Cerebellar Ataxia
Conditions
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.
Interventions
BIOLOGICALAllogeneic adult adipose-derived mesenchymal stem cells
Patients will receive intravenously one dose of 5-7x10\^7 cells of allogeneic adipose-derived mesenchymal stem cells
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 12 months | Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positron emission tomography | 9 months | 18F-FDG used for the assessment of glucose metabolism in the brain |
| Magnetic resonance spectroscopy | 12 months | NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity |
| Alterations in SARA score | 12 months | — |
| Evaluation of syncope | 12 months | Tilt table test |
| Balance test | 12 months | — |
| Assessment of language and swallowing functions | 12 months | changes in levels of severity: normal/slight/mild/moderate/severe |
Countries
Taiwan
Outcome results
None listed