Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells | NCT01649687

Studies
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

NCT01649687

Sponsor

National Yang Ming Chiao Tung University

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

7Actual

Phase

Phase 1Phase 2

Conditions

Cerebellar Ataxia

Interventions

Allogeneic adult adipose-derived mesenchymal stem cells

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Jul 22, 2012

First Posted Date

Jul 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oscar Kuang-Sheng Lee, Director of Stem Cell Research Centre, National Yang Ming Chiao Tung UniversityPrincipal Investigator

Lead Sponsor

National Yang Ming Chiao Tung UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stem cells(MSC) treatment	Experimental	All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells	Biological: Allogeneic adult adipose-derived mesenchymal stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allogeneic adult adipose-derived mesenchymal stem cells	Biological	Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Alterations in SARA score		12 months
Positron emission tomography	18F-FDG used for the assessment of glucose metabolism in the brain	9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D002524	Cerebellar Ataxia

Ancestor Terms

ID	Term
D002526	Cerebellar Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided