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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by National University of Malaysia
Sponsor:
Collaborator:
Cytopeutics Sdn Bhd
Information provided by (Responsible Party):
Dr Norlinah Mohamed Ibrahim, National University of Malaysia
ClinicalTrials.gov Identifier:
NCT01461720
First received: October 25, 2011
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by National University of Malaysia:

Primary Outcome Measures:
  • Change in NIH Stroke Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in Barthel Index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in modified Rankin Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in size of infarct based on brain MRI stroke sequences [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Stroke Specific Quality of Life Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in Stroke Impact Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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)
  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.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
  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: March 30, 2015
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, Middle Cerebral Artery
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Infarction
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on September 01, 2015