Clinical Research Directory

Inclusion Criteria: * Diagnosis of a congenital hear defect with functionally single right ventricle (such as HLHS, HLHS variants, unbalanced AV septal defect with R dominance, DORV with Hypoplastic LV) undergoing Fontan surgical palliation * At least 2 and less than or equal to 5 years of age at time of Fontan surgical palliation * For subjects enrolling in the treatment arm, previous participation in clinical trial Umbilical Cord Blood Collection and Processing for Hypoplastic Left Heart Syndrome patients (NCT01856049) with autologous UCB-MNC product collected and available for distribution is required. Exclusion Criteria: * History of DMSO reaction (treatment arm only subjects). * Parent(s) or legal guardian 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. * History of cancer. * Any of the following complications of his/her congenital heart disease: * any condition requiring urgent, or unplanned intervention procedure within 15 days prior to Fontan surgical palliation, 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 tot he stem cell product or its injection procedure, during or after Fontan surgical palliation. * Individuals with severe heart failure that requires heart transplantation * Individuals with refractory or worsening arrhythmia * Individuals with an automated implantable cardioverter defibrillator (AICD) or pacemaker * Patient with prior surgical complications during the Fontan surgical palliation that resulted in or could be reasonably expected to significantly decrease cardiac function