NCT03431480

Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery

Safety Study of Autologous Cord Blood Stem Cell Treatment in Hypoplastic Left Heart Syndrome Patients Undergoing the Norwood Heart Operation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 2 Days – 4 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoplastic Left Heart Syndrome
• Heart Defects, Congenital
• Pediatric Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Placental Cord Blood Mononuclear Cells	Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation

Timeline

• Start date: 2018-02-16
• Primary completion: 2021-11-01
• Completion: 2022-06-30
• First posted: 2018-02-13
• Last updated: 2022-07-22

Locations

1 site across 1 country: Australia