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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Stem Cell Institute
Panama City, Panama
Number of participants with adverse events
Time frame: 12 months
Number of participants with a change in disease activity index as measured by 28-DAS Score
Time frame: 12 months
Number of participants with a change in current disease activity as measured by EULAR Response Criteria
Time frame: 12 months
Change from baseline quality of life measure (based on Stanford HAQ)
Time frame: 12 months
Change from baseline C-reactive protein
Time frame: 12 months
Change from baseline erythrocyte sedimentation rate (ESR)
Time frame: 12 months
Change from baseline anti-citrulline antibody measure
Time frame: 12 months
Change from baseline rheumatoid factor (RF)
Time frame: 12 months
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