NCT03406884

The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 1 Day – 21 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoplastic Left Heart Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	c-kit+ cells	The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL.

Timeline

• Start date: 2019-10-16
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2018-01-23
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study