Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)
Congenital Heart Disease (CHD)
About this trial
This is an interventional treatment trial for Congenital Heart Disease (CHD)
Eligibility Criteria
Inclusion Criteria:
- Neonatal and young infantile patients who are ≤ 3 months of age
Scheduled to undergo reparative two-ventricle repair for congenital heart defects without aortic arch reconstruction, including the following:
a. D-Transposition of the Great Arteries (d-TGA) Group: i. d-TGA with intact ventricular septum (d-TGA, IVS) ii. d-TGA with ventricular septal defect (d-TGA, VSD) b. Ventricular Septal Defect (VSD) Group: i. VSD without aortic arch obstruction (AAO) ii. Complete common atrioventricular canal defect (CAVC) c. Tetralogy of Fallot (TOF) Group: i. Tetralogy of Fallot (TOF) ii. Tetralogy of Fallot with Pulmonary Atresia (TOF,PA) iii. Truncus arteriosus (TA) iv. Double outlet right ventricle (DORV)
- Scheduled surgery at or before three months of age.
- Parent/guardian capable of providing informed consent.
Exclusion Criteria:
- Birth weight less than 2.0 kg
- Recognizable phenotypic syndrome
- Associated extracardiac anomalies of greater than minor severity
- Previous cardiac surgery
- Associated cardiovascular anomalies requiring aortic arch reconstruction and/or additional open cardiac surgical procedures in infancy
- Prior severe hypoxic event
- Significant screening test values that place subjects at increased risk of complications from participation in the study
Sites / Locations
- Children's National Health System
Arms of the Study
Arm 1
Experimental
Bone marrow-derived mesenchymal stromal cell (BM-MSC)
The dose-escalation methods with a modified continual reassessment at the five dose levels (1x10^6, 10x10^6, 20x10^6, 40x10^6, 80x10^6 cells/kg) will be performed to determine safety and feasibility of allogeneic BM-MSC infusion during pediatric cardiac surgery and the maximum tolerated dose in infants with CHD.