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Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Results first posted: Jul 8, 2025
    • Secondary endpoints: 11 to 12
    v10
  2. Primary endpoints revised (4)
    • Secondary endpoints: 12 to 11
    v9
  3. Primary completion date changed from estimate of Jan 2023 to May 22, 2022v8
  4. Primary completion date: Jun 2022 to Jan 2023v7
  5. Primary completion date: Sep 2021 to Jun 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 95
    • Study sites: 9 to 8
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Feb 2020 to Sep 2021v5 Show 5 more changesShow less
    • Start date: Dec 12, 2018 to Jun 6, 2019
    • Primary endpoints: 2 to 4
    • Study sites: 8 to 9
    • Secondary endpoints: details revised at 1 of 12 entries
    • Collaborators: 7 to 8
  2. Study sites: 7 to 8
    • Collaborators: 6 to 7
    v4
  3. Lead sponsor: Timothy J. Nelson to Timothy J Nelson, MD, PhDv3 Show 6 more changesShow less
    • Study sites: 6 to 7
    • Start date changed from estimate of Apr 2019 to Dec 12, 2018
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (12)
    • Collaborators: 5 to 6
    • Study title shortened, about 1 word
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Dec 2018 to Apr 2019
    • Primary completion date: Dec 2020 to Feb 2020
    • Study completion date: Dec 2024 to Feb 2026
    • Secondary endpoints: 14 to 12
    • Site details revised at 6 of 6 sites
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
Trial Details
NCT Number NCT03779711
Lead Sponsor Timothy J Nelson, MD, PhD
Collaborators: University of Oklahoma, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Children's Hospital Colorado, Children's Hospitals and Clinics of Minnesota, Ochsner Health System, Children's of Alabama, Children's Hospital Medical Center, Cincinnati
Conditions
(from sponsor)		 Hypoplastic Left Heart Syndrome
Related terms Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Univentricular Heart
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov