 7.05

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Change from baseline in Weight in kg.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Weight in kg. Baseline Value	79.65 kg Standard Deviation 23.298	78.94 kg Standard Deviation 21.280
Weight in kg. Week 4	0.43 kg Standard Deviation 1.551	0.33 kg Standard Deviation 1.038
Weight in kg. Week 8	1.75 kg Standard Deviation 8.868	0.44 kg Standard Deviation 0.981
Weight in kg. Week 16	1.73 kg Standard Deviation 9.009	1.39 kg Standard Deviation 2.354
Weight in kg. Week 24	-1.12 kg Standard Deviation 2.995	1.04 kg Standard Deviation 2.222
Weight in kg. Week 32	-0.97 kg Standard Deviation 3.580	1.02 kg Standard Deviation 2.790
Weight in kg. Week 42	-2.11 kg Standard Deviation 5.441	3.48 kg Standard Deviation 7.931
Weight in kg. Week 52	-1.77 kg Standard Deviation 5.046	0.60 kg Standard Deviation 2.926

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Change from baseline in CMP values with units of mg/dL

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (mg/dL) Bilirubin (mg/dL) Baseline Value	0.46 mg/dL Standard Deviation 0.150	0.46 mg/dL Standard Deviation 0.124
Laboratory Values. CMP (mg/dL) Bilirubin (mg/dL) Week 24	0.03 mg/dL Standard Deviation 0.139	0.10 mg/dL Standard Deviation 0.212
Laboratory Values. CMP (mg/dL) Bilirubin (mg/dL) Week 52	0.05 mg/dL Standard Deviation 0.177	0.09 mg/dL Standard Deviation 0.262
Laboratory Values. CMP (mg/dL) Calcium (mg/dL) Baseline Value	9.63 mg/dL Standard Deviation 0.410	9.56 mg/dL Standard Deviation 0.357
Laboratory Values. CMP (mg/dL) Calcium (mg/dL) Week 24	-0.06 mg/dL Standard Deviation 0.374	0.12 mg/dL Standard Deviation 0.387
Laboratory Values. CMP (mg/dL) Calcium (mg/dL) Week 52	0.09 mg/dL Standard Deviation 0.252	-0.07 mg/dL Standard Deviation 0.442
Laboratory Values. CMP (mg/dL) Creatinine (mg/dL) Baseline Value	0.898 mg/dL Standard Deviation 0.1243	0.910 mg/dL Standard Deviation 0.2579
Laboratory Values. CMP (mg/dL) Creatinine (mg/dL) Week 24	-0.016 mg/dL Standard Deviation 0.0755	-0.019 mg/dL Standard Deviation 0.2204
Laboratory Values. CMP (mg/dL) Creatinine (mg/dL) Week 52	-0.031 mg/dL Standard Deviation 0.1058	-0.082 mg/dL Standard Deviation 0.1664
Laboratory Values. CMP (mg/dL) Glucose (mg/dL) Baseline Value	99.7 mg/dL Standard Deviation 20.78	100.4 mg/dL Standard Deviation 16.96
Laboratory Values. CMP (mg/dL) Glucose (mg/dL) Week 24	3.7 mg/dL Standard Deviation 25.95	10.0 mg/dL Standard Deviation 24.17
Laboratory Values. CMP (mg/dL) Glucose (mg/dL) Week 52	0.1 mg/dL Standard Deviation 24.14	0.4 mg/dL Standard Deviation 20.88
Laboratory Values. CMP (mg/dL) Urea Nitrogen (mg/dL) Baseline valuse	16.5 mg/dL Standard Deviation 3.83	15.4 mg/dL Standard Deviation 4.10
Laboratory Values. CMP (mg/dL) Urea Nitrogen (mg/dL) Week 24	0.4 mg/dL Standard Deviation 2.61	1.4 mg/dL Standard Deviation 3.05
Laboratory Values. CMP (mg/dL) Urea Nitrogen (mg/dL) Week 52	0.0 mg/dL Standard Deviation 3.44	1.7 mg/dL Standard Deviation 3.84

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of g/dL

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (g/dL) Albumin (g/dL) Baseline Value	4.51 g/dL Standard Deviation 0.225	4.53 g/dL Standard Deviation 0.278
Laboratory Values. CMP (g/dL) Albumin (g/dL) Week 24	-0.03 g/dL Standard Deviation 0.246	0.08 g/dL Standard Deviation 0.222
Laboratory Values. CMP (g/dL) Albumin (g/dL) Week 52	-0.01 g/dL Standard Deviation 0.267	-0.04 g/dL Standard Deviation 0.167
Laboratory Values. CMP (g/dL) Globulin (g/dL) Baseline Value	2.61 g/dL Standard Deviation 0.328	2.42 g/dL Standard Deviation 0.497
Laboratory Values. CMP (g/dL) Globulin (g/dL) Week 24	-0.04 g/dL Standard Deviation 0.206	0.07 g/dL Standard Deviation 0.173
Laboratory Values. CMP (g/dL) Globulin (g/dL) Week 52	-0.01 g/dL Standard Deviation 0.264	-0.09 g/dL Standard Deviation 0.176
Laboratory Values. CMP (g/dL) Protein (g/dL) Baseline Value	7.11 g/dL Standard Deviation 0.391	6.96 g/dL Standard Deviation 0.520
Laboratory Values. CMP (g/dL) Protein (g/dL) Week 24	-0.07 g/dL Standard Deviation 0.406	0.14 g/dL Standard Deviation 0.300
Laboratory Values. CMP (g/dL) Protein (g/dL) Week 52	-0.03 g/dL Standard Deviation 0.394	-0.13 g/dL Standard Deviation 0.250

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of IU/L.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (IU/L) Alkaline Phosphatase (IU/L) Baseline Value	63.9 IU/L Standard Deviation 17.33	75.7 IU/L Standard Deviation 17.79
Laboratory Values. CMP (IU/L) Alkaline Phosphatase (IU/L) Week 24	2.3 IU/L Standard Deviation 10.25	3.7 IU/L Standard Deviation 11.81
Laboratory Values. CMP (IU/L) Alkaline Phosphatase (IU/L) Week 52	2.3 IU/L Standard Deviation 12.97	-0.1 IU/L Standard Deviation 6.41
Laboratory Values. CMP (IU/L) Alanine Aminotransferase (IU/L) Baseline Value	14.13 IU/L Standard Deviation 8.007	18.31 IU/L Standard Deviation 11.221
Laboratory Values. CMP (IU/L) Alanine Aminotransferase (IU/L) Week 24	-0.13 IU/L Standard Deviation 6.611	-2.43 IU/L Standard Deviation 8.754
Laboratory Values. CMP (IU/L) Alanine Aminotransferase (IU/L) Week 52	1.13 IU/L Standard Deviation 5.657	0.68 IU/L Standard Deviation 8.277
Laboratory Values. CMP (IU/L) Aspartate Aminotransferase (IU/L) Baseline Value	20.3 IU/L Standard Deviation 6.80	20.3 IU/L Standard Deviation 6.32
Laboratory Values. CMP (IU/L) Aspartate Aminotransferase (IU/L) Week 24	0.0 IU/L Standard Deviation 4.34	-0.1 IU/L Standard Deviation 3.10
Laboratory Values. CMP (IU/L) Aspartate Aminotransferase (IU/L) Week 52	3.3 IU/L Standard Deviation 9.52	0.8 IU/L Standard Deviation 3.77

