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Trial registered on ANZCTR


Registration number
ACTRN12624000968572
Ethics application status
Approved
Date submitted
23/07/2024
Date registered
8/08/2024
Date last updated
8/08/2024
Date data sharing statement initially provided
8/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Autologous cord blood-derived cell therapy for extremely preterm infants: An international, multicentre randomised controlled trial
Scientific title
Effect of autologous cord blood-derived cell therapy on neurodevelopment of extremely preterm infants: An international, multicentre randomised controlled trial
Secondary ID [1] 312585 0
Nil
Universal Trial Number (UTN)
Trial acronym
CORD-CELL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 334509 0
preterm brain injury 334510 0
Condition category
Condition code
Reproductive Health and Childbirth 331125 331125 0 0
Complications of newborn
Neurological 331182 331182 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One to two intravenous infusions of autologous umbilical cord blood derived cells (UCBCs) at a dose of 50 million total nucleated cells per kg given over 1 hour

Cord blood collected from baby's own umbilical cord, processed, UCBCs characterized, cryopreserved, and then infused when all testing confirms cell product is safe to use.
Infusion between Day 10-15 - one or two infusion depending on number of UCBCs extracted
Administered in participating neonatal units under site investigator supervision by a registered nurse using an intravenous pump.
Standard operating procedures will be harmonized across sites, with regular coordinating centre input and feedback.
Intervention code [1] 329103 0
Treatment: Other
Comparator / control treatment
Placebo therapy (0.9% normal saline) given intravenously over 1 hour (1 or 2 infusions as per above)
Control group
Placebo

Outcomes
Primary outcome [1] 338881 0
Survival free of moderate-severe neurodisability at 24-30 months of corrected age (moderate-severe disability defined as any component of Bayley-4 (or III as available) scores less than 2 standard deviations (SD), cerebral palsy GMFCS grade >2, deafness, blindness (<6/60) or other moderate-severe neurological impairment)
Timepoint [1] 338881 0
24-30 months of corrected age
Secondary outcome [1] 437781 0
Survival free of early features of significant neurodisability (based on General Movement Assessment, Hammersmith Infant Neurological Examination and medical assessment at 3-4 months corrected age (where available))
Timepoint [1] 437781 0
3-4 months corrected age
Secondary outcome [2] 437782 0
Serious adverse events related to UCBC administration during and for 48 hrs post-infusion
Timepoint [2] 437782 0
24-48 hrs post cell infusion
Secondary outcome [3] 437783 0
Death, until 24-30 months of corrected age
Timepoint [3] 437783 0
24-30 months CA
Secondary outcome [4] 438233 0
Bayley-4 (or III) individual scores as assessed at 24-30 months of corrected age
Timepoint [4] 438233 0
24-30 months CA
Secondary outcome [5] 438234 0
Developmental delay, assessed any time until 24-30 months of corrected age
Timepoint [5] 438234 0
24-30 months CA
Secondary outcome [6] 438235 0
Cerebral palsy (including GMFCS grade), assessed at 24 -30 months of corrected age
Timepoint [6] 438235 0
24-30 months CA
Secondary outcome [7] 438236 0
Blindness (<6/60), assessed any time until 24-30 months corrected age
Timepoint [7] 438236 0
24-30 months CA
Secondary outcome [8] 438237 0
Deafness, assessed any time until 24-30 months corrected age
Timepoint [8] 438237 0
24-30 months CA
Secondary outcome [9] 438238 0
Moderate to severe bronchopulmonary dysplasia, assessed at 36 weeks of postmenstrual age
Timepoint [9] 438238 0
Term corrected age
Secondary outcome [10] 438239 0
Severe retinopathy of prematurity (needing treatment) or its sequalae, assessed anytime until 24-30 months corrected age
Timepoint [10] 438239 0
24-30 months CA
Secondary outcome [11] 438240 0
Necrotising enterocolitis (>Bell’s stage IIa), assessed before neonatal discharge
Timepoint [11] 438240 0
Neonatal discharge
Secondary outcome [12] 438241 0
Culture proven neonatal sepsis, assessed before neonatal discharge
Timepoint [12] 438241 0
Neonatal discharge
Secondary outcome [13] 438242 0
Term equivalent age MRI findings (where available): brain injury score (Kidokoro)
Timepoint [13] 438242 0
Term equivalent age
Secondary outcome [14] 438398 0
Term equivalent age MRI findings (where available): growth measurements of brain structures
Timepoint [14] 438398 0
Term equivalent age

Eligibility
Key inclusion criteria
Extremely preterm infants born less than 28 weeks completed gestation
Minimum age
0 Days
Maximum age
0 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Extremely preterm infants where parental consent could not be obtained, or where a major brain malformation was known antenatally.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will happen automatically via the web-based system. Only members of the laboratory team (preparing the final product) will be aware of the allocation after eligibility has been confirmed and randomisation done. Coloured syringes and infusion tubing will be used to administer the intervention and control/placebo infusions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using permuted random blocks and will be stratified by site and gestational age (less than or more than 26 weeks at birth).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2029
Actual
Date of last data collection
Anticipated
31/07/2032
Actual
Sample size
Target
334
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 26445 0
United States of America
State/province [1] 26445 0
Country [2] 26446 0
Canada
State/province [2] 26446 0
Country [3] 26447 0
Singapore
State/province [3] 26447 0

Funding & Sponsors
Funding source category [1] 317016 0
Government body
Name [1] 317016 0
Monash Health
Country [1] 317016 0
Australia
Funding source category [2] 317020 0
Government body
Name [2] 317020 0
NHMRC
Country [2] 317020 0
Australia
Primary sponsor type
Government body
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 319261 0
University
Name [1] 319261 0
Monash University
Address [1] 319261 0
Country [1] 319261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315772 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315772 0
Ethics committee country [1] 315772 0
Australia
Date submitted for ethics approval [1] 315772 0
16/01/2024
Approval date [1] 315772 0
30/04/2024
Ethics approval number [1] 315772 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135746 0
A/Prof Atul Malhotra
Address 135746 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 135746 0
Australia
Phone 135746 0
+61385723650
Fax 135746 0
Email 135746 0
atul.malhotra@monash.edu
Contact person for public queries
Name 135747 0
Atul Malhotra
Address 135747 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 135747 0
Australia
Phone 135747 0
+61385723650
Fax 135747 0
Email 135747 0
atul.malhotra@monash.edu
Contact person for scientific queries
Name 135748 0
Atul Malhotra
Address 135748 0
Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
Country 135748 0
Australia
Phone 135748 0
+61385723650
Fax 135748 0
Email 135748 0
atul.malhotra@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.