Overview

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

Status:
Not yet recruiting

Trial end date:
2025-07-01

Target enrollment:
30

Participant gender:
All

Summary

Male or female neonates, < 28 days (inclusive) diagnosed with hypoplastic left heart syndrome (HLHS) undergoing Stage I surgery. A total of 30 patients will be enrolled for this pilot study in a staged enrollment diagnosed with HLHS.All patients will be followed for 12 months post-treatment.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Joshua M Hare

Collaborator:

University of Maryland

Criteria

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