Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle

IRB-P00020575

Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS), unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged LV recruitment following bidirectional Glenn (BDG) or undergoing BDG with plans for LV recruitment will be considered for enrollment in this study. Those patients enrolled in the study will be randomized to either the experimental arm or control arm of the study. Those patients randomized to the experimental arm will receive mesenchymal precursor cells (MPCs) injected directly into the LV endocardium during their LV recruitment or BDG procedure. Those patients randomized to the control arm will receive normal standard of care during their procedure with no injection of MPCs. It is believed that injection of MPCs will help improve the chances of those patients with single ventricle or borderline left ventricle being converted to biventricular circulation which could improve quality of life and longevity over palliation.

2017-11-27

2022-12-19

2024-01-01

Active (not recruiting)

Early phase I

19

Inclusion Criteria: * Patients with a history of single ventricle palliation (Stage 1 palliation, PA band, or hybrid procedure) undergoing bidirectional Glenn (BDG) with simultaneous left ventricle (LV) recruitment procedures or those patients undergoing LV recruitment procedures will be considered for enrollment. Exclusion Criteria: * Patients with current or history of myocardial tumors * Patients with aortic or mitral atresia * Patients with a history of high grade ventricular arrhythmias * Patients with a known allergy to dimethyl sulfoxide (DMSO) * Patient has known allergy to mouse and/or cow products. * Patient is prior recipient of stem cell therapy for cardiac repair. * Patient has received treatment and/or is within an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization.

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2023-04-21