Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

Study Overview
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Brief Summary
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This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.

Detailed Description
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Objective: The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (> 3 and < 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory. Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.

Official Title
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Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke

Conditions
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Infarction, Middle Cerebral Artery

Intervention / Treatment
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* Other: Autologous cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory age between 18 and 75 years old NIHSS between 4 and 20 spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI signed informed consent Exclusion Criteria: difficult in obtaining vascular access for percutaneous procedures vascular impossibility to reach the middle cerebral artery through percutaneous approach severe carotid stenosis( >70%, by Doppler) related to the severe stroke neurological worsening (>4 points in the NIHSS ) due to edema or intracerebral hemorrhage primary hematological disease neurodegenerative disorder previous stroke with mRS > 2 intracardiac thrombosis auto-imune disorders osteopathies that could increase the risk of bone marrow harvesting procedure thrombophilias liver failure chronic renal failure (creatinine > 2mg/ml) life support dependence lacunar stroke pregnancy history of neoplasia or other comorbidity that could impact patient's short-term survival any condition that in the judgment of the investigator would place the patient under undue risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Autologous cell transplantation|Intra-arterial or intravenous delivery of autologous bone marrow cells|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neurological deficits |  | 4 months | 
| Improvement in the neuroimaging exams |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute stroke, middle cerebral artery, autologous transplantation, bone marrow cells, stem cells, cell therapy