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NCT03779711 · ClinicalTrials.gov registry record · Phase 2
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
A Phase 2 study of Hypoplastic Left Heart Syndrome, sponsored by Timothy J Nelson, MD, PhD.
- Active
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 8
- Study locations
NCT03779711 is a Phase 2 study of Hypoplastic Left Heart Syndrome that is active but no longer recruiting, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 95 participants, roughly in line with the 90-participant average among 3 other Hypoplastic Left Heart Syndrome trials with a reported enrollment target. The trial reports 8 study locations across 8 states.
The verdict
NCT03779711, a Phase 2 study of Hypoplastic Left Heart Syndrome, is active but no longer recruiting, sponsored by Timothy J Nelson, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 8
- Study locations
Study Summary
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
Conditions Studied
Interventions
- BIOLOGICAL Autologous (self) mononuclear cells derived from umbilical cord blood
- PROCEDURE Stage II Surgical repair
Study Locations (8)
Alabama
- Children's of Alabama - Birmingham
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Louisiana
- Ocshner Medical Center - New Orleans
Minnesota
- Children's Hospitals of Minnesota - Minneapolis
Ohio
- Cincinnati Children's Hospital and Medical Center - Cincinnati
Oklahoma
- Oklahoma University Medical Center - Oklahoma City
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2026-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03779711
The ClinicalTrials.gov registry entry for NCT03779711 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 90-participant average among 3 other Hypoplastic Left Heart Syndrome trials with a reported enrollment target. The listed sponsor is Timothy J Nelson, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoplastic Left Heart Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Autologous (self) mononuclear cells derived from umbilical cord blood is the first listed.
NCT03779711 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Alabama, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03779711 about?
NCT03779711 is a clinical study titled "Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome". Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want ...
What is the current status of trial NCT03779711?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2019-06-06. Estimated completion is 2026-02.
What conditions does trial NCT03779711 study?
This clinical trial studies the following conditions: Hypoplastic Left Heart Syndrome.
What interventions are being tested in trial NCT03779711?
The interventions under investigation include: Autologous (self) mononuclear cells derived from umbilical cord blood (BIOLOGICAL), Stage II Surgical repair (PROCEDURE).
Who is sponsoring clinical trial NCT03779711?
This trial is sponsored by Timothy J Nelson, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03779711 being conducted?
This trial has 8 study locations across Alabama, California, Colorado, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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