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| Sponsor: | The University of Texas Health Science Center, Houston |
|---|---|
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00859014 |
Purpose
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 |
|---|---|---|
|
Ischemic Stroke |
Biological: Autologous stem cell |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients |
| Estimated Enrollment: | 30 |
| 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 |
|---|---|
| Experimental: 1 |
Biological: Autologous stem cell
Peripheral IV infusion of autologous stem cell
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 83 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CT and/or Multimodal MRI exclusion criteria will be:
Contacts and Locations| Contact: Susan E Alderman, RN, BSN | Susan.alderman@uth.tmc.edu |
| United States, Texas | |
| Memorial Hermann Hospital-Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Susan E Alderman, RN, BSN Susan.alderman@uth.tmc.edu | |
| Principal Investigator: Sean I. Savitz, MD | |
| Principal Investigator: | Sean I. Savitz, M.D. | University of Texas Heath Science Center- Houston |
More Information
| Responsible Party: | Sean Savitz, M.D., The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00859014 History of Changes |
| Other Study ID Numbers: | N01-HB-37163-05 |
| Study First Received: | March 9, 2009 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |