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Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Withdrawn

Conditions

Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT01576757
UL-11.0146

Details and patient eligibility

About

The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Any heart failure patient scheduled for RHC without contraindication for biopsy.
  2. Any patient undergoing biopsy for diagnostic purposes may also be included in the study.

Exclusion criteria

  1. Severe comorbidities (AST, ALT, serum creatinine > 3 times the upper limit of normal).
  2. Pregnancy or women of childbearing potential.
  3. Anticoagulation which cannot be stopped for 5-7 days.
  4. Hepatitis B, C or HIV.
  5. Inability to give informed consent.

Trial design

0 participants in 1 patient group

Heart failure
Description:
Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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