Status:
ACTIVE_NOT_RECRUITING
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Lead Sponsor:
Timothy J Nelson, MD, PhD
Collaborating Sponsors:
University of Oklahoma
Children's Hospital of Philadelphia
Conditions:
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief Summary
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 sing...
Detailed Description
This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into the myocardium of the right ventricle of the heart at the time of Stage II surgical repair will provide an...
Eligibility Criteria
Inclusion
- Diagnosis of HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and undergoing Stage II surgical repair.
- Less than 13 months of age at time of Stage II surgical repair
- Previous participation in the UCB collection protocol with autologous UCB-MNC product that is acceptable for use (treatment arm only)
Exclusion
- History of DMSO reaction (treatment arm only).
- Parent(s) and/or legal guardian(s) 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.
- Known history of cancer.
- Any of the following complications of his/her congenital heart disease:
- Any condition requiring urgent, or unplanned interventional procedure within 15 days prior to Stage II surgical repair, 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 to the stem cell product or its injection procedure, during or after Stage II surgical repair.
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03779711
Start Date
June 6 2019
End Date
February 1 2026
Last Update
July 8 2025
Active Locations (8)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Ocshner Medical Center
New Orleans, Louisiana, United States, 70121