Clinical trialNCT03779711Active, not recruitingPhase 2Interventional

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

SponsorTimothy J Nelson, MD, PhDEnrollment95Hypoplastic Left Heart Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Benjamin Peeler, M.D.
Ochsner Health System
Principal Investigator
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David M. Overman, M.D.
Children's Minnesota
Principal Investigator
clinicaltrials.gov ↗
Frank Cetta, MD
Mayo Clinic
Principal Investigator
clinicaltrials.gov ↗
Harold M. Burkhart, M.D.
Children's Hospital Oklahoma University Medical Center
Principal Investigator
clinicaltrials.gov ↗
James Jaggers, M.D.
Children's Hospital Colorado
Principal Investigator
clinicaltrials.gov ↗
James Tweddell, M.D.
Children's Hospital Medical Center, Cincinnati
Principal Investigator
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Joseph W. Rossano, M.D.
Children's Hospital of Philadelphia
Principal Investigator
clinicaltrials.gov ↗
Ram Kumar Subramanyan, M.D., Ph.D.
Children's Hospital Los Angeles
Principal Investigator
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Waldemar Carlo, M.D.
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S of Alabama
Birmingham, Alabama, United States
Children'S Hospital of Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Ocshner Medical Center
New Orleans, Louisiana, United States
Children'S Hospitals of Minnesota
Minneapolis, Minnesota, United States
Cincinnati Children'S Hospital and Medical Center
Cincinnati, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Autologous mononuclear cells derived from umbilical cord blood

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 6 Jun 2019
Primary completion: 22 May 2022
Completion: 28 Feb 2026
Last update posted: 8 Jul 2025
Registered enrollment: 95
Registry id: NCT03779711

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.