Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies|
- Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biopsy samples are taken at the time of right heart catheterization. They are frozen in a GMP facility at the University of Louisville. The tissue is shipped either to the Institue of Molecular Caridology, Louisville, KY or shipped overnight to the Brigham and Women's Hospital in Boston, MA. The tissue is enzymatically dissociated, and cardiac stem cells are isolated and maintained in culture for 6-8 passages (point of clinical utility). During that time period, experimentation is carried out to charcterize the biological attributes of these cell populations. After this experimentation is complete, the cultures are destroyed in accordance with the biohazard handling policies of the individual institution.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria.
Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576757
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Roberto Bolli, MD||University of Louisville|