Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

• Status: Terminated
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joshua M Hare; Longeveron Inc.
• Collaborator: University of Maryland

Criteria

Inclusion Criteria:

• Subjects with hypoplastic left heart syndrome (all types) requiring BDCPA surgery.

Exclusion Criteria:

• Have HLHS and restrictive or intact atrial septum.

• Be undergoing the Norwood procedure that do not have HLHS.

• Have significant coronary artery sinusoids.

• Require mechanical circulatory support prior to surgery.

• Have an underlying evidence of arrhythmia requiring anti-arrhythmia therapy.

• Parent or guardian unwilling or unable to comply with necessary follow-up(s)

• Be serum positive for HIV, hepatitis BsAg (B Surface Antigen) or viremic hepatitis C.

• Be unsuitable for inclusion in the study, in the opinion of the investigator.

• Need for concomitant surgery for aortic coarctation or tricuspid valve repair.