Multiple SclerosisPhase 1/2NCT01895439
Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis
A Phase 1/2 study testing Autologous Mesenchymal Stem Cells in people with Multiple Sclerosis, run by University of Jordan at 1 site in Jordan.
Trial summary
1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Autologous Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2012to Feb 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- Expanded Disability Status Scale (EDSS) ≤ 6
- Failure of standard medical therapy
- Disease duration of at least three years prior to enrollment.
Who cannot join
- Pregnant and lactating women
- Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
- Recent MS relapse in the month prior to enrollment
- Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
- Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
- Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
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- Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
- Positive serology for HIV, Hepatitis B or Hepatitis C
- Any history of malignancy or exposure to radiation at any time prior to enrollment
- Any contra-indication to lumbar puncture
- Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
- Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
- Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
- Assessing the therapeutic benefits on the participants in the trial as per established methods.
- Conditions
- Multiple Sclerosis
- Being tested
- Autologous Mesenchymal Stem Cells
- Keywords
- Bone marrow derived Mesenchymal Stem Cells, Multiple Sclerosis, Oligodendrocytes, Neuroimmunology, Autoimmune disease
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mesenchymal Stem CellsBiological
| Study group | Role | What they receive |
|---|---|---|
| MSCs injection | Experimental | Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients Receives: Biological: Autologous Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with any relevant side effects observed
Assessing the safety of autologous Mesenchymal Stem Cells injection
Measured: 18 months
Secondary outcomes (1)
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.
For every patient tests would be performed at baseline and repeated at 3, 6, and 18 months post-injection
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Jamali, University of Jordan
- Investigators
- Abdallah Awidi, MD., Study director, Cell Therapy CenterSaid Dahbour, MD., Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895439
- Sponsor's protocol ID
- MSUJCTC
- Status last verified
- May 2017
- First submitted
- 24 Jun 2013
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
- ClinicalTrials.gov ID
- NCT01895439
- Acronym / sponsor ID
- MSUJCTC
- Conditions
- Multiple Sclerosis
- Keywords
- Bone marrow derived Mesenchymal Stem Cells, Multiple Sclerosis, Oligodendrocytes, Neuroimmunology, Autoimmune disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Jul 2013 (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.
- Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
- Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
- Assessing the therapeutic benefits on the participants in the trial as per established methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs injection | Experimental | Biological: Autologous Mesenchymal Stem CellsAutologous bone marrow derived stem cells injected intrathecally to enrolled MS patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- Expanded Disability Status Scale (EDSS) ≤ 6
- Failure of standard medical therapy
- Disease duration of at least three years prior to enrollment.
Key exclusion criteria (11 listed)
- Pregnant and lactating women
- Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
- Recent MS relapse in the month prior to enrollment
- Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
- Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
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 Mesenchymal Stem Cells | Biological | MSCs injection |
Primary outcome
The number of patients with any relevant side effects observed
Time frame: 18 months
Assessing the safety of autologous Mesenchymal Stem Cells injection
1 secondary outcome
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.
Time frame: 18 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 2 May 2017.
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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.
Abdallah Awidi, MD. study director
Cell Therapy Center
Said Dahbour, MD. principal investigator
Jordan University Hospital
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 Mesenchymal Stem Cells in people with Multiple Sclerosis, run by University of Jordan at 1 site in Jordan.
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 4 inclusion and 11 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 2 May 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 Jordan. 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?
The number of patients with any relevant side effects observed (time frame: 18 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 2 May 2017.