Trial Outcomes & Findings for Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome (NCT NCT05126563)

Last Updated: 2025-09-26

Results Overview

Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

Baseline to Weeks 26

Results posted on

2025-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	HB-adMSCs HB-adMSCs (allogeneic): HB-adMSCs allogenic	Placebo Placebo: Placebo comarator
Overall Study STARTED	39	40
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic)	Placebo n=40 Participants Placebo comarator	Total n=79 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	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 10.90 • n=5 Participants	42.4 years STANDARD_DEVIATION 10.79 • n=7 Participants	41.5 years STANDARD_DEVIATION 10.81 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	31 Participants n=7 Participants	61 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	0 Participants n=5 Participants	2 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	39 participants n=5 Participants	40 participants n=7 Participants	79 participants n=5 Participants
Height	170.76 centimeter STANDARD_DEVIATION 7.917 • n=5 Participants	174.62 centimeter STANDARD_DEVIATION 9,992 • n=7 Participants	172.71 centimeter STANDARD_DEVIATION 9.177 • n=5 Participants
Weight	79.35 kilograms STANDARD_DEVIATION 19.229 • n=5 Participants	79.28 kilograms STANDARD_DEVIATION 15.197 • n=7 Participants	79.32 kilograms STANDARD_DEVIATION 17.193 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model)	-2.376 score on a scale (10 points total) Standard Error 0.496	-2.430 score on a scale (10 points total) Standard Error 0.529

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model)	-1.908 score on a scale (10 points total) Standard Error 0.462	-1.736 score on a scale (10 points total) Standard Error 0.493

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model)	-0.755 score on a scale (10 points total) Standard Error 0.348	-1.154 score on a scale (10 points total) Standard Error 0.371

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model)	-2.005 score on a scale (10 points total) Standard Error 0.486	-2.547 score on a scale (10 points total) Standard Error 0.518

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model)	-0.509 score on a scale (10 points total) Standard Error 0.314	-0.462 score on a scale (10 points total) Standard Error 0.335

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model)	-0.623 score on a scale (10 points total) Standard Error 0.241	-0.463 score on a scale (10 points total) Standard Error 0.258

PRIMARY outcome

Timeframe: Baseline to Week 26

Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) Infusion 4 (Week 10)	-2.010 score on a scale (10 points total) Standard Error 0.463	-2.018 score on a scale (10 points total) Standard Error 0.494
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) EOS (Week 26)	-2.330 score on a scale (10 points total) Standard Error 0.490	-2.492 score on a scale (10 points total) Standard Error 0.522
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) Infusion 2 (Week 2)	-1.010 score on a scale (10 points total) Standard Error 0.406	-0.772 score on a scale (10 points total) Standard Error 0.428
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) Infusion 3 (Week 6)	-1.214 score on a scale (10 points total) Standard Error 0.438	-1.439 score on a scale (10 points total) Standard Error 0.468

PRIMARY outcome

Timeframe: Baseline to Week 26

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) Infusion 2 (Week 2)	-1.134 score on a scale (10 points total) Standard Error 0.352	-0.944 score on a scale (10 points total) Standard Error 0.371
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) Infusion 3 (Week 6)	-1.425 score on a scale (10 points total) Standard Error 0.377	-0.837 score on a scale (10 points total) Standard Error 0.402
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) Infusion 4 (Week 10)	-2.281 score on a scale (10 points total) Standard Error 0.419	-1.532 score on a scale (10 points total) Standard Error 0.446
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) End of Study (Week 26)	-1.827 score on a scale (10 points total) Standard Error 0.467	-1.818 score on a scale (10 points total) Standard Error 0.497

PRIMARY outcome

Timeframe: Baseline to Week 26

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) Infusion 2 (Week 2)	-0.362 score on a scale (10 points total) Standard Error 0.400	-0.548 score on a scale (10 points total) Standard Error 0.422
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) Infusion 3 (Week 6)	-0.504 score on a scale (10 points total) Standard Error 0.388	-0.648 score on a scale (10 points total) Standard Error 0.414
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) Infusion 4 (Week 10)	-0.696 score on a scale (10 points total) Standard Error 0.385	-0.870 score on a scale (10 points total) Standard Error 0.411
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) End Of Study (Week 26)	-0.741 score on a scale (10 points total) Standard Error 0.346	-1.181 score on a scale (10 points total) Standard Error 0.369

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) Infusion 3 (Week 6)	-1.845 score on a scale (10 points total) Standard Error 0.462	-1.813 score on a scale (10 points total) Standard Error 0.492
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) Infusion 4 (Week 10)	-2.028 score on a scale (10 points total) Standard Error 0.466	-2.095 score on a scale (10 points total) Standard Error 0.497
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) End of Study (Week 26)	-2.016 score on a scale (10 points total) Standard Error 0.479	-2.551 score on a scale (10 points total) Standard Error 0.510
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) Infusion 2 (Week 2)	-1.331 score on a scale (10 points total) Standard Error 0.340	-0.730 score on a scale (10 points total) Standard Error 0.357

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) Infusion 2 (Week 2)	-0.450 score on a scale (10 points total) Standard Error 0.234	0.235 score on a scale (10 points total) Standard Error 0.247
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) Infusion 4 (Week 10)	-0.654 score on a scale (10 points total) Standard Error 0.339	-0.365 score on a scale (10 points total) Standard Error 0.362
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) End of Study (Week 26)	-0.569 score on a scale (10 points total) Standard Error 0.318	-0.408 score on a scale (10 points total) Standard Error 0.339
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) Infusion 3 (Week 6)	-0.372 score on a scale (10 points total) Standard Error 0.325	0.523 score on a scale (10 points total) Standard Error 0.346

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) Infusion 2 (Week 2)	-0.336 score on a scale (10 points total) Standard Error 0.273	0.617 score on a scale (10 points total) Standard Error 0.288
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) Infusion 3 (Week 6)	-0.112 score on a scale (10 points total) Standard Error 0.264	-0.013 score on a scale (10 points total) Standard Error 0.281
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) Infusion 4 (Week 10)	-0.678 score on a scale (10 points total) Standard Error 0.242	-0.196 score on a scale (10 points total) Standard Error 0.258
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) End Of Study (Week 26)	-0.653 score on a scale (10 points total) Standard Error 0.241	-0.438 score on a scale (10 points total) Standard Error 0.256

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in CBC values.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Basophils Baseline/Infusion 1 (Week 0)	0.0454 x10^3 cells/uL Standard Error 0.00531	0.0415 x10^3 cells/uL Standard Error 0.00315
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Basophils Infusion 4 (Week 10)	0.0017 x10^3 cells/uL Standard Error 0.00344	0.0047 x10^3 cells/uL Standard Error 0.00327
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Basophils End of Study (Week 26)	-0.0019 x10^3 cells/uL Standard Error 0.00407	0.0037 x10^3 cells/uL Standard Error 0.00344
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Eosinophils Baseline/Infusion 1 (Week 0)	0.1177 x10^3 cells/uL Standard Error 0.01258	0.1965 x10^3 cells/uL Standard Error 0.03371
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Eosinophils Infusion 4 (Week 10)	0.0006 x10^3 cells/uL Standard Error 0.00903	-0.0356 x10^3 cells/uL Standard Error 0.02410
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Eosinophils End of Study (Week 26)	0.0105 x10^3 cells/uL Standard Error 0.01051	-0.0373 x10^3 cells/uL Standard Error 0.03355
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Lymphocytes Baseline/Infusion 1 (Week 0)	1.9733 x10^3 cells/uL Standard Error 0.10847	1.8820 x10^3 cells/uL Standard Error 0.09517
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Lymphocytes Infusion 4 (Week 10)	-0.0623 x10^3 cells/uL Standard Error 0.07443	-0.0203 x10^3 cells/uL Standard Error 0.06454
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Lymphocytes End of Study (Week 26)	0.0851 x10^3 cells/uL Standard Error 0.09160	-0.0777 x10^3 cells/uL Standard Error 0.07055
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Monocytes Baseline/Infusion 1 (Week 0)	0.4877 x10^3 cells/uL Standard Error 0.02321	0.4663 x10^3 cells/uL Standard Error 0.01919
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Monocytes Infusion 4 (Week 10)	-0.0269 x10^3 cells/uL Standard Error 0.02181	0.0084 x10^3 cells/uL Standard Error 0.01992
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Monocytes End of Study (Week 26)	0.0324 x10^3 cells/uL Standard Error 0.02022	-0.0040 x10^3 cells/uL Standard Error 0.01791
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Neutrophils Baseline/Infusion 1 (Week 0)	3.4426 x10^3 cells/uL Standard Error 0.18489	3.2103 x10^3 cells/uL Standard Error 0.16672
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Neutrophils Infusion 4 (Week 10)	0.0900 x10^3 cells/uL Standard Error 0.29868	0.0591 x10^3 cells/uL Standard Error 0.15940
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Absolute Neutrophils End of Study (Week 26)	0.1785 x10^3 cells/uL Standard Error 0.19430	0.0883 x10^3 cells/uL Standard Error 0.15998
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Platelet Baseline/Infusion 1 (Week 0)	269.1 x10^3 cells/uL Standard Error 8.73	249.4 x10^3 cells/uL Standard Error 8.25
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Platelet Infusion 4 (Week 10)	-11.9 x10^3 cells/uL Standard Error 5.77	2.3 x10^3 cells/uL Standard Error 6.18
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) Platelet End of Study (Week 26)	-2.1 x10^3 cells/uL Standard Error 5.37	2.1 x10^3 cells/uL Standard Error 5.94
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) WBC Baseline/Infusion 1 (Week 0)	6.08 x10^3 cells/uL Standard Error 0.279	5.82 x10^3 cells/uL Standard Error 0.255
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) WBC Infusion 4 (Week 10)	0.01 x10^3 cells/uL Standard Error 0.311	0.02 x10^3 cells/uL Standard Error 0.188
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) WBC End of Study (Week 26)	0.30 x10^3 cells/uL Standard Error 0.261	-0.04 x10^3 cells/uL Standard Error 0.183

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in CBC values.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC. (% of WBC) Basophils Baseline/Infusion 1 (Week 0)	0.91 % of WBC Standard Error 0.135	1.07 % of WBC Standard Error 0.168
Changes in Laboratory Values. - CBC. (% of WBC) Basophils Infusion 4 (Week 10)	-0.21 % of WBC Standard Error 0.144	-0.08 % of WBC Standard Error 0.188
Changes in Laboratory Values. - CBC. (% of WBC) Basophils End of Study (Week 26)	-0.08 % of WBC Standard Error 0.197	0.02 % of WBC Standard Error 0.136
Changes in Laboratory Values. - CBC. (% of WBC) Eosinophils Baseline/Infusion 1 (Week 0)	1.99 % of WBC Standard Error 0.252	3.00 % of WBC Standard Error 0.468
Changes in Laboratory Values. - CBC. (% of WBC) Eosinophils Infusion 4 (Week 10)	-0.11 % of WBC Standard Error 0.243	-0.52 % of WBC Standard Error 0.461
Changes in Laboratory Values. - CBC. (% of WBC) Eosinophils End of Study (Week 26)	0.26 % of WBC Standard Error 0.326	-0.41 % of WBC Standard Error 0.421
Changes in Laboratory Values. - CBC. (% of WBC) Lymphocytes Baseline/Infusion 1 (Week 0)	34.29 % of WBC Standard Error 1.213	36.20 % of WBC Standard Error 1.239
Changes in Laboratory Values. - CBC. (% of WBC) Lymphocytes Infusion 4 (Week 10)	-0.49 % of WBC Standard Error 1.662	-1.46 % of WBC Standard Error 1.548
Changes in Laboratory Values. - CBC. (% of WBC) Lymphocytes End of Study (Week 26)	-0.56 % of WBC Standard Error 1.379	-3.25 % of WBC Standard Error 1.444
Changes in Laboratory Values. - CBC. (% of WBC) Monocytes End of Study (Week 26)	0.24 % of WBC Standard Error 0.642	0.54 % of WBC Standard Error 0.472
Changes in Laboratory Values. - CBC. (% of WBC) Neutrophils Baseline/Infusion 1 (Week 0)	54.95 % of WBC Standard Error 1.162	52.37 % of WBC Standard Error 1.508
Changes in Laboratory Values. - CBC. (% of WBC) Neutrophils Infusion 4 (Week 10)	1.05 % of WBC Standard Error 1.850	1.44 % of WBC Standard Error 2.131
Changes in Laboratory Values. - CBC. (% of WBC) Neutrophils End of Study (Week 26)	0.06 % of WBC Standard Error 1.681	3.03 % of WBC Standard Error 1.675
Changes in Laboratory Values. - CBC. (% of WBC) Monocytes Baseline/Infusion 1 (Week 0)	7.79 % of WBC Standard Error 0.545	7.27 % of WBC Standard Error 0.382
Changes in Laboratory Values. - CBC. (% of WBC) Monocytes Infusion 4 (Week 10)	-0.29 % of WBC Standard Error 0.426	0.61 % of WBC Standard Error 0.583

