Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00859014|
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Biological: Autologous Bone Marrow Mononuclear Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients|
|Study Start Date :||January 2009|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Experimental: Autologous Bone Marrow Mononuclear Cells
Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Biological: Autologous Bone Marrow Mononuclear Cells
Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells
- Study Related Serious Adverse Events (SR-SAE) [ Time Frame: 2 Years ]Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
- Functional Outcome [ Time Frame: 90-days ]Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859014
|United States, Texas|
|Memorial Hermann Hospital-Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sean I Savitz, MD||University of Texas Heath Science Center- Houston|