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Abstract: Objectives To evaluate the safety and tolerability of the intravenous administration of Cx611, a preparation of allogeneic expanded adipose-derived stem cells (eASCs), in patients with refractory rheumatoid arthritis (RA), as well as to obtain preliminary clinical efficacy data in this population. Methods It is a multicentre, dose escalation, randomised, single-blind (double-blind for efficacy), placebo-controlled, phase Ib/IIa clinical trial. Patients with active refractory RA (failure to at least two biologicals) were randomised to receive three intravenous infusions of Cx611: 1 million/kg (cohort A), 2 million/kg (cohort B), 4 million/kg (cohort C) or placebo, on days 1, 8 and 15, and they were followed for therapy assessment for 24 weeks. Results Fifty-three patients were treated (20 in cohort A, 20 in cohort B, 6 in cohort C and 7 in placebo group). A total of 141 adverse events (AEs) were reported. Seventeen patients from the group A (85%), 15 from the group B (75%), 6 from the group C (100%) and 4 from the placebo group (57%) experienced at least one AE. Eight AEs from 6 patients were grade 3 in intensity (severe), 5 in cohort A (lacunar infarction, diarrhoea, tendon rupture, rheumatoid nodule and arthritis), 2 in cohort B (sciatica and RA) and 1 in the placebo group (asthenia). Only one of the grade 3 AEs was serious (the lacunar infarction). American College of Rheumatology 20 responses for cohorts A, B, C and placebo were 45%, 20%, 33% and 29%, respectively, at month 1, and 25%, 15%, 17% and 0%, respectively, at month 3. Conclusions The intravenous infusion of Cx611 was in general well tolerated, without evidence of doserelated toxicity at the dose range and time period studied. In addition, a trend for clinical efficacy was observed. These data, in our opinion, justify further investigation of this innovative therapy in patients with RA.
Fuente: Annals of the Rheumatic Diseases, 2017, 76(1), 196-202
Editorial: BMJ Publishing Group
Año de publicación: 2017
Nº de páginas: 8
Tipo de publicación: Artículo de Revista
DOI: 10.1136/annrheumdis-2015-208918
ISSN: 0003-4967,1468-2060
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ÁLVARO GRACIA, JOSE M.
JOVER, JUAN A.
GARCÍA VICUÑA, ROSARIO
CARREÑO, LUIS
ALONSO, ALBERTO
MARSAL, SARA
BLANCO, FRANCISCO
VICTOR MANUEL MARTINEZ TABOADA
TAYLOR, PETER
MARTÍN MARTÍN, CRISTINA
DELAROSA, OLGA
TAGARRO, IGNACIO
DÍAZ GONZÁLEZ, FEDERICO
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