Relapsing-Remitting Multiple SclerosisPhase 1NCT00813969
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
A Phase 1 study testing Autologous mesenchymal stem cell transplantation in people with Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 ambulatory participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- What is being tested?
- Autologous mesenchymal stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2014
- 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
- Age 18 to 55, inclusive.
- Diagnosis of MS
- Relapsing form of MS (relapsing-remitting, secondary progressive, or progressive-relapsing course).
- EDSS score 3.0-6.5, inclusive. (Must be able to walk)
- Active disease during prior 24 months.
- Documented evidence of involvement of the anterior afferent visual system: previous optic neuritis, optic atrophy or an afferent pupillary defect on exam, RNFL thickness on OCT <LLN in at least one eye OR documented VEP latency in at least 1 eye.
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- Cranial MRI scan demonstrating T2-hyperintense lesions satisfying diagnostic criteria for MS
- Ability to perform the component tests of the MSFC (T25FW, 9HPT, PASAT3).
- Ability to perform SLCLA.
- Has given written informed consent to participate in the study.
Who cannot join
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit.
- History of cancer other than basal cell carcinoma of the skin.
- History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of BM aspiration, infusion of autologous MSCs, or performance of any of the planned study assessments.
- Abnormal blood tests which exceed designated limits.
- Positive screening tests for hepatitis B, hepatitis C, HIV 1\&2, HTLV I/II, CMV, West Nile virus, syphilis, blood parasite infection.
- Clinically significant abnormality on chest X-ray.
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- Clinically significant abnormality on EKG.
- Oxygen-saturation <90% on room air.
- History of alcohol or drug abuse within one year.
- Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI with Gd administration.
- Uncontrolled glaucoma or other ocular condition that precludes performing OCT or interpreting the results.
- MS relapse with onset within 30 days prior to the Screening Visit or the participant has not stabilized from a previous relapse at the time of the Screening Visit.
- Current treatment with an investigational MS disease therapy.
- Prior treatment with:
- Total lymphoid irradiation. Cladribine. T-cell or T-cell receptor vaccination. Campath-1h (alemtuzumab). Rituxan (rituximab).
- Prior treatment within three months with:
- Tysabri (natalizumab). Gilenya (Fingolimod/FTY720). Zenapax (daclizumab). Cytoxan (cyclophosphamide). Novantrone (mitoxantrone). Cyclosporine. CellCept (mycophenolate mofetil). Imuran (azathioprine). Rheumatrex (methotrexate). IV gamma globulin. Plasma exchange.
- Prior treatment within one month:
- Systemic corticosteroids with daily dose equivalent to Prednisone 60 mg or greater.
- Female participants who are not post-menopausal for at least one year, not surgically sterile, or not willing to practice effective contraception.
- Nursing mothers, pregnant women, or women planning to become pregnant during the study.
- Male participants who are not willing to practice effective contraception.
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the Principal Investigator, is likely to affect the participant's ability to comply with the study protocol.
- Any other reason that, in the opinion of the Principal Investigator, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Mellen Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis
The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 ambulatory participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Being tested
- Autologous mesenchymal stem cell transplantation
- Keywords
- Mesenchymal Stem Cell, MSC, Autologous, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cell transplantationBiological
A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
| Study group | Role | What they receive |
|---|---|---|
| Autologous MSC transplantation | Experimental | Not described Receives: Biological: Autologous mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS
Measured: 1 month
Secondary outcomes (2)
To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Measured: 1 month
To evaluate safety and tolerability of autologous MSC transplantation over 6 months
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 posted23 Dec 2008 (estimated)
- Study startMar 2011
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Cohen, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813969
- Sponsor's protocol ID
- MS-MSC-001
- Status last verified
- Mar 2016
- First submitted
- 22 Dec 2008
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen JA, Imrey PB, Planchon SM, Bermel RA, Fisher E, Fox RJ, Bar-Or A, Sharp SL, Skaramagas TT, Jagodnik P, Karafa M, Morrison S, Reese Koc J, Gerson SL, Lazarus HM. Pilot trial of intravenous autologous culture-expanded mesenchymal stem cell transplantation in multiple sclerosis. Mult Scler. 2018 Apr;24(4):501-511. doi: 10.1177/1352458517703802. Epub 2017 Apr 6.
PubMed 28381130
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00813969
- Acronym / sponsor ID
- MS-MSC-001
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Keywords
- Mesenchymal Stem Cell, MSC, Autologous, Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- Mar 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Dec 2008 (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 study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 ambulatory participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous MSC transplantation | Experimental | Biological: Autologous mesenchymal stem cell transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18 to 55, inclusive.
- Diagnosis of MS
- Relapsing form of MS (relapsing-remitting, secondary progressive, or progressive-relapsing course).
- EDSS score 3.0-6.5, inclusive. (Must be able to walk)
- Active disease during prior 24 months.
Key exclusion criteria (24 listed)
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit.
- History of cancer other than basal cell carcinoma of the skin.
- History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of BM aspiration, infusion of autologous MSCs, or performance of any of the planned study assessments.
- Abnormal blood tests which exceed designated limits.
- Positive screening tests for hepatitis B, hepatitis C, HIV 1\&2, HTLV I/II, CMV, West Nile virus, syphilis, blood parasite infection.
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 cell transplantationA single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion | Biological | Autologous MSC transplantation |
Primary outcome
To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS
Time frame: 1 month
2 secondary outcomes
To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Time frame: 1 month
To evaluate safety and tolerability of autologous MSC transplantation over 6 months
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 30 Mar 2016.
- Derived from this study: PubMed 28381130Cohen JA, Imrey PB, Planchon SM, Bermel RA, Fisher E, Fox RJ, Bar-Or A, Sharp SL, Skaramagas TT, Jagodnik P, Karafa M, Morrison S, Reese Koc J, Gerson SL, Lazarus HM. Pilot trial of intravenous autologous culture-expanded mesenchymal stem cell transplantation in multiple sclerosis. Mult Scler. 2018 Apr;24(4):501-511. doi: 10.1177/1352458517703802. Epub 2017 Apr 6.
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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.
Jeffrey A Cohen, M.D. principal investigator
The Cleveland Clinic
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 mesenchymal stem cell transplantation in people with Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by The Cleveland Clinic at 1 site in United States.
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 10 inclusion and 24 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 30 Mar 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 United States. 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?
To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00813969, which also lists 1 linked publication.
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 30 Mar 2016.