Viewing Study NCT01576757


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Study NCT ID: NCT01576757
Status: WITHDRAWN
Last Update Posted: 2018-07-26
First Post: 2012-04-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Sponsor: University of Louisville
Organization:

Study Overview

Official Title: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Status: WITHDRAWN
Status Verified Date: 2018-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: There were no funds for the study.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: