Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University of Louisville
- Locations
- 1
- Primary Endpoint
- Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.
Detailed Description
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.
Investigators
Roberto Bolli
Endowed Chair Professor
University of Louisville
Eligibility Criteria
Inclusion Criteria
- •Any heart failure patient scheduled for RHC without contraindication for biopsy.
- •Any patient undergoing biopsy for diagnostic purposes may also be included in the study.
Exclusion Criteria
- •Severe comorbidities (AST, ALT, serum creatinine \> 3 times the upper limit of normal).
- •Pregnancy or women of childbearing potential.
- •Anticoagulation which cannot be stopped for 5-7 days.
- •Hepatitis B, C or HIV.
- •Inability to give informed consent.
Outcomes
Primary Outcomes
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.
Time Frame: 6 weeks