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

Completed · Phase 1/Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03691909

Run by

Hope Biosciences LLC

People needed

15

Starts

2018-09-25

Expected to finish

2020-09-28

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Accurate Clinical Research — Pasadena, Texas, United States

Full record on ClinicalTrials.gov

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