Intravenous Stem Cells After Ischemic Stroke - Full Text View

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

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 2014
Estimated Primary Completion Date:	August 2012 (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:	December 12, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

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, 2012