This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.
This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) was delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 10 antenatally diagnosed HLHS patients within 2-3 days of birth. Safety and clinical status monitoring was performed to Stage II surgical intervention for HLHS (at approximately 3 months of age). Treated patients will continue to be assessed beyond the trial during follow up between Stage II and III (Fontan) surgical interventions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation
Royal Children's Hospital
Melbourne, Victoria, Australia
Incidence of adverse cardiac events
Monitoring of adverse events including death, heart or other organ failure, myocardial infarction, sustained/symptomatic ventricular tachycardia, bleeding, stroke
Time frame: 1 month
Change in right ventricular function -fractional shortening (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-diastolic wall thickness (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-diastolic volume (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-systolic volume (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Increase in body weight
Body weight measured in kilograms
Time frame: baseline, 1 month, 3 months, 12 months
Composite measure of height and head circumference
Body height and head circumference measured in meters
Time frame: baseline, 1 month, 3 months, 12 months
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