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Trial record 13 of 90 for:    "Brain Diseases" AND "Multiple System Atrophy"

Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00911365
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Yonsei University

Tracking Information
First Submitted Date  ICMJE May 26, 2009
First Posted Date  ICMJE June 1, 2009
Last Update Posted Date August 4, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
Scores on unified MSA rating scale [ Time Frame: one month ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
Unified MSA rating scale by every month and every year
Change History Complete list of historical versions of study NCT00911365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Official Title  ICMJE A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Multiple System Atrophy
Intervention  ICMJE
  • Biological: autologous mesenchymal stem cells

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

    -> Total four times

  • Biological: normal saline
    saline
Study Arms  ICMJE
  • Placebo Comparator: normal saline
    Intervention: Biological: normal saline
  • Experimental: autologous mesenchymal stem cells
    Intervention: Biological: autologous mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2011)
27
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00911365
Other Study ID Numbers  ICMJE 4-2008-0137
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philhyu Lee/Associate Professor, Severance Hospital
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP