Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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).
- 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.