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (mL/Min/1.73m^2) Glomerular Filtration Rate (mL/min/1.73m^2) Baseline Value	80.7 mL/min/1.73m^2 Standard Deviation 11.26	81.9 mL/min/1.73m^2 Standard Deviation 16.07
Laboratory Values. CMP (mL/Min/1.73m^2) Glomerular Filtration Rate (mL/min/1.73m^2) Week 24	4.6 mL/min/1.73m^2 Standard Deviation 6.57	5.7 mL/min/1.73m^2 Standard Deviation 19.04
Laboratory Values. CMP (mL/Min/1.73m^2) Glomerular Filtration Rate (mL/min/1.73m^2) Week 52	6.4 mL/min/1.73m^2 Standard Deviation 9.19	9.9 mL/min/1.73m^2 Standard Deviation 14.50

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of mmol/L.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (mmol/L) Chloride (mmol/L) Baseline Value	104.5 mmol/L Standard Deviation 1.41	104.4 mmol/L Standard Deviation 2.19
Laboratory Values. CMP (mmol/L) Chloride (mmol/L) Week 24	0.5 mmol/L Standard Deviation 1.73	-2.0 mmol/L Standard Deviation 1.80
Laboratory Values. CMP (mmol/L) Chloride (mmol/L) Week 52	-0.3 mmol/L Standard Deviation 2.31	-0.1 mmol/L Standard Deviation 2.42
Laboratory Values. CMP (mmol/L) Carbon Dioxide (mmol/L) Baseline Value	25.7 mmol/L Standard Deviation 2.28	26.2 mmol/L Standard Deviation 2.54
Laboratory Values. CMP (mmol/L) Carbon Dioxide (mmol/L) Week 24	-0.9 mmol/L Standard Deviation 2.13	-1.2 mmol/L Standard Deviation 2.39
Laboratory Values. CMP (mmol/L) Carbon Dioxide (mmol/L) Week 52	0.0 mmol/L Standard Deviation 1.89	-0.2 mmol/L Standard Deviation 2.22
Laboratory Values. CMP (mmol/L) Potassium (mmol/L) Baseline Value	4.29 mmol/L Standard Deviation 0.287	4.31 mmol/L Standard Deviation 0.190
Laboratory Values. CMP (mmol/L) Potassium (mmol/L) Week 24	0.04 mmol/L Standard Deviation 0.333	-0.01 mmol/L Standard Deviation 0.220
Laboratory Values. CMP (mmol/L) Potassium (mmol/L) Week 52	0.02 mmol/L Standard Deviation 0.273	-0.01 mmol/L Standard Deviation 0.209
Laboratory Values. CMP (mmol/L) Sodium (mmol/L) Baseline Value	141.5 mmol/L Standard Deviation 1.88	142.2 mmol/L Standard Deviation 1.64
Laboratory Values. CMP (mmol/L) Sodium (mmol/L) Week 24	-0.1 mmol/L Standard Deviation 1.98	-1.9 mmol/L Standard Deviation 1.54
Laboratory Values. CMP (mmol/L) Sodium (mmol/L) Week 52	0.1 mmol/L Standard Deviation 2.37	-1.0 mmol/L Standard Deviation 2.00

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) Albumin/Globulin (RATIO) Baseline Value	1.75 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.236	1.96 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.467
Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) Albumin/Globulin (RATIO) Week 24	0.03 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.118	-0.03 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.150
Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) Albumin/Globulin (RATIO) Week 52	0.02 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.214	0.03 Ratio: Albumin(g/dL) to Globulin(g/dL) Standard Deviation 0.166

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) Urea Nitrogen/Creatinine (RATIO) Baseline Value	18.5 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 4.49	18.0 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 5.07
Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) Urea Nitrogen/Creatinine (RATIO) Week 24	1.1 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 3.27	1.1 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 5.73
Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) Urea Nitrogen/Creatinine (RATIO) Week 52	0.8 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 3.91	4.4 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL) Standard Deviation 9.00

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in Coagulation Panel values with units of seconds.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. Coagulation Panel (Seconds) Prothrombin Time (sec) Baseline Value	13.20 seconds Standard Deviation 0.332	13.22 seconds Standard Deviation 0.814
Laboratory Values. Coagulation Panel (Seconds) Prothrombin Time (sec) Week 24	0.07 seconds Standard Deviation 0.505	-0.08 seconds Standard Deviation 0.604
Laboratory Values. Coagulation Panel (Seconds) Prothrombin Time (sec) Week 52	0.13 seconds Standard Deviation 0.294	-0.08 seconds Standard Deviation 0.751
Laboratory Values. Coagulation Panel (Seconds) Partial Thromboplastin Time (sec) Baseline Value	29.47 seconds Standard Deviation 2.446	31.00 seconds Standard Deviation 7.112
Laboratory Values. Coagulation Panel (Seconds) Partial Thromboplastin Time (sec) Week 24	0.42 seconds Standard Deviation 1.026	-1.47 seconds Standard Deviation 5.437
Laboratory Values. Coagulation Panel (Seconds) Partial Thromboplastin Time (sec) Week 52	0.11 seconds Standard Deviation 1.235	-1.37 seconds Standard Deviation 6.275

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24, and End of Study (Week 52)

Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) Prothrombin Intl. Normalized Ratio (RATIO) Baseline Value	0.97 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.049	0.96 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.073
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) Prothrombin Intl. Normalized Ratio (RATIO) Week 24	0.01 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.074	0.02 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.067
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) Prothrombin Intl. Normalized Ratio (RATIO) Week 52	0.01 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.035	-0.00 Ratio: PT (seconds) / MNPT (seconds) Standard Deviation 0.050

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Changes from Baseline in Respiratory Rate.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Vital Signs. - Respiratory Rate (Breaths Per Minute) Baseline Value	16.3 breaths/minute Standard Deviation 0.70	16.0 breaths/minute Standard Deviation 0.00
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 4	0 breaths/minute Standard Deviation 0	0.2 breaths/minute Standard Deviation 0.67
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 8	0.1 breaths/minute Standard Deviation 1.19	0.2 breaths/minute Standard Deviation 0.67
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 16	-0.1 breaths/minute Standard Deviation 0.52	0.0 breaths/minute Standard Deviation 0.0
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 24	0.1 breaths/minute Standard Deviation 0.92	0.4 breaths/minute Standard Deviation 0.88
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 32	0.7 breaths/minute Standard Deviation 0.98	0.7 breaths/minute Standard Deviation 1.00
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 42	0.4 breaths/minute Standard Deviation 1.12	0.4 breaths/minute Standard Deviation 0.88
Vital Signs. - Respiratory Rate (Breaths Per Minute) Week 52	0.3 breaths/minute Standard Deviation 0.70	0.7 breaths/minute Standard Deviation 1.00

