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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431480
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Salvatore Pepe, Murdoch Childrens Research Institute

Study Description
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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 syndrome (HLHS) patients.

Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Heart Defects, Congenital Pediatric Disorder Biological: Autologous Human Placental Cord Blood Mononuclear Cells Phase 1

Detailed Description:
This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) will be delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 12 antenatally diagnosed HLHS patients within 2-3 days of birth. Safety and clinical status monitoring will performed to Stage II surgical intervention for HLHS (at approximately 3 months of age). Treated patients will be continue to be assessed during follow up between Stage II and III (Fontan) surgical interventions.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: hCBMNC
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
Other Name: Cord blood buffycoat mononuclear cells, incl stem cells


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Increase in body weight [ Time Frame: baseline, 1 month, 3 months, 12 months ]
    Body weight measured in kilograms

  6. Composite measure of height and head circumference [ Time Frame: baseline, 1 month, 3 months, 12 months ]
    Body height and head circumference measured in meters


Eligibility Criteria
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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Salvatore Pepe +61 3 9345 4114 salvatore.pepe@mcri.edu.au; salvatore.pepe2@rch.org.au
Contact: Christian P Brizard +61 3 9345 5200 christian.brizard@mcri.edu.au; christian.brizard@rch.org.au

Locations
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Australia, Victoria
Royal Children's Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Salvatore Pepe    +61 3 9345 4114    salvatore.pepe@mcri.edu.au; salvatore.pepe2@rch.org.au   
Contact: Christian P Brizard    +61 3 9345 5200    christian.brizard@mcri.edu.au; christian.brizard@rch.org.au   
Sponsors and Collaborators
Murdoch Childrens Research Institute
Investigators
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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)
More Information
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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: September 2, 2020
Last Verified: August 2020
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.

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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
Keywords provided by Salvatore Pepe, Murdoch Childrens Research Institute:
cord blood stem cell
Norwood heart surgery
congenital
heart
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Congenital Abnormalities
Syndrome
Disease
 Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases