A Phase 2 interventional study of Autologous mesenchymal stem cells in Ischemia and Stroke, sponsored by University Hospital, Grenoble. Completed at 3 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by University Hospital, Grenoble · Phase 2, Interventional, and Treatment
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).
2,062 studies on the registry are indexed under Ischemia; 345 are open to participants now.
This study's enrollment of 31 is below the median of 80 across 1,361 interventional studies indexed under Ischemia.
Browse Ischemia studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control group without intervention nor placebo
First dose of stem cells
Genetic: Autologous mesenchymal stem cells
Second dose of stem cells
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
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
Clinical and functional effects 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
Determination of the most effective dose of stem cells
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best criteria for a future trial (phase III)
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best target population for a future study
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Grenoble →