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Trial record 6 of 74 for:    "multiple system atrophy"

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

This study has been completed.
Information provided by:
Yonsei University Identifier:
First received: May 26, 2009
Last updated: August 2, 2011
Last verified: July 2011
This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).

Condition Intervention Phase
Multiple System Atrophy Biological: autologous mesenchymal stem cells Biological: normal saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.

Enrollment: 27
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: normal saline Biological: normal saline
Experimental: autologous mesenchymal stem cells 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


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00911365

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Philhyu Lee/Associate Professor, Severance Hospital Identifier: NCT00911365     History of Changes
Other Study ID Numbers: 4-2008-0137
Study First Received: May 26, 2009
Last Updated: August 2, 2011

Keywords provided by Yonsei University:
voluntary participants
75 years old or less

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017