Amyotrophic Lateral SclerosisPhase 1NCT02383654
Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis
A Phase 1 study testing Autologous Adipose-Tissue Derived Stem Cells in people with Amyotrophic Lateral Sclerosis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men only
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Autologous Adipose-Tissue Derived Stem Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 1
- 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 35 to 50 years
- Men only
- No healthy volunteers
- Adult
Compassionate Treatment
The number of participants for a person.
The patients (Guo XX) of 28% of lung function assessment (normal lung function was greater than 80%), the daily life of motor function score was 17 points (normal function score of 40 points).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
The purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.
Read the detailed description
This pilot clinical trial is design to see the safety and possible efficiency of ADSCs treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3 months, 6 months 9 months and 12 months.
Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety before and after brain implantation.
Timing of Study: 12months recruitment period after approvals
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Autologous Adipose-Tissue Derived Stem Cells
- Keywords
- Amyotrophic Lateral Sclerosis, Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose-Tissue Derived Stem CellsProcedure or surgery
Also called ADSCs
- Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells
- Patient will receive brain implantation of approximately 100 -400million Autologous Adipose-Tissue Derived Stem Cells.
Patient will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice , before brain implantation, and will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice, after brain implantation .
| Study group | Role | What they receive |
|---|---|---|
| Compassionate Treatment | Other | ALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation. Receives: Procedure: Autologous Adipose-Tissue Derived Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of ALS-FRS score
using ALS-FRS score to assess patient's function after transplantation.
Measured: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months
changes of respiratory function
check the changes of respiratory functions after intervention .
Measured: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
changes of neurologic function
check any changes of neurologic functions after intervention .
Measured: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
Secondary outcomes (1)
changes of brain structure
check changes of MRI after intervention
Measured: Baseline-Day 60- 6 mounths-12 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinn-Zong Lin, China Medical University Hospital
- Investigators
- Shinn-Zong Lin, M.D.;PhD., Principal investigator, China Medical University Beigand Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383654
- Sponsor's protocol ID
- CMUH103-REC2-072
- Status last verified
- Jan 2016
- First submitted
- 8 Feb 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis With Brain Transplants of Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
- ClinicalTrials.gov ID
- NCT02383654
- Acronym / sponsor ID
- CMUH103-REC2-072
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Autologous Adipose-Tissue Derived Stem Cells (ADSCs)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Mar 2015 (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 purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.
Detailed description
This pilot clinical trial is design to see the safety and possible efficiency of ADSCs treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3 months, 6 months 9 months and 12 months.
Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety before and after brain implantation.
Timing of Study: 12months recruitment period after approvals
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassionate Treatment | Other | Procedure: Autologous Adipose-Tissue Derived Stem CellsALS patients are received Intravenous and intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells (ADSCs), Rehabilitation. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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-Tissue Derived Stem CellsAlso: ADSCs1. Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells 2. Patient will receive brain implantation of approximately 100 -400million Autologous Adipose-Tissue Derived Stem Cells. Patient will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice , before brain implantation, and will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice, after brain implantation . | Procedure or surgery | Compassionate Treatment |
Primary outcome
changes of ALS-FRS score
Time frame: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months
using ALS-FRS score to assess patient's function after transplantation.
changes of respiratory function
Time frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
check the changes of respiratory functions after intervention .
changes of neurologic function
Time frame: Baseline-Day 28-Day 44-Day 60-6 mouths-9mouths-12mouths
check any changes of neurologic functions after intervention .
1 secondary outcome
changes of brain structure
Time frame: Baseline-Day 60- 6 mounths-12 mounths
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 1 Feb 2016.
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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.
Shinn-Zong Lin, M.D.;PhD. principal investigator
China Medical University Beigand Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Adipose-Tissue Derived Stem Cells in people with Amyotrophic Lateral Sclerosis, run by China Medical University Hospital 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?
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 1 Feb 2016. 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 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.
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?
changes of ALS-FRS score (time frame: Baseline-Day 28-Day 44-Day 60-6 months-9months-12months). The study lists 3 primary outcomes in all. 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 1 Feb 2016.