Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally growing and may be the most amendable to regenerative strategies. Therefore, identifying autologous cells (cells from the patient's own body) would be important to initiate these studies. This study aims to validate the use of umbilical cord blood as a source of autologous cells for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from the cord blood to help us determine the feasibility of collection, processing, and storage of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left heart syndrome. This study may be useful for the development of pre-clinical and clinical studies aimed at the long-term goal of repairing damaged heart muscle.

Who is eligible to participate?

Inclusion Criteria: - Any pregnant woman, regardless of age, with a prenatal diagnosis of HLHS - One or both parents willing to consent to the storage of umbilical cord blood for the specific purpose of regenerative research - Mother is willing to provide a blood sample for serology testing Exclusion Criteria: - Individuals unwilling to participate

Karen Krucker

Last updated:

8/29/2014

NCT ID:

NCT01856049

IRB Number:

11-007176