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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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

FieldValue
Enrollment Target 95 participants
Start Date 2019-06-06
Est. Completion 2026-02
Phase Phase 2

Sponsor

Timothy J Nelson, MD, PhD

5 total trials

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.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.