Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2010-08-31
2017-10-20
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Control group without intervention nor placebo
No interventions assigned to this group
2
First dose of stem cells
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
3
Second dose of stem cells
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Persistent neurological deficit (NIHSS \>=7).
* Optimal medical treatment(antithrombotics, antihypertensive, statins).
* General state compatible with a program of functional rehabilitation.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Commissariat A L'energie Atomique
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Grenoble
OTHER
Responsible Party
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AdministrateurCIC
Dr Olivier DETANTE
Principal Investigators
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Olivier Detante, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Neuroradiology/MRI, University Hospital of Grenoble
Grenoble, , France
Stroke Unit, University Hospital of Grenoble
Grenoble, , France
Tissular and cell therapy unit, UniversityHospitalof Grenoble
Grenoble, , France
Countries
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References
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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.
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.
Other Identifiers
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DCIC 06 25
Identifier Type: -
Identifier Source: org_study_id