Autologous Bone Marrow Stem Cells in Ischemic Stroke.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00535197
First received: September 25, 2007
Last updated: July 2, 2012
Last verified: July 2012
  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 or partial anterior circulation syndrome (TACS/PACS).


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:


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 ] [ Designated as safety issue: Yes ]
    safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results


Secondary Outcome Measures:
  • Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery
    intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
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.

  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) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00535197     History of Changes
Other Study ID Numbers: HHSC/003
Study First Received: September 25, 2007
Last Updated: July 2, 2012
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 July 22, 2014