Status:
COMPLETED
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Eligibility:
All Genders
2-4 years
Phase:
PHASE1
Brief 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 sy...
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 cardiop...
Eligibility Criteria
Inclusion
- Male and females with antenatally diagnosed Hypoplastic Left Heart Syndrome (all types requiring Norwood operation)
- Written informed consent by parents/legal guardian
- Successful aseptic collection of autologous cord blood unit and transfer of buffy coat mononucleocyte fraction to cold storage pending cardiac surgery within 2-4 days
Exclusion
- Patient:
- does not have autologous cord blood cells available at the time of cardiopulmonary bypass surgery
- has evidence of arrhythmia requiring anti-arrhythmia therapy
- has an additional congenital diagnosis that contributes to conditions such as an immune system disorder, immune deficiency, complex metabolic disorder, brain dysplasia or progressive neurological degenerative disorder
- has other clinical complexity deemed by the cardiac surgeon to make the patient unsuitable for inclusion in the trial
- Mother:
- • is serum positive for HIV, hepatitis or other significant pathogen and has known allergies to penicillin, streptomycin or other antibiotic
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03431480
Start Date
February 16 2018
End Date
June 30 2022
Last Update
July 22 2022
Active Locations (1)
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1
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052