Cerebellar AtaxiaPhase 1/2NCT01649687
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
A Phase 1/2 study testing Allogeneic adult adipose-derived mesenchymal stem cells in people with Cerebellar Ataxia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Allogeneic adult adipose-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2012to Jan 2014
- Phase
- Phase 1/2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
- Subject's SARA score at 10~20 points.
- Ages between 20~70 years.
- Signed informed consent from the patient and/or guardian.
Who cannot join
- Subjects enrolled in any other cell therapy studies within the past 30 days.
- Pregnancy test positive.
- Subjects deemed to be not suitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.
- Conditions
- Cerebellar Ataxia
- Being tested
- Allogeneic adult adipose-derived mesenchymal stem cells
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adult adipose-derived mesenchymal stem cellsBiological
Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells(MSC) treatment | Experimental | All subjects will receive allogeneic adult adipose-derived mesenchymal stem cells Receives: Biological: Allogeneic adult adipose-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
Measured: 12 months
Secondary outcomes (6)
Alterations in SARA score
Measured: 12 months
Positron emission tomography
18F-FDG used for the assessment of glucose metabolism in the brain
Measured: 9 months
Magnetic resonance spectroscopy
NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity
Measured: 12 months
Assessment of language and swallowing functions
changes in levels of severity: normal/slight/mild/moderate/severe
Measured: 12 months
Evaluation of syncope
Tilt table test
Measured: 12 months
Balance test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Kuang-Sheng Lee, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649687
- Sponsor's protocol ID
- SB-VGH-201001
- Status last verified
- Sep 2014
- First submitted
- 10 Apr 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01649687
- Acronym / sponsor ID
- SB-VGH-201001
- Conditions
- Cerebellar Ataxia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Jul 2012 (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.
The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells(MSC) treatment | Experimental | Biological: Allogeneic adult adipose-derived mesenchymal stem cellsAll subjects will receive allogeneic adult adipose-derived mesenchymal stem cells |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
- Subject's SARA score at 10~20 points.
- Ages between 20~70 years.
- Signed informed consent from the patient and/or guardian.
Key exclusion criteria (3 listed)
- Subjects enrolled in any other cell therapy studies within the past 30 days.
- Pregnancy test positive.
- Subjects deemed to be not suitable for the study by the investigator.
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 |
|---|---|---|
| Allogeneic adult adipose-derived mesenchymal stem cellsPatients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells | Biological | Mesenchymal stem cells(MSC) treatment |
Primary outcome
Safety evaluation
Time frame: 12 months
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)
6 secondary outcomes
Alterations in SARA score
Time frame: 12 months
Positron emission tomography
Time frame: 9 months
Magnetic resonance spectroscopy
Time frame: 12 months
Assessment of language and swallowing functions
Time frame: 12 months
Evaluation of syncope
Time frame: 12 months
Balance test
Time frame: 12 months
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 12 Sep 2014.
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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 1/2 study testing Allogeneic adult adipose-derived mesenchymal stem cells in people with Cerebellar Ataxia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 4 inclusion and 3 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 12 Sep 2014. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety evaluation (time frame: 12 months). 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 12 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.