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Trial record 46 of 66 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct

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ClinicalTrials.gov Identifier: NCT01461720
Recruitment Status : Unknown
Verified March 2015 by Dr Norlinah Mohamed Ibrahim, National University of Malaysia.
Recruitment status was:  Recruiting
First Posted : October 28, 2011
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Cytopeutics Sdn Bhd
Information provided by (Responsible Party):
Dr Norlinah Mohamed Ibrahim, National University of Malaysia

Brief Summary:
This study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.

Condition or disease Intervention/treatment Phase
Middle Cerebral Artery Infarction Other: Standard medical care Biological: Autologous bone marrow-derived mesenchymal stem cells Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open Lable, Phase II Exploratory Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Standard medical care
This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke
Other: Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.

Experimental: BM-MSCs
Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)
Other: Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.

Biological: Autologous bone marrow-derived mesenchymal stem cells
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.




Primary Outcome Measures :
  1. Change in NIH Stroke Scale [ Time Frame: 1 year ]
  2. Change in Barthel Index [ Time Frame: 1 year ]
  3. Change in modified Rankin Scale [ Time Frame: 1 year ]
  4. Change in size of infarct based on brain MRI stroke sequences [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change in Stroke Specific Quality of Life Scale [ Time Frame: 1 year ]
  2. Change in Stroke Impact Scale [ Time Frame: 1 year ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experiences stroke onset within 2 weeks to 2 months
  • NIHSS score of >10-35
  • Never received or failed thrombolysis
  • Evidence of unilateral middle cerebral artery infarct on brain MRI

Exclusion Criteria:

  • Medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity)
  • 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)

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 ClinicalTrials.gov identifier (NCT number): NCT01461720


Contacts
Contact: Norlinah Mohamed Ibrahim, MD norlinah@ppukm.ukm.edu.my, norlinah@gmail.com

Locations
Malaysia
UKM Medical Centre Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Norlinah Mohamed Ibrahim, MD         
Principal Investigator: Norlinah Mohamed Ibrahim, MBBCH,MRCP,BAO         
Sub-Investigator: Hui-Jan Tan, MRCP, MMed         
Sponsors and Collaborators
National University of Malaysia
Cytopeutics Sdn Bhd
Investigators
Principal Investigator: Norlinah Mohamed Ibrahim, MD UKM Medical Centre

Responsible Party: Dr Norlinah Mohamed Ibrahim, Consultant Neurologist, National University of Malaysia
ClinicalTrials.gov Identifier: NCT01461720     History of Changes
Other Study ID Numbers: FF-115-2011
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Dr Norlinah Mohamed Ibrahim, National University of Malaysia:
Bone marrow
Autologous
Mesenchymal stem cells
Unilateral middle cerebral artery infarct

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases