NCT01649687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

April 10, 2012

Last Update Submit

September 11, 2014

Conditions

Cerebellar Ataxia

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation

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

    12 months

Secondary Outcomes (6)

  • Alterations in SARA score

    12 months

  • Positron emission tomography

    9 months

  • Magnetic resonance spectroscopy

    12 months

  • Assessment of language and swallowing functions

    12 months

  • Evaluation of syncope

    12 months

  • +1 more secondary outcomes

Study Arms (1)

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

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

Mesenchymal stem cells(MSC) treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Stem Cell Research Centre

Study Record Dates

First Submitted

April 10, 2012

First Posted

July 25, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

TW(1)