Clinical Trial: Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
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 Summary:
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.
Sponsor: Universidade Federal do Rio de Janeiro
Current Primary Outcome: Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. [ Time Frame: 4 months ]
Original Primary Outcome:
- Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
- No abnormalities in neuroimaging exams
- Absence of epileptiform activity during the procedure ans /or in the 4 months follow-up.
Current Secondary Outcome:
- Improvement of neurological deficits [ Time Frame: 4 months ]
- Improvement in the neuroimaging exams [ Time Frame: 4 months ]
Original Secondary Outcome:
- Improvement of neurological deficits
- Improvement in the neuroimaging exams
Information By: Universidade Federal do Rio de Janeiro
Dates:
Date Received: May 10, 2007
Date Started: December 2005
Date Completion:
Last Updated: May 18, 2011
Last Verified: May 2011