Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

This study has been completed.
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: September 11, 2014
Last verified: September 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Resource links provided by NLM:


Further study details as provided by National Yang Ming University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: May 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649687

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

No publications provided

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
Study First Received: April 10, 2012
Last Updated: September 11, 2014
Health Authority: Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014