Intravenous Stem Cells After Ischemic Stroke

Stroke Clinical Trial

— ISIS  

Official title:

Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875654
• Other study ID #: DCIC 06 25
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: October 30, 2017
• Start date: August 2010
• Est. completion date: October 20, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	Neuroradiology/MRI, University Hospital of Grenoble	Grenoble
France	Stroke Unit, University Hospital of Grenoble	Grenoble
France	Tissular and cell therapy unit, UniversityHospitalof Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Commissariat à l'Energie Atomique, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Determination of the most effective dose of stem cells		2 weeks, 1, 2, 4, 6 months and 1, 2 years
Secondary	To define the best criteria for a future trial (phase III)		2 weeks, 1, 2, 4, 6 months and 1, 2 years
Secondary	To define the best target population for a future study		2 weeks, 1, 2, 4, 6 months and 1, 2 years