Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
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|ClinicalTrials.gov Identifier: NCT00813969|
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : March 30, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis||Biological: Autologous mesenchymal stem cell transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||May 2014|
|Experimental: Autologous MSC transplantation||
Biological: Autologous mesenchymal stem cell transplantation
A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
- 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 ]
- 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 ]
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813969
|United States, Ohio|
|Cleveland Clinic Mellen Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jeffrey A Cohen, M.D.||The Cleveland Clinic|
|Responsible Party:||The Cleveland Clinic|
|Other Study ID Numbers:||
|First Posted:||December 23, 2008 Key Record Dates|
|Last Update Posted:||March 30, 2016|
|Last Verified:||March 2016|
Mesenchymal Stem Cell
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases