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Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT01649687
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cerebellar Ataxia Biological: Allogeneic adult adipose-derived mesenchymal stem cells Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Study Start Date : May 2012
Primary Completion Date : January 2014
Study Completion Date : January 2014


Arms and Interventions

Arm Intervention/treatment
Experimental: Mesenchymal stem cells(MSC) treatment
All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells
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


Outcome Measures

Primary Outcome Measures :
  1. Safety evaluation [ Time Frame: 12 months ]
    Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)


Secondary Outcome Measures :
  1. Alterations in SARA score [ Time Frame: 12 months ]
  2. Positron emission tomography [ Time Frame: 9 months ]
    18F-FDG used for the assessment of glucose metabolism in the brain

  3. Magnetic resonance spectroscopy [ Time Frame: 12 months ]
    NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity

  4. Assessment of language and swallowing functions [ Time Frame: 12 months ]
    changes in levels of severity: normal/slight/mild/moderate/severe

  5. Evaluation of syncope [ Time Frame: 12 months ]
    Tilt table test

  6. Balance test [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649687


Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Yang Ming University
More Information

Responsible Party: Oscar Kuang-Sheng Lee, Director of Stem Cell Research Centre, National Yang Ming University
ClinicalTrials.gov Identifier: NCT01649687     History of Changes
Other Study ID Numbers: SB-VGH-201001
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases