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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03431480




Registration number
NCT03431480
Ethics application status
Date submitted
30/01/2018
Date registered
13/02/2018
Date last updated
22/07/2022

Titles & IDs
Public title
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
Scientific title
Safety Study of Autologous Cord Blood Stem Cell Treatment in Hypoplastic Left Heart Syndrome Patients Undergoing the Norwood Heart Operation
Secondary ID [1] 0 0
HREC37112A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoplastic Left Heart Syndrome 0 0
Heart Defects, Congenital 0 0
Pediatric Disorder 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Autologous Human Placental Cord Blood Mononuclear Cells

Experimental: hCBMNC - Autologous human placental cord blood mononuclear cells (buffy coat fraction)


Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse cardiac events
Timepoint [1] 0 0
1 month
Secondary outcome [1] 0 0
Change in right ventricular function -fractional shortening (% units)
Timepoint [1] 0 0
baseline, 1 month, 3 months, 12 months
Secondary outcome [2] 0 0
Change in right ventricular end-diastolic wall thickness (% units)
Timepoint [2] 0 0
baseline, 1 month, 3 months, 12 months
Secondary outcome [3] 0 0
Change in right ventricular end-diastolic volume (% units)
Timepoint [3] 0 0
baseline, 1 month, 3 months, 12 months
Secondary outcome [4] 0 0
Change in right ventricular end-systolic volume (% units)
Timepoint [4] 0 0
baseline, 1 month, 3 months, 12 months
Secondary outcome [5] 0 0
Increase in body weight
Timepoint [5] 0 0
baseline, 1 month, 3 months, 12 months
Secondary outcome [6] 0 0
Composite measure of height and head circumference
Timepoint [6] 0 0
baseline, 1 month, 3 months, 12 months

Eligibility
Key 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
Minimum age
2 Days
Maximum age
4 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03431480
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Salvatore Pepe
Address 0 0
Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03431480