Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept Study

Inclusion Criteria: * 1\) Males and females with a diagnosis of MS 1. Relapsing remitting MS (RRMS) not responding to at least 1 year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab) as evidenced by at least one of the following: * i) ≥1 clinically documented relapse in past 12 months * ii) ≥2 clinically documented relapses in past 24 months * iii) ≥1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months 2. 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, dimethylfumarate, teriflunomide, alemtuzumab) 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 past 12 months * ii) ≥1 clinically documented relapse or ≥ 1 gadolinium-enhancing lesion (GEL) at MRI within the past 12 months 3. 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 past 12 months * ii) ≥ 1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months * iii) positive cerebrospinal fluid (CSF) (oligoclonal banding) * 2\) Age 18 to 50 years old, inclusive at time of informed consent * 3\) Disease duration 2 to 15 years (inclusive) * 4\) EDSS 2.5 to 6.5 * 5\) Able and willing to sign informed consent prior to any study-related activities Exclusion Criteria: * 1\) RRMS not fulfilling inclusion criteria * 2\) SPMS not fulfilling inclusion criteria * 3\) PPMS not fulfilling inclusion criteria * 4\) A history of active or chronic infection including infection with HIV1-2, chronic Hepatitis B or Hepatitis C * 5\) Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization * 6\) Previous treatment with cladribine or alemtuzumab * 7\) Treatment with interferon-beta, glatiramer acetate, teriflunomide or dimethyl fumarate within the 30 days prior to randomization (all teriflunomide patients will be required to have followed a wash-out with either cholestyramine or activated charcoal as indicated in the product monograph) * 8\) Treatment with corticosteroids within the 30 days prior to randomization * 9\) Relapse occurred during the 60 days prior to randomization * 10\) Previous history of a malignancy (patient reported) other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year * 11\) Severely limited life expectancy by any other co-morbid illness * 12\) History of previous diagnosis of myelodysplasia or previous hematologic disease (patient reported) or current clinically relevant abnormalities of white blood cell counts * 13\) Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study) * 14\) eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination * 15\) Known allergy to gentamicin or related aminoglycosides * 16\) Inability to give written informed consent in accordance with research ethics board guidelines * 17\) Concomitant participation in another clinical trial * 18\) Inability to adhere to protocol according to the investigator's medical judgement