Multiple SclerosisPhase 1/2NCT01377870
Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple Sclerosis
A Phase 1/2 study testing intravenous injection of mesenchymal stem cells and injection of cell free media in people with Multiple Sclerosis, run by Royan Institute at 1 site in Iran.
Trial summary
Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter problems. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- intravenous injection of mesenchymal stem cells and injection of cell free media
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIran
- Study dates
- Dec 2011to Apr 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Age: 18-55years
- Duration of disease: 2-10 years
- Relapsing remitting with drug resistance
- EDSS: 3-6.5
- Resistance to immunomodulatory and cytotoxic drugs:
Show all 12Show fewer
- At least 1-2 sever relapse during 1 year drug treatment
- At least increase 1 point of EDSS during 1 year drug treatment
- Secondary progressive or relapsing multiple sclerosis
- Primary progressive MS with relapse or GAD positive enhancement
- Secondary progressive MS with relapse
- Secondary progressive MS without relapse:progression of disease with 1 point increase of EDSS during last 18 months
Who cannot join
- Pregnancy positive test
- Under treatment with cytotoxic drugs at the same time or during last 3 months
- Under treatment with immunomodulatory drugs at the same time or during last month
- Relapse of disease 30 days or less than 30 days before transplantation
- Primary progressive MS with out relapse or GAD positive enhancement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Side Effect of Mesenchymal Stem Cell in Multiple Sclerosis
Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter problems. The disease is caused by an autoimmune mechanism, ie the immune system produces antibodies and cells which attack the self myelin antigens, causing therefore demyelination. The disease is clinically evident with relapses of neurological disability due to the dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs. Disability can accumulate with time and the disease enters a progressive phase due to damage of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of MS (like Copaxone and interferons), there is no effective means today to stop the progression of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to the neuronal stem cells) immunomodulatory and neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the animal model of chronic experimental autoimmune encephalomyelitis (EAE). These bone marrow derived MSCs offer practical advantages for clinical therapeutic applications, since they can be obtained from the adult bone marrow and therefore the patient can be the donor for himself, without any danger for rejection of the cells. In addition, MSCs carry a safer profile and are less prone to malignant transformation.
Our center will perform a clinical trial with intra venous transplantation of bone marrow derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell transplantation after 1year following up.
Read the detailed description
In the clinical trial 30 patients with multiple sclerosis who are drug resistance will take apart.Based on inclusion and exclusion criteria patients are chosen.Bone marrow aspiration will be done for all of them under local anesthesia.Patients are randomly divided in 2 groups:case and control. Then mesenchymal stem cells which are separated and prepared will be transplanted by intravenous injection to the patients in case group and the cells which obtain from patients in control group are frozen and inject after 6 months. Patients will be followed by Evaluation of EDSS MSFC RAO Test brain and cervical MRI and quality of life questionnaire after 1th 3th 6th and 12th months after transplantation.all these tests will be done before transplantation as basic evaluation.
- Conditions
- Multiple Sclerosis
- Being tested
- intravenous injection of mesenchymal stem cells, injection of cell free media
- Keywords
- multiple sclerosis mesenchymal stem cell intravenous injection
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous injection of mesenchymal stem cellsBiological
Also called stem cell transplantation
15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell
injection of cell free mediaBiological
Also called control group
Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.
| Study group | Role | What they receive |
|---|---|---|
| cell free media | Placebo comparator | 15 patients with relapsing remitting multiple sclerosis who receive cell free media Receives: Biological: injection of cell free media |
| mesenchymal stem cell reciepiants | Experimental | Patients with relapsing remitting multiple sclerosis who underwent intravenous injection of mesenchymal stem cells Receives: Biological: intravenous injection of mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI metrics changes
evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
Measured: 6 months
Brain atrophy
evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
Measured: 12 months
number of sever relapses
evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
Measured: 6 months
EDSS
Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
Measured: 6 months
MSFC
Evaluation the effect of mesenchymal stem cells transplantation on MSFC
Measured: 6 months
Secondary outcomes (3)
quality of life
Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life
Measured: 6 months
RAO Test
Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.
