Amyotrophic Lateral SclerosisPhase 1NCT02492516
Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
A Phase 1 study testing mesenchymal stem cells in people with Amyotrophic Lateral Sclerosis, run by Royan Institute at 1 site in Iran.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to Apr 2017
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Age: 18-55
- Sporadic form of disease
- ALS-FRS> = 24
- FVC >= 40%
Who cannot join
- Familial form of ALS
- Malignancy
- Autoimmune disease
- Diagnosis of other motor neuron diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.
Read the detailed description
the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- mesenchymal stem cells
- Keywords
- adipose tissue mesenchymal stem cell intravenous injection ALS
- 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.
mesenchymal stem cellsBiological
mesenchymal stem cells injection via peripheral vein.
| Study group | Role | What they receive |
|---|---|---|
| Stem cell | Experimental | The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell. Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
fever
The increase of body temperature that is defined as fever, within 72 hours after injection.
Measured: 72hours
Unconsciousness
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
Measured: 72hours
Secondary outcomes (2)
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
Measured: 2 months
FVC
Evaluation the improvement of FVC by spirometry, 2 months after cell injection.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionApr 2017
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.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of department of Regenerative Medicine,Royasn InstituteMasood Nabavi, MD, Study director, Professor associated of neurology, Shahed UniversityLeila Arab, MD, Principal investigator, Department of Regenerative Medicine, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492516
- Sponsor's protocol ID
- Royan-Nerve-008
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
- ClinicalTrials.gov ID
- NCT02492516
- Acronym / sponsor ID
- Royan-Nerve-008
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- adipose tissue mesenchymal stem cell intravenous injection ALS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Jul 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.
Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.
Detailed description
the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell | Experimental | Biological: mesenchymal stem cellsThe patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender
- Age: 18-55
- Sporadic form of disease
- ALS-FRS> = 24
- FVC >= 40%
Key exclusion criteria (4 listed)
- Familial form of ALS
- Malignancy
- Autoimmune disease
- Diagnosis of other motor neuron diseases
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 |
|---|---|---|
| mesenchymal stem cellsmesenchymal stem cells injection via peripheral vein. | Biological | Stem cell |
Primary outcome
fever
Time frame: 72hours
The increase of body temperature that is defined as fever, within 72 hours after injection.
Unconsciousness
Time frame: 72hours
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
2 secondary outcomes
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Time frame: 2 months
FVC
Time frame: 2 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 28 Apr 2017.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of department of Regenerative Medicine,Royasn Institute
Masood Nabavi, MD study director
Professor associated of neurology, Shahed University
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 mesenchymal stem cells in people with Amyotrophic Lateral Sclerosis, run by Royan Institute at 1 site in Iran.
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 5 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 28 Apr 2017. 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 Iran. 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?
fever (time frame: 72hours). The study lists 2 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 28 Apr 2017.