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).
- Autologous mesenchymal stem cells Genetic
Intervention Desc: Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke ARM 1: Kind: Experimental Label: 2 Description: First dose of stem cells ARM 2: Kind: Experimental Label: 3 Description: Second dose of stem cells
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke||2 weeks, 1, 2, 4, 6 months and 1, 2 years||Yes|
|Secondary||Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke||2 weeks, 1, 2, 4, 6 months and 1, 2 years||Yes|
|Secondary||Determination of the most effective dose of stem cells||2 weeks, 1, 2, 4, 6 months and 1, 2 years||No|
|Secondary||To define the best criteria for a future trial (phase III)||2 weeks, 1, 2, 4, 6 months and 1, 2 years||No|
|Secondary||To define the best target population for a future study||2 weeks, 1, 2, 4, 6 months and 1, 2 years||No|