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| Name | Class |
|---|---|
| Commissariat A L'energie Atomique | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Control group without intervention nor placebo | |
| 2 | Experimental | First dose of stem cells |
|
| 3 | Experimental | Second dose of stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Genetic | Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Determination of the most effective dose of stem cells | 2 weeks, 1, 2, 4, 6 months and 1, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Detante, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroradiology/MRI, University Hospital of Grenoble | Grenoble | 38000 | France | |||
| Stroke Unit, University Hospital of Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32462427 | Derived | Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O; (for the ISIS-HERMES Study Group). Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial. Transl Stroke Res. 2020 Oct;11(5):910-923. doi: 10.1007/s12975-020-00787-z. Epub 2020 May 27. | |
| 32438012 |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| To define the best criteria for a future trial (phase III) | 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 |
| Grenoble |
| 38000 |
| France |
| Tissular and cell therapy unit, UniversityHospitalof Grenoble | Grenoble | 38000 | France |
| Derived |
| Hannanu FF, Goundous I, Detante O, Naegele B, Jaillard A. Spatiotemporal patterns of sensorimotor fMRI activity influence hand motor recovery in subacute stroke: A longitudinal task-related fMRI study. Cortex. 2020 Aug;129:80-98. doi: 10.1016/j.cortex.2020.03.024. Epub 2020 Apr 17. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |