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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: National University of Malaysia

Current Primary Outcome:

  • Change in NIH Stroke Scale [ Time Frame: 1 year ]
  • Change in Barthel Index [ Time Frame: 1 year ]
  • Change in modified Rankin Scale [ Time Frame: 1 year ]
  • Change in size of infarct based on brain MRI stroke sequences [ Time Frame: 1 year ]


Original Primary Outcome:

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


Current Secondary Outcome:

  • Change in Stroke Specific Quality of Life Scale [ Time Frame: 1 year ]
  • Change in Stroke Impact Scale [ Time Frame: 1 year ]


Original Secondary Outcome:

  • Change from baseline in quality of life at 12 months by Stroke Specific Quality of Life Scale [ Time Frame: 12 months ]
  • Change from baseline in quality of life at 12 months by Stroke Impact Scale [ Time Frame: 12 months ]


Information By: National University of Malaysia

Dates:
Date Received: October 25, 2011
Date Started: March 2012
Date Completion: March 2016
Last Updated: March 30, 2015
Last Verified: March 2015