NCT01985464

Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Translational Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical cord mesenchymal stem cells

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2013-11-15
• Last updated: 2019-06-20

Locations

1 site across 1 country: Panama