NCT00875654

Intravenous Stem Cells After Ischemic Stroke

Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ischemia
• Stroke

Interventions

Type	Name	Description
GENETIC	Autologous mesenchymal stem cells	Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume\<100ml) less than 6 weeks after stroke

Timeline

• Start date: 2010-08-01
• Primary completion: 2017-10-20
• Completion: 2017-10-20
• First posted: 2009-04-03
• Last updated: 2017-11-01

Locations

3 sites across 1 country: France