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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911365
First Posted: June 1, 2009
Last Update Posted: August 4, 2011
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.
Information provided by:
Yonsei University
  Purpose
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
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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911365


Locations
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
ClinicalTrials.gov Identifier: NCT00911365     History of Changes
Other Study ID Numbers: 4-2008-0137
First Submitted: May 26, 2009
First Posted: June 1, 2009
Last Update Posted: August 4, 2011
Last Verified: July 2011

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

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases