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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT01985464
Study type Interventional
Source Translational Biosciences
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date October 2013
Completion date June 2020

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