Multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: This group received the fingolimod and autologous bone marrow derived mesenchymal stem cells proliferating in the culture medium, at the same time . The cells are
Sponsors
Vice-presidency for science and technology
Sinacell research and production company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Clinical diagnosis of RRMS. EDSS less than 6 Patients who have used the first line of DMD for one year and who have had a clinical attack or deteriorating brain and Cervical Spinal Cord MRI findings in the one past-year. Disease progression or the onset of re-attack or deteriorating MRI findings within the one past- year prior to inclusion Normal macula. Patients' written consent to participate in the study.
Exclusion criteria
Exclusion criteria: Proven clinical attack 30 days prior to the patient's entry into the study. Use of corticosteroid drug (MePDN) 30 days prior to the patient's entry into the study. Having infectious diseases. A history of another underlying disease Including neoplasm. The presence of clear disorders in consciousness and cognition. Creatinine greater than 1.7 mg/dl Or Liver enzymes three times the upper limit of the normal range or more, Or a white blood cell count less than 3,000/mm3 and hemoglobin less than 10.7 g/dL. Treatment with cytotoxic drugs 6 months before starting the study. Positive laboratory tests for hepatitis B, C, HIV , HTLV, JCV, or syphilis. The presence of any contain metallic particles implant in the body, due to the limitations in performing the MRI Positive TB (PPD) test. Pregnancy or pregnancy intention during treatment in female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: Month of 1,2,3,4,5,6,8,10 and 12. Method of measurement: Evaluation of side effects during one year after intervention .;Efficacy. Timepoint: Month of 1,2,3,4,5,6,8,10 and 12. Method of measurement: Number of clinical relapses during one year after intervention . | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of gadolinium enhancing lesions in comparison to baseline in two groups. Timepoint: In the months of 0,6,12. Method of measurement: MRI.;Prevention of EDSS progression in comparison of baseline EDSS in two groups. Timepoint: In the months of 0,1,2,3,4,5,6,8,10 and 12. Method of measurement: The Kurtzke Expanded Disability Status Scale (EDSS) method.;Visual evoked potential. Timepoint: In the months of 0,3,6,12. Method of measurement: Electrooculogram.;Total survival rate of the patient. Timepoint: One year follow up. Method of measurement: Visual.;Progression Free Survival rate. Timepoint: One year follow up. Method of measurement: The results of clinical and para-clinical evaluation.;The number of new T2 lesions in comparison to baseline in two groups. Timepoint: The month of 0, 6, 12. Method of measurement: MRI. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMandana Mohyeddin Bonab
Sinacell research and production Company
Outcome results
None listed