Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery (NCT03431480) | Clinical Trial Compass
CompletedPhase 1
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
Australia10 participantsStarted 2018-02-16
Plain-language 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.
Who can participate
Age range2 Days – 4 Days
SexALL
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Inclusion Criteria:
* 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 Criteria:
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