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

NCT03431480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-07-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Salvatore Pepe · Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)

  • Christian P Brizard · Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Days
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2021-11-01
Completion
2022-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431480 on ClinicalTrials.gov