Status:
COMPLETED
Pilot Investigation of Stem Cells in Stroke
Lead Sponsor:
ReNeuron Limited
Conditions:
Stroke
Eligibility:
MALE
60-85 years
Phase:
PHASE1
Brief Summary
The study is designed to test the safety of a manufactured neural stem cell line (CTX cells) delivered by injection into the damaged brains of male patients 60 years of age or over who remain moderate...
Detailed Description
Design: The trial is an open label, single administration, ascending dose, single site trial using CTX neural stem cells with 24-month patient monitoring following treatment. Pre-treatment selection ...
Eligibility Criteria
Inclusion
- Males
- 60 years or over
- Unilateral ischemic stroke involving subcortical white matter or Basal Ganglia 6 months to 5 years before entry
- NIHSS score minimum 6 with hemiparesis (2 or more for motor arm and leg)
- Neurologically stable for 2 m
- modified Rankin score of 2-4
- Fit for general anesthesia, neurosurgery
- Capacity to consent
- Infarct at least 1cm diameter
Exclusion
- Structural brain vascular lesions requiring surgery or increasing the risk of stereotaxic implantation
- Unstable medical conditions with expected survival \<12 months
- Any medical condition that would impair participation (eg progressive neurological disorders, mental illness)
- Major surgery within 30 days
- Previous allogeneic tissue transplant
- MMSE \< 24
- Epilepsy
- Coagulation disorders or anticoagulant treatment that cannot be interrupted
- Stimulants, botox, tamoxifen
- Contraindications to MRI
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01151124
Start Date
June 1 2010
End Date
October 1 2022
Last Update
July 6 2023
Active Locations (1)
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1
Division of Clinical Neurosciences, Glasgow Southern General Hospital
Glasgow, United Kingdom, G51 4TF