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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of Amnion Cell Therapy for Ischaemic Stroke (I-ACT)
Scientific title
I-ACT: Phase I trial of Amnion Cell Therapy for Ischaemic Stroke to establish the maximum tolerable dose
Secondary ID [1] 293728 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Amnion Cell Therapy for Ischaemic Stroke (I-ACT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Stroke 306092 0
Condition category
Condition code
Stroke 305218 305218 0 0

Study type
Description of intervention(s) / exposure
dose escalation of amnion stem cell. the dose is given once intravenously in the hospital after acute ischaemic stroke. The design is similar to 3+3 dose escalation. The first group of 3 patients receives 2 million cells/kg. the next group receives 4 million cells/kg. the next group receives 8 million cells/kg, then 16 million cells/kg and the final group receives 32 million cells/kg
Intervention code [1] 299979 0
Treatment: Other
Comparator / control treatment
No control group
Control group

Primary outcome [1] 304374 0
the maximal tolerable dose (MTD) is estimated using the BOIN package (R statistical foundation)
Timepoint [1] 304374 0
90 days post stroke onset
Primary outcome [2] 304446 0
We define a treatment-emergent adverse effect/AE (TEAE) as any event not present before the initiation of treatment or any event already present that worsened in either intensity or frequency after exposure to the study treatment. We classify TEAEs as mild, moderate, severe or life-threatening according to standard procedures. Dose-limiting toxicity (DLT) is defined here to be equivalent to SAE and includes any untoward effect such as death, life threatening, requires hospitalisation (for outpatient), prolonged hospitalisation (for inpatients) or requires intervention to prevent permanent damage.
Timepoint [2] 304446 0
90 days
Secondary outcome [1] 341759 0
National Institute of Health Stroke Scale (NIHSS)
Timepoint [1] 341759 0
90 days post stroke onset
Secondary outcome [2] 341760 0
volume of vasogenic oedema on MRI
Timepoint [2] 341760 0
5-7 days post stroke onset
Secondary outcome [3] 341761 0

Infarct expansion ratio on MRI (between initial MR scan and at 1 week)
Timepoint [3] 341761 0
5-7 days post stroke onset

Key inclusion criteria
Patients are eligible if:
1)-they have ischaemic stroke in the territory of the large main artery (middle cerebral artery); 2)- present within 24 hours of stroke onset and are not eligible for TPA or clot retrieval;
3)-age is between 18-85 years old;
4)-have National Institute of Health Stroke Scale/NIHSS (tool used in clinical trials for measuring stroke severity) between 6-15.
Minimum age
18 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients are excluded if there is evidence of:
1)-autoimmune disease, organ transplant, malignancy, splenectomised individuals, or have infection at the time of stroke;
2)-neurodegenerative disease such as dementia or Parkinson’s disease;
4)-have contra-indications for MR imaging [patients with initial infarct (on DWI) volume <5 ml will also be excluded. This is a common strategy used in many studies to exclude infarcts with very small volume and likely good outcome;
5) eligible for TPA and/or ECR;
6)-patients with mild stroke (NIHSS <6) or very severe stroke (NIHSS >15).

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
dose escalation 3+3
Phase 1
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistics will be used to describe patient demographics, safety and SAE of hAEC.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9694 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 18463 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 298343 0
Government body
Name [1] 298343 0
Address [1] 298343 0
Physical address

16 Marcus Clarke St
Canberra ACT 2601
Postal address
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601
Country [1] 298343 0
Primary sponsor type
Prof Thanh Phan
Monash Medical Centre, Monash Health
246 Clayton Rd Clayton
VIC Australia 3168
Secondary sponsor category [1] 297462 0
Name [1] 297462 0
Monash Health
Address [1] 297462 0
246 Clayton Rd Clayton VIC Australia 3168
Country [1] 297462 0

Ethics approval
Ethics application status
Ethics committee name [1] 299336 0
The Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 299336 0
246 Clayton Rd Clayton VIC 3168
Ethics committee country [1] 299336 0
Date submitted for ethics approval [1] 299336 0
Approval date [1] 299336 0
Ethics approval number [1] 299336 0

Brief summary
This trial is a dose escalation study to determine the maximal tolerable dose of human amnion stem cell for the treatment of acute ischaemic stroke (focal brain ischaemia from blood clot obstructing the vessel lumen).
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 80098 0
Prof Thanh Phan
Address 80098 0
Monash Medical Centre, 246 Clayton Rd Clayton VIC 3168
Country 80098 0
Phone 80098 0
Fax 80098 0
Email 80098 0
Contact person for public queries
Name 80099 0
Prof Thanh Phan
Address 80099 0
Monash Medical Centre, 246 Clayton Rd Clayton VIC 3168
Country 80099 0
Phone 80099 0
Fax 80099 0
Email 80099 0
Contact person for scientific queries
Name 80100 0
Prof Thanh Phan
Address 80100 0
Monash Medical Centre, 246 Clayton Rd Clayton, VIC 3168
Country 80100 0
Phone 80100 0
Fax 80100 0
Email 80100 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
de-identified data will be provided and analysed as a group
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 845 0
Statistical analysis plan
Citation [1] 845 0
Link [1] 845 0
Email [1] 845 0
Other [1] 845 0
Attachment [1] 845 0
Summary results
No Results