Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000662763
Ethics application status
Approved
Date submitted
26/04/2022
Date registered
5/05/2022
Date last updated
5/05/2022
Date data sharing statement initially provided
5/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Stem cells following haemorrhagic or ischaemic fetal stroke (STELLAR)
Scientific title
The feasibility and safety of autologous umbilical cord blood derived cell administration following antenatally diagnosed fetal stroke
Secondary ID [1] 307000 0
Nil
Universal Trial Number (UTN)
Trial acronym
STELLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal stroke 326117 0
Condition category
Condition code
Stroke 323473 323473 0 0
Haemorrhagic
Stroke 323474 323474 0 0
Ischaemic
Reproductive Health and Childbirth 323475 323475 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous umbilical cord blood derived cell administration in babies with known antenatal fetal stroke
- intervention delivered by doctors/ nurses
- dose 25-50 million cells/ kg - up to 3 infusions
- infusion lasting 1 hour- repeat infusion after 5 days
- under direct supervision of research team
Intervention code [1] 323444 0
Treatment: Other
Comparator / control treatment
No control group in this Phase I trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331177 0
Feasibility of autologous cord blood collection and cell retrieval following antenatal diagnosis of fetal stroke, as proven by at least 20 mls of cord blood collected after cord clamping at birth (cord collection by research team)
Timepoint [1] 331177 0
At the end of cord blood collection and processing (first 48 hours)
Primary outcome [2] 331178 0
Safety of umbilical cord blood derived cells (UCBC) administration as determined by absence of any adverse events (AE) necessitating cessation of cell infusion (e.g. anaphylaxis or major change in cardio-respiratory status), or any AE attributable to cell administration within first 48 hours of infusion (e.g. bacterial infection).
These will be assessed by close monitoring and collection of data on a case report from by research team.
Timepoint [2] 331178 0
48 hours post cell infusion(s)
Secondary outcome [1] 409095 0
Neurodevelopmental assessments at 3-4 months (GMA, HINE)
Timepoint [1] 409095 0
3-4 months of (corrected) age
Secondary outcome [2] 409096 0
Neurodevelopmental assessments at 1 year (HINE, GMFM-66 scale)
Timepoint [2] 409096 0
1 year (corrected) age
Secondary outcome [3] 409097 0
Neurodevelopmental assessments at 2 year (BSID-IV, hearing, vision, physical assessment).
Timepoint [3] 409097 0
2 years corrected age

Eligibility
Key inclusion criteria
Infants with brain injury associated with fetal stroke after confirmation of brain injury on postnatal imaging (Cranial ultrasound, MRI brain) soon after birth. Whilst there is no gestational age cut off, it is expected most infants will be born at or near term gestation.
Minimum age
5 Days
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants who are likely to have redirection of care (palliation) for any reason.

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



Intervention assignment
Single group
Other design features
Feasibility and safety study
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
NA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22249 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 37413 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311311 0
Hospital
Name [1] 311311 0
Monash Health
Country [1] 311311 0
Australia
Funding source category [2] 311312 0
Government body
Name [2] 311312 0
NHMRC
Country [2] 311312 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 312682 0
None
Name [1] 312682 0
Address [1] 312682 0
Country [1] 312682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310815 0
Monash Health HREC
Ethics committee address [1] 310815 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 310815 0
Australia
Date submitted for ethics approval [1] 310815 0
Approval date [1] 310815 0
15/03/2022
Ethics approval number [1] 310815 0
Provisional

Summary
Brief summary
We propose that i) collection of sufficient cord blood will be feasible in infants with antenatally diagnosed fetal stroke, and ii) (multiple) autologous intravenous administration of processed umbilical cord blood derived cells in these infants in the newborn period will be safe.
This phase I trial will be the first study in the translational pipeline for this neurological condition, and will test the feasibility of cord blood collection, sufficient cell availability and safety of cell administration in this vulnerable group. Following successful completion of this study, an efficacy trial will be planned to determine the efficacy of autologous UCB cell administration in fetal stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118958 0
A/Prof Atul Malhotra
Address 118958 0
Monash Health
246 Clayton Rd
Clayton VIC 3168
Country 118958 0
Australia
Phone 118958 0
+613 857 23650
Fax 118958 0
Email 118958 0
atul.malhotra@monash.edu
Contact person for public queries
Name 118959 0
A/Prof Atul Malhotra
Address 118959 0
Monash Health
246 Clayton Rd
Clayton
VIC 3168
Country 118959 0
Australia
Phone 118959 0
+61 3 857 23650
Fax 118959 0
Email 118959 0
atul.malhotra@monash.edu
Contact person for scientific queries
Name 118960 0
A/Prof Atul Malhotra
Address 118960 0
Monash Health
246 Clayton Rd
Clayton
VIC 3168
Country 118960 0
Australia
Phone 118960 0
+61 400 108 901
Fax 118960 0
Email 118960 0
atul.malhotra@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All relevant information
When will data be available (start and end dates)?
Start - After end of study and publication
No end date
Available to whom?
Researchers and clinicians on reasonable request
Available for what types of analyses?
Systematic reviews
How or where can data be obtained?
Contact atul.malhotra@monash.edu


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.