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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01576757

Enrollment

Registered

2012-04-12

Start date

2011-02-28

Completion date

2012-04-30

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Stem cell therapy

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Countries

United States

Outcome results