Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

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:
• •1. 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
• •2. Severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure)
• •3. 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.