Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Cerebellar Ataxia Clinical Trial

Official title:

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649687
• Other study ID #: SB-VGH-201001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 10, 2012
• Last updated: September 11, 2014
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation	Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)	12 months	Yes
Secondary	Alterations in SARA score		12 months	No
Secondary	Positron emission tomography	18F-FDG used for the assessment of glucose metabolism in the brain	9 months	No
Secondary	Magnetic resonance spectroscopy	NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity	12 months	No
Secondary	Assessment of language and swallowing functions	changes in levels of severity: normal/slight/mild/moderate/severe	12 months	No
Secondary	Evaluation of syncope	Tilt table test	12 months	No
Secondary	Balance test		12 months	No