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Change from baseline in Heart Rate.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Vital Signs. - Heart Rate (Beats Per Minute) Baseline Value	70.7 beats/minute Standard Deviation 10.80	69.8 beats/minute Standard Deviation 9.61
Vital Signs. - Heart Rate (Beats Per Minute) Week 4	-1.3 beats/minute Standard Deviation 6.27	1.9 beats/minute Standard Deviation 8.72
Vital Signs. - Heart Rate (Beats Per Minute) Week 8	-2.1 beats/minute Standard Deviation 6.46	0.4 beats/minute Standard Deviation 4.36
Vital Signs. - Heart Rate (Beats Per Minute) Week 16	-2.1 beats/minute Standard Deviation 8.46	3.4 beats/minute Standard Deviation 13.18
Vital Signs. - Heart Rate (Beats Per Minute) Week 24	4.3 beats/minute Standard Deviation 9.30	1.1 beats/minute Standard Deviation 6.95
Vital Signs. - Heart Rate (Beats Per Minute) Week 32	3.8 beats/minute Standard Deviation 6.61	1.7 beats/minute Standard Deviation 3.77
Vital Signs. - Heart Rate (Beats Per Minute) Week 42	3.5 beats/minute Standard Deviation 6.22	-0.3 beats/minute Standard Deviation 7.68
Vital Signs. - Heart Rate (Beats Per Minute) Week 52	5.3 beats/minute Standard Deviation 10.54	0.7 beats/minute Standard Deviation 4.21

PRIMARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Change from baseline in Body Temperature.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Vital Signs. - Body Temperature (Celsius ) Week 32	0.12 Celsius Standard Deviation 0.334	0.11 Celsius Standard Deviation 0.330
Vital Signs. - Body Temperature (Celsius ) Week 42	0.13 Celsius Standard Deviation 0.324	-0.06 Celsius Standard Deviation 0.350
Vital Signs. - Body Temperature (Celsius ) Baseline Value	36.59 Celsius Standard Deviation 0.245	36.54 Celsius Standard Deviation 0.133
Vital Signs. - Body Temperature (Celsius ) Week 4	0.09 Celsius Standard Deviation 0.351	-0.03 Celsius Standard Deviation 0.194
Vital Signs. - Body Temperature (Celsius ) Week 8	-0.02 Celsius Standard Deviation 0.288	-0.11 Celsius Standard Deviation 0.232
Vital Signs. - Body Temperature (Celsius ) Week 16	0.09 Celsius Standard Deviation 0.275	-0.01 Celsius Standard Deviation 0.247
Vital Signs. - Body Temperature (Celsius ) Week 24	0.05 Celsius Standard Deviation 0.409	-0.07 Celsius Standard Deviation 0.316
Vital Signs. - Body Temperature (Celsius ) Week 52	0.05 Celsius Standard Deviation 0.342	0.03 Celsius Standard Deviation 0.296

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in MDS-UPDRS Part I. Baseline Value	8.73 score on a scale (52 points total) Standard Deviation 5.95	6.78 score on a scale (52 points total) Standard Deviation 4.94
Change From Baseline in MDS-UPDRS Part I. Week 4	-1.47 score on a scale (52 points total) Standard Deviation 2.50	0.33 score on a scale (52 points total) Standard Deviation 2.83
Change From Baseline in MDS-UPDRS Part I. Week 8	-1.67 score on a scale (52 points total) Standard Deviation 3.02	-0.33 score on a scale (52 points total) Standard Deviation 2.96
Change From Baseline in MDS-UPDRS Part I. Week 16	-2.53 score on a scale (52 points total) Standard Deviation 3.80	0.33 score on a scale (52 points total) Standard Deviation 2.92
Change From Baseline in MDS-UPDRS Part I. Week 24	-1.40 score on a scale (52 points total) Standard Deviation 3.94	0.22 score on a scale (52 points total) Standard Deviation 3.11
Change From Baseline in MDS-UPDRS Part I. Week 32	-2.07 score on a scale (52 points total) Standard Deviation 4.11	-0.33 score on a scale (52 points total) Standard Deviation 3.67
Change From Baseline in MDS-UPDRS Part I. Week 42	-0.87 score on a scale (52 points total) Standard Deviation 4.26	1.56 score on a scale (52 points total) Standard Deviation 3.75
Change From Baseline in MDS-UPDRS Part I. Week 52	-0.47 score on a scale (52 points total) Standard Deviation 4.27	0.78 score on a scale (52 points total) Standard Deviation 4.15

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part III tests "Motor examination". Motor Examination includes speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in MDS-UPDRS Part III. Baseline Value	26.27 score on a scale (132 points total) Standard Deviation 12.76	20.56 score on a scale (132 points total) Standard Deviation 8.35
Change From Baseline in MDS-UPDRS Part III. Week 4	-5.33 score on a scale (132 points total) Standard Deviation 8.72	-0.33 score on a scale (132 points total) Standard Deviation 10.74
Change From Baseline in MDS-UPDRS Part III. Week 8	-8.33 score on a scale (132 points total) Standard Deviation 12.73	-1.78 score on a scale (132 points total) Standard Deviation 9.85
Change From Baseline in MDS-UPDRS Part III. Week 16	-8.13 score on a scale (132 points total) Standard Deviation 13.52	-0.22 score on a scale (132 points total) Standard Deviation 11.63
Change From Baseline in MDS-UPDRS Part III. Week 24	-10.07 score on a scale (132 points total) Standard Deviation 16.50	-2.78 score on a scale (132 points total) Standard Deviation 12.25
Change From Baseline in MDS-UPDRS Part III. Week 32	-11.27 score on a scale (132 points total) Standard Deviation 13.82	-4.33 score on a scale (132 points total) Standard Deviation 8.93
Change From Baseline in MDS-UPDRS Part III. Week 42	-8.47 score on a scale (132 points total) Standard Deviation 15.25	-3.56 score on a scale (132 points total) Standard Deviation 11.28
Change From Baseline in MDS-UPDRS Part III. Week 52	-9.07 score on a scale (132 points total) Standard Deviation 14.23	-4.11 score on a scale (132 points total) Standard Deviation 6.31

