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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart failure

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No