MEsenchymal StEm Cells for Multiple Sclerosis

You may be eligible if

• \- 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 point of the expanded disability status scale (EDSS) (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