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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
Fuente: Ann Rheum Dis. 2017;76(1):196-202
Editorial: BMJ Publishing Group
Año de publicación: 2017
Nº de páginas: 8
Tipo de publicación: Artículo de Revista
ÁLVARO GRACIA, JOSE M.
JOVER, JUAN A.
GARCÍA VICUÑA, ROSARIO
VICTOR MANUEL MARTINEZ TABOADA
MARTÍN MARTÍN, CRISTINA
DÍAZ GONZÁLEZ, FEDERICO