Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle
Hypoplastic Left Heart Syndrome, Atrioventricular Canal
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring biventricular conversion
Eligibility Criteria
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.
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Treatment Arm
Control Arm
Those randomized to the treatment arm will receive MPCs injected directly into the LV endocardium following clinical surgical maneuvers to recruit the LV (mitral valve repair, aortic valve repair, and/or resection of endocardial fibroelastosis) or BDG. MPCs will be delivered directly into the LV endocardium via a 23-25 gauge needle following completion of all surgical procedures. A total dose of 20 million cells will be delivered, divided evenly into ~11 injections of 50 µL each. The total volume is not to exceed 2.0 mL.
Those subjects randomized to the control arm will receive standard LV recruitment or BDG with no injection.