Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome (AutoCell-S2)

This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into
the myocardium of the right ventricle of the heart at the time of Stage II surgical repair
will provide an improvement in cardiac function, reaching growth and developmental
milestones, and quality of life, while also providing a reduction in the cumulative days of
hospitalization following Stage II surgical repair. Long-term improvement in cardiac
function, reaching growth and developmental milestones, reaching Stage III surgical repair
pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of
life will also be determined.

Inclusion Criteria:

- Child that participated in the UCB Collection protocol with autologous UCB-MNC product
that is acceptable for use (treatment arm only).

- Child with HLHS or HLHS variant with single right ventricular dependent CHD having
undergone Stage I surgical repair and Stage II surgical repair.

- Child is < 9 months of age.

Exclusion Criteria:

- History of DMSO reaction for either the child or mother (treatment arm only).

- Parent(s) and/or guardian(s) unwilling to have their child participate or unwilling to
follow the study procedures.

- Child with severe chronic diseases at the discretion of the treating physician.

- Extensive extra-cardiac syndromic features.

- Known history of cancer.

- Child with the following complications of their congenital heart disease:

1. Any condition requiring urgent, or unplanned 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 during or after Stage II surgical repair.