95
Participants
Start Date
June 6, 2019
Primary Completion Date
May 22, 2022
Study Completion Date
February 28, 2026
Autologous (self) mononuclear cells derived from umbilical cord blood
The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair.
Stage II Surgical repair
This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Children's Hospital of Philadelphia, Philadelphia
Children's of Alabama, Birmingham
Cincinnati Children's Hospital and Medical Center, Cincinnati
Children's Hospitals of Minnesota, Minneapolis
Ocshner Medical Center, New Orleans
Oklahoma University Medical Center, Oklahoma City
Children's Hospital Colorado, Aurora
Children's Hospital of Los Angeles, Los Angeles
Collaborators (1)
University of Oklahoma
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Hospital Los Angeles
OTHER
Children's Hospital Colorado
OTHER
Children's Hospitals and Clinics of Minnesota
OTHER
Ochsner Health System
OTHER
Children's of Alabama
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Timothy J Nelson, MD, PhD
OTHER