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

Heart Defects, Congenital Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03431480
Study type Interventional
Source Murdoch Childrens Research Institute
Contact
Status Completed
Phase Phase 1
Start date February 16, 2018
Completion date June 30, 2022
View Details
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