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Trial record 16 of 3260 for:    Louisville

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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Heart Failure

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 Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
Study Start Date : April 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures. [ Time Frame: 6 weeks ]

Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576757


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Brigham and Women's Hospital
Investigators
Principal Investigator: Roberto Bolli, MD University of Louisville
More Information

Responsible Party: Roberto Bolli, Endowed Chair Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01576757     History of Changes
Other Study ID Numbers: UL-11.0146
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Roberto Bolli, University of Louisville:
Stem cell therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases