Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Hypoplastic Left Heart Syndrome, sponsored by Timothy J Nelson, MD, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
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 |
What the registry record for NCT03779711 still lists
NCT03779711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, roughly in line with the 90-participant average among 3 other Hypoplastic Left Heart Syndrome trials with a reported enrollment target.
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Hypoplastic Left Heart Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03339128 · 95 participants · Phase 2
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
- NCT03509961 · 95 participants · Phase 2
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
- NCT03694756 · 95 participants · NA
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
- NCT04206215 · 95 participants · NA
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI