Clinical Trial: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Brief Summary: The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.

Detailed Summary:
Sponsor: National Yang Ming University

Current Primary Outcome: Safety evaluation [ Time Frame: 12 months ]

Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Alterations in SARA score [ Time Frame: 12 months ]
  • Positron emission tomography [ Time Frame: 9 months ]
    18F-FDG used for the assessment of glucose metabolism in the brain
  • Magnetic resonance spectroscopy [ Time Frame: 12 months ]
    NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
  • Assessment of language and swallowing functions [ Time Frame: 12 months ]
    changes in levels of severity: normal/slight/mild/moderate/severe
  • Evaluation of syncope [ Time Frame: 12 months ]
    Tilt table test
  • Balance test [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: National Yang Ming University

Dates:
Date Received: April 10, 2012
Date Started: May 2012
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014