Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

National Yang Ming Chiao Tung University7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebellar Ataxia

Interventions

Allogeneic adult adipose-derived mesenchymal stem cellsBIOLOGICAL

Patients will receive intravenously one dose of 5-7x10\^7 cells of allogeneic adipose-derived mesenchymal stem cells

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Safety evaluation

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

Time frame: 12 months

Secondary Outcomes

Alterations in SARA score

Time frame: 12 months

Positron emission tomography

18F-FDG used for the assessment of glucose metabolism in the brain

Time frame: 9 months

Magnetic resonance spectroscopy

NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity

Time frame: 12 months

Assessment of language and swallowing functions

changes in levels of severity: normal/slight/mild/moderate/severe

Time frame: 12 months

Evaluation of syncope

Tilt table test

Time frame: 12 months

Balance test

Time frame: 12 months

Data from ClinicalTrials.gov

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