Status:
COMPLETED
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
Lead Sponsor:
Joshua M Hare
Conditions:
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation and to observe effects on clin...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03406884
Start Date
October 16 2019
End Date
July 1 2024
Last Update
November 26 2024
Active Locations (3)
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1
Emory University Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
2
University of Maryland - Division of Cardiac Surgery
Baltimore, Maryland, United States, 21201
3
Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109