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Trial from ANZCTR

I-ACT: Phase I trial of Amnion Cell Therapy for Ischaemic Stroke to establish the maximum tolerable dose

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Not yet submitted
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
    (provisional)
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 18/1/2018)
  • Ethics status: Not yet submitted
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618000076279p

Date registered

18 January 2018

Health condition

Ischaemic Stroke

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

30 April 2018

Ethics application status

Not yet submitted

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).

Eligibility

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

Gender

Both males and females

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;
3)-pregnancy;
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).

Contact details and further information

Primary Sponsor

Type: Individual
Name: Prof Thanh Phan
Address: Monash Medical Centre, Monash Health
246 Clayton Rd Clayton
VIC Australia 3168
Country: Australia

Contact person for information and recruitment

Prof Thanh Phan
Monash Medical Centre, 246 Clayton Rd Clayton VIC 3168
Australia
613-85722612
thanh.phan@monash.edu