The CHILD Trial: Hypoplastic Left Heart Syndrome Study. (CHILD)
Hypoplastic Left Heart Syndrome
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring stem cells, pediatric
Eligibility Criteria
Inclusion Criteria:
For inclusion in the study, subjects must meet all of the inclusion criteria:
Subjects with hypoplastic left heart syndrome (all types) requiring Stage I Norwood operation.
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are met:
- Subjects undergoing the Stage I Norwood operation who do not have HLHS.
- Subjects requiring mechanical circulatory support immediately prior to Stage II BDCPA operation (within 5 days).
- Parent or guardian unwilling or unable to comply with necessary follow-up(s).
- Mother is serum positive for HIV 1/2, hepatitis BsAg or viremic hepatitis C and Treponema pallidum.
- Subjects who are unsuitable for inclusion in the study in the opinion of the investigator(s).
Sites / Locations
- Emory University Children's Healthcare of Atlanta - Egleston CampusRecruiting
- University of Maryland - Division of Cardiac SurgeryRecruiting
- Michigan Medicine Congenital Heart Center/C.S. Mott Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Open label C-kit+ cells Group A
C-kit+ cells Group B
No Intervention Group
Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially.
Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially.
Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells.