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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01576757
• Other study ID #: UL-11.0146
• Status: Withdrawn
• Start date: February 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.		6 weeks