Rheumatoid Arthritis Clinical Trial
Official title:
Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
Allogeneic human umbilical cord tissue-derived stem cells will be injected intravenously once per day for 5 days is a 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
allogeneic UC-MSC administered to 20 patients with disease modifying antirheumatic drug
(DMARD)-resistant Rheumatoid Arthritis (RA) who have been non-responsive 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 3 and 12 of efficacy endpoints of C reactive protein
(CRP), erythrocyte sedimentation rate (ESR), anti-citrulline antibody, rheumatoid factor
(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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