Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is safe and useful procedure in inducing remission of RA in patients resistant to standard DMARD therapy.
The proposed study will assess primarily safety and secondary efficacy endpoints of autologous stromal vascular fraction (SVF) cells administered to 20 patients with disease modifying antirheumatic drug (DMARD)-resistant Rheumatoid Arthritis (RA) who have been nonresponsive to at least one course of one DMARD selected from a group comprising of: gold salts, leflunomide, methotrexate, and hydroxychloroquine. The primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 1, 2, 3 and 6 of efficacy endpoints of CRP, ESR, anti-citrulline antibody, RF, Quality of Life Questionnaire, 28-joint disease activity score (DAS28), European League against Rheumatism (EULAR) response criteria and immunological parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Stem Cell Institute
Panama City, Panama
Number of participants with adverse events
Time frame: 6 months
Change from baseline 28-DAS Score at 6 months
Time frame: 6 months
Change from baseline EULAR Response Criteria at 6 months
Change in European League against Rheumatism (EULAR) response criteria and immunological parameters from baseline to 6 months.
Time frame: 6 months
Change from baseline quality of life measure (based on Stanford HAQ) at 6 months
Time frame: 6 months
Change from baseline C-reactive protein at 6 months
Time frame: 6 months
Change from baseline erythrocyte sedimentation rate (ESR) at 6 months
Time frame: 6 months
Change from baseline anti-citrulline antibody measure at 6 months
Time frame: 6 months
Change from baseline rheumatoid factor (RF) at 6 months
Time frame: 6 months
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