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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00859014 |
The purpose of this research study is to find out if bone marrow treatment (bone marrow aspiration and infusion of stem cells) can be safely used in adults who have recently (within 24-72 hours)suffered an acute ischemic stroke.
Condition | Intervention | Phase |
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Acute Ischemic Stroke |
Biological: Autologous stem cell |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients |
Estimated Enrollment: | 10 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Autologous stem cell
Peripheral IV infusion of autologous stem cell
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Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
acute ischemic stroke in the MCA circulation, Multimodal MRI inclusion criteria will be:
Exclusion Criteria:
Contact: Debora L East, RN, BS, BA, CCRC | 713-500-5141 | Debora.East@uth.tmc.edu |
United States, Texas | |
Memorial Hermann Hospital-Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Debora East, RN, BS, BA, CCRC 713-500-5141 Debora.East@uth.tmc.edu | |
Contact: Mary Hess, RN/BSN 713-500-7078 mary.jane.hess@uth.tmc.edu | |
Principal Investigator: Sean I. Savitz, MD |
Principal Investigator: | Sean I. Savitz, M.D. | University of Texas Heath Science Center- Houston |
Responsible Party: | The University of Texas Health Science Center, Houston ( Sean Savitz, M.D. ) |
Study ID Numbers: | N01-HB-37163-05 |
Study First Received: | March 9, 2009 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00859014 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Ischemia Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |