Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

Inclusion Criteria:

- Diagnosis of MS as defined by the McDonald criteria

- Diagnosis of primary progressive or secondary progressive MS

- Between the ages of 18-65 years

- Significant disability shown by an Expanded Disability Status Score (EDSS) of greater
than or equal to 3.0, and less than or equal to 6.5, that was not acquired within the
last 12 months.

- Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI
and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the
last six months and no significant change in EDSS (1 point or more) in the last 12
months

- Must agree to undergo four MRIs: at the time of enrollment, after year 1, after year
2, and after year 3

- Patients either within the geographical area or who are able to arrange reliable
travel during the study period

Exclusion Criteria:

- EDSS greater than 6.5

- Duration of Disease >15 years at time of screening

- Change of disease modifying agent < 6 months prior to beginning treatment.
Additionally, no changes in disease modifying agent will be made during the course of
the study.

- Change in MS symptom management treatment < 6 months prior to beginning treatment.
Additionally, no changes in MS symptom management treatments will be made during the
course of the study, unless there has been clinical improvement, in which case, a
patient may discontinue a medication.

- Start of any new orthotic device or durable medical equipment < 6 months prior to
beginning treatment or during the course of the study (patients may discontinue use of
these devices during the course of the study if they show clinical improvement).

- All patients who have ever been on Lemtrada (alemtuzumab)

- All patients who have had any prior stem cell treatments, including HSCT

- Pregnant or nursing mothers, or any woman intending to become pregnant in the next
three years

- All patients will have screening blood tests done. Only patients whose values are in
the normal range as determined by the laboratory norms based on age and sex will be
allowed to participate. Exceptions may be made for borderline normal laboratory values
manifesting no clinical symptoms at the discretion of the Principal Investigator.

- Use of systemic chemotherapeutic or anti-mitotic medications within three months of
study start date due to the possibility of interference with bone marrow procedure

- Any patients with a history of or with active malignancy

- Use of steroids within three months of the study start date, as this would suggest an
active disease state

- History of cirrhosis due to increased risk of central nervous system (CNS) infection

- Significantly uncontrolled hypertension because of increased risk for stroke or CNS
hemorrhage.

- Patients with active thyroid disease resulting in hyperthyroidism or hypothyroidism
(Only well controlled patients with labs in the normal range will be included) because
of hormone influence on cell growth

- History of central nervous system infection or immunodeficiency syndromes due to
increased risk of CNS infection

- Preexisting blood disease (such as bone marrow hypoplasia, leukopenia,
thrombocytopenia, or significant anemia) due to invasive nature of bone-marrow
aspiration

- Previous or current history of a coagulation disorder

- Any metal in the body, which is contraindicated for MRI studies

- Patients with alcohol or other substance abuse problems that may affect stem cell
growth; habitual drug (including marijuana and nicotine) abusers, will be excluded
from the study

- Other major disease that, in the opinion of the Principal Investigator, would preclude
participation in the study

- Patients with Hepatitis B (HBV), Hepatitis C (HCV), syphilis, HIV-1, or HIV-2.

- Any evidence of significant cognitive dysfunction based on a screening history and
physical examination because it would preclude giving a truly informed consent

- Patients who are enrolled in another clinical trial for MS treatment or who have
received any study drug/biologics within the last 6 months. Additionally, while in the
trial, patients may not enroll in any other clinical trial for MS or any other
condition.

- Patients who are anticipated to have difficultly accessing the intrathecal space
related to scoliosis, obesity, or any other relevant factors determined by the PI.