The research team investigated the effects of administering allogeneic umbilical cord-derived mesenchymal stromal cells (MSC-UC) obtained from a cell stock produced at the University College of London and administered as a single intra -venous on eight patients suffering from severe SLE and refractory to prior conventional immunosuppressive treatments.
The primary endpoint was the rate of serious adverse events (SAEs; grade ≥ 3) during the first ten days after MSC-UC infusion. A single infusion of allogeneic MSCs was found to be safe in all eight study patients, with no serious adverse events reported during the observation period.
« The clinical results observed have enabled lasting remissions and clinical benefits in the short term for certain patients. These data suggest that this therapeutic innovation can have an early effect on the stabilization of the disease, likely to be maintained at least one year after the injection.. » notes Professor Dominique Farge, professor at Paris Cité University and head of department, CRMR MATHEC internal medicine unit, autoimmune diseases and cellular therapy at Saint-Louis AP-HP hospital.
« This study also contributes to better understanding the mechanisms of action of these new therapies and therefore to defining companion tests making it possible to better select and monitor patients likely to respond. » adds Professor Karin Tarte, director of the laboratory for immunological monitoring of innovative therapeutics (SITI) at Rennes University Hospital, EFS Bretagne and director of UMR U1236 Inserm, Rennes University.
-« These encouraging initial results pave the way for further randomized controlled studies designed to evaluate the safety and efficacy of repeated injections of allogeneic MSCs from different tissue sources in severe autoimmune diseases in France and internationally.. », concludes Professor Dominique Farge.
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