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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576757
First Posted: April 12, 2012
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Roberto Bolli, University of Louisville
  Purpose
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies

Resource links provided by NLM:


Further study details as provided by Roberto Bolli, University of Louisville:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart failure
Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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 Submitted: April 10, 2012
First Posted: April 12, 2012
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