Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Phase 1

Completed

• Conditions: Cerebellar Ataxia
• Interventions: Biological: Allogeneic adult adipose-derived mesenchymal stem cells

• Registration Number: NCT01649687
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-10
• Study Start: 2012-05
• Study First Submitted QC: 2012-07-22
• Study First Posted: 2012-07-25
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells(MSC) treatment	Allogeneic adult adipose-derived mesenchymal stem cells	All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Safety evaluation	12 months	Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan