- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535197
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
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 Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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London
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Paddington, London, United Kingdom, W2 1NY
- St Marys Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CD34+ stem/progenitor cell therapy
Patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≥8).
CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery.
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intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Time Frame: Duration of study
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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
Outcome Measure |
Time Frame |
---|---|
Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.
Time Frame: Duration of study
|
Duration of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nagy Habib, Professor, Imperial College London U.K.
Publications and helpful links
General Publications
- Banerjee S, Bentley P, Hamady M, Marley S, Davis J, Shlebak A, Nicholls J, Williamson DA, Jensen SL, Gordon M, Habib N, Chataway J. Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke. Stem Cells Transl Med. 2014 Nov;3(11):1322-30. doi: 10.5966/sctm.2013-0178. Epub 2014 Aug 8.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Brain Infarction
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Cerebral Infarction
- Infarction
- Stroke
- Ischemic Stroke
- Infarction, Middle Cerebral Artery
Other Study ID Numbers
- HHSC/003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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