Multiple Sclerosis Clinical Trial

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

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 involvement of the anterior afferent visual system.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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.

Exclusion Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00813969

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cleveland Clinic Mellen Center
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00813969

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider