Autologous Bone Marrow Stem Cells in Ischemic Stroke. (NCT00535197) | Clinical Trial Compass
CompletedPhase 1/2
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
United Kingdom5 participantsStarted 2007-09
Plain-language summary
The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).
Who can participate
Age range30 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results