Intravenous Stem Cells After Ischemic Stroke "ISIS"

Active, not recruiting

Phase 2 Results N/A

Update History

6 Sep '14
A location was updated in Grenoble.
New
The overall status was removed for Stroke Unit, University Hospital of Grenoble.
A location was updated in Grenoble.
New
The overall status was removed for Neuroradiology/MRI, University Hospital of Grenoble.
A location was updated in Grenoble.
New
The overall status was removed for Tissular and cell therapy unit, UniversityHospitalof Grenoble.
6 Sep '13
The eligibility criteria were updated.
New
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. - 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.
Old
Inclusion Criteria: - right or left carotid ischemic stroke in the 14 previous days, confirmed by MRI. - Persistent neurological deficit (NIHSS > 2). - Optimal medical treatment(anti-thrombotics, anti-hypertensive, 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 thrombo-embolic disease or less than 6 month old. - Patient with organ transplantation. - Medical history of infection (HIV,HTLV, HBV, HCV). - Current immuno suppressive/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 corrigeable 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.