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The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

NCT03406884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-23

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • William Mahle, MD · Emory University

  • Kristopher Deatrick, MD · University of Maryland

  • Richard Ohye, MD · Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2024-07-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406884 on ClinicalTrials.gov