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Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01649687
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University

Tracking Information
First Submitted Date  ICMJE April 10, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
Safety evaluation [ Time Frame: 12 months ]
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebellar Ataxia
Intervention  ICMJE Biological: Allogeneic adult adipose-derived mesenchymal stem cells
Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells
Study Arms  ICMJE Experimental: Mesenchymal stem cells(MSC) treatment
All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells
Intervention: Biological: Allogeneic adult adipose-derived mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2014)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2012)
8
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
  • Subject's SARA score at 10~20 points.
  • Ages between 20~70 years.
  • Signed informed consent from the patient and/or guardian.

Exclusion Criteria:

  • Subjects enrolled in any other cell therapy studies within the past 30 days.
  • Pregnancy test positive.
  • Subjects deemed to be not suitable for the study by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649687
Other Study ID Numbers  ICMJE SB-VGH-201001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oscar Kuang-Sheng Lee, National Yang Ming University
Study Sponsor  ICMJE National Yang Ming University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Yang Ming University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP