The Sequelae Caused by Severe Brain InjuryPhase 1/2NCT01649700
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
A Phase 1/2 study testing autologous adipose-derived mesenchymal stem cells in people with The Sequelae Caused by Severe Brain Injury, 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 autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- The Sequelae Caused by Severe Brain Injury
- What is being tested?
- autologous 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
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to May 2013
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
- Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
- Subject's modified Rankin scale (mRS) grades IV~V.
- Ages between 20~40 years.
- Estimated life expectancy must be greater than 2 months.
- Signed informed consent from the subject.
Who cannot join
- Pregnancy test positive.
- Subject infected with hepatitis C, HIV or syphilis.
- Subject not suitable for liposuction surgery.
- Subject not eligible for PET or MRI.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject 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 autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
- Being tested
- autologous adipose-derived mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose-derived mesenchymal stem cellsBiological
Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells treatment | Experimental | All subjects will receive autologous adipose-derived mesenchymal stem cells Receives: Biological: autologous 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: 16 months
Secondary outcomes (9)
Positron emission tomography
18F-FDG used for the assessment of glucose metabolism in the brain
Measured: 13 months
Magnetic Resonance Imaging
changes in the volume of brain lesions
Measured: 16 months
Electroencephalogram
improvement of continuous slow-waves and irritative features
Measured: 16 months
Neuropsychological assessment
Measured: 16 months
Electrodiagnostic Testing
improvement of subjects' sensory neurologic pathways
Measured: 16 months
Assessment of language and swallowing functions
changes in levels of severity: normal/slight/mild/moderate/severe
Measured: 16 months
Measure of the severity of disability
Measured: 16 months
Assessment of spasticity and strength
Measured: 16 months
Assessment of brain motor control
measurement of the electrical activities in the muscles during specific testing procedures
Measured: 16 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 startOct 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Sequelae Caused by Severe Brain InjuryStudies 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
- 1 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
- NCT01649700
- Sponsor's protocol ID
- SB-VGH-201101
- Status last verified
- Sep 2014
- First submitted
- 9 Apr 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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 Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01649700
- Acronym / sponsor ID
- SB-VGH-201101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (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 autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
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 treatment | Experimental | Biological: autologous adipose-derived mesenchymal stem cellsAll subjects will receive autologous adipose-derived mesenchymal stem cells |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
- Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
- Subject's modified Rankin scale (mRS) grades IV~V.
- Ages between 20~40 years.
- Estimated life expectancy must be greater than 2 months.
Key exclusion criteria (6 listed)
- Pregnancy test positive.
- Subject infected with hepatitis C, HIV or syphilis.
- Subject not suitable for liposuction surgery.
- Subject not eligible for PET or MRI.
- Subject enrolled in any other cell therapy studies within the past 30 days.
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 adipose-derived mesenchymal stem cellsPatients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells. | Biological | Mesenchymal stem cells treatment |
Primary outcome
Safety evaluation
Time frame: 16 months
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
9 secondary outcomes
Positron emission tomography
Time frame: 13 months
Magnetic Resonance Imaging
Time frame: 16 months
Electroencephalogram
Time frame: 16 months
Neuropsychological assessment
Time frame: 16 months
Electrodiagnostic Testing
Time frame: 16 months
Assessment of language and swallowing functions
Time frame: 16 months
Measure of the severity of disability
Time frame: 16 months
Assessment of spasticity and strength
Time frame: 16 months
Assessment of brain motor control
Time frame: 16 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.
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 autologous adipose-derived mesenchymal stem cells in people with The Sequelae Caused by Severe Brain Injury, 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 6 inclusion and 6 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: 16 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.