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

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

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (pg) MCH Baseline/Infusion 1 (Week 0)	30.40 pg Standard Error 0.242	30.64 pg Standard Error 0.226
Changes in Laboratory Values. - CBC (pg) MCH Infusion 4 (Week 10)	-0.00 pg Standard Error 0.134	-0.06 pg Standard Error 0.133
Changes in Laboratory Values. - CBC (pg) MCH End of Study (Week 26)	-0.06 pg Standard Error 0.169	-0.14 pg Standard Error 0.201

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

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

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (g/dL) MCHC Baseline/Infusion 1 (Week 0)	33.90 g/dL Standard Error 0.155	34.05 g/dL Standard Error 0.138
Changes in Laboratory Values. - CBC (g/dL) MCHC Infusion 4 (Week 10)	-0.05 g/dL Standard Error 0.143	0.04 g/dL Standard Error 0.185
Changes in Laboratory Values. - CBC (g/dL) MCHC End of Study (Week 26)	-0.24 g/dL Standard Error 0.160	-0.23 g/dL Standard Error 0.245
Changes in Laboratory Values. - CBC (g/dL) Hemoglobin Baseline/Infusion 1 (Week 0)	14.35 g/dL Standard Error 0.235	14.34 g/dL Standard Error 0.211
Changes in Laboratory Values. - CBC (g/dL) Hemoglobin Infusion 4 (Week 10)	-0.11 g/dL Standard Error 0.133	0.13 g/dL Standard Error 0.102
Changes in Laboratory Values. - CBC (g/dL) Hemoglobin End of Study (Week 26)	-0.13 g/dL Standard Error 0.131	0.13 g/dL Standard Error 0.158

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

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

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (fL) MCV Baseline/Infusion 1 (Week 0)	89.68 fL Standard Error 0.575	90.00 fL Standard Error 0.485
Changes in Laboratory Values. - CBC (fL) MCV Infusion 4 (Week 10)	0.14 fL Standard Error 0.204	-0.29 fL Standard Error 0.327
Changes in Laboratory Values. - CBC (fL) MCV End of Study (Week 26)	0.42 fL Standard Error 0.350	0.21 fL Standard Error 0.318

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Changes from baseline in CBC laboratory values with unit of 10\^6 cells/uL.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (x10^6 Cells/uL) RBC Baseline/Infusion 1 (Week 0)	4.729 10^6 cells/uL Standard Error 0.0822	4.690 10^6 cells/uL Standard Error 0.0804
Changes in Laboratory Values. - CBC (x10^6 Cells/uL) RBC Infusion 4 (Week 10)	-0.039 10^6 cells/uL Standard Error 0.0460	0.052 10^6 cells/uL Standard Error 0.0384
Changes in Laboratory Values. - CBC (x10^6 Cells/uL) RBC End of Study (Week 26)	-0.033 10^6 cells/uL Standard Error 0.0507	0.062 10^6 cells/uL Standard Error 0.0547

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) RDW Baseline/Infusion 1 (Week 0)	12.58 % difference in volume and size of RBC Standard Error 0.107	12.58 % difference in volume and size of RBC Standard Error 0.104
Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) RDW Infusion 4 (Week 10)	-0.03 % difference in volume and size of RBC Standard Error 0.071	-0.08 % difference in volume and size of RBC Standard Error 0.100
Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) RDW End of Study (Week 26)	0.01 % difference in volume and size of RBC Standard Error 0.096	0.01 % difference in volume and size of RBC Standard Error 0.060

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) Hematocrit Baseline/Infusion 1 (Week 0)	42.33 % of Total Blood Cell Count Standard Error 0.652	42.11 % of Total Blood Cell Count Standard Error 0.600
Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) Hematocrit Infusion 4 (Week 10)	-0.27 % of Total Blood Cell Count Standard Error 0.405	0.32 % of Total Blood Cell Count Standard Error 0.336
Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) Hematocrit End of Study (Week 26)	-0.11 % of Total Blood Cell Count Standard Error 0.444	0.64 % of Total Blood Cell Count Standard Error 0.443

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (g/dL) Albumin Baseline/Infusion 1 (Week 0)	4.65 g/dL Standard Error 0.052	4.63 g/dL Standard Error 0.045
Changes in Laboratory Values. - CMP (g/dL) Albumin Infusion 4 (Week 10)	-0.11 g/dL Standard Error 0.039	-0.02 g/dL Standard Error 0.044
Changes in Laboratory Values. - CMP (g/dL) Albumin End of Study (Week 26)	-0.13 g/dL Standard Error 0.039	-0.02 g/dL Standard Error 0.052
Changes in Laboratory Values. - CMP (g/dL) Calc Globulin Baseline/Infusion 1 (Week 0)	2.63 g/dL Standard Error 0.125	2.46 g/dL Standard Error 0.063
Changes in Laboratory Values. - CMP (g/dL) Calc Globulin Infusion 4 (Week 10)	-0.08 g/dL Standard Error 0.045	0.03 g/dL Standard Error 0.043
Changes in Laboratory Values. - CMP (g/dL) Calc Globulin End of Study (Week 26)	-0.07 g/dL Standard Error 0.061	-0.05 g/dL Standard Error 0.047
Changes in Laboratory Values. - CMP (g/dL) Protein Baseline/Infusion 1 (Week 0)	7.28 g/dL Standard Error 0.113	7.09 g/dL Standard Error 0.068
Changes in Laboratory Values. - CMP (g/dL) Protein Infusion 4 (Week 10)	-0.19 g/dL Standard Error 0.068	0.02 g/dL Standard Error 0.057
Changes in Laboratory Values. - CMP (g/dL) Protein End of Study (Week 26)	-0.20 g/dL Standard Error 0.072	-0.07 g/dL Standard Error 0.075

