Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis

Inclusion Criteria:

1. Patients diagnosed with multiple sclerosis in inflammatory forms:

   1. Course outbreaks (relapsing-remitting form), who have not responded to at least one year of treatment with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod), confirmed by one or more of the following criteria: (ii) ≥ 1 clinically documented outbreak in the last 12 months. (iii)≥ 2 clinically documented outbreaks in the last 24 months (iv) ≥ 1 lesion with gadolinium magnetic resonance image done in the last 12 months.
   2. Secondary progressive forms, which have not responded to at least one year of treatment with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod). That meet the following criteria:

   (i) An increase of 1 point or more on the EDSS if the baseline score is less than or equal to 5.0, or 0.5 point increase if baseline score is greater than or equal to 5.5, in the last 12 months. (ii) clinically documented outbreak ≥ 1 or ≥ 1 lesion with gadolinium on magnetic resonance image,within the last 12 months.

   c. Primary progressive forms that meet the following three criteria: (i) An increase of 1 point or more on the EDSS if the baseline score is less than or equal to 5.0, or 0.5 point increase if baseline score is greater than or equal to 5.5, in the last 12 months. (ii) ≥ 1 lesion on magnetic resonance image Gadolinium within the last 12 months.

   (iii) oligoclonal bands in cerebrospinal fluid (CSF).

2. Normal laboratory parameters, defined by:

   • Leukocytes ≥ 3000
   • Neutrophils ≥ 1500
   • Platelets ≥ 100,000
   • Aspartate aminotransferase (AST)/ Alanine transaminase (ALT)≤ 2.5 standard range institution
   • Creatinine ≤ 2.5 mg / dl
3. Patients of both sexes aged between 18 and 50 years.
4. Disease duration ≥ 2 years and ≤ 10 years.
5. Expanded Disability Status Scale (EDSS) between 3.0 and 6.5 points.
6. Patients who give informed consent for clinical trial participation.
7. Women of childbearing potential must have negative results on a pregnancy test done at the time of inclusion in the study and agree to use a medically approved method of contraception for the duration of the study.

Exclusion Criteria:

1. Any active or chronic infection, including infection with Hepatitis B (HBV) virus,Hepatitis C virus (HCV) or Human immunodeficiency virus (HIV).
2. Immunosuppressive therapy in the 3 months prior to randomization (including natalizumab and fingolimod).
3. Treatment with interferon beta or glatiramer acetate in the 30 days prior to randomization.
4. Corticosteroid treatment in 30 days prior to randomization.
5. Time since the last outbreak exceeding 60 days prior to randomization.
6. History of malignancy (excluding basal cell carcinoma of skin and carcinoma in situ in remission for over a year).
7. Life expectancy severely limited by other co-morbidities.
8. Background prior myelodysplasia or hematological disease, or clinically relevant changes currently in the leukocyte count.
9. Pregnancy / risk of pregnancy (including refusal to use contraception
10. Renal failure (eGFR <60 mL/min/1.37m2
11. Inability to undergo magnetic resonance (MR) scans
12. Inability to give written informed consent.