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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00911365
First received: May 26, 2009
Last updated: August 2, 2011
Last verified: July 2011
  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 Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911365

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

No publications provided

Responsible Party: Philhyu Lee/Associate Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT00911365     History of Changes
Other Study ID Numbers: 4-2008-0137
Study First Received: May 26, 2009
Last Updated: August 2, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on April 17, 2014