NCT00875654

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

7.2 years

First QC Date

April 2, 2009

Last Update Submit

October 30, 2017

Conditions

IschemiaStroke

Keywords

Cell therapyStrokeNeuronal PlasticityRecoveryMesenchymal Stem CellsTransplantation

Outcome Measures

Primary Outcomes (1)

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

    2 weeks, 1, 2, 4, 6 months and 1, 2 years

Secondary Outcomes (4)

  • Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke

    2 weeks, 1, 2, 4, 6 months and 1, 2 years

  • Determination of the most effective dose of stem cells

    2 weeks, 1, 2, 4, 6 months and 1, 2 years

  • To define the best criteria for a future trial (phase III)

    2 weeks, 1, 2, 4, 6 months and 1, 2 years

  • To define the best target population for a future study

    2 weeks, 1, 2, 4, 6 months and 1, 2 years

Study Arms (3)

1

NO INTERVENTION

Control group without intervention nor placebo

2

EXPERIMENTAL

First dose of stem cells

Genetic: Autologous mesenchymal stem cells

3

EXPERIMENTAL

Second dose of stem cells

Genetic: Autologous mesenchymal stem cells

Interventions

Autologous mesenchymal stem cellsGENETIC

Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume\<100ml) less than 6 weeks after stroke

23

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Neuroradiology/MRI, University Hospital of Grenoble

Grenoble, 38000, France

Location

Stroke Unit, University Hospital of Grenoble

Grenoble, 38000, France

Location

Tissular and cell therapy unit, UniversityHospitalof Grenoble

Grenoble, 38000, France

Location

Related Publications (2)

  • 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.

    PMID: 32462427DERIVED

  • 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.

    PMID: 32438012DERIVED

MeSH Terms

Conditions

IschemiaStroke

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier Detante, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Olivier DETANTE

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

August 1, 2010

Primary Completion

October 20, 2017

Study Completion

October 20, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)