This is an investigational new drug clinical trial for combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using intravenous injection of autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients. All subjects are monitored for safety (adverse events/severe adverse events) and evaluated for RAPID3, DAS28 and ACR20 regarding AdMSCs up to 52 weeks study duration.
Must pass communicable disease screen tests for HIV, syphilis, Hepatitis B and C Consistent with American Rheumatism Association-European League Against Rheumatism (ACR/EULAR) 2010 rheumatoid arthritis classification criteria
Active Rheumatoid Arthritis, see RA functional status of class I-IV
Patients must meet at least one of the following: > 6 swollen joints and ≥ 6 involved joints (tenderness, swelling, deformity, pain on motion, or decreased motion) and morning stiffness ≥ 45 minutes based on 68 joint count.
Patients must also meet at least one of the following: rheumatoid factor (RF) > 15 IU/mL or > 1:16, C-reactive protein (CRP) > 2.0 mg/dL, Erythrocyte Sedimentation Rate (ESR) > 30 mm/hour, and anti-cyclic citrullinated protein (Anti-CCP) > 20 U/mL, TNFα > 2.8 pg/mL.
Current or prior to treatment
Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
Evidence of immune suppression related to prior/current therapy
> 10% change in delivered monthly dose of anti-rheumatoid medications within 4 weeks prior to this stem cell infusion
Sequential
autologous adipose derived stem cells
Biological/VaccineCulture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
Adverse Events and Sever Adverse Events
The total number of adverse events and severe adverse events related and non-related with AdMSCs will be recorded to indicate the safety and tolerability.
Efficacy of Celltex AdMSCs
Proportion of ACR 20 patients (swollen joints, tender joints, patient assessment of pain, RAPID3, DAS28-CRP and blood inflammatory panel tests) in comparison between baseline and post-treatment follow-up data.
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