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NCT03406884 · ClinicalTrials.gov registry record · Phase 1
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
A Phase 1 study, sponsored by Joshua M Hare.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT03406884 is a Phase 1 study that has completed, run by Joshua M Hare. The registered enrollment target is 25 participants.
The verdict
NCT03406884, a Phase 1 study, has completed, sponsored by Joshua M Hare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL c-kit+ cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-16 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03406884
The ClinicalTrials.gov registry entry for NCT03406884 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joshua M Hare, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which c-kit+ cells is the first listed.
NCT03406884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03406884 about?
NCT03406884 is a clinical study titled "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 functi...
What is the current status of trial NCT03406884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-10-16. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT03406884?
The interventions under investigation include: c-kit+ cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03406884?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
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