NCT03691909: HB-adMSCs

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

Completed Phase 1, PHASE2 Results posted Last updated 26 September 2025

What this trial tests

Phase 1, PHASE2 trial testing HB-adMSCs in Rheumatoid Arthritis in 15 participants. Completed in 28 September 2020.

Timeline

25 September 2018

Primary endpoint
17 August 2020

28 September 2020

Quick facts

Lead sponsor	Hope Biosciences LLC
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	25 September 2018
Primary completion	17 August 2020
Estimated completion	28 September 2020
Sites	1 location across United States

Drugs / interventions tested

• HB-adMSCs — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Hope Biosciences LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Adverse Events and Serious Adverse Events Primary · 12 months

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

Total Adverse Events

Group	Value	95% CI
Treatment Arm	27

Mild Adverse Events

Group	Value	95% CI
Treatment Arm	15

Moderate Adverse Events

Group	Value	95% CI
Treatment Arm	8

Severe Adverse Events

Group	Value	95% CI
Treatment Arm	4

Treatment Related Mild Adverse Events

Group	Value	95% CI
Treatment Arm	4

Treatment Related Moderate Adverse Events

Group	Value	95% CI
Treatment Arm	0

Treatment Related Severe Adverse Events

Group	Value	95% CI
Treatment Arm	0

The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA Secondary · 12 months

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.

Group	Value	95% CI
Treatment Arm	1.15	0.73 – 2.28

The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA Secondary · 12 months

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

Group	Value	95% CI
Treatment Arm	4.60	2.75 – 13.9

The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA Secondary · 12 months

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

Group	Value	95% CI
Treatment Arm	6.00	3.00 – 12.0

The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA Secondary · 12 months

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.

Group	Value	95% CI
Treatment Arm	34.5	23.8 – 62.8

The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA. Secondary · 12 months

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.

Tender

Group	Value	95% CI
Treatment Arm	1.00	0.00 – 4.00

Swollen

Group	Value	95% CI
Treatment Arm	1.00	0.00 – 3.00

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 4/15 (27%)

Deaths: 0/15

Serious adverse events (5 terms)

Reaction	System	Treatment Arm
Skin Infection	Skin and subcutaneous tissue disorders	—
Intestinal Resection	Surgical and medical procedures	—
Intestinal Obstruction	Gastrointestinal disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Urinary Tract Infection	Renal and urinary disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Treatment Arm
Rheumatoid arthritis	Immune system disorders	—
Anemia	Blood and lymphatic system disorders	—
Hematuria	Vascular disorders	—
Renal Failure	Renal and urinary disorders	—
Skin Infection	Skin and subcutaneous tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Intestinal Obstruction	Gastrointestinal disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Influenza	Infections and infestations	—
Eye Pruritus	Eye disorders	—
Cyst	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Muscle Spasms	Musculoskeletal and connective tissue disorders	—
Tooth Infection	Infections and infestations	—
Tooth Extraction	Surgical and medical procedures	—

Most-reported serious reactions: Skin Infection, Intestinal Resection, Intestinal Obstruction, Abdominal Pain, Urinary Tract Infection.

Data from ClinicalTrials.gov NCT03691909 adverse events section.

Sponsor's own description

Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
2. Mesenchymal Stem/Stromal Cells for Rheumatoid Arthritis Treatment: An Update on Clinical Applications.
   Lopez-Santalla M, Fernandez-Perez R, Garin MI. · · 2020 · cited 98× · PMID 32784608 · DOI 10.3390/cells9081852
3. Synovial fibroblasts as potential drug targets in rheumatoid arthritis, where do we stand and where shall we go?
   Németh T, Nagy G, Pap T. · · 2022 · cited 86× · PMID 35715191 · DOI 10.1136/annrheumdis-2021-222021
4. Adipose-Derived Mesenchymal Stromal Cells in Basic Research and Clinical Applications.
   Czerwiec K, Zawrzykraj M, Deptuła M, Skoniecka A, et al · · 2023 · cited 53× · PMID 36835295 · DOI 10.3390/ijms24043888
5. Rheumatoid arthritis: the old issue, the new therapeutic approach.
   Babaahmadi M, Tayebi B, Gholipour NM, Kamardi MT, et al · · 2023 · cited 42× · PMID 37741991 · DOI 10.1186/s13287-023-03473-7
6. Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial.
   Vij R, Stebbings KA, Kim H, Park H, et al · · 2022 · cited 37× · PMID 35241141 · DOI 10.1186/s13287-022-02763-w
7. Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.
   Han X, Liao R, Li X, Zhang C, et al · · 2025 · cited 34× · PMID 40841367 · DOI 10.1038/s41392-025-02313-9
8. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782