Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Infarction, Middle Cerebral Artery
- Sponsor
- Universidade Federal do Rio de Janeiro
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
Time Frame: 4 months
Secondary Outcomes
- Improvement of neurological deficits(4 months)
- Improvement in the neuroimaging exams(4 months)