Trial record 14 of 36 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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by National University of Malaysia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cytopeutics Pte. Ltd.
Information provided by (Responsible Party):
Dr Norlinah Mohamed Ibrahim, National University of Malaysia
ClinicalTrials.gov Identifier:
NCT01461720
First received: October 25, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

Current emphasis of acute ischemic stroke treatment is directed primarily at restoring perfusion to reduce the total infarct volume by either intravenous or mechanical thrombolysis and by preventing recurrent event rates with anti-platelet therapy. Although effective in appropriately selected patients, thrombolytic therapy and other pharmacological-based neuroprotective strategies can only be administered to patients who present within hours of stroke onset. In reality, approximately less than 10% of patients with acute ischemic stroke will ultimately benefit from such treatments.

There is a pressing need to develop other treatment modalities which could restore cell function, especially in strokes involving large arterial territory such as the middle cerebral artery, as subsequent disability rates are higher. One of the most promising neurorestorative strategies in ischemic stroke, which has gained importance recently, is cell based therapy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct

Resource links provided by NLM:


Further study details as provided by National University of Malaysia:

Primary Outcome Measures:
  • Change from baseline in neurologic deficit by NIH Stroke Scale [ Time Frame: 3 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in functional recovery by Barthel Index [ Time Frame: 6 weeks, 3 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in functional recovery by modified Rankin Scale [ Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in size of infarct at 6 and 12 months by MRI [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in quality of life at 12 months by Stroke Specific Quality of Life Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life at 12 months by Stroke Impact Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard medical care 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: Bone marrow mesenchymal stem cells
Autologous bone marrow-derived mesenchymal stem cells
Biological: Autologous bone marrow-derived mesenchymal stem cells
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experiences stroke onset within 1 week to 2 months
  • NIHSS score of >10-30
  • Never received 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)
  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: NCT01461720

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

Locations
Malaysia
UKM Medical Centre Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Norlinah Mohamed Ibrahim, MD         
Principal Investigator: Norlinah Mohamed Ibrahim, MD         
Sub-Investigator: Hui-Jan Tan, MD         
Sponsors and Collaborators
National University of Malaysia
Cytopeutics Pte. Ltd.
Investigators
Principal Investigator: Norlinah Mohamed Ibrahim, MD UKM Medical Centre
  More Information

No publications provided

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
Study First Received: October 25, 2011
Last Updated: October 26, 2011
Health Authority: Malaysia: Institutional Review Board
Malaysia: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014