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in MDS-UPDRS Part IV. Week 52	-1.07 score on a scale (24 points total) Standard Deviation 3.10	-1.67 score on a scale (24 points total) Standard Deviation 1.66
Change From Baseline in MDS-UPDRS Part IV. Baseline Value	2.67 score on a scale (24 points total) Standard Deviation 3.77	3.56 score on a scale (24 points total) Standard Deviation 2.30
Change From Baseline in MDS-UPDRS Part IV. Week 4	-0.67 score on a scale (24 points total) Standard Deviation 2.19	-0.33 score on a scale (24 points total) Standard Deviation 1.94
Change From Baseline in MDS-UPDRS Part IV. Week 8	-0.87 score on a scale (24 points total) Standard Deviation 1.51	-0.44 score on a scale (24 points total) Standard Deviation 2.46
Change From Baseline in MDS-UPDRS Part IV. Week 16	-1.00 score on a scale (24 points total) Standard Deviation 1.93	-1.00 score on a scale (24 points total) Standard Deviation 1.94
Change From Baseline in MDS-UPDRS Part IV. Week 24	-1.87 score on a scale (24 points total) Standard Deviation 2.88	0.00 score on a scale (24 points total) Standard Deviation 2.00
Change From Baseline in MDS-UPDRS Part IV. Week 32	-2.20 score on a scale (24 points total) Standard Deviation 3.28	-0.67 score on a scale (24 points total) Standard Deviation 2.45
Change From Baseline in MDS-UPDRS Part IV. Week 42	-0.80 score on a scale (24 points total) Standard Deviation 2.01	-1.11 score on a scale (24 points total) Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Communication Week 16	0.67 score on a scale (25 points total) Standard Deviation 1.45	1.56 score on a scale (25 points total) Standard Deviation 4.69
Change From Baseline in Neuro-QOL. - Communication Baseline Value	22.87 score on a scale (25 points total) Standard Deviation 2.83	21.78 score on a scale (25 points total) Standard Deviation 4.55
Change From Baseline in Neuro-QOL. - Communication Week 4	0.40 score on a scale (25 points total) Standard Deviation 0.83	2.00 score on a scale (25 points total) Standard Deviation 4.66
Change From Baseline in Neuro-QOL. - Communication Week 8	0.53 score on a scale (25 points total) Standard Deviation 1.92	1.33 score on a scale (25 points total) Standard Deviation 2.92
Change From Baseline in Neuro-QOL. - Communication Week 24	0.00 score on a scale (25 points total) Standard Deviation 0.85	1.89 score on a scale (25 points total) Standard Deviation 4.31
Change From Baseline in Neuro-QOL. - Communication Week 32	0.27 score on a scale (25 points total) Standard Deviation 1.22	1.89 score on a scale (25 points total) Standard Deviation 4.59
Change From Baseline in Neuro-QOL. - Communication Week 42	0.00 score on a scale (25 points total) Standard Deviation 0.76	1.78 score on a scale (25 points total) Standard Deviation 4.68
Change From Baseline in Neuro-QOL. - Communication Week 52	-0.60 score on a scale (25 points total) Standard Deviation 2.67	1.00 score on a scale (25 points total) Standard Deviation 4.61

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Ability to Participate in Social Roles and Activities" short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Social Roles and Activities Baseline Value	36.00 score on a scale (40 points total) Standard Deviation 4.68	35.22 score on a scale (40 points total) Standard Deviation 5.14
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 4	0.93 score on a scale (40 points total) Standard Deviation 2.62	1.00 score on a scale (40 points total) Standard Deviation 5.15
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 8	0.47 score on a scale (40 points total) Standard Deviation 3.04	1.22 score on a scale (40 points total) Standard Deviation 5.38
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 16	1.73 score on a scale (40 points total) Standard Deviation 4.13	0.56 score on a scale (40 points total) Standard Deviation 6.84
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 24	-2.27 score on a scale (40 points total) Standard Deviation 8.03	2.33 score on a scale (40 points total) Standard Deviation 6.26
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 32	-0.40 score on a scale (40 points total) Standard Deviation 2.69	0.78 score on a scale (40 points total) Standard Deviation 5.12
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 42	0.13 score on a scale (40 points total) Standard Deviation 4.70	0.56 score on a scale (40 points total) Standard Deviation 6.44
Change From Baseline in Neuro-QOL. - Social Roles and Activities Week 52	-1.93 score on a scale (40 points total) Standard Deviation 7.16	0.33 score on a scale (40 points total) Standard Deviation 7.09

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Anxiety" short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Changes From Baseline in Neuro-QOL. - Anxiety Baseline Value	17.87 score on a scale (40 points total) Standard Deviation 6.51	14.11 score on a scale (40 points total) Standard Deviation 4.11
Changes From Baseline in Neuro-QOL. - Anxiety Week 4	-1.40 score on a scale (40 points total) Standard Deviation 3.74	-1.00 score on a scale (40 points total) Standard Deviation 2.60
Changes From Baseline in Neuro-QOL. - Anxiety Week 8	-2.40 score on a scale (40 points total) Standard Deviation 2.35	-1.44 score on a scale (40 points total) Standard Deviation 2.92
Changes From Baseline in Neuro-QOL. - Anxiety Week 16	-3.07 score on a scale (40 points total) Standard Deviation 4.22	-0.22 score on a scale (40 points total) Standard Deviation 4.38
Changes From Baseline in Neuro-QOL. - Anxiety Week 24	-2.33 score on a scale (40 points total) Standard Deviation 5.45	-1.67 score on a scale (40 points total) Standard Deviation 3.57
Changes From Baseline in Neuro-QOL. - Anxiety Week 32	-1.80 score on a scale (40 points total) Standard Deviation 5.10	-1.44 score on a scale (40 points total) Standard Deviation 4.50
Changes From Baseline in Neuro-QOL. - Anxiety Week 42	-2.07 score on a scale (40 points total) Standard Deviation 5.68	-2.00 score on a scale (40 points total) Standard Deviation 4.06
Changes From Baseline in Neuro-QOL. - Anxiety Week 52	-2.00 score on a scale (40 points total) Standard Deviation 4.36	-1.56 score on a scale (40 points total) Standard Deviation 3.84

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Depression" short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Depression Baseline Value	12.40 score on a scale (40 points total) Standard Deviation 4.81	9.89 score on a scale (40 points total) Standard Deviation 2.26
Change From Baseline in Neuro-QOL. - Depression Week 4	-2.27 score on a scale (40 points total) Standard Deviation 3.39	0.11 score on a scale (40 points total) Standard Deviation 2.15
Change From Baseline in Neuro-QOL. - Depression Week 8	-2.00 score on a scale (40 points total) Standard Deviation 3.44	-0.11 score on a scale (40 points total) Standard Deviation 3.26
Change From Baseline in Neuro-QOL. - Depression Week 16	-2.60 score on a scale (40 points total) Standard Deviation 3.36	0.44 score on a scale (40 points total) Standard Deviation 1.24
Change From Baseline in Neuro-QOL. - Depression Week 24	-1.00 score on a scale (40 points total) Standard Deviation 5.44	0.00 score on a scale (40 points total) Standard Deviation 1.32
Change From Baseline in Neuro-QOL. - Depression Week 32	-1.47 score on a scale (40 points total) Standard Deviation 3.91	1.56 score on a scale (40 points total) Standard Deviation 3.97
Change From Baseline in Neuro-QOL. - Depression Week 42	-1.80 score on a scale (40 points total) Standard Deviation 4.97	0.11 score on a scale (40 points total) Standard Deviation 1.96
Change From Baseline in Neuro-QOL. - Depression Week 52	-1.40 score on a scale (40 points total) Standard Deviation 4.32	1.11 score on a scale (40 points total) Standard Deviation 2.98

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Dyscontrol" short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Dyscontrol Baseline Value	13.47 score on a scale (40 points total) Standard Deviation 5.36	10.89 score on a scale (40 points total) Standard Deviation 3.37
Change From Baseline in Neuro-QOL. - Dyscontrol Week 4	-0.33 score on a scale (40 points total) Standard Deviation 3.56	-0.11 score on a scale (40 points total) Standard Deviation 2.47
Change From Baseline in Neuro-QOL. - Dyscontrol Week 8	-1.07 score on a scale (40 points total) Standard Deviation 1.87	-0.67 score on a scale (40 points total) Standard Deviation 2.55
Change From Baseline in Neuro-QOL. - Dyscontrol Week 16	-1.67 score on a scale (40 points total) Standard Deviation 3.52	0.22 score on a scale (40 points total) Standard Deviation 3.70
Change From Baseline in Neuro-QOL. - Dyscontrol Week 24	-1.07 score on a scale (40 points total) Standard Deviation 2.99	-1.11 score on a scale (40 points total) Standard Deviation 2.20
Change From Baseline in Neuro-QOL. - Dyscontrol Week 32	0.20 score on a scale (40 points total) Standard Deviation 4.35	-0.78 score on a scale (40 points total) Standard Deviation 2.86
Change From Baseline in Neuro-QOL. - Dyscontrol Week 42	-0.73 score on a scale (40 points total) Standard Deviation 4.01	-0.78 score on a scale (40 points total) Standard Deviation 2.64
Change From Baseline in Neuro-QOL. - Dyscontrol Week 52	-0.93 score on a scale (40 points total) Standard Deviation 3.17	-0.78 score on a scale (40 points total) Standard Deviation 2.59

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Fatigue" short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Changes From Baseline in Neuro-QOL. - Fatigue Baseline Value	16.67 score on a scale (40 points total) Standard Deviation 7.90	14.11 score on a scale (40 points total) Standard Deviation 4.46
Changes From Baseline in Neuro-QOL. - Fatigue Week 4	-1.73 score on a scale (40 points total) Standard Deviation 3.10	0.11 score on a scale (40 points total) Standard Deviation 3.69
Changes From Baseline in Neuro-QOL. - Fatigue Week 8	-1.67 score on a scale (40 points total) Standard Deviation 3.46	-1.11 score on a scale (40 points total) Standard Deviation 4.86
Changes From Baseline in Neuro-QOL. - Fatigue Week 16	-2.40 score on a scale (40 points total) Standard Deviation 4.75	1.67 score on a scale (40 points total) Standard Deviation 5.63
Changes From Baseline in Neuro-QOL. - Fatigue Week 24	-1.13 score on a scale (40 points total) Standard Deviation 6.24	0.33 score on a scale (40 points total) Standard Deviation 4.82
Changes From Baseline in Neuro-QOL. - Fatigue Week 32	-2.00 score on a scale (40 points total) Standard Deviation 4.99	0.11 score on a scale (40 points total) Standard Deviation 7.17
Changes From Baseline in Neuro-QOL. - Fatigue Week 42	-0.93 score on a scale (40 points total) Standard Deviation 6.09	-0.33 score on a scale (40 points total) Standard Deviation 5.85
Changes From Baseline in Neuro-QOL. - Fatigue Week 52	1.47 score on a scale (40 points total) Standard Deviation 5.04	0.67 score on a scale (40 points total) Standard Deviation 5.89

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Mobility" short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Mobility Baseline Value	37.00 score on a scale (40 points total) Standard Deviation 3.09	38.22 score on a scale (40 points total) Standard Deviation 3.11
Change From Baseline in Neuro-QOL. - Mobility Week 4	-0.53 score on a scale (40 points total) Standard Deviation 1.88	0.33 score on a scale (40 points total) Standard Deviation 3.08
Change From Baseline in Neuro-QOL. - Mobility Week 8	-0.33 score on a scale (40 points total) Standard Deviation 3.46	0.22 score on a scale (40 points total) Standard Deviation 2.68
Change From Baseline in Neuro-QOL. - Mobility Week 16	0.53 score on a scale (40 points total) Standard Deviation 3.50	1.22 score on a scale (40 points total) Standard Deviation 2.91
Change From Baseline in Neuro-QOL. - Mobility Week 24	0.13 score on a scale (40 points total) Standard Deviation 3.14	0.11 score on a scale (40 points total) Standard Deviation 3.98
Change From Baseline in Neuro-QOL. - Mobility Week 32	-0.07 score on a scale (40 points total) Standard Deviation 2.79	-0.33 score on a scale (40 points total) Standard Deviation 4.50
Change From Baseline in Neuro-QOL. - Mobility Week 42	-0.53 score on a scale (40 points total) Standard Deviation 2.88	-0.33 score on a scale (40 points total) Standard Deviation 3.43
Change From Baseline in Neuro-QOL. - Mobility Week 52	-1.67 score on a scale (40 points total) Standard Deviation 5.00	-0.67 score on a scale (40 points total) Standard Deviation 2.96

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Positive Affect and Well-Being" short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Well-Being Baseline Value	36.87 score on a scale (45 points total) Standard Deviation 5.22	39.00 score on a scale (45 points total) Standard Deviation 4.39
Change From Baseline in Neuro-QOL. - Well-Being Week 4	3.00 score on a scale (45 points total) Standard Deviation 3.23	-1.22 score on a scale (45 points total) Standard Deviation 5.21
Change From Baseline in Neuro-QOL. - Well-Being Week 8	2.73 score on a scale (45 points total) Standard Deviation 2.94	0.33 score on a scale (45 points total) Standard Deviation 5.05
Change From Baseline in Neuro-QOL. - Well-Being Week 16	4.33 score on a scale (45 points total) Standard Deviation 5.05	-0.44 score on a scale (45 points total) Standard Deviation 4.33
Change From Baseline in Neuro-QOL. - Well-Being Week 24	0.80 score on a scale (45 points total) Standard Deviation 4.63	1.00 score on a scale (45 points total) Standard Deviation 5.57
Change From Baseline in Neuro-QOL. - Well-Being Week 32	1.67 score on a scale (45 points total) Standard Deviation 3.89	-1.89 score on a scale (45 points total) Standard Deviation 5.53
Change From Baseline in Neuro-QOL. - Well-Being Week 42	1.67 score on a scale (45 points total) Standard Deviation 5.60	0.00 score on a scale (45 points total) Standard Deviation 4.50
Change From Baseline in Neuro-QOL. - Well-Being Week 52	2.67 score on a scale (45 points total) Standard Deviation 4.42	-1.78 score on a scale (45 points total) Standard Deviation 8.97

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Sleep disturbance" short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Sleep Baseline Value	16.20 score on a scale (40 points total) Standard Deviation 6.32	14.33 score on a scale (40 points total) Standard Deviation 4.74
Change From Baseline in Neuro-QOL. - Sleep Week 4	-2.33 score on a scale (40 points total) Standard Deviation 4.45	-1.89 score on a scale (40 points total) Standard Deviation 2.98
Change From Baseline in Neuro-QOL. - Sleep Week 8	-1.73 score on a scale (40 points total) Standard Deviation 5.27	-1.89 score on a scale (40 points total) Standard Deviation 3.55
Change From Baseline in Neuro-QOL. - Sleep Week 16	-2.60 score on a scale (40 points total) Standard Deviation 5.74	-0.11 score on a scale (40 points total) Standard Deviation 3.86
Change From Baseline in Neuro-QOL. - Sleep Week 24	-3.27 score on a scale (40 points total) Standard Deviation 5.50	-1.22 score on a scale (40 points total) Standard Deviation 3.87
Change From Baseline in Neuro-QOL. - Sleep Week 32	-3.00 score on a scale (40 points total) Standard Deviation 5.73	-2.33 score on a scale (40 points total) Standard Deviation 4.95
Change From Baseline in Neuro-QOL. - Sleep Week 42	-1.93 score on a scale (40 points total) Standard Deviation 6.12	-1.22 score on a scale (40 points total) Standard Deviation 5.38
Change From Baseline in Neuro-QOL. - Sleep Week 52	-1.93 score on a scale (40 points total) Standard Deviation 5.04	-1.67 score on a scale (40 points total) Standard Deviation 5.41

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Upper Extremity Function (Fine Motor, ADL)" short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Fine Motor Baseline Value	36.07 score on a scale (40 points total) Standard Deviation 4.37	37.33 score on a scale (40 points total) Standard Deviation 2.65
Change From Baseline in Neuro-QOL. - Fine Motor Week 4	0.80 score on a scale (40 points total) Standard Deviation 2.11	1.67 score on a scale (40 points total) Standard Deviation 2.50
Change From Baseline in Neuro-QOL. - Fine Motor Week 8	0.47 score on a scale (40 points total) Standard Deviation 1.68	1.11 score on a scale (40 points total) Standard Deviation 1.69
Change From Baseline in Neuro-QOL. - Fine Motor Week 16	1.93 score on a scale (40 points total) Standard Deviation 3.10	0.78 score on a scale (40 points total) Standard Deviation 2.17
Change From Baseline in Neuro-QOL. - Fine Motor Week 24	0.87 score on a scale (40 points total) Standard Deviation 2.33	1.22 score on a scale (40 points total) Standard Deviation 1.48
Change From Baseline in Neuro-QOL. - Fine Motor Week 32	0.40 score on a scale (40 points total) Standard Deviation 2.56	0.56 score on a scale (40 points total) Standard Deviation 1.42
Change From Baseline in Neuro-QOL. - Fine Motor Week 42	-0.60 score on a scale (40 points total) Standard Deviation 4.14	0.44 score on a scale (40 points total) Standard Deviation 1.42
Change From Baseline in Neuro-QOL. - Fine Motor Week 52	-0.53 score on a scale (40 points total) Standard Deviation 3.09	0.67 score on a scale (40 points total) Standard Deviation 1.50

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Stigma" short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Stigma Baseline Value	12.33 score on a scale (40 points total) Standard Deviation 4.48	12.00 score on a scale (40 points total) Standard Deviation 3.87
Change From Baseline in Neuro-QOL. - Stigma Week 4	-1.20 score on a scale (40 points total) Standard Deviation 3.71	-1.22 score on a scale (40 points total) Standard Deviation 2.82
Change From Baseline in Neuro-QOL. - Stigma Week 8	-0.67 score on a scale (40 points total) Standard Deviation 3.75	-1.44 score on a scale (40 points total) Standard Deviation 2.46
Change From Baseline in Neuro-QOL. - Stigma Week 16	-1.27 score on a scale (40 points total) Standard Deviation 3.49	-0.33 score on a scale (40 points total) Standard Deviation 2.92
Change From Baseline in Neuro-QOL. - Stigma Week 24	-1.40 score on a scale (40 points total) Standard Deviation 3.52	-1.22 score on a scale (40 points total) Standard Deviation 2.49
Change From Baseline in Neuro-QOL. - Stigma Week 32	-0.67 score on a scale (40 points total) Standard Deviation 3.75	-0.89 score on a scale (40 points total) Standard Deviation 1.36
Change From Baseline in Neuro-QOL. - Stigma Week 42	-1.87 score on a scale (40 points total) Standard Deviation 3.89	-0.56 score on a scale (40 points total) Standard Deviation 1.81
Change From Baseline in Neuro-QOL. - Stigma Week 52	-0.93 score on a scale (40 points total) Standard Deviation 3.84	-1.89 score on a scale (40 points total) Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Satisfaction with Social Roles and Activities" short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Social Roles Baseline Value	30.47 score on a scale (40 points total) Standard Deviation 5.68	33.78 score on a scale (40 points total) Standard Deviation 5.31
Change From Baseline in Neuro-QOL. - Social Roles Week 4	3.27 score on a scale (40 points total) Standard Deviation 7.39	1.22 score on a scale (40 points total) Standard Deviation 4.71
Change From Baseline in Neuro-QOL. - Social Roles Week 8	2.87 score on a scale (40 points total) Standard Deviation 6.57	1.89 score on a scale (40 points total) Standard Deviation 4.99
Change From Baseline in Neuro-QOL. - Social Roles Week 16	3.87 score on a scale (40 points total) Standard Deviation 8.74	-0.44 score on a scale (40 points total) Standard Deviation 8.16
Change From Baseline in Neuro-QOL. - Social Roles Week 24	2.27 score on a scale (40 points total) Standard Deviation 6.31	-1.67 score on a scale (40 points total) Standard Deviation 7.81
Change From Baseline in Neuro-QOL. - Social Roles Week 32	1.53 score on a scale (40 points total) Standard Deviation 8.42	1.56 score on a scale (40 points total) Standard Deviation 3.68
Change From Baseline in Neuro-QOL. - Social Roles Week 42	1.53 score on a scale (40 points total) Standard Deviation 9.03	1.67 score on a scale (40 points total) Standard Deviation 4.66
Change From Baseline in Neuro-QOL. - Social Roles Week 52	1.20 score on a scale (40 points total) Standard Deviation 6.65	0.44 score on a scale (40 points total) Standard Deviation 3.64

