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

Running, not enrolling · Phase 1

Conditions studied: Congenital Heart Disease, SRV Dependent

In brief

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.

Key facts

Study ID

NCT04907526

Run by

Timothy J Nelson, MD, PhD

People needed

30

Starts

2021-06-01

Expected to finish

2025-08-30

Last updated by the study team

2025-06-27

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a congenital hear defect with functionally single right ventricle (such as HLHS, HLHS variants, unbalanced AV septal defect with R dominance, DORV with Hypoplastic LV) undergoing Fontan surgical palliation
• At least 2 and less than or equal to 5 years of age at time of Fontan surgical palliation
• For subjects enrolling in the treatment arm, previous participation in clinical trial Umbilical Cord Blood Collection and Processing for Hypoplastic Left Heart Syndrome patients (NCT01856049) with autologous UCB-MNC product collected and available for distribution is required.

You may not qualify if…

• History of DMSO reaction (treatment arm only subjects).
• Parent(s) or legal guardian unwilling to have their child participate or unwilling to follow the study procedures.
• Severe chronic diseases at the discretion of the treating physician.
• Extensive extra-cardiac syndromic features.
• History of cancer.
• Any of the following complications of his/her congenital heart disease:
• any condition requiring urgent, or unplanned intervention procedure within 15 days prior to Fontan surgical palliation, unless complete and full cardiac recovery is documented by site investigator.
• severe pulmonary hypertension (reported in the medical record as >70% systemic pressure)
• Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome, not directly related tot he stem cell product or its injection procedure, during or after Fontan surgical palliation.
• Individuals with severe heart failure that requires heart transplantation
• Individuals with refractory or worsening arrhythmia
• Individuals with an automated implantable cardioverter defibrillator (AICD) or pacemaker
• Patient with prior surgical complications during the Fontan surgical palliation that resulted in or could be reasonably expected to significantly decrease cardiac function

Where it is running

• University of Alabama Medical Center — Birmingham, Alabama, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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