Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I / II for the evaluation of the safety and feasibility of intravenous
      infusion of mesenchymal cells from autologous bone marrow in patients with Multiple
      Sclerosis.

      Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and
      safe and can be effective in treating patients suffering from multiple sclerosis.
    

Detailed description: 
      The study population will consist of a total of 30 patients diagnosed with multiple
      sclerosis, who meet all inclusion criteria and none of the exclusion set and express their
      agreement to participate in the study by signing the informed consent of those whose results
      can be clinically evaluable.

      Selected patients who consent will be enrolled in the trial and randomized to one of the
      following groups:

        -  Group 1 receiving a single intravenous administration of cellular product on Day 0 and
           placebo infusion on day + 180.

        -  Group 2 receiving a placebo infusion on day 0 and a single cell product administration
           on day +180.

      Randomization will be 1:1, so that 15 patients will receive the cellular product on Day 0
      (Group 1) and 15 patients on day +180 (group 2), always maintaining at all times the
      double-blind status of the test (patients and researchers).

      The bone marrow will be extract from all patients immediately after inclusion in the study,
      under local anesthesia with sedation. For patients in group 1 autologous mesenchymal cells
      will be obtained from the bone marrow and infuse immediately after the time necessary for
      their production. For patients in group 2, bone marrow cells will be frozen for later
      procedure of mesenchymal cells and their infusion after six months.

      Patients will be evaluated by clinical, radiological, and electrophysiological as well as
      detailed in section 8 corresponding to Development Test and Evaluation of Response.

      It is estimated that the inclusion period is approximately 12-18 months, and each patient
      tracking another twelve months. Therefore the total duration of the study will be about 24 to
      30 months from the inclusion of the first patient to completion follow-up period of the last
      patient included.

      Study objectives:

        -  Main objectives: 1. To evaluate the safety of intravenous infusion of autologous bone
           marrow mesenchymal cells in multiple sclerosis patients diagnosed by evaluating
           complications and adverse effects of the therapy itself and study procedures.

           2. Assessing the difference in the number of lesions on magnetic resonance image with
           gadolinium, between the groups undergoing treatment at weeks 4, 12 and 24.

        -  Secondary objectives: 1. To evaluate the feasibility and efficacy of the indication of
           the treatment by analysis comparative results and exploratory clinical variables of
           patients at baseline (pretreatment) and at 6 and 12 months follow-up.

           2. Compare the results of safety, feasibility and efficacy between the administration
           initial cell therapy treatment (day 0) and that delayed (day +180).

           3. Evaluating the immunomodulatory effect of treatment by quantifying cell subsets and
           cytokines, functional analysis of the immune response. Cerebrospinal fluid metabolomic
           profile of gene expression of the cells present in blood and cerebrospinal fluid, with
           the aim of identifying new biomarkers with diagnosis of interest, prognosis or
           monitoring, and potential therapeutic targets that can be derived from it.

           4. Providing our results to the study proposed by the International Mesenchymal Stem
           Cell Transplant Study Group under whose directives will be performed the test.
    

Intervention name(s): Bone marrow mesenchymal stem cells autologous; Placebo comparator
Intervention type(s): Other; Other
Intervention description(s): Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg; Lactated Ringer's solution, 2.5% glucose and 1% human albumin.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment