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Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

This study is currently recruiting participants.
Verified July 2012 by National Yang Ming University
Sponsor:
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT01649687
First received: April 10, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes

April 10, 2012
July 25, 2012
May 2012
March 2014   (final data collection date for primary outcome measure)
Safety evaluation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
Same as current
Complete list of historical versions of study NCT01649687 on ClinicalTrials.gov Archive Site
  • Alterations in SARA score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Positron emission tomography [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    18F-FDG used for the assessment of glucose metabolism in the brain
  • Magnetic resonance spectroscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
  • Assessment of language and swallowing functions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    changes in levels of severity: normal/slight/mild/moderate/severe
  • Evaluation of syncope [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Tilt table test
  • Balance test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebellar Ataxia
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
March 2015
March 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
Contact: Bing-Wen Soong, MD/PhD 886-2871-2121 ext 3178 bwsoong@ym.edu.tw
Contact: Oscar Kuang-sheng Lee, MD/PhD 886-2875-7391 kslee@vghtpe.gov.tw
Taiwan
 
NCT01649687
SB-VGH-201001
Yes
Oscar Kuang-Sheng Lee, National Yang Ming University
National Yang Ming University
Not Provided
Not Provided
National Yang Ming University
July 2012

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