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Completed

NCT Number: NCT03406884

The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

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.

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Key information

Conditions

Hypoplastic Left Heart Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

c-kit+ cells

Biological

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.

Other names: Autologous c-kit-positive cells (c-kit+ cells)

Primary outcomes

  1. Number of Incidence of Treatment Related Major Adverse Cardiac Events

    Time frame: 30 days

    Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

  2. Number of C-kit+ Products

    Time frame: Day 1

    Feasibility will be reported as the number of c-kit+ products that can be manufactured and delivered to subjects

  3. Number of Participants Completing Magnetic Resonance Imaging (MRI)

    Time frame: Baseline, 6 Months, 12 months

    Feasibility will be reported as the number of participants that complete the baseline, 6-months, and 12-months follow up MRI.

  4. Change in Right Ventricular Function (RVEF)

    Time frame: Baseline, 6 Months, 12 months

    Efficacy will be reported as the change in right ventricular function assessed as a percentage and will be measuring using serial echocardiograms and MRI scan.

  5. Change in Right Ventricular End-diastolic Volume (RVEDV)

    Time frame: Baseline, 6 months, 12 months

    Efficacy will be reported as the change in right ventricular end-diastolic assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.

  6. Change in Right Ventricular End-systolic Volume (RVESV)

    Time frame: Baseline, 6 months, 12 months

    Efficacy will be reported as the change in right ventricular end-systolic volume assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.

  7. Change in Tricuspid Regurgitation

    Time frame: Baseline, 6 months, 12 months

    Efficacy will be reported as the change tricuspid regurgitation assessed as a percentage and will be measured using serial echocardiograms and MRI scan.

Secondary outcomes

  1. Number of Incidence of Serious Adverse Events

    Time frame: Up to 12 months

    Incidence of the following after the BDCPA / GLENN Procedure including: All-cause mortality; Cardiovascular mortality; Need for transplantation; Hospitalization for heart failure; Cardiovascular morbidity, including stroke or heart failure or sustained/symptomatic arrhythmias.

  2. Change in Somatic Growth Velocity - Length (cm)

    Time frame: Baseline, 6 months, 12 months

    Changes in somatic growth velocity will be evaluated by length (cm) over 12 months post study product injection.

  3. Change in Somatic Growth Velocity - Weight (kg)

    Time frame: Baseline, 6 months, 12 months

    Changes in somatic growth velocity will be evaluated by weight (kg) over 12 months post study product injection.

  4. Change in Somatic Growth Velocity - Head Circumference (cm)

    Time frame: Baseline, 6 months, 12 months

    Changes in somatic growth velocity will be evaluated by head circumference (cm) over 12 months post study product injection.

  5. Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health

    Time frame: Baseline, 12 months

    The Infant Toddler Quality of Life Survey (ITQOL) is a validated 47-item parent-reported questionnaire assessing multiple domains of child health, including overall health, physical abilities, growth and development, discomfort/pain, mood, and behavior. Domain scores are transformed to a 0-100 scale, where 0 reflects the poorest health-related quality of life and 100 reflects the best. Higher scores indicate better quality of life.

  6. Incidence of Mortality or Need for Transplantation

    Time frame: Up to 12 months

    Incidence of mortality or need for transplantation after the Stage II BDCPA operation will be reported

Sponsors and collaborators

Lead sponsor

Joshua M Hare

Other

Registry information

Official study title

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

Acronym: CHILD

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2018
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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