Clinical Trials

Inclusion Criteria:

• Child’s UCB-MNC product is determined by the sponsor to be acceptable for release to the investigational site for investigational use.
• Mother’s serology test results are negative for HIV, Hepatitis B, and Hepatitis C.
• Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glenn surgery.
• Ages up to 18 months are eligible if written informed consent can be obtained from both parents (unless one parent is not reasonably available) and/or legal guardians.

Exclusion Criteria

• History of DMSO reaction for either the child or mother.
• Parent(s)/child unwilling to participate.
• Child with severe chronic diseases, extensive extra-cardiac syndromic features, or history of cancer.
• Child has not completed or will not be completing all pre-procedure work-up within 10 days of the Stage II Glenn surgery as listed in section 6 of this protocol AND lack of pre-procedure work-up documented as a safety concern by a site investigator.
• Child whose cells have been compromised after cells released to investigational site.
• Child with the following complications of their congenital heart disease:
  • Any condition requiring urgent, or unplanned procedure within 15 days prior to Stage II surgical repair;
  • 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 during or after Stage II surgical repair.