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NCT04907526 · ClinicalTrials.gov registry record · Phase 1
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
A Phase 1 study of Congenital Heart Disease, SRV Dependent, sponsored by Timothy J Nelson, MD, PhD.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT04907526: Active Phase 1 study of Congenital Heart Disease, SRV Dependent, sponsored by Timothy J Nelson, MD, PhD.
NCT04907526 is a Phase 1 study of Congenital Heart Disease, SRV Dependent that is active but no longer recruiting, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04907526, a Phase 1 study of Congenital Heart Disease, SRV Dependent, is active but no longer recruiting, sponsored by Timothy J Nelson, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Measure of new or worsening adverse events
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 |
What the registry record for NCT04907526 still lists
NCT04907526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
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.
NCT04907526 lists 6 locations in 6 states (Alabama, California, Colorado).
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.
What interventions are being tested in trial NCT04907526?
The interventions under investigation include: Autologous mononuclear cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04907526?
This trial is sponsored by Timothy J Nelson, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04907526's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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