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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Hope Biosciences autologous adipose-derived mesenchymal stem cells
Accurate Clinical Research
Pasadena, Texas, United States
Total Number of Adverse Events and Serious Adverse Events
Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA
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.
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA
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
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA
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
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA
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.
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.
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.
Time frame: 12 months
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