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ACTIVE NOT RECRUITING Phase 2

Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

NCT03779711 · View on ClinicalTrials.gov ↗

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

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Timothy J Nelson, MD, PhD, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03779711 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Alabama, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03779711?

This trial is sponsored by Timothy J Nelson, MD, PhD, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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