A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis

• Status: Active, not recruiting
• Trial end date: 2020-03-01
• Target enrollment: 15
• Participant gender: All

Summary

Hope Biosciences is conducting a research study of an investigational product called 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hope Biosciences

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 (3.5G/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.