Measured: 6 months
intravenous cell transplantation
evaluation the side effect of intravenous transplantation of mesenchymal stem cell
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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 cell therapy center of Royan InstituteMasoud Nabavi, MD, Principal investigator, scientist and clinicianLeila Arab, MD, Principal investigator, Department of regenerative medicine,Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377870
- Sponsor's protocol ID
- Royn-nerve-001
- Status last verified
- Aug 2010
- First submitted
- 19 Jun 2011
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Side Effect of Mesenchymal Stem Cell in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01377870
- Acronym / sponsor ID
- Royn-nerve-001
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis mesenchymal stem cell intravenous injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jun 2011 (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.
Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter problems. The disease is caused by an autoimmune mechanism, ie the immune system produces antibodies and cells which attack the self myelin antigens, causing therefore demyelination. The disease is clinically evident with relapses of neurological disability due to the dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs. Disability can accumulate with time and the disease enters a progressive phase due to damage of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of MS (like Copaxone and interferons), there is no effective means today to stop the progression of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to the neuronal stem cells) immunomodulatory and neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the animal model of chronic experimental autoimmune encephalomyelitis (EAE). These bone marrow derived MSCs offer practical advantages for clinical therapeutic applications, since they can be obtained from the adult bone marrow and therefore the patient can be the donor for himself, without any danger for rejection of the cells. In addition, MSCs carry a safer profile and are less prone to malignant transformation.
Our center will perform a clinical trial with intra venous transplantation of bone marrow derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell transplantation after 1year following up.
Detailed description
In the clinical trial 30 patients with multiple sclerosis who are drug resistance will take apart.Based on inclusion and exclusion criteria patients are chosen.Bone marrow aspiration will be done for all of them under local anesthesia.Patients are randomly divided in 2 groups:case and control. Then mesenchymal stem cells which are separated and prepared will be transplanted by intravenous injection to the patients in case group and the cells which obtain from patients in control group are frozen and inject after 6 months. Patients will be followed by Evaluation of EDSS MSFC RAO Test brain and cervical MRI and quality of life questionnaire after 1th 3th 6th and 12th months after transplantation.all these tests will be done before transplantation as basic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell free media | Placebo comparator | Biological: injection of cell free media15 patients with relapsing remitting multiple sclerosis who receive cell free media |
| mesenchymal stem cell reciepiants | Experimental | Biological: intravenous injection of mesenchymal stem cellsPatients with relapsing remitting multiple sclerosis who underwent intravenous injection of mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Both gender
- Age: 18-55years
- Duration of disease: 2-10 years
- Relapsing remitting with drug resistance
- EDSS: 3-6.5
Key exclusion criteria (5 listed)
- Pregnancy positive test
- Under treatment with cytotoxic drugs at the same time or during last 3 months
- Under treatment with immunomodulatory drugs at the same time or during last month
- Relapse of disease 30 days or less than 30 days before transplantation
- Primary progressive MS with out relapse or GAD positive enhancement
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 |
|---|---|---|
| intravenous injection of mesenchymal stem cellsAlso: stem cell transplantation15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell | Biological | mesenchymal stem cell reciepiants |
| injection of cell free mediaAlso: control groupPatients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell. | Biological | cell free media |
Primary outcome
MRI metrics changes
Time frame: 6 months
evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
Brain atrophy
Time frame: 12 months
evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
number of sever relapses
Time frame: 6 months
evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
EDSS
Time frame: 6 months
Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
MSFC
Time frame: 6 months
Evaluation the effect of mesenchymal stem cells transplantation on MSFC
3 secondary outcomes
quality of life
Time frame: 6 months
RAO Test
Time frame: 6 months
intravenous cell transplantation
Time frame: 6 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 7 Mar 2018.
- 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 cell therapy center of Royan Institute
Masoud Nabavi, MD principal investigator
scientist and clinician
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 intravenous injection of mesenchymal stem cells and injection of cell free media in people with Multiple 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 12 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: finished, as of the sponsor's last update on 7 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
MRI metrics changes (time frame: 6 months). The study lists 5 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 7 Mar 2018.