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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 <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.
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.
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