Trial Outcomes & Findings for Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis (NCT NCT03691909)

NCT ID: NCT03691909

Last Updated: 2025-09-26

Results Overview

Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-09-26

Participant Flow

Participants were recruited based on physician referral and 6 participants were recruited through clinicaltrials.gov. First participant was enrolled on 09/25/2018 and last participant was enrolled on 05/23/2019.

Of 23 screened participants, 15 met inclusion criteria, were enrolled, and given treatment.

Participant milestones

Measure	Treatment Arm Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs).
Overall Study STARTED	15
Overall Study Per Protocol Population Day 1	15
Overall Study Per Protocol Population Week 1	15
Overall Study Per Protocol Population Week 4	14
Overall Study Per Protocol Population Week 8	13
Overall Study Per Protocol Population Week 12	15
Overall Study Per Protocol Population Week 26	14
Overall Study Per Protocol Population Week 52	13
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Baseline Tumor Necrosis Factor alpha (TNF-a) in patients with acute RA	1.45 pg/mL n=5 Participants
Baseline Interleukin-6 (IL-6) in patients with acute RA	4.90 pg/mL n=5 Participants
Baseline C-Reactive Protein (CRP) in patients with acute RA	10.0 mg/L n=5 Participants
Baseline Erythrocyte Sedimentation Rate (ESR) in patients with acute RA	43.0 mm/hr n=5 Participants
Baseline joint count in patients with acute RA. Tender	20.0 number of joints n=5 Participants
Baseline joint count in patients with acute RA. Swollen	12.0 number of joints n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
Total Number of Adverse Events and Serious Adverse Events Total Adverse Events	27 count of events
Total Number of Adverse Events and Serious Adverse Events Mild Adverse Events	15 count of events
Total Number of Adverse Events and Serious Adverse Events Moderate Adverse Events	8 count of events
Total Number of Adverse Events and Serious Adverse Events Severe Adverse Events	4 count of events
Total Number of Adverse Events and Serious Adverse Events Treatment Related Mild Adverse Events	4 count of events
Total Number of Adverse Events and Serious Adverse Events Treatment Related Moderate Adverse Events	0 count of events
Total Number of Adverse Events and Serious Adverse Events Treatment Related Severe Adverse Events	0 count of events

SECONDARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Tumor Necrosis factor (TNF-a) (pg/mL) measured during trial.

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA	1.15 pg/mL Interval 0.73 to 2.28

SECONDARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of interleukin 6 (IL-6) (pg/mL) during the trial

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA	4.60 pg/mL Interval 2.75 to 13.9

SECONDARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of C-reactive protein (CRP) (mg/L) during the trial

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA	6.00 mg/L Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of erythrosedimentation rate (ESR) (mm/hr) during the trial.

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA	34.5 mm/hr Interval 23.8 to 62.8

SECONDARY outcome

Timeframe: 12 months

Population: All participants who received treatment and completed at least 5 of 7 follow up assessments.

Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Joint Count 66/68 (# joints - tender and swollen) during the trial.

Outcome measures

Measure	Treatment Arm n=15 Participants Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs) cells.
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA. Tender	1.00 number of joints Interval 0.0 to 4.0
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA. Swollen	1.00 number of joints Interval 0.0 to 3.0

Adverse Events

Treatment Arm

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=15 participants at risk Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
Skin and subcutaneous tissue disorders Skin Infection	6.7% 1/15 • Number of events 3 • 12 months
Surgical and medical procedures Intestinal Resection	6.7% 1/15 • Number of events 1 • 12 months
Gastrointestinal disorders Intestinal Obstruction	6.7% 1/15 • Number of events 1 • 12 months
Gastrointestinal disorders Abdominal Pain	6.7% 1/15 • Number of events 1 • 12 months
Renal and urinary disorders Urinary Tract Infection	6.7% 1/15 • Number of events 1 • 12 months

Other adverse events

Measure	Treatment Arm n=15 participants at risk Single IV administration of Hope Biosciences autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
Immune system disorders Rheumatoid arthritis	13.3% 2/15 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Skin Infection	6.7% 1/15 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • Number of events 1 • 12 months
Gastrointestinal disorders Intestinal Obstruction	6.7% 1/15 • Number of events 1 • 12 months
Blood and lymphatic system disorders Anemia	13.3% 2/15 • Number of events 2 • 12 months
Vascular disorders Hematuria	13.3% 2/15 • Number of events 2 • 12 months
Blood and lymphatic system disorders Thrombocytopenia	6.7% 1/15 • Number of events 1 • 12 months
Infections and infestations Influenza	6.7% 1/15 • Number of events 1 • 12 months
Renal and urinary disorders Renal Failure	13.3% 2/15 • Number of events 2 • 12 months
Eye disorders Eye Pruritus	6.7% 1/15 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst	6.7% 1/15 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muscle Spasms	6.7% 1/15 • Number of events 1 • 12 months
Infections and infestations Tooth Infection	6.7% 1/15 • Number of events 1 • 12 months
Surgical and medical procedures Tooth Extraction	6.7% 1/15 • Number of events 1 • 12 months

Additional Information

Linette Rehkopf RPh

Hope Biosciences Stem Cell Research Foundation

Phone: 346-900-0340

Email: linette@hopebio.org

Results disclosure agreements

• Principal investigator is a sponsor employee In the protocol signature page, the investigator agreed to the following: "I further agree to treat the results of this Study as confidential information and will not submit the results of the Study for publication without prior written authorization from Hope Biosciences. "
• Publication restrictions are in place

Restriction type: OTHER