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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Timothy J Nelson, MD, PhD · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase I study is a multicenter, prospective, open-label, non-randomized study designed to evaluate the safety, of autologous UCB-MNC delivered into the right ventricular myocardium of subjects with severe CHD defined by single right ventricular dependent circulatory systems at the time of a planned Fontan surgical palliation. This will be achieved by comparing the data collected in the treatment arm to the equivalent data collected in the control arm. The purpose of this non-randomized open-label Phase I clinical study is to prospectively evaluate the safety, as measured by the short-term and long-term safety endpoints and change in baseline comparatives, for the autologous UCB-MNC intramyocardial injections into the single, morphologically right ventricle of subjects with severe CHD requiring Fontan surgical palliation. The treatment group will be compared to an untreated control group.

Conditions

• Congenital Heart Disease, SRV Dependent

Interventions

Type	Name	Description
BIOLOGICAL	Autologous mononuclear cells	Autologous mononuclear cells delivered into right ventricle at time of Stage III Fontan surgery.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-05-24
• Completion: 2025-08-30
• First posted: 2021-05-28
• Last updated: 2025-06-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study