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

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ClinicalTrials.gov Identifier: NCT01576757
Recruitment Status : Enrolling by invitation
First Posted : April 12, 2012
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Roberto Bolli, University of Louisville

April 10, 2012
April 12, 2012
July 2, 2017
April 2011
December 2018   (Final data collection date for primary outcome measure)
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures. [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT01576757 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.
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.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Biopsy samples are taken at the time of right heart catheterization. They are frozen in a GMP facility at the University of Louisville. The tissue is shipped either to the Institue of Molecular Caridology, Louisville, KY or shipped overnight to the Brigham and Women's Hospital in Boston, MA. The tissue is enzymatically dissociated, and cardiac stem cells are isolated and maintained in culture for 6-8 passages (point of clinical utility). During that time period, experimentation is carried out to charcterize the biological attributes of these cell populations. After this experimentation is complete, the cultures are destroyed in accordance with the biohazard handling policies of the individual institution.
Non-Probability Sample
Patients with heart failure undergoing evaluation for medical management at the University of Louisville or Jewish Hospital in Louisville, KY will be considered for participation based on the evaluation of enrollment criteria.
Heart Failure
Not Provided
Heart failure
Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01576757
UL-11.0146
No
Not Provided
Not Provided
Roberto Bolli, University of Louisville
University of Louisville
Brigham and Women's Hospital
Principal Investigator: Roberto Bolli, MD University of Louisville
University of Louisville
June 2017