Clinical trialNCT04907526Active, not recruitingPhase 1Interventional

Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD

SponsorTimothy J Nelson, MD, PhDEnrollment30Congenital Heart Disease, SRV Dependent

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 autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery. They want to see if there are changes in the electrical activity, the structure, and the function of the heart following this stem cell-based therapy. Researchers will compare the results from people who receive the stem cells to the results from people who do not receive the stem cells.

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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, MD
Ochsner Health System
Principal Investigator
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David M Overman
Children's Minnesota
Principal Investigator
clinicaltrials.gov ↗
Harold M Burkhart
Children's Hospital Oklahoma University Medical Center
Principal Investigator
clinicaltrials.gov ↗
James Jaggers, MD
Children's Hospital Colorado
Principal Investigator
clinicaltrials.gov ↗
James Tweddell, M.D.
Children's Hospital Medical Center, Cincinnati
Principal Investigator
clinicaltrials.gov ↗
Jason Maynes, MD
The Hospital forSick Children
Principal Investigator
clinicaltrials.gov ↗
John D Cleveland, MD
Children's Hospital Los Angeles
Principal Investigator
clinicaltrials.gov ↗
Joseph Dearani
Mayo Clinic
Principal Investigator
clinicaltrials.gov ↗
Joseph w Rossano
Children's Hospital of Philadelphia
Principal Investigator
clinicaltrials.gov ↗
Waldemer 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

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

United States

University of Alabama Medical Center
Birmingham, Alabama, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Oklahoma 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

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: 1 Jun 2021
Primary completion: 24 May 2023
Completion: 30 Aug 2025
Last update posted: 27 Jun 2025
Registered enrollment: 30
Registry id: NCT04907526

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.