Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct
NCT ID: NCT01461720
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2012-03-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard medical care
This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke
Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
BM-MSCs
Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)
Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Autologous bone marrow-derived mesenchymal stem cells
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
Interventions
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Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Autologous bone marrow-derived mesenchymal stem cells
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
Eligibility Criteria
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Inclusion Criteria
* NIHSS score of \>10-35
* Never received or failed thrombolysis
* Evidence of unilateral middle cerebral artery infarct on brain MRI
Exclusion Criteria
* Evidence of any tumor or other space-occupying lesion on brain MRI
* Evidence of hemorrhagic stroke on brain CT or MRI
* Experiences transient ischemic attack or lacunar infarct
* Has any acute or chronic infections such as Hepatitis B, Hepatitis C and HIV
* Is diagnosed with concurrent malignancy or primary hematological disorders
* Renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min
* Liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range
* Any contraindication to stem cell transplantation or bone marrow biopsy
* Any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis)
* Any contraindication to brain MRI (eg. metal implants, pacemaker, joint implants and ocular implants)
30 Years
75 Years
ALL
No
Sponsors
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Cytopeutics Sdn. Bhd.
INDUSTRY
National University of Malaysia
OTHER
Responsible Party
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Dr Norlinah Mohamed Ibrahim
Consultant Neurologist
Principal Investigators
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Norlinah Mohamed Ibrahim, MD
Role: PRINCIPAL_INVESTIGATOR
UKM Medical Centre
Locations
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UKM Medical Centre
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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Norlinah Mohamed Ibrahim, MD
Role: primary
Other Identifiers
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FF-115-2011
Identifier Type: -
Identifier Source: org_study_id
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