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

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911365
• Other study ID #: 4-2008-0137
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2009
• Last updated: August 2, 2011
• Start date: May 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

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
• normal saline
saline

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on unified MSA rating scale	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.	one month	No