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds INR Baseline/Infusion 1 (Week 0)	0.99 Ratio Standard Error 0.010	0.97 Ratio Standard Error 0.011
Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds INR Infusion 4 (Week 10)	-0.01 Ratio Standard Error 0.008	0.01 Ratio Standard Error 0.010
Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds INR End of Study (Week 26)	0.00 Ratio Standard Error 0.011	-0.01 Ratio Standard Error 0.013

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Respiratory Rate (breaths per minute)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) Baseline	17.0 breaths/min Standard Error 0.16	16.8 breaths/min Standard Error 0.16
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) Infusion 2 (Week 2)	0.1 breaths/min Standard Error 0.19	0.2 breaths/min Standard Error 0.22
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) Infusion 3 (Week 6)	-0.1 breaths/min Standard Error 0.21	0.2 breaths/min Standard Error 0.19
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) Infusion 4 (Week 10)	-0.3 breaths/min Standard Error 0.15	-0.1 breaths/min Standard Error 0.22
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) End of Study (Week 26)	0.1 breaths/min Standard Error 0.20	0.3 breaths/min Standard Error 0.24

PRIMARY outcome

Timeframe: Baseline to Weeks 26

Clinically significant changes in Heart Rate (beats per minute)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) Baseline	73.9 beats per minute Standard Error 1.88	70.0 beats per minute Standard Error 1.76
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) Infusion 2 (Week 2)	-0.6 beats per minute Standard Error 1.67	3.6 beats per minute Standard Error 1.65
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) Infusion 3 (Week 6)	0.5 beats per minute Standard Error 2.07	6.1 beats per minute Standard Error 2.14
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) Infusion 4 (Week 10)	-3.5 beats per minute Standard Error 1.91	3.2 beats per minute Standard Error 1.65
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) End of Study (Week 26)	-4.2 beats per minute Standard Error 2.09	2.4 beats per minute Standard Error 1.54

PRIMARY outcome

Timeframe: Baseline to Week 10, End of Study at Weeks 26

Clinically significant changes in Body Temperature (Celsius)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Vital Signs. - Body Temperature (Celsius) Baseline	36.63 degrees Celsius Standard Error 0.043	36.70 degrees Celsius Standard Error 0.039
Changes From Baseline in Vital Signs. - Body Temperature (Celsius) Infusion 2 (Week 2)	0.01 degrees Celsius Standard Error 0.047	-0.04 degrees Celsius Standard Error 0.040
Changes From Baseline in Vital Signs. - Body Temperature (Celsius) Infusion 3 (Week 6)	0.05 degrees Celsius Standard Error 0.050	-0.03 degrees Celsius Standard Error 0.050
Changes From Baseline in Vital Signs. - Body Temperature (Celsius) Infusion 4 (Week 10)	0.01 degrees Celsius Standard Error 0.051	-0.05 degrees Celsius Standard Error 0.038
Changes From Baseline in Vital Signs. - Body Temperature (Celsius) End of Study (Week 26)	-0.08 degrees Celsius Standard Error 0.052	-0.05 degrees Celsius Standard Error 0.053

PRIMARY outcome

Timeframe: Baseline to Weeks 10, End of Study at Week 26

Clinically significant changes in Blood Pressure.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Vital Signs. - Blood Pressure (mmHg) Systolic Basline/Infusion 1 (Week 0)	122.2 mmHg Standard Error 1.91	125.2 mmHg Standard Error 1.78
Changes in Vital Signs. - Blood Pressure (mmHg) Systolic Infusion 2 (Week 2)	-0.7 mmHg Standard Error 1.82	-1.8 mmHg Standard Error 1.51
Changes in Vital Signs. - Blood Pressure (mmHg) Systolic Infusion 3 (Week 6)	-0.6 mmHg Standard Error 1.85	1.1 mmHg Standard Error 1.57
Changes in Vital Signs. - Blood Pressure (mmHg) Systolic Infusion 4 (Week 10)	-3.1 mmHg Standard Error 2.10	-3.1 mmHg Standard Error 1.52
Changes in Vital Signs. - Blood Pressure (mmHg) Systolic End of Study (Week 26)	-0.2 mmHg Standard Error 1.74	0.3 mmHg Standard Error 1.78
Changes in Vital Signs. - Blood Pressure (mmHg) Diastolic Baseline/Infusion 1 (Week 0)	79.4 mmHg Standard Error 1.32	80.1 mmHg Standard Error 1.06
Changes in Vital Signs. - Blood Pressure (mmHg) Diastolic Infusion 2 (Week 2)	-0.9 mmHg Standard Error 0.98	-0.7 mmHg Standard Error 0.92
Changes in Vital Signs. - Blood Pressure (mmHg) Diastolic Infusion 3 (Week 6)	-2.2 mmHg Standard Error 1.48	0.1 mmHg Standard Error 1.31
Changes in Vital Signs. - Blood Pressure (mmHg) Diastolic Infusion 4 (Week 10)	-0.8 mmHg Standard Error 1.50	-0.6 mmHg Standard Error 1.46
Changes in Vital Signs. - Blood Pressure (mmHg) Diastolic End of Study (Week 26)	0.0 mmHg Standard Error 1.32	1.1 mmHg Standard Error 1.39

PRIMARY outcome

Timeframe: Baseline to Weeks 10, End of Study at Week 26

Change from baseline in Weight in kg.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Weight in kg. Baseline/ Infusion 1 (Week 0)	79.35 kg Standard Error 3.079	79.28 kg Standard Error 2.403
Changes in Weight in kg. Infusion 2 (Week 2)	-0.06 kg Standard Error 0.342	0.80 kg Standard Error 0.551
Changes in Weight in kg. Infusion 3 (Week 6)	0.26 kg Standard Error 0.476	1.15 kg Standard Error 0.602
Changes in Weight in kg. Infusion 4 (Week 10)	0.49 kg Standard Error 0.645	0.56 kg Standard Error 0.627
Changes in Weight in kg. End of Study (Week 26)	-0.30 kg Standard Error 0.751	1.14 kg Standard Error 0.925

