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

Prof Thanh Phan0 个研究点目标入组 8 人开始时间: 2018年1月18日最近更新: 2021年12月27日

适应症

试验速览

The trial show safety of amnion stem cell up to 8 million cell/kg

•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.

•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).

发起方

Prof Thanh Phan