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

Withdrawn

• Conditions: Heart Failure

• Registration Number: NCT01576757
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.	6 weeks

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States