Safety of UCB-MNC Delivered into the Myocardium in HLHS Subjects
Phase I safety of autologous umbilical cord blood derived mononuclear cells during surgical Stage II palliation of Hypoplastic Left Heart Syndrome
To determine the safety and feasibility of autologous umbilical cord blood-derived mononuclear cells delivered into the myocardium of the right ventricle during planned Stage II Glen surgical procedure for individuals with hypoplastic left heart syndrome.
CHLA IRB Number
1. Child's autologous Umbilical cord blood as the source for mononuclear cells (UCB-MNC)product is determined by the sponsor to be acceptable for release to the investigational site for investigational use. 2. Mother's serology test results are negative for HIV, Hepatitis B, and Hepatitis C. 3. Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glen surgery. 4. Ages up to 18 months are eligible
Does this study also recruit healthy volunteers?