53 patients with active rheumatoid arthritis (28-joint disease activity score >3.2) who had not responded to at least two biologic agents were randomly assigned to three once-weekly infusions of allogeneic Cx611 adipose-tissue derived stem cells (which resemble mesenchymal stem cells) at doses of 1×106, 2×106 or 4×106 cells per kg, or placebo. Treatment was generally well tolerated, and no dose-limiting toxic effects were observed. Although the study was not designed to assess efficacy, a trend towards improved response was observed in Cx611-treated patients versus those who received placebo.
References
Álvaro-Gracia, J. M. et al. Intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis (Cx611): results of a multicentre, dose escalation, randomised, single-blind, placebo-controlled phase Ib/IIa clinical trial. Ann. Rheum. Dis. http://dx.doi.org/10.1136/annrheumdis-2015-208918 (2016)
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Barranco, C. Stem cell therapy seems safe in refractory RA. Nat Rev Rheumatol 12, 436 (2016). https://doi.org/10.1038/nrrheum.2016.105
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DOI: https://doi.org/10.1038/nrrheum.2016.105
