Phase 1
N=25
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
Hypoplastic Left Heart Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03406884 ↗Enrolled (actual)
25
Serious AEs
64.0%
Results posted
Jan 2026
Primary outcome: Primary: Number of Incidence of Treatment Related Major Adverse Cardiac Events — 1; 0; 6 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- c-kit+ cells (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Joshua M Hare
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Incidence of Treatment Related Major Adverse Cardiac Events |
1; 0; 6 | — |
| PRIMARY Number of C-kit+ Products |
9; 7; 0 | — |
| PRIMARY Number of Participants Completing Magnetic Resonance Imaging (MRI) |
9; 7; 7; 6; 6; 5 | — |
| PRIMARY Change in Right Ventricular Function (RVEF) |
49.33; 55; 45.4; 48; 50.83; 47 | — |
| PRIMARY Change in Right Ventricular End-diastolic Volume (RVEDV) |
112.57; 119.1; 123.98; 129.5; 123.08; 130.27 | — |
| PRIMARY Change in Right Ventricular End-systolic Volume (RVESV) |
57.43; 55.53; 68.66; 68.38; 55.17; 70.66 | — |
| PRIMARY Change in Tricuspid Regurgitation |
8.28; 5; 5; 35.07; 9.23; 15.35 | — |
| SECONDARY Number of Incidence of Serious Adverse Events |
1; 0; 6 | — |
| SECONDARY Change in Somatic Growth Velocity - Length (cm) |
60.33; 59.5; 60.07; 69.72; 69.79; 70.8 | — |
| SECONDARY Change in Somatic Growth Velocity - Weight (kg) |
5.7; 5.6; 5.65; 7.67; 8.39; 8.36 | — |
| SECONDARY Change in Somatic Growth Velocity - Head Circumference (cm) |
38.51; 39.58; 38.33; 45.04; 45.18; 45.42 | — |
| SECONDARY Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health |
86; 62.14; 77.86; 88; 85.71; 72.5 | — |
| SECONDARY Incidence of Mortality or Need for Transplantation |
0; 0; 3 | — |
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 Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.
Eligibility Criteria
Inclusion Criteria
- For inclusion in the study, subjects must meet all of the inclusion criteria:
- Subjects with hypoplastic left heart syndrome (HLHS) (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 B surface antigen or viremic hepatitis C and Treponema pallidum.
- Subjects who are unsuitable for inclusion in the study in the opinion of the investigator(s).
Data sourced from ClinicalTrials.gov (NCT03406884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.