Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring Hypoplastic Left Heart Syndrome, HLHS, Congenital Heart Disease, Umbilical Cord Blood, UCB, Cord blood, Stem cells, Regenerative therapy, Stage II Glenn, Glenn Surgery, single ventricle
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Children's of Alabama
- Children's Hospital of Los Angeles
- Children's Hospital Colorado
- Ocshner Medical Center
- Children's Hospitals of Minnesota
- Cincinnati Children's Hospital and Medical Center
- Oklahoma University Medical Center
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Treatment
Control
Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery .
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study.