Rheumatoid Arthritis Clinical Trial
Official title:
Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
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.
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