Autologous Bone Marrow Stem Cells in Ischemic Stroke.
Information source: Imperial College London
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke, Acute; Infarction, Middle Cerebral Artery
Intervention: Infusion of autologous CD34+ stem cells into middle cerebral artery (Procedure)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Imperial College London Official(s) and/or principal investigator(s):
Nagy Habib, Professor, Principal Investigator, Affiliation: Imperial College London U.K.
Overall contact:
Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK), Phone: 020 7886 6666, Ext: 6889, Email: Jeremy.Chataway@imperial.nhs.uk
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 anterior circulation syndrome (TACS).
Clinical Details
Official title: A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-Selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke
Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Primary outcome: Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Secondary outcome: Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.
Detailed description:
The proposed trial will involve the recruitment of a total of 10 patients.
The cells will be collected from each subject recruited, via bone marrow sampling. CD34+
stem cells will then be isolated and harvested during a process of immuno-selection in
accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be
directly infused into the area of the stroke intra-arterially using the middle cerebral
artery.
Initially, the investigator will monitor each patient for a period of 6 months post-stem
cell infusion. Thereafter, they will be subjected to a final review after a further one
month, before reverting to their previous treatment regime in the clinic.
Assessment of adverse events will be by physical examination and measurement of laboratory
parameters. Assessment of efficacy will be by physical examination and the measurement of
laboratory, CT and MRI parameters.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
- An age range of 30-80 years old
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
Locations and Contacts
Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK), Phone: 020 7886 6666, Ext: 6889, Email: Jeremy.Chataway@imperial.nhs.uk
St Marys Hospital, Paddington, London W2 1NY, United Kingdom; Recruiting
Soma Banerjee, BSc(Hons), MBBS, MRCP(UK), Phone: +44 20 7886 6889, Email: soma.banerjee08@imperial.ac.uk
Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK), Principal Investigator
Additional Information
Starting date: September 2007
Ending date: June 2010
Last updated: February 13, 2009
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