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Abdomen body system

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Abdomen Baseline/Infusion 1 (Week 0) · Normal	38 Participants	38 Participants
Changes in Physical Examination Results. - Abdomen Baseline/Infusion 1 (Week 0) · Abnormal	1 Participants	2 Participants
Changes in Physical Examination Results. - Abdomen Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Abdomen Infusion 2 (Week 2) · Normal	37 Participants	36 Participants
Changes in Physical Examination Results. - Abdomen Infusion 2 (Week 2) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Abdomen Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Abdomen Infusion 3 (Week 6) · Normal	36 Participants	34 Participants
Changes in Physical Examination Results. - Abdomen Infusion 3 (Week 6) · Abnormal	1 Participants	1 Participants
Changes in Physical Examination Results. - Abdomen Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Abdomen Infusion 4 (Week 10) · Normal	35 Participants	32 Participants
Changes in Physical Examination Results. - Abdomen Infusion 4 (Week 10) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Abdomen Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Abdomen End of Study (Week 26) · Normal	34 Participants	30 Participants
Changes in Physical Examination Results. - Abdomen End of Study (Week 26) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Abdomen End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

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=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) Calc A/G Ratio Baseline/Infusion 1 (Week 0)	1.86 Ratio Standard Error 0.057	1.94 Ratio Standard Error 0.060
Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) Calc A/G Ratio Infusion 4 (Week 10)	0.02 Ratio Standard Error 0.044	-0.03 Ratio Standard Error 0.046
Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) Calc A/G Ratio End of Study (Week 26)	0.04 Ratio Standard Error 0.053	0.03 Ratio Standard Error 0.043

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values with units of U/L.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (U/L) Alkaline Phosphatase Baseline/Infusion 1 (Week 0)	66.9 U/L Standard Error 2.31	74.5 U/L Standard Error 3.42
Changes in Laboratory Values. - CMP (U/L) Alkaline Phosphatase Infusion 4 (Week 10)	-3.2 U/L Standard Error 1.51	0.1 U/L Standard Error 1.29
Changes in Laboratory Values. - CMP (U/L) Alkaline Phosphatase End of Study (Week 26)	-4.1 U/L Standard Error 1.56	-0.5 U/L Standard Error 1.87
Changes in Laboratory Values. - CMP (U/L) Alanine aminotransferase Baseline/Infusion 1 (Week 0)	25.15 U/L Standard Error 1.836	21.28 U/L Standard Error 1.718
Changes in Laboratory Values. - CMP (U/L) Alanine aminotransferase Infusion 4 (Week 10)	-5.14 U/L Standard Error 1.272	2.81 U/L Standard Error 1.353
Changes in Laboratory Values. - CMP (U/L) Alanine aminotransferase End of Study (Week 26)	0.26 U/L Standard Error 3.321	2.00 U/L Standard Error 1.211
Changes in Laboratory Values. - CMP (U/L) Aspartate Aminotransferase Baseline/Infusion 1 (Week 0)	23.8 U/L Standard Error 1.63	20.7 U/L Standard Error 0.96
Changes in Laboratory Values. - CMP (U/L) Aspartate Aminotransferase Infusion 4 (Week 10)	-2.9 U/L Standard Error 1.56	1.5 U/L Standard Error 1.17
Changes in Laboratory Values. - CMP (U/L) Aspartate Aminotransferase End of Study (Week 26)	-0.7 U/L Standard Error 2.25	0.6 U/L Standard Error 1.09

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values with units of mg/dL.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (mg/dL) Bilirubin Baseline/Infusion 1 (Week 0)	0.52 mg/dL Standard Error 0.029	0.50 mg/dL Standard Error 0.043
Changes in Laboratory Values. - CMP (mg/dL) Bilirubin Infusion 4 (Week 10)	-0.05 mg/dL Standard Error 0.035	0.03 mg/dL Standard Error 0.034
Changes in Laboratory Values. - CMP (mg/dL) Bilirubin End of Study (Week 26)	-0.12 mg/dL Standard Error 0.032	-0.01 mg/dL Standard Error 0.047
Changes in Laboratory Values. - CMP (mg/dL) Calcium Baseline/Infusion 1 (Week 0)	9.56 mg/dL Standard Error 0.085	9.54 mg/dL Standard Error 0.055
Changes in Laboratory Values. - CMP (mg/dL) Calcium Infusion 4 (Week 10)	-0.04 mg/dL Standard Error 0.099	-0.01 mg/dL Standard Error 0.058
Changes in Laboratory Values. - CMP (mg/dL) Calcium End of Study (Week 26)	-0.06 mg/dL Standard Error 0.098	-0.03 mg/dL Standard Error 0.065
Changes in Laboratory Values. - CMP (mg/dL) Creatinine Baseline/Infusion 1 (Week 0)	0.885 mg/dL Standard Error 0.0337	0.872 mg/dL Standard Error 0.0290
Changes in Laboratory Values. - CMP (mg/dL) Creatinine Infusion 4 (Week 10)	-0.022 mg/dL Standard Error 0.0146	-0.010 mg/dL Standard Error 0.0103
Changes in Laboratory Values. - CMP (mg/dL) Creatinine End of Study (Week 26)	-0.012 mg/dL Standard Error 0.0190	0.014 mg/dL Standard Error 0.0106
Changes in Laboratory Values. - CMP (mg/dL) Glucose Baseline/Infusion 1 (Week 0)	98.5 mg/dL Standard Error 6.43	94.2 mg/dL Standard Error 1.93
Changes in Laboratory Values. - CMP (mg/dL) Glucose Infusion 4 (Week 10)	-5.0 mg/dL Standard Error 6.40	0.7 mg/dL Standard Error 2.35
Changes in Laboratory Values. - CMP (mg/dL) Glucose End of Study (Week 26)	-2.9 mg/dL Standard Error 4.92	2.0 mg/dL Standard Error 1.41
Changes in Laboratory Values. - CMP (mg/dL) Blood Urea Nitrogen Baseline/Infusion 1 (Week 0)	13.9 mg/dL Standard Error 0.61	13.8 mg/dL Standard Error 0.51
Changes in Laboratory Values. - CMP (mg/dL) Blood Urea Nitrogen Infusion 4 (Week 10)	-0.3 mg/dL Standard Error 0.54	-0.1 mg/dL Standard Error 0.64
Changes in Laboratory Values. - CMP (mg/dL) Blood Urea Nitrogen End of Study (Week 26)	0.4 mg/dL Standard Error 0.67	-0.2 mg/dL Standard Error 0.62

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values with units of mEq/L.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (mEq/L) Chloride Baseline/Infusion 1 (Week 0)	103.3 mEq/L Standard Error 0.45	104.1 mEq/L Standard Error 0.35
Changes in Laboratory Values. - CMP (mEq/L) Chloride Infusion 4 (Week 10)	0.2 mEq/L Standard Error 0.45	-0.3 mEq/L Standard Error 0.37
Changes in Laboratory Values. - CMP (mEq/L) Chloride End of Study (Week 26)	0.6 mEq/L Standard Error 0.42	-0.3 mEq/L Standard Error 0.40
Changes in Laboratory Values. - CMP (mEq/L) Carbon Dioxide Baseline/Infusion 1 (Week 0)	24.7 mEq/L Standard Error 0.33	25.2 mEq/L Standard Error 0.35
Changes in Laboratory Values. - CMP (mEq/L) Carbon Dioxide Infusion 4 (Week 10)	-0.2 mEq/L Standard Error 0.39	-0.3 mEq/L Standard Error 0.43
Changes in Laboratory Values. - CMP (mEq/L) Carbon Dioxide End of Study (Week 26)	0.0 mEq/L Standard Error 0.47	-0.4 mEq/L Standard Error 0.45
Changes in Laboratory Values. - CMP (mEq/L) Potassium Baseline/Infusion 1 (Week 0)	4.40 mEq/L Standard Error 0.059	4.44 mEq/L Standard Error 0.086
Changes in Laboratory Values. - CMP (mEq/L) Potassium Infusion 4 (Week 10)	-0.08 mEq/L Standard Error 0.067	-0.08 mEq/L Standard Error 0.128
Changes in Laboratory Values. - CMP (mEq/L) Potassium End of Study (Week 26)	-0.14 mEq/L Standard Error 0.080	-0.11 mEq/L Standard Error 0.118
Changes in Laboratory Values. - CMP (mEq/L) Sodium Baseline/Infusion 1 (Week 0)	140.2 mEq/L Standard Error 0.38	141.1 mEq/L Standard Error 0.31
Changes in Laboratory Values. - CMP (mEq/L) Sodium Infusion 4 (Week 10)	-0.1 mEq/L Standard Error 0.45	0.2 mEq/L Standard Error 0.50
Changes in Laboratory Values. - CMP (mEq/L) Sodium End of Study (Week 26)	0.2 mEq/L Standard Error 0.51	-0.5 mEq/L Standard Error 0.49

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values with units of mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) Estimated Glomerular Filtration Rate Baseline/Infusion 1 (Week 0)	97.6 mL/min/1.73m^2 Standard Error 2.45	101.1 mL/min/1.73m^2 Standard Error 2.06
Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) Estimated Glomerular Filtration Rate Infusion 4 (Week 10)	1.8 mL/min/1.73m^2 Standard Error 1.54	0.9 mL/min/1.73m^2 Standard Error 1.10
Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) Estimated Glomerular Filtration Rate End of Study (Week 26)	0.7 mL/min/1.73m^2 Standard Error 1.88	-1.2 mL/min/1.73m^2 Standard Error 1.27

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) Calc BUN/Creat Baseline/Infusion 1 (Week 0)	16.5 Ratio Standard Error 0.97	16.4 Ratio Standard Error 0.68
Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) Calc BUN/Creat Infusion 4 (Week 10)	-0.0 Ratio Standard Error 0.64	-0.1 Ratio Standard Error 0.68
Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) Calc BUN/Creat End of Study (Week 26)	0.7 Ratio Standard Error 0.82	-0.4 Ratio Standard Error 0.75

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 10, and End of Study (Week 26)

Clinically significant changes in Coagulation Panel values with units of seconds.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Laboratory Values. - Coagulation Panel. (Seconds) Prothrombin Time Baseline/Infusion 1 (Week 0)	13.42 seconds Standard Error 0.092	13.27 seconds Standard Error 0.097
Changes in Laboratory Values. - Coagulation Panel. (Seconds) Prothrombin Time Infusion 4 (Week 10)	-0.11 seconds Standard Error 0.057	0.05 seconds Standard Error 0.081
Changes in Laboratory Values. - Coagulation Panel. (Seconds) Prothrombin Time End of Study (Week 26)	-0.12 seconds Standard Error 0.115	-0.05 seconds Standard Error 0.085
Changes in Laboratory Values. - Coagulation Panel. (Seconds) PTT Baseline/Infusion 1 (Week 0)	29.36 seconds Standard Error 0.486	29.93 seconds Standard Error 0.416
Changes in Laboratory Values. - Coagulation Panel. (Seconds) PTT Infusion 4 (Week 10)	-0.54 seconds Standard Error 0.302	-0.51 seconds Standard Error 0.198
Changes in Laboratory Values. - Coagulation Panel. (Seconds) PTT End of Study (Week 26)	-0.48 seconds Standard Error 0.261	-0.73 seconds Standard Error 0.238

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Cardiovascular body system

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Cardiovascular Baseline/Infusion 1 (Week 0) · Normal	38 Participants	39 Participants
Changes in Physical Examination Results. - Cardiovascular Baseline/Infusion 1 (Week 0) · Abnormal	1 Participants	1 Participants
Changes in Physical Examination Results. - Cardiovascular Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 2 (Week 2) · Normal	37 Participants	36 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 2 (Week 2) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 3 (Week 6) · Normal	37 Participants	33 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 3 (Week 6) · Abnormal	0 Participants	2 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 4 (Week 10) · Normal	35 Participants	32 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 4 (Week 10) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Cardiovascular Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Cardiovascular End of Study (Week 26) · Normal	34 Participants	30 Participants
Changes in Physical Examination Results. - Cardiovascular End of Study (Week 26) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Cardiovascular End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Baseline/Infusion 1 (Week 0) · Normal	39 Participants	40 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Baseline/Infusion 1 (Week 0) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 2 (Week 2) · Normal	37 Participants	36 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 2 (Week 2) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 3 (Week 6) · Normal	36 Participants	35 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 3 (Week 6) · Abnormal	1 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 4 (Week 10) · Normal	35 Participants	32 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 4 (Week 10) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat End of Study (Week 26) · Normal	34 Participants	30 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat End of Study (Week 26) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Lymph Node

