NCT00911365

Brief Summary

This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2008

Typical duration for phase_2

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

Study Start

First participant enrolled

May 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2011

Enrollment Period

3.1 years

First QC Date

May 26, 2009

Last Update Submit

August 2, 2011

Conditions

Multiple System Atrophy

Keywords

voluntary participants75 years old or less

Outcome Measures

Primary Outcomes (1)

  • Scores on unified MSA rating scale

    The statistical difference between scores before and after autologous mesenchymal stem cells treatment of unified MSA rating scale will be measured every month and every year using paired t-test.

    one month

Study Arms (2)

normal saline

PLACEBO COMPARATOR
Biological: normal saline

autologous mesenchymal stem cells

EXPERIMENTAL
Biological: autologous mesenchymal stem cells

Interventions

autologous mesenchymal stem cellsBIOLOGICAL

4\*107 stem cell (100ml) Intra arterial infusion/ one time, then 4\*107 stem cell(100ml)Intravenous infusion 3 times/monthly -\> Total four times

autologous mesenchymal stem cells
normal salineBIOLOGICAL

saline

normal saline

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Years Old or Less
  • Multiple System Atrophy
  • Voluntary Participants

You may not qualify if:

  • Doubted dementia (MMSE \< 24)
  • Severe febrile condition
  • Serum SGOT/SGPT three times above
  • Malignant mass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120752, South Korea

Location

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2009

First Posted

June 1, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-07

Locations

KR(1)