Autologous Bone Marrow Stem Cells in Ischemic Stroke. - Full Text View

Sponsor:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00535197

Purpose

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).

Condition	Intervention	Phase
Stroke, Acute Infarction, Middle Cerebral Artery	Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

Genetics Home Reference related topics: cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results [ Time Frame: Duration of study ]

Secondary Outcome Measures:

Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale. [ Time Frame: Duration of study ]

Estimated Enrollment:	10
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535197

Contacts

Contact: Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK)

020 7886 6666 ext 6889

Jeremy.Chataway@imperial.nhs.uk

Locations

United Kingdom
St Marys Hospital	Recruiting
Paddington, London, United Kingdom, W2 1NY
Contact: Soma Banerjee, BSc(Hons), MBBS, MRCP(UK) +44 20 7886 6889 soma.banerjee08@imperial.ac.uk
Principal Investigator: Jeremy Chataway, MA, BM BCH, PhD, MRCP (UK)

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Nagy Habib, Professor

Imperial College London U.K.

More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.

ClinicalTrials.gov Identifier:	NCT00535197 History of Changes
Other Study ID Numbers:	HHSC/003
Study First Received:	September 25, 2007
Last Updated:	February 13, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Infarction
Stroke
Cerebral Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 22, 2012