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Cognition Function" short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Neuro-QOL. - Cognition Baseline Value	33.47 score on a scale (40 points total) Standard Deviation 6.21	33.67 score on a scale (40 points total) Standard Deviation 5.68
Change From Baseline in Neuro-QOL. - Cognition Week 4	2.53 score on a scale (40 points total) Standard Deviation 3.29	1.44 score on a scale (40 points total) Standard Deviation 2.55
Change From Baseline in Neuro-QOL. - Cognition Week 8	1.33 score on a scale (40 points total) Standard Deviation 3.74	0.89 score on a scale (40 points total) Standard Deviation 2.89
Change From Baseline in Neuro-QOL. - Cognition Week 16	2.80 score on a scale (40 points total) Standard Deviation 5.05	1.00 score on a scale (40 points total) Standard Deviation 2.18
Change From Baseline in Neuro-QOL. - Cognition Week 24	2.87 score on a scale (40 points total) Standard Deviation 4.98	2.00 score on a scale (40 points total) Standard Deviation 3.04
Change From Baseline in Neuro-QOL. - Cognition Week 32	0.73 score on a scale (40 points total) Standard Deviation 7.46	2.44 score on a scale (40 points total) Standard Deviation 3.88
Change From Baseline in Neuro-QOL. - Cognition Week 42	0.87 score on a scale (40 points total) Standard Deviation 5.91	2.44 score on a scale (40 points total) Standard Deviation 4.33
Change From Baseline in Neuro-QOL. - Cognition Week 52	0.47 score on a scale (40 points total) Standard Deviation 7.12	1.56 score on a scale (40 points total) Standard Deviation 4.36

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as "strongly disagree", "disagree", "do not agree or disagree", "agree", and "strongly agree", which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Baseline Value	37.20 score on a scale (80 points total) Standard Deviation 18.18	34.11 score on a scale (80 points total) Standard Deviation 15.21
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 4	-0.73 score on a scale (80 points total) Standard Deviation 10.59	-8.33 score on a scale (80 points total) Standard Deviation 9.46
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 8	0.20 score on a scale (80 points total) Standard Deviation 5.23	-4.33 score on a scale (80 points total) Standard Deviation 12.25
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 16	-3.40 score on a scale (80 points total) Standard Deviation 7.70	-2.33 score on a scale (80 points total) Standard Deviation 9.79
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 24	-2.33 score on a scale (80 points total) Standard Deviation 10.38	-4.11 score on a scale (80 points total) Standard Deviation 8.45
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 32	-3.00 score on a scale (80 points total) Standard Deviation 12.58	-3.56 score on a scale (80 points total) Standard Deviation 12.08
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 42	-1.00 score on a scale (80 points total) Standard Deviation 11.43	-4.11 score on a scale (80 points total) Standard Deviation 8.34
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16). Week 52	2.67 score on a scale (80 points total) Standard Deviation 5.29	-2.89 score on a scale (80 points total) Standard Deviation 11.77

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Baseline Value	28.13 score on a scale (100 points total) Standard Deviation 20.20	18.67 score on a scale (100 points total) Standard Deviation 12.18
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 4	-4.87 score on a scale (100 points total) Standard Deviation 10.03	-2.78 score on a scale (100 points total) Standard Deviation 8.71
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 8	-4.67 score on a scale (100 points total) Standard Deviation 14.36	-4.33 score on a scale (100 points total) Standard Deviation 12.49
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 16	-6.60 score on a scale (100 points total) Standard Deviation 14.25	-0.11 score on a scale (100 points total) Standard Deviation 14.34
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 24	-7.07 score on a scale (100 points total) Standard Deviation 13.25	0.11 score on a scale (100 points total) Standard Deviation 14.38
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 32	-6.93 score on a scale (100 points total) Standard Deviation 12.48	-2.67 score on a scale (100 points total) Standard Deviation 9.75
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 42	-4.93 score on a scale (100 points total) Standard Deviation 13.41	-2.33 score on a scale (100 points total) Standard Deviation 12.76
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39). Week 52	-0.33 score on a scale (100 points total) Standard Deviation 16.60	0.33 score on a scale (100 points total) Standard Deviation 12.31

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the "no muscle spasm" anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Total Visual Analog Scale Baseline Value	35.93 score on a scale (200 points total) Standard Deviation 37.75	19.89 score on a scale (200 points total) Standard Deviation 21.80
Change From Baseline in Total Visual Analog Scale Week 4	-5.33 score on a scale (200 points total) Standard Deviation 32.87	2.89 score on a scale (200 points total) Standard Deviation 16.80
Change From Baseline in Total Visual Analog Scale Week 8	-8.27 score on a scale (200 points total) Standard Deviation 10.92	-3.33 score on a scale (200 points total) Standard Deviation 10.69
Change From Baseline in Total Visual Analog Scale Week 16	-3.53 score on a scale (200 points total) Standard Deviation 20.78	16.11 score on a scale (200 points total) Standard Deviation 68.18
Change From Baseline in Total Visual Analog Scale Week 24	-11.0 score on a scale (200 points total) Standard Deviation 37.63	6.78 score on a scale (200 points total) Standard Deviation 29.85
Change From Baseline in Total Visual Analog Scale Week 32	-15.13 score on a scale (200 points total) Standard Deviation 37.05	9.22 score on a scale (200 points total) Standard Deviation 34.82
Change From Baseline in Total Visual Analog Scale Week 42	-7.80 score on a scale (200 points total) Standard Deviation 31.93	9.89 score on a scale (200 points total) Standard Deviation 22.65
Change From Baseline in Total Visual Analog Scale Week 52	-6.73 score on a scale (200 points total) Standard Deviation 21.53	-10.00 score on a scale (200 points total) Standard Deviation 16.41

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Dosage of medications.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Dosage of Carbidopa/Levodopa Week 24	0 mg Standard Deviation 0	11.1 mg Standard Deviation 33.33
Change From Baseline in Dosage of Carbidopa/Levodopa Week 32	0 mg Standard Deviation 0	11.1 mg Standard Deviation 33.33
Change From Baseline in Dosage of Carbidopa/Levodopa Baseline Value	439.3 mg Standard Deviation 599.96	285.6 mg Standard Deviation 273.92
Change From Baseline in Dosage of Carbidopa/Levodopa Week 4	0 mg Standard Deviation 0	0 mg Standard Deviation 0
Change From Baseline in Dosage of Carbidopa/Levodopa Week 8	0 mg Standard Deviation 0	0 mg Standard Deviation 0
Change From Baseline in Dosage of Carbidopa/Levodopa Week 16	20. mg Standard Deviation 77.46	11.1 mg Standard Deviation 33.33
Change From Baseline in Dosage of Carbidopa/Levodopa Week 42	0 mg Standard Deviation 0	36.1 mg Standard Deviation 54.65
Change From Baseline in Dosage of Carbidopa/Levodopa Week 52	-10.0 mg Standard Deviation 89.04	47.2 mg Standard Deviation 75.46

SECONDARY outcome

Timeframe: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Changes in Oxygen Saturation.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Change From Baseline in Vital Signs. - Oxygen Saturation. Baseline Value	97.8 percent of oxygen Standard Deviation 1.01	97.6 percent of oxygen Standard Deviation 1.74
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 4	-0.2 percent of oxygen Standard Deviation 2.14	-1.0 percent of oxygen Standard Deviation 2.65
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 8	0.2 percent of oxygen Standard Deviation 1.08	0.6 percent of oxygen Standard Deviation 1.42
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 16	0.1 percent of oxygen Standard Deviation 0.88	-0.2 percent of oxygen Standard Deviation 1.72
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 24	-0.5 percent of oxygen Standard Deviation 0.83	0.1 percent of oxygen Standard Deviation 1.05
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 32	-0.3 percent of oxygen Standard Deviation 0.82	0.3 percent of oxygen Standard Deviation 1.73
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 42	-0.6 percent of oxygen Standard Deviation 1.18	0.0 percent of oxygen Standard Deviation 1.41
Change From Baseline in Vital Signs. - Oxygen Saturation. Week 52	-0.7 percent of oxygen Standard Deviation 1.50	0.3 percent of oxygen Standard Deviation 1.00

Adverse Events

HB-adMSCs

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HB-adMSCs n=15 participants at risk Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 participants at risk Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)

Other adverse events

Additional Information

Ridhima Vij, PhD

Hope Biosciences Research Foundation

Phone: 346-900-0340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	HB-adMSCs n=15 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 Participants Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Laboratory Values. CBC (% of WBC) Basophils (%) Baseline Value	0.73 % of white blood cell count Standard Deviation 0.947	0.87 % of white blood cell count Standard Deviation 0.752
Laboratory Values. CBC (% of WBC) Basophils (%) Week 24	0.05 % of white blood cell count Standard Deviation 1.196	0.27 % of white blood cell count Standard Deviation 0.994
Laboratory Values. CBC (% of WBC) Basophils (%) Week 52	0.29 % of white blood cell count Standard Deviation 1.92	0.16 % of white blood cell count Standard Deviation 1.078
Laboratory Values. CBC (% of WBC) Eosinophils (%) Baseline Value	1.49 % of white blood cell count Standard Deviation 1.838	2.50 % of white blood cell count Standard Deviation 1.752
Laboratory Values. CBC (% of WBC) Eosinophils (%) Week 24	0.24 % of white blood cell count Standard Deviation 1.962	0.03 % of white blood cell count Standard Deviation 2.492
Laboratory Values. CBC (% of WBC) Eosinophils (%) Week 52	-0.03 % of white blood cell count Standard Deviation 1.649	-0.18 % of white blood cell count Standard Deviation 2.080
Laboratory Values. CBC (% of WBC) Lymphocytes (%) Baseline Value	32.35 % of white blood cell count Standard Deviation 7.020	33.33 % of white blood cell count Standard Deviation 9.462
Laboratory Values. CBC (% of WBC) Lymphocytes (%) Week 24	0.13 % of white blood cell count Standard Deviation 9.277	-0.51 % of white blood cell count Standard Deviation 5.113
Laboratory Values. CBC (% of WBC) Lymphocytes (%) Week 52	-0.06 % of white blood cell count Standard Deviation 6.194	-1.17 % of white blood cell count Standard Deviation 6.361
Laboratory Values. CBC (% of WBC) Monocytes (%) Baseline value	7.33 % of white blood cell count Standard Deviation 2.609	6.72 % of white blood cell count Standard Deviation 4.615
Laboratory Values. CBC (% of WBC) Monocytes (%) Week 24	-0.87 % of white blood cell count Standard Deviation 3.229	0.56 % of white blood cell count Standard Deviation 4.073
Laboratory Values. CBC (% of WBC) Monocytes (%) Week 52	-0.49 % of white blood cell count Standard Deviation 3.670	1.81 % of white blood cell count Standard Deviation 3.538
Laboratory Values. CBC (% of WBC) Neutrophils (%) Baseline Value	56.31 % of white blood cell count Standard Deviation 8.385	56.24 % of white blood cell count Standard Deviation 8.213
Laboratory Values. CBC (% of WBC) Neutrophils (%) Week 24	0.43 % of white blood cell count Standard Deviation 8.622	-0.34 % of white blood cell count Standard Deviation 8.259
Laboratory Values. CBC (% of WBC) Neutrophils (%) Week 52	0.29 % of white blood cell count Standard Deviation 7.828	-0.62 % of white blood cell count Standard Deviation 4.788

Measure	HB-adMSCs n=15 participants at risk Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).	Placebo n=9 participants at risk Six IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at visit 2, 6, and 9. MDS-Unified Parkinson's Disease Rating Scale questionnaires will be assessed at all visits (Visit 1 - 9).
Nervous system disorders Headache	33.3% 5/15 • Number of events 11 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 6 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Tremor	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	44.4% 4/9 • Number of events 6 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Balance Difficulty	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Dystonia	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Frozen Gait	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Migraine	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Near Syncope	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Neuralgia	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Nervous system disorders Sedation	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Fatigue	26.7% 4/15 • Number of events 5 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Influenza-like symptoms	13.3% 2/15 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Ankle edema	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Chills	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Drug Ineffective	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Feverish	6.7% 1/15 • Number of events 2 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Musculoskeletal and connective tissue disorders Muscle rigidity	13.3% 2/15 • Number of events 2 • Week 0 (Infusion 1) through Week 52 (End of Study)	33.3% 3/9 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)
General disorders Joint Pain	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Musculoskeletal and connective tissue disorders Limb Stiffness	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Musculoskeletal and connective tissue disorders Spasms	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Musculoskeletal and connective tissue disorders Stiff Neck	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Musculoskeletal and connective tissue disorders Swollen ankles	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Eye disorders Hazy Vision	13.3% 2/15 • Number of events 2 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Eye disorders Cataract	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Eye disorders Eyelid twitching	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Eye disorders Eyes heavy feeling of	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Infections and infestations COVID-19	20.0% 3/15 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Injury, poisoning and procedural complications Fall	13.3% 2/15 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Psychiatric disorders Insomnia	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Psychiatric disorders Mixed anxiety and depressive disorder	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Psychiatric disorders Suicidal ideation	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Skin and subcutaneous tissue disorders Psoriasis	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Vascular disorders Flushing	6.7% 1/15 • Number of events 3 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Vascular disorders Hypertension	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Gastrointestinal disorders Increased salivation	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Investigations COVID-19 virus test positive	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Metabolism and nutrition disorders Hypercholesterolemia	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Renal and urinary disorders Kidney Stone	0.00% 0/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	11.1% 1/9 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)
Surgical and medical procedures Eye laser surgery	6.7% 1/15 • Week 0 (Infusion 1) through Week 52 (End of Study)	0.00% 0/9 • Week 0 (Infusion 1) through Week 52 (End of Study)