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

NCT03691909 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HBRA01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

arthritis; stem cells; MSCs; adipose MSCs

Outcome Measures

Primary Outcomes (1)

• Total Number of Adverse Events and Serious Adverse Events

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

  12 months

Secondary Outcomes (5)

• The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA

  12 months

• The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA

  12 months

• The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA

  12 months

• The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA

  12 months

• The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.

  12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Single IV administration of autologous adipose-derived mesenchymal stem cells Baseline laboratory data will be collected prior to infusion; follow up data will be compared against baseline at 1, 3, 6 and 12 months. Joint Assessment 68 will be administered at 1, 3, 6 and 12 months.

Biological: HB-adMSCs

Interventions

HB-adMSCs BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female between the ages of 18 and 65
• Patients have active RA as confirmed by the following criteria:
• ≥ 6 swollen joints and ≥ 6 tender joints at screening (68-joint count)
• Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at screening OR abnormal ESR defined as:
• CRP \> 4.9 mg/L or ESR \> 10mm/hr for men, \> 20mm/hr for women
• Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening

You may not qualify if:

• Inability to understand and provide signed informed consent
• Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screening.
• Currently diagnosed any malignant neoplasm. Any patient who was successfully treated for cancer and has been disease-free, with no recurrence, for at least 5 years, will be considered.
• Uncontrolled systemic illness, including, but not limited to: hypertension (systolic \>150 mm Hg or diastolic \>95 mm Hg); diabetes; renal, hepatic, or cardiac failure or any laboratory abnormality that poses a safety risk to the subject such as:
• Hemoglobin ≤8.5 g/dL
• White blood cells (WBCs) ≤3,500/mm3 (3.5 G/L)
• Any other illness which, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study
• Participation in another study with an investigational drug or device within 4 weeks prior to treatment or 5 half-lives of the investigational product used (whichever is longer).
• Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening (excluding patients who are tested positive for HBsAb alone due to a hepatitis B vaccination).
• Positive history of Treponema pallidum.

Sponsors & Collaborators

• Hope Biosciences LLC: lead

Study Sites (1)

Accurate Clinical Research

Pasadena, Texas, 77034, United States

Location

Related Publications (1)

• Vij R, Stebbings KA, Kim H, Park H, Chang D. 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. Stem Cell Res Ther. 2022 Mar 3;13(1):88. doi: 10.1186/s13287-022-02763-w.

  PMID: 35241141 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Linette Rehkopf RPh
• Organization: Hope Biosciences Stem Cell Research Foundation

linette@hopebio.org

346-900-0340

Study Officials

• Philip Waller, MD

  Accurate Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 2, 2018
• Study Start: September 25, 2018
• Primary Completion: August 17, 2020
• Study Completion: September 28, 2020
• Last Updated: September 26, 2025
• Results First Posted: March 22, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)