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Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
NCT04907526 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Autologous mononuclear cells
Study Locations (6)
Alabama
- University of Alabama Medical Center — Birmingham
California
- Children's Hospital Los Angeles — Los Angeles
Colorado
- Children's Hospital Colorado — Aurora
Minnesota
- Mayo Clinic — Rochester
Oklahoma
- University of Oklahoma Medical Center — Oklahoma City
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04907526
The ClinicalTrials.gov registry entry for NCT04907526 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 30 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 Congenital Heart Disease, SRV Dependent appearing as the primary indexed condition, and to 1 intervention — of which Autologous mononuclear cells 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: NCT04907526 reports 6 study locations spanning 6 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 NCT04907526 about?
NCT04907526 is a clinical study titled "Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD". 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...
What is the current status of trial NCT04907526?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-06-01. Estimated completion is 2025-08-30.
What conditions does trial NCT04907526 study?
This clinical trial studies the following conditions: Congenital Heart Disease, SRV Dependent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04907526?
The interventions under investigation include: Autologous mononuclear cells (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04907526?
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 NCT04907526 being conducted?
This trial has 6 study locations across Alabama, California, Colorado, Minnesota, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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