Status:
ACTIVE_NOT_RECRUITING
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Lead Sponsor:
Timothy J Nelson, MD, PhD
Collaborating Sponsors:
Mayo Clinic
University of Oklahoma
Conditions:
Congenital Heart Disease, SRV Dependent
Eligibility:
All Genders
2-5 years
Phase:
PHASE1
Brief 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 ...
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04907526
Start Date
June 1 2021
End Date
August 30 2025
Last Update
June 27 2025
Active Locations (6)
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1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35233
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Mayo Clinic
Rochester, Minnesota, United States, 55905