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Lymph Node Baseline/Infusion 1 (Week 0) · Normal	39 Participants	40 Participants
Changes in Physical Examination Results. - Lymph Node Baseline/Infusion 1 (Week 0) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 2 (Week 2) · Normal	37 Participants	36 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 2 (Week 2) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 3 (Week 6) · Normal	37 Participants	35 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 3 (Week 6) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 4 (Week 10) · Normal	35 Participants	32 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 4 (Week 10) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Lymph Node End of Study (Week 26) · Normal	34 Participants	30 Participants
Changes in Physical Examination Results. - Lymph Node End of Study (Week 26) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Lymph Node End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Musculoskeletal

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Musculoskeletal Baseline/Infusion 1 (Week 0) · Normal	37 Participants	40 Participants
Changes in Physical Examination Results. - Musculoskeletal Baseline/Infusion 1 (Week 0) · Abnormal	2 Participants	0 Participants
Changes in Physical Examination Results. - Musculoskeletal Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 2 (Week 2) · Normal	35 Participants	35 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 2 (Week 2) · Abnormal	2 Participants	1 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 3 (Week 6) · Normal	35 Participants	34 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 3 (Week 6) · Abnormal	2 Participants	1 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 4 (Week 10) · Normal	34 Participants	32 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 4 (Week 10) · Abnormal	1 Participants	0 Participants
Changes in Physical Examination Results. - Musculoskeletal Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Musculoskeletal End of Study (Week 26) · Normal	33 Participants	30 Participants
Changes in Physical Examination Results. - Musculoskeletal End of Study (Week 26) · Abnormal	1 Participants	0 Participants
Changes in Physical Examination Results. - Musculoskeletal End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Neurological

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Neurological Infusion 2 (Week 2) · Abnormal	2 Participants	0 Participants
Changes in Physical Examination Results. - Neurological Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Neurological Baseline/ Infusion 1 · Normal	30 Participants	39 Participants
Changes in Physical Examination Results. - Neurological Baseline/ Infusion 1 · Abnormal	9 Participants	1 Participants
Changes in Physical Examination Results. - Neurological Baseline/ Infusion 1 · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Neurological Infusion 2 (Week 2) · Normal	35 Participants	36 Participants
Changes in Physical Examination Results. - Neurological Infusion 3 (Week 6) · Normal	32 Participants	35 Participants
Changes in Physical Examination Results. - Neurological Infusion 3 (Week 6) · Abnormal	5 Participants	0 Participants
Changes in Physical Examination Results. - Neurological Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Neurological Infusion 4 (Week 10) · Normal	31 Participants	31 Participants
Changes in Physical Examination Results. - Neurological Infusion 4 (Week 10) · Abnormal	4 Participants	1 Participants
Changes in Physical Examination Results. - Neurological Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Neurological End of Study (Week 26) · Normal	31 Participants	30 Participants
Changes in Physical Examination Results. - Neurological End of Study (Week 26) · Abnormal	3 Participants	0 Participants
Changes in Physical Examination Results. - Neurological End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Respiratory

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Respiratory Baseline/Infusion 1 (Week 0) · Normal	38 Participants	39 Participants
Changes in Physical Examination Results. - Respiratory Baseline/Infusion 1 (Week 0) · Abnormal	1 Participants	1 Participants
Changes in Physical Examination Results. - Respiratory Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Respiratory Infusion 2 (Week 2) · Normal	37 Participants	36 Participants
Changes in Physical Examination Results. - Respiratory Infusion 2 (Week 2) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Respiratory Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Respiratory Infusion 3 (Week 6) · Normal	37 Participants	35 Participants
Changes in Physical Examination Results. - Respiratory Infusion 3 (Week 6) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Respiratory Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Respiratory Infusion 4 (Week 10) · Normal	35 Participants	31 Participants
Changes in Physical Examination Results. - Respiratory Infusion 4 (Week 10) · Abnormal	0 Participants	1 Participants
Changes in Physical Examination Results. - Respiratory Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Respiratory End of Study (Week 26) · Normal	34 Participants	29 Participants
Changes in Physical Examination Results. - Respiratory End of Study (Week 26) · Abnormal	0 Participants	1 Participants
Changes in Physical Examination Results. - Respiratory End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Physical Examination Results. - Skin Baseline/Infusion 1 (Week 0) · Normal	39 Participants	39 Participants
Changes in Physical Examination Results. - Skin Baseline/Infusion 1 (Week 0) · Abnormal	0 Participants	1 Participants
Changes in Physical Examination Results. - Skin Baseline/Infusion 1 (Week 0) · Not Examined (No Longer In Study)	0 Participants	0 Participants
Changes in Physical Examination Results. - Skin Infusion 2 (Week 2) · Normal	35 Participants	34 Participants
Changes in Physical Examination Results. - Skin Infusion 2 (Week 2) · Abnormal	2 Participants	2 Participants
Changes in Physical Examination Results. - Skin Infusion 2 (Week 2) · Not Examined (No Longer In Study)	2 Participants	4 Participants
Changes in Physical Examination Results. - Skin Infusion 3 (Week 6) · Normal	37 Participants	34 Participants
Changes in Physical Examination Results. - Skin Infusion 3 (Week 6) · Abnormal	0 Participants	1 Participants
Changes in Physical Examination Results. - Skin Infusion 3 (Week 6) · Not Examined (No Longer In Study)	2 Participants	5 Participants
Changes in Physical Examination Results. - Skin Infusion 4 (Week 10) · Normal	34 Participants	31 Participants
Changes in Physical Examination Results. - Skin End of Study (Week 26) · Abnormal	0 Participants	0 Participants
Changes in Physical Examination Results. - Skin End of Study (Week 26) · Not Examined (No Longer In Study)	5 Participants	10 Participants
Changes in Physical Examination Results. - Skin Infusion 4 (Week 10) · Abnormal	1 Participants	1 Participants
Changes in Physical Examination Results. - Skin Infusion 4 (Week 10) · Not Examined (No Longer In Study)	4 Participants	8 Participants
Changes in Physical Examination Results. - Skin End of Study (Week 26) · Normal	34 Participants	30 Participants

