drugset / Trial / NCT01851070
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
RandomizedParallel-groupTriple-blindTreatment
Summary
Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-05
- Completion
- 2017-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rexlemestrocel-L | Cell therapy | 1 cells/kg | Intravenous |
| Comparator | Rexlemestrocel-L | Cell therapy | 2 cells/kg | Intravenous |