Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

September 11, 2014 updated by: Oscar Kuang-Sheng Lee, National Yang Ming University
The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: 12 months
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations in SARA score
Time Frame: 12 months
12 months
Positron emission tomography
Time Frame: 9 months
18F-FDG used for the assessment of glucose metabolism in the brain
9 months
Magnetic resonance spectroscopy
Time Frame: 12 months
NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
12 months
Assessment of language and swallowing functions
Time Frame: 12 months
changes in levels of severity: normal/slight/mild/moderate/severe
12 months
Evaluation of syncope
Time Frame: 12 months
Tilt table test
12 months
Balance test
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

July 22, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-VGH-201001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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