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Trial record 13 of 168 for:    stem cell stroke

Autologous Bone Marrow Stem Cells in Ischemic Stroke.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535197
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Imperial College London

Brief 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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

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.
Biological: Infusion of autologous CD34+ stem cells into middle cerebral artery
intra-arterial infusion into ipsilateral MCA, via trans-femoral approach

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535197

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United Kingdom
St Marys Hospital
Paddington, London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Nagy Habib, Professor Imperial College London U.K.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London Identifier: NCT00535197     History of Changes
Other Study ID Numbers: HHSC/003
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Middle Cerebral Artery
Additional relevant MeSH terms:
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Pathologic Processes
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases