A Phase I/II safety and tolerability study following autologous infusion of adult haematopoietic cells to patients with acute total anterior circulation ischaemic stroke
- Conditions
- Acute Total Anterior Circulation Ischaemic Stroke
- Registration Number
- EUCTR2006-000281-36-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Symptoms and signs of clinically definite acute stroke
Time of onset is known & treatment can be started within 7 days of onset
CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
The stroke is severe and conforming to total anterior circulation phenotype (weakness, homonymous hemianopia and focal cognitive deficit (e.g. aphasia) or reduction in consciousness.
An age range of 30 to 80 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Known defect of clotting or platelet function
Haematological causes of stroke
Severe co-morbidity
Hepatic or renal dysfuction
Patients with evidence of life-threatening infection (e.g. HIV) or life-threatening illness (e.g. advanced cancer)
Patient should be excluded if blood glucose <3.0 or >20.0mmol/L
Patient was already dependent in activities of daily living before the present stroke.
Patients who have been included in any other clinical trial within the previous month
Patients who are unavailable for follow-up (e.g. no fixed home address)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method