A Phase 1 interventional study of Autologous Human Placental Cord Blood Mononuclear Cells in Hypoplastic Left Heart Syndrome, Heart Defects, Congenital and Pediatric Disorder, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Australia. Open to participants aged 2 Days to 4 Days. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Murdoch Childrens Research Institute · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
67 studies on the registry are indexed under Hypoplastic Left Heart Syndrome; 12 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 41 interventional studies indexed under Hypoplastic Left Heart Syndrome.
Browse Hypoplastic Left Heart Syndrome studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient:
Mother:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autologous human placental cord blood mononuclear cells (buffy coat fraction)
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
Also known as: Cord blood buffycoat mononuclear cells, incl stem cells
Incidence of adverse cardiac events
Monitoring of adverse events including death, heart or other organ failure, myocardial infarction, sustained/symptomatic ventricular tachycardia, bleeding, stroke
Time frame: 1 month
Change in right ventricular function -fractional shortening (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-diastolic wall thickness (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-diastolic volume (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Change in right ventricular end-systolic volume (% units)
Measured by cardiac imaging with serial echocardiography and MRI scans
Time frame: baseline, 1 month, 3 months, 12 months
Increase in body weight
Body weight measured in kilograms
Time frame: baseline, 1 month, 3 months, 12 months
Composite measure of height and head circumference
Body height and head circumference measured in meters
Time frame: baseline, 1 month, 3 months, 12 months
Plan to share: Undecided — IPD may be available following study publication and discussion between CIs and other researchers regarding future multicentre studies.
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Nov 2021, 44 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hypoplastic Left Heart Syndrome →
Murdoch Childrens Research Institute