Mesenchymal Stem Cells for Multiple Sclerosis

Inclusion Criteria

• •1. Diagnosis of MS
• •a. Relapsing remitting MS (RRMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by one or more of the following: i. ≥1 clinically documented relapse in past 12 months ii. ≥2 clinically documented relapses in last 24 months iii. ≥1 GEL at MRI performed within the last 12 months
• •b. Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.
• •c. Primary progressive MS (PPMS) patients with all the following features: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the last twelve months ii. ≥ 1 GEL at MRI performed within the last 12 months iii. positive cerebrospinal fluid (CSF) (oligoclonal banding)
• •2. Age 18 to 50 years
• •3. Disease duration 2 to 10 years (included)
• •4. EDSS 3.0 to 6.5
• •4. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
• •5. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
• •6. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
• •7. Treatment with corticosteroids within the 30 days prior to randomization
• •8. Relapse occurred during the 60 days prior to randomization
• •9. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
• •10. Severely limited life expectancy by another co-morbid illness
• •11. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
• •12. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
• •13. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
• •14. Inability to give written informed consent in accordance with research ethics board guidelines