A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke
|Ischemic Stroke||Biological: Allogeneic adult mesenchymal bone marrow stem cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke|
- The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period. [ Time Frame: 12 month ]The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
- National Institutes of Health Stroke Scale Score. [ Time Frame: 12 months ]The change from the baseline in National Institutes of Health Stroke Scale score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available:
- Mini Mental Status Exam score. [ Time Frame: 12 month ]The change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.
- Barthel Index Score. [ Time Frame: 12 month ]The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
- The Geriatric Depression Scale Score. [ Time Frame: 12 month ]The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Stem cells
All subjects will receive allogeneic adult mesenchymal bone marrow stem cells
Biological: Allogeneic adult mesenchymal bone marrow stem cells
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells
Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in >150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297413
|United States, Arizona|
|Mercy Gilbert and Chandler Medical Center|
|Gilbert, Arizona, United States, 85224|
|United States, California|
|University of California Irvine Department of Neurology|
|Orange, California, United States, 92868|
|University of California San Diego Division of Neurological Surgery|
|San Diego, California, United States, 92123|
|Study Director:||Lev Verkh, PhD||Stemedica Cell Technologies, Inc.|