search
Back to results

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Primary Purpose

Cerebellar Ataxia

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Allogeneic adult adipose-derived mesenchymal stem cells
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stem cells(MSC) treatment

Arm Description

All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells

Outcomes

Primary Outcome Measures

Safety evaluation
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)

Secondary Outcome Measures

Alterations in SARA score
Positron emission tomography
18F-FDG used for the assessment of glucose metabolism in the brain
Magnetic resonance spectroscopy
NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
Assessment of language and swallowing functions
changes in levels of severity: normal/slight/mild/moderate/severe
Evaluation of syncope
Tilt table test
Balance test

Full Information

First Posted
April 10, 2012
Last Updated
September 11, 2014
Sponsor
National Yang Ming University
search

1. Study Identification

Unique Protocol Identification Number
NCT01649687
Brief Title
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Official Title
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells(MSC) treatment
Arm Type
Experimental
Arm Description
All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
Allogeneic adult adipose-derived mesenchymal stem cells
Intervention Description
Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety evaluation
Description
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Alterations in SARA score
Time Frame
12 months
Title
Positron emission tomography
Description
18F-FDG used for the assessment of glucose metabolism in the brain
Time Frame
9 months
Title
Magnetic resonance spectroscopy
Description
NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
Time Frame
12 months
Title
Assessment of language and swallowing functions
Description
changes in levels of severity: normal/slight/mild/moderate/severe
Time Frame
12 months
Title
Evaluation of syncope
Description
Tilt table test
Time Frame
12 months
Title
Balance test
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

We'll reach out to this number within 24 hrs