CompletedPhase 1ACTRN12618000076279

Trial of Amnion Cell Therapy for Ischaemic Stroke (I-ACT)

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

Sponsor

Prof Thanh Phan

Enrollment

8 participants

Start Date

Feb 4, 2019

Study Type

Interventional

Conditions

Ischaemic Stroke

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Inclusion Criteria4

Patients are eligible if:
-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;
-age is between 18-85 years old;
-have National Institute of Health Stroke Scale/NIHSS (tool used in clinical trials for measuring stroke severity) between 6-15.

Exclusion Criteria7

Patients are excluded if there is evidence of:
-autoimmune disease, organ transplant, malignancy, splenectomised individuals, or have infection at the time of stroke;
-neurodegenerative disease such as dementia or Parkinson’s disease;
-pregnancy;
-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;
eligible for TPA and/or ECR;
-patients with mild stroke (NIHSS <6) or very severe stroke (NIHSS >15).

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Interventions

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