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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT04907526

Public ClinicalTrials.gov record NCT04907526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 6:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Study of Intramyocardial Injection of Autologous Umbilical Cord Blood-Derived Mononuclear Cells During Fontan Surgical Palliation of Single Right Ventricle-Dependent Congenital Heart Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04907526
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Timothy J Nelson, MD, PhD
Other
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 5 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 1, 2021 (Actual)
Primary completion
May 24, 2023 (Actual)
Completion
Aug 30, 2025 (Estimated)
Last update posted
Jun 27, 2025

2021 – 2025

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of Alabama Medical Center Birmingham Alabama 35233 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Children's Hospital Colorado Aurora Colorado 80045 —
Mayo Clinic Rochester Minnesota 55905 —
University of Oklahoma Medical Center Oklahoma City Oklahoma 73104 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04907526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 27, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04907526 live on ClinicalTrials.gov.

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