deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 2-arm NCT04907526

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

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

Sponsor: Children's Hospital Colorado

Updated 7 times since 2021 Last updated: Jun 24, 2025 Started: Jun 1, 2021 Primary completion: May 24, 2023 Completion: Aug 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Congenital Heart Disease, SRV Dependent and is currently ongoing. Children's Hospital Colorado leads this study, which shows 7 recorded versions since 2021 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

~Jun 2021 – ~Jun 2022 · 12 months · monthly snapshotNot Yet Recruiting~Jun 2022 – ~Feb 2023 · 8 months · monthly snapshotRecruiting~Feb 2023 – ~Mar 2024 · 13 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshotActive Not Recruiting~Jul 2025 – present · 14 months · monthly snapshotActive Not Recruiting

Change History

7 versions recorded
  1. Jul 2025 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Sep 2024 — Jul 2025 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  5. Feb 2023 — Mar 2024 [monthly]

    Recruiting PHASE1

Show 2 earlier versions
  1. Jun 2022 — Feb 2023 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  2. Jun 2021 — Jun 2022 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Children's Hospital Colorado
  • Children's Hospital Los Angeles
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
  • Children's Hospitals and Clinics of Minnesota
  • Children's of Alabama
  • Mayo Clinic
  • Ochsner Health System
  • The Hospital for Sick Children
  • Timothy J Nelson, MD, PhD
  • University of Oklahoma
Data source: ReGen Theranostics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .