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

This is an interventional treatment trial for Multiple Sclerosis Read More

Inclusion Criteria:

1. Patients diagnosed with MS in their inflammatory forms :

1. Course outbreaks ( relapsing- remitting ) , 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 ) At least one clinically documented outbreak in the past 12 months. ( iii ) At least two clinically documented outbreaks in the last 24 months ( iv ) At least one lesion with gadolinium on MRI performed in the last 12 months.

   b . Secondary progressive forms that have not responded to at least one year of treatment with one or more of the approved therapies ( interferon beta , glatiramer acetate, natalizumab , mitoxantrone, fingolimod ) . That meet the following criteria:

   ( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.

   ( ii ) at least one clinically documented outbreak or at least one lesion with gadolinium on MRI within the last 12 months.

   c . Primary progressive forms that meet the following three criteria:

   ( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.

   ( ii ) At least 1 lesion with gadolinium on MRI 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 aminotransferase (ALT) ≤ 2.5 standard range institution

   • Creatinine ≤ 2.5 mg / dl

     3 . Patients of both sexes aged between 18 and 50.

     4 . Disease duration ≥ 2 years and ≤ 10 years.

     5 . EDSS (Expanded Disability Status Scale) between 3.0 and 6.5 points.

     6. Patients give their informed consent for participation in the clinical trial consent.

     7. Women of childbearing potential must have negative results on a pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study

   Exclusion Criteria:

   1. Any active or chronic infection, including Hepatitis B virus (HBV), Hepatitis C virus (HCV) or 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 therapy in the 30 days prior to randomization.
   5. Time since last exceeding 60 days prior to randomization outbreak.
   6. History of malignancy ( basal cell carcinoma of skin and carcinoma in situ are excluded in remission for over a year).
   7. Life expectancy severely limited by other co - morbidities.
   8. Previous history of 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 MRI scans
   12. Inability to give written informed consent.