Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.

All subjects with the diagnosis of hypoplastic left heart syndrome (HLHS) undergo a
palliative reconstructive surgery performed in the first two weeks of life, termed the
Norwood procedure. The second stage in the palliation of HLHS is a scheduled bidirectional
cavopulmonary anastomosis (BDCPA) that occurs between 4 to 6 months of age. During this
surgery when the patient is on cardiopulmonary bypass for the BDCPA, the study product will
be given from the previously harvested, isolated, and expanded autologous c-kit+ cardiac stem
cells into the aorta directly through the cardioplegia needle into the coronary circulation.

In summary, the aim is to overlay a novel cell therapeutic strategy on the two-stage surgical
procedures that HLHS patients typically undergo in the first year of life: Stage I Norwood
operation in the neonatal period and Stage II BDPCA operation at approximately 4 months of
age.

Inclusion Criteria:

For inclusion in the study, subjects must meet all of the inclusion criteria:

1. Subjects < 28 days of age.

2. Subjects with hypoplastic left heart syndrome (all types) requiring Norwood surgery.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are met:

1. Subjects with HLHS and restrictive or intact atrial septum.

2. Subjects undergoing the Norwood procedure who do not have HLHS.

3. Subjects with significant coronary artery sinusoids.

4. Subjects with birth weights of less than 2 kilograms

5. Subjects requiring mechanical circulatory support prior to surgery

6. Subjects with underlying evidence of arrhythmia requiring anti-arrhythmia therapy

7. Subjects who are unwilling or unable to comply with necessary follow-up

8. Subjects who are unsuitable for inclusion in the study in the opinion of the
investigators