Intravenous Stem Cells After Ischemic Stroke (ISIS)

October 30, 2017 updated by: AdministrateurCIC, University Hospital, Grenoble

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Neuroradiology/MRI, University Hospital of Grenoble
      • Grenoble, France, 38000
        • Stroke Unit, University Hospital of Grenoble
      • Grenoble, France, 38000
        • Tissular and cell therapy unit, UniversityHospitalof Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks, 1, 2, 4, 6 months and 1, 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks, 1, 2, 4, 6 months and 1, 2 years
Determination of the most effective dose of stem cells
Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best criteria for a future trial (phase III)
Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best target population for a future study
Time Frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
2 weeks, 1, 2, 4, 6 months and 1, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Commissariat A L'energie Atomique

Investigators

  • Principal Investigator: Olivier Detante, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 20, 2017

Study Completion (Actual)

October 20, 2017

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 06 25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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