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model)	-1.354 score on a scale (10 points total) Standard Error 0.275	-0.976 score on a scale (10 points total) Standard Error 0.293

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea)

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model)	-1.472 score on a scale (10 points total) Standard Error 0.379	-1.269 score on a scale (10 points total) Standard Error 0.405

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model)	-0.553 score on a scale (10 points total) Standard Error 0.292	-0.248 score on a scale (10 points total) Standard Error 0.312

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model)	-0.893 score on a scale (10 points total) Standard Error 0.446	-1.511 score on a scale (10 points total) Standard Error 0.476

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain).

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model)	-1.319 score on a scale (10 points total) Standard Error 0.440	-1.790 score on a scale (10 points total) Standard Error 0.470

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model)	-8.094 score on a scale (50 points total) Standard Error 1.442	-6.660 score on a scale (50 points total) Standard Error 1.538

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health)	6.205 score on a scale (100 points total) Standard Error 3.292	12.301 score on a scale (100 points total) Standard Error 3.520

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) \[30\].

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Subject's Level of Depression - PHQ 9 Scale.	-3.666 score on a scale (27 points total) Standard Error 0.938	-3.545 score on a scale (27 points total) Standard Error 1.001

SECONDARY outcome

Timeframe: Baseline (Infusion 1) to Weeks 26 (End of Study)

Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Outcome measures
Measure	HB-adMSCs n=39 Participants HB-adMSCs (allogeneic): HB-adMSCs allogeneic	Placebo n=40 Participants Placebo: Placebo comarator
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score)	13.785 score on a scale (100 points total) Standard Error 3.244	17.210 score on a scale (100 points total) Standard Error 3.461

Adverse Events

HB-adMSCs

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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=39 participants at risk HB-adMSCs (allogeneic): HB-adMSCs allogenic	Placebo n=40 participants at risk Placebo: Placebo comarator
General disorders Fatigue	41.0% 16/39 • Number of events 20 • Week 0 (Infusion 1) through Week 26 (End of Study)	20.0% 8/40 • Number of events 14 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Influenza like illness	30.8% 12/39 • Number of events 24 • Week 0 (Infusion 1) through Week 26 (End of Study)	10.0% 4/40 • Number of events 6 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Chills	10.3% 4/39 • Number of events 4 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Pain	5.1% 2/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	5.0% 2/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Pyrexia	7.7% 3/39 • Number of events 4 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Malaise	5.1% 2/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Asthenia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Feeling abnormal	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
General disorders Feeling hot	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Headache	41.0% 16/39 • Number of events 25 • Week 0 (Infusion 1) through Week 26 (End of Study)	25.0% 10/40 • Number of events 16 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Dizziness	7.7% 3/39 • Number of events 4 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Brain Fog	5.1% 2/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Cognitive Disorder	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	5.0% 2/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Depressed level of consciousness	2.6% 1/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Migraine	5.1% 2/39 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Somnolence	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	5.0% 2/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Ageusia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Anosmia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Coordination abnormal	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Dysgeusia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Lethargy	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Multiple Sclerosis	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Muscle contractions involuntarily	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Neuropathy peripheral	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Paresthesia	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Parkinsonism	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Nervous system disorders Tremor	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations COVID-19	5.1% 2/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	7.5% 3/40 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Sinusitis	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	5.0% 2/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Urinary tract infection	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Cellulitis	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Clostridium difficile colitis	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Epididymitis	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Genital herpes simplex	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Genital infection male	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Herpes zoster	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Infected bite	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Infectious mononucleosis	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Lyme disease	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Oral herpes	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Suspected COVID-19	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Viral infection	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Gastrointestinal disorders Nausea	10.3% 4/39 • Number of events 5 • Week 0 (Infusion 1) through Week 26 (End of Study)	20.0% 8/40 • Number of events 12 • Week 0 (Infusion 1) through Week 26 (End of Study)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Diarrhoea	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Dyspepsia	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Gastrointestinal disorder	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Paraesthesia oral	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Infections and infestations Toothache	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Musculoskeletal and connective tissue disorders Back pain	7.7% 3/39 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	7.5% 3/40 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study)
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	5.0% 2/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.1% 2/39 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Artificial crown procedure	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Cataract operation	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Endodontic procedure	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Hip surgery	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Mole excision	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Oral surgery	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Surgical and medical procedures Tongue tie operation	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Investigations Alanine aminotransferase increased	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Investigations Blood glucose increased	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Investigations Hepatic enzyme increased	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Investigations Rheumatoid factor positive	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Skin and subcutaneous tissue disorders Night sweats	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Skin and subcutaneous tissue disorders Rash	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Skin and subcutaneous tissue disorders Sensitive skin	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Eye disorders Eye movement disorder	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Eye disorders Lacrimation increased	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Eye disorders Vitreous floaters	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Injury, poisoning and procedural complications Exposure to toxic agent	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Injury, poisoning and procedural complications Skin laceration	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Injury, poisoning and procedural complications Tooth fracture	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Vascular disorders Flushing	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Vascular disorders Peripheral ischaemia	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Cardiac disorders Palpitations	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Ear and labyrinth disorders Vertigo	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Endocrine disorders Hyperthyroidism	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Metabolism and nutrition disorders Glucose tolerance impaired	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Psychiatric disorders Insomnia	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Renal and urinary disorders Haematuria	0.00% 0/39 • Week 0 (Infusion 1) through Week 26 (End of Study)	2.5% 1/40 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)
Reproductive system and breast disorders Breast pain	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)
Reproductive system and breast disorders Breast tenderness	2.6% 1/39 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study)	0.00% 0/40 • Week 0 (Infusion 1) through Week 26 (End of Study)