Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
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ClinicalTrials.gov Identifier: NCT03431480 |
Recruitment Status :
Completed
First Posted : February 13, 2018
Last Update Posted : July 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hypoplastic Left Heart Syndrome Heart Defects, Congenital Pediatric Disorder | Biological: Autologous Human Placental Cord Blood Mononuclear Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Safety |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety Study of Autologous Cord Blood Stem Cell Treatment in Hypoplastic Left Heart Syndrome Patients Undergoing the Norwood Heart Operation |
Actual Study Start Date : | February 16, 2018 |
Actual Primary Completion Date : | November 1, 2021 |
Actual Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
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Experimental: hCBMNC
Autologous human placental cord blood mononuclear cells (buffy coat fraction)
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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
Other Name: Cord blood buffycoat mononuclear cells, incl stem cells |
- Incidence of adverse cardiac events [ Time Frame: 1 month ]Monitoring of adverse events including death, heart or other organ failure, myocardial infarction, sustained/symptomatic ventricular tachycardia, bleeding, stroke
- Change in right ventricular function -fractional shortening (% units) [ Time Frame: baseline, 1 month, 3 months, 12 months ]Measured by cardiac imaging with serial echocardiography and MRI scans
- Change in right ventricular end-diastolic wall thickness (% units) [ Time Frame: baseline, 1 month, 3 months, 12 months ]Measured by cardiac imaging with serial echocardiography and MRI scans
- Change in right ventricular end-diastolic volume (% units) [ Time Frame: baseline, 1 month, 3 months, 12 months ]Measured by cardiac imaging with serial echocardiography and MRI scans
- Change in right ventricular end-systolic volume (% units) [ Time Frame: baseline, 1 month, 3 months, 12 months ]Measured by cardiac imaging with serial echocardiography and MRI scans
- Increase in body weight [ Time Frame: baseline, 1 month, 3 months, 12 months ]Body weight measured in kilograms
- Composite measure of height and head circumference [ Time Frame: baseline, 1 month, 3 months, 12 months ]Body height and head circumference measured in meters

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Ages Eligible for Study: | 2 Days to 4 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431480
Australia, Victoria | |
Royal Children's Hospital | |
Melbourne, Victoria, Australia, 3052 |
Principal Investigator: | Salvatore Pepe | Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics) | |
Principal Investigator: | 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) |
Responsible Party: | Salvatore Pepe, Trial Study Coordinator, Murdoch Childrens Research Institute |
ClinicalTrials.gov Identifier: | NCT03431480 |
Other Study ID Numbers: |
HREC37112A |
First Posted: | February 13, 2018 Key Record Dates |
Last Update Posted: | July 22, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | IPD may be available following study publication and discussion between CIs and other researchers regarding future multicentre studies. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
cord blood stem cell Norwood heart surgery congenital heart |
Heart Defects, Congenital Hypoplastic Left Heart Syndrome Congenital Abnormalities Syndrome Disease |
Pathologic Processes Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |