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Intravenous Stem Cells After Ischemic Stroke (ISIS)

Primary Purpose

Ischemia, Stroke

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Autologous mesenchymal stem cells
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring Cell therapy, Stroke, Neuronal Plasticity, Recovery, Mesenchymal Stem Cells, Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Control group without intervention nor placebo

First dose of stem cells

Second dose of stem cells

Outcomes

Primary Outcome Measures

feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke

Secondary Outcome Measures

Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Determination of the most effective dose of stem cells
To define the best criteria for a future trial (phase III)
To define the best target population for a future study

Full Information

First Posted
April 2, 2009
Last Updated
October 30, 2017
Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT00875654
Brief Title
Intravenous Stem Cells After Ischemic Stroke
Acronym
ISIS
Official Title
Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Stroke
Keywords
Cell therapy, Stroke, Neuronal Plasticity, Recovery, Mesenchymal Stem Cells, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control group without intervention nor placebo
Arm Title
2
Arm Type
Experimental
Arm Description
First dose of stem cells
Arm Title
3
Arm Type
Experimental
Arm Description
Second dose of stem cells
Intervention Type
Genetic
Intervention Name(s)
Autologous mesenchymal stem cells
Intervention Description
Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Determination of the most effective dose of stem cells
Time Frame
2 weeks, 1, 2, 4, 6 months and 1, 2 years
Title
To define the best criteria for a future trial (phase III)
Time Frame
2 weeks, 1, 2, 4, 6 months and 1, 2 years
Title
To define the best target population for a future study
Time Frame
2 weeks, 1, 2, 4, 6 months and 1, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Detante, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuroradiology/MRI, University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Stroke Unit, University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Tissular and cell therapy unit, UniversityHospitalof Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32462427
Citation
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.
Results Reference
derived
PubMed Identifier
32438012
Citation
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.
Results Reference
derived

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Intravenous Stem Cells After Ischemic Stroke

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