Status:
COMPLETED
Intravenous Stem Cells After Ischemic Stroke
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Commissariat A L'energie Atomique
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Ischemia
Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Medical history of chemotherapy.
- Known chronic kidney failure(clearance of creatinin \< 90 ml/min/1,73m2).
- Known hepatic failure(diminution of prothrombin level (TP) not corrigiable with vitamin K).
- Obesity hinding the bone-marrow sampling in the iliac crest.
- Pathology implying vital prognosis in the 3 month following stroke.
- Refusal to participate.
- Patient unable to give personally his/her consent.
- Pregnant, parturient and feeding women.
- Woman in age to procreate who could not receive an effective method of contraception during the study.
- Participation to another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
- Privation of liberty with a decision of justice or administration, legal protection.
- Non affiliation to social security.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00875654
Start Date
August 1 2010
End Date
October 20 2017
Last Update
November 1 2017
Active Locations (3)
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1
Neuroradiology/MRI, University Hospital of Grenoble
Grenoble, France, 38000
2
Stroke Unit, University Hospital of Grenoble
Grenoble, France, 38000
3
Tissular and cell therapy unit, UniversityHospitalof Grenoble
Grenoble, France, 38000