Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ischemia
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 31
- Locations
- 3
- Primary Endpoint
- feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
AdministrateurCIC
Dr Olivier DETANTE
University Hospital, Grenoble
Eligibility Criteria
Inclusion Criteria
- •right or left carotid ischemic stroke in the 14 previous days, confirmed by MRI.
- •Persistent neurological deficit (NIHSS \>=7).
- •Optimal medical treatment(antithrombotics, antihypertensive, statins).
- •General state compatible with a program of functional rehabilitation.
Exclusion Criteria
- •Severe extensive stroke implying vital prognosis.
- •Severe persistent neurological deficit (NIHSS \> 24).
- •Medical history of neurological pathology with a deficit as consequence (Rankin \< 3 before stroke).
- •Serious psychiatric disease.
- •Myocardial infarction less than 3 month old.
- •Recurring thromboembolic disease or less than 6 month old.
- •Patient with organ transplantation.
- •Medical history of infection (HIV,HTLV, HBV, HCV).
- •Current immunosuppressive/immunomodulating treatment.
- •Medical history of cancer.
Outcomes
Primary Outcomes
feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Secondary Outcomes
- Determination of the most effective dose of stem cells(2 weeks, 1, 2, 4, 6 months and 1, 2 years)
- To define the best target population for a future study(2 weeks, 1, 2, 4, 6 months and 1, 2 years)
- To define the best criteria for a future trial (phase III)(2 weeks, 1, 2, 4, 6 months and 1, 2 years)
- 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)