phase 1/2a clinical trial to assess the safety of hb-admscs for the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

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.

this is a phase 1/2a, open-label, single-dose study in subjects with active rheumatoid arthritis (ra). 12-15 patients will be enrolled for the study. the overall objective of this study is to evaluate the safety profile of a single iv infusion of autologous adipose-derived mesenchymal stem cells (hb-admscs) in subjects with clinical diagnosis of ra. the primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. the second endpoint of this study is to evaluate the ability of hb-admscs to alter ra-related inflammation via measuring levels of tumor necrosis factor alpha (tnf-a), interleukin-6 (il-6), c-reactive protein (crp), erythrocyte sedimentation rate (esr) and joint count 66/68 after a single infusion of autologous hb-admscs for up to 12-month post-infusion.

Eligibility 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 (3.5 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.

Keywords: arthritis stem cells mscs adipose mscs