Stroke Clinical Trial
Official title:
Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke
The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).
Stroke is the leading cause of acquired adult disability. Except the hospitalization in
stroke units, only thrombolysis has been shown to be efficient to treat acute ischemic stroke
in the first three hours after the onset. Increasing brain plasticity after stroke represents
an important alternative strategy. Cell therapy provides a functional improvement after
cerebral ischemia in rodent models. This "restorative" therapy aims to replace destroyed
cerebral tissue with a stem cells graft. Despite these encouraging experiments, we do not
know yet the best way of administration of the stem cells, the best dose and the optimal
delay of the graft. The pioneer clinical studies failed to reproduce this benefit for
patients probably because of the limited number of studied patients. Therefore, more
translational studies are needed to improve our knowledge in this promising field. Among
different cell sources, mesenchymal (or stromal) stem cells (MSC) derived from bone marrow
offer the advantage of arising from a non tumoral and no modified source and are not sources
of immunological or ethical problems.
Our research project involves a development of cell therapy in a phase IIa clinical trial of
feasibility and safety in patients (randomised, controlled, open, with 3 parallel groups).
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