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Trial record 19 of 19 for:    Open Studies | "Cerebellar Diseases"
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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
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 8
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649687

Contacts
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

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
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: July 25, 2012
Health Authority: Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013