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

This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).

Completed

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Key information

Conditions

Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Primary Dysautonomias Synucleinopathies

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, 120752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous mesenchymal stem cells

Biological

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

-> Total four times

Normal Saline

Biological

saline

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jun 1, 2009
Registry last updated: Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed