None listed
Conditions
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).
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
Sponsors
Prof Thanh Phan
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed