Intravenous Stem Cells After Ischemic Stroke (ISIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Grenoble
Sponsor:
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: July 15, 2014
Last verified: July 2014

April 2, 2009
July 15, 2014
August 2010
August 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00875654 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Stem Cells After Ischemic Stroke
Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ischemia
  • Stroke
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
  • No Intervention: 1
    Control group without intervention nor placebo
  • Experimental: 2
    First dose of stem cells
    Intervention: Genetic: Autologous mesenchymal stem cells
  • Experimental: 3
    Second dose of stem cells
    Intervention: Genetic: Autologous mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2016
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Jean-Luc Cracowski, MD, PhD jlcracowski@chu-grenoble.fr
Contact: Adeline Paris, PharmD, PhD
France
 
NCT00875654
DCIC 06 25
Yes
AdministrateurCIC, University Hospital, Grenoble
University Hospital, Grenoble
  • Commissariat à l'Energie Atomique
  • Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Olivier Detante, MD University Hospital, Grenoble
University Hospital, Grenoble
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP