Back to resultsTrial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Primary Purpose
Multiple System Atrophy
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
autologous mesenchymal stem cells
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Multiple System Atrophy focused on measuring voluntary participants, 75 years old or less
Eligibility Criteria
Inclusion Criteria:
- 75 Years Old or Less
- Multiple System Atrophy
- Voluntary Participants
Exclusion Criteria:
- Doubted dementia (MMSE < 24)
- Severe febrile condition
- Serum SGOT/SGPT three times above
- Malignant mass
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
normal saline
autologous mesenchymal stem cells
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00911365
Brief Title
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Official Title
A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
voluntary participants, 75 years old or less
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Title
autologous mesenchymal stem cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
autologous mesenchymal stem cells
Intervention Description
4*107 stem cell (100ml) Intra arterial infusion/ one time, then 4*107 stem cell(100ml)Intravenous infusion 3 times/monthly
-> Total four times
Intervention Type
Biological
Intervention Name(s)
normal saline
Intervention Description
saline
Primary Outcome Measure Information:
Title
Scores on unified MSA rating scale
Description
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.
Time Frame
one month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
75 Years Old or Less
Multiple System Atrophy
Voluntary Participants
Exclusion Criteria:
Doubted dementia (MMSE < 24)
Severe febrile condition
Serum SGOT/SGPT three times above
Malignant mass
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
We'll reach out to this number within 24 hrs