Autologous Bone Marrow Stem Cells in Ischemic Stroke.


Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Symptoms and signs of clinically definite acute stroke
- Time of stroke onset is known and 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 the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
- An age range of 30-80 years old
- Stroke confined to MCA territory on CT or MRI brain imaging
- NIHSS score >/= 8

Exclusion Criteria

- Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
- Haematological causes of stroke
- Severe co-morbidity
- Hepatic or renal dysfunction
- The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
- Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L
- Patient is likely to be unavailable for follow-up e.g. no fixed home address
- Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
- Patient was already dependent in activities of daily living before the present acute stroke
- Patients who have been included in any other clinical trial within the previous month