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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion date: Jun 30, 2025 to Aug 30, 2025v5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 30, 2023 to May 24, 2023
    • Site details revised at 6 of 6 sites
    v4
  3. Primary completion date: Dec 31, 2022 to Jun 30, 2023
    • Study sites: 5 to 6
    • Study completion date: Jun 30, 2024 to Jun 30, 2025
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04907526
Lead Sponsor Timothy J Nelson, MD, PhD
Collaborators: Mayo Clinic, University of Oklahoma, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Children's Hospitals and Clinics of Minnesota, Children's Hospital Colorado, Ochsner Health System, Children's of Alabama, Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children
Conditions
(from sponsor)		 Congenital Heart Disease, SRV Dependent
Related terms Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov