Amyotrophic Lateral SclerosisPhase 1/2NCT02116634
Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis
A Phase 1/2 study testing mesenchymal stem cell in people with Amyotrophic Lateral Sclerosis, run by Alzahra Hospital, Iran at 1 site in Iran.
Trial summary
Whether the mesenchymal injection on ALS patients is effective or not? Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIran
- Study dates
- May 2015to May 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- sporadic ALS according to escorial criteria
- onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
- mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
- normal polysomnography
- Signed consent form
Who cannot join
- pregnancy or lactation,
- vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
- Hospitalization due to serious illness in the last two months
- survival time less than two years
- Hypersensitivity to any component used in the cell culture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
Whether the mesenchymal injection on ALS patients is effective or not?
Read the detailed description
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- mesenchymal stem cell
- 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 cellBiological
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cell | Experimental | intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline Receives: Biological: mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS
Measured: every 6 months up 2 years after transplantation
Secondary outcomes (2)
ALS-FRS(functional rating scale) score and EMG scale
Measured: before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation
FVC (forced vital capacity)and DWSE±QoL score
Measured: before transplantation and every 6 months up 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Because economic problems
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzahra Hospital, Iran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rokhsareh meamar, Alzahra Hospital, Iran
- Investigators
- keivan basiri, MD, Principal investigator, Isfahan neurosciences research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116634
- Sponsor's protocol ID
- rokhsareh
- Other IDs
- stem cell injection in ALS
- Status last verified
- Jan 2016
- First submitted
- 6 Apr 2014
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
- ClinicalTrials.gov ID
- NCT02116634
- Acronym / sponsor ID
- rokhsareh
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because economic problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alzahra Hospital, IranUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Apr 2014 (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.
Whether the mesenchymal injection on ALS patients is effective or not?
Detailed description
After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
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 cell | Experimental | Biological: mesenchymal stem cellintra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- sporadic ALS according to escorial criteria
- onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
- mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
- normal polysomnography
- Signed consent form
Key exclusion criteria (5 listed)
- pregnancy or lactation,
- vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
- Hospitalization due to serious illness in the last two months
- survival time less than two years
- Hypersensitivity to any component used in the cell culture
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 cellintra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline | Biological | mesenchymal stem cell |
Primary outcome
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS
Time frame: every 6 months up 2 years after transplantation
2 secondary outcomes
ALS-FRS(functional rating scale) score and EMG scale
Time frame: before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation
FVC (forced vital capacity)and DWSE±QoL score
Time frame: before transplantation and every 6 months up 2 years after transplantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
keivan basiri, MD principal investigator
Isfahan neurosciences research center
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 mesenchymal stem cell in people with Amyotrophic Lateral Sclerosis, run by Alzahra Hospital, Iran 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 5 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: withdrawn, as of the sponsor's last update on 14 Jan 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 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS (time frame: every 6 months up 2 years after transplantation). 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 14 Jan 2016.