Multiple System AtrophyPhase 2NCT00911365
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
A Phase 2 study testing autologous mesenchymal stem cells and normal saline in people with Multiple System Atrophy, run by Yonsei University at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- autologous mesenchymal stem cells and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 75 Years Old or Less
- Multiple System Atrophy
- Voluntary Participants
Who cannot join
- Doubted dementia (MMSE < 24)
- Severe febrile condition
- Serum SGOT/SGPT three times above
- Malignant mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Placebo-controlled Randomized Clinical 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).
- Conditions
- Multiple System Atrophy
- Being tested
- autologous mesenchymal stem cells, normal saline
- Keywords
- voluntary participants, 75 years old or less
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous mesenchymal stem cellsBiological
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 salineBiological
saline
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | Not described Receives: Biological: normal saline |
| autologous mesenchymal stem cells | Experimental | Not described Receives: Biological: autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911365
- Sponsor's protocol ID
- 4-2008-0137
- Status last verified
- Jul 2011
- First submitted
- 26 May 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT00911365
- Acronym / sponsor ID
- 4-2008-0137
- Conditions
- Multiple System Atrophy
- Keywords
- voluntary participants, 75 years old or less
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Biological: normal saline |
| autologous mesenchymal stem cells | Experimental | Biological: autologous mesenchymal stem cells |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 75 Years Old or Less
- Multiple System Atrophy
- Voluntary Participants
Key exclusion criteria (4 listed)
- Doubted dementia (MMSE < 24)
- Severe febrile condition
- Serum SGOT/SGPT three times above
- Malignant mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous mesenchymal stem cells4*107 stem cell (100ml) Intra arterial infusion/ one time, then 4*107 stem cell(100ml)Intravenous infusion 3 times/monthly -> Total four times | Biological | autologous mesenchymal stem cells |
| normal salinesaline | Biological | normal saline |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous mesenchymal stem cells and normal saline in people with Multiple System Atrophy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on unified MSA rating scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.