Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which
      affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter
      problems. The disease is caused by an autoimmune mechanism, ie the immune system produces
      antibodies and cells which attack the self myelin antigens, causing therefore demyelination.
      The disease is clinically evident with relapses of neurological disability due to the
      dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.
      Disability can accumulate with time and the disease enters a progressive phase due to damage
      of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist
      which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of
      MS (like Copaxone and interferons), there is no effective means today to stop the progression
      of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal
      cells (MSC) were shown to induce similar (to the neuronal stem cells) immunomodulatory and
      neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the
      animal model of chronic experimental autoimmune encephalomyelitis (EAE). These bone marrow
      derived MSCs offer practical advantages for clinical therapeutic applications, since they can
      be obtained from the adult bone marrow and therefore the patient can be the donor for
      himself, without any danger for rejection of the cells. In addition, MSCs carry a safer
      profile and are less prone to malignant transformation.

      Our center will perform a clinical trial with intra venous transplantation of bone marrow
      derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell
      transplantation after 1year following up.
    

Detailed description: 
      In the clinical trial 30 patients with multiple sclerosis who are drug resistance will take
      apart.Based on inclusion and exclusion criteria patients are chosen.Bone marrow aspiration
      will be done for all of them under local anesthesia.Patients are randomly divided in 2
      groups:case and control. Then mesenchymal stem cells which are separated and prepared will be
      transplanted by intravenous injection to the patients in case group and the cells which
      obtain from patients in control group are frozen and inject after 6 months. Patients will be
      followed by Evaluation of EDSS MSFC RAO Test brain and cervical MRI and quality of life
      questionnaire after 1th 3th 6th and 12th months after transplantation.all these tests will be
      done before transplantation as basic evaluation.
    

Intervention name(s): intravenous injection of mesenchymal stem cells; injection of cell free media
Intervention type(s): Biological; Biological
Intervention description(s): 15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell; Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.
Other intervention name(s): stem cell transplantation; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: multiple sclerosis mesenchymal stem cell intravenous injection