Autologous Bone Marrow Stem Cells in Ischemic Stroke

NIHR

UK Clinical Trials, clinical research london

Primary Trial ID Number
NCT00535197

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).
Research Details
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 revert 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.
Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Study Type
Interventional
Intervention
Procedure : Infusion of autologous CD34+ stem cells into middle cerebral artery
Intervention Type
See Interventions above
Primary Outcome Measures

Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results; Duration of study
Secondary Outcome Measures

Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.; Duration of study

Gender
Both
Age Range
30 Years – 80 Years
Who Can Participate
Patients
Number of Participants
10
Participant Inclusion 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

Trial Location(s)
St Mary’s Hospital
Paddington
London
W2 1NY

Trial Contact(s)
Primary Trial Contact

Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK)
Jeremy.Chataway@imperial.nhs.uk
6889 020 7886 6666

Countries Recruiting
United Kingdom

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=17796 →