Intravenous Stem Cells After Ischemic Stroke (ISIS)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Grenoble
Sponsor:
University Hospital, Grenoble
Collaborators:
Commissariat à l'Energie Atomique
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00875654
First received: April 2, 2009
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemia Stroke |
Genetic: Autologous mesenchymal stem cells |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke |
Further study details as provided by University Hospital, Grenoble:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Determination of the most effective dose of stem cells [ Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years ] [ Designated as safety issue: No ]
- To define the best criteria for a future trial (phase III) [ Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years ] [ Designated as safety issue: No ]
- To define the best target population for a future study [ Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Control group without intervention nor placebo
|
|
|
Experimental: 2
First 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
|
|
Experimental: 3
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875654
Contacts
| Contact: Jean-Luc Cracowski, MD, PhD | jlcracowski@chu-grenoble.fr | |
| Contact: Adeline Paris, PharmD, PhD |
Locations
| France | |
| Stroke Unit, University Hospital of Grenoble | Recruiting |
| Grenoble, France, 38000 | |
| Contact: Olivier Detante, MD | |
| Contact: Marie-Jeanne Richard, PharmD | |
| Principal Investigator: Olivier Detante, MD | |
| Sub-Investigator: Katia Garambois, MD | |
| Neuroradiology/MRI, University Hospital of Grenoble | Active, not recruiting |
| Grenoble, France, 38000 | |
| Tissular and cell therapy unit, UniversityHospitalof Grenoble | Active, not recruiting |
| Grenoble, France, 38000 | |
Sponsors and Collaborators
University Hospital, Grenoble
Commissariat à l'Energie Atomique
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | Olivier Detante, MD | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | AdministrateurCIC, Dr Olivier DETANTE, University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00875654 History of Changes |
| Other Study ID Numbers: | DCIC 06 25 |
| Study First Received: | April 2, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Grenoble:
|
Cell therapy Stroke Neuronal Plasticity |
Recovery Mesenchymal Stem Cells Transplantation |
Additional relevant MeSH terms:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013