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IRCT20191004044975N1 IRCT 2020-01-10 Vice-presidency for science and technology Investigating the effect of the bone marrow-drived mesenchymal stem cells in MS patients under fingolimod therapy. Evaluation of safety and efficacy of Intravenous and Interatechal injection of autologous bone marrow-drived mesenchymal stem cells in RRMS patients under fingolimod therapy: randomized clinical trial with control group, Phase 2 and 3. 2020-02-04 anticipated 120 Complete https://irct.ir/trial/44197 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The "http://www.randomization.com" site will be used to generate random code.The permuted-block randomization method was used to balance the number of patients and to randomly assign patients to the control and intervention group and the control group.The blocks vary in size in each disease category. (with block size =10 and 4), Blinding description: Unlike Fingolimod Therapy, the type of cell therapy intervention requires bone marrow aspiration . Ethically, the patients are not blinded for the intervention and, consequently, the physician who applies the intervention is not blind to the treatment of the patients. But clinical examinations, laboratory results and evaluations (such as MRI imaging, etc.) will be performed by physicians who are unaware of the patient's specific treatment, and to determine the final data, the statistical analyzer does not know the actual treatment and the groups are locked (A and B labeled) and sent for statistical analysis. 2-3 Multiple sclerosis. 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 suspended in serum physiology medium enriched with human serum albumin, which is administered twice. For the first time intravenously in a dose of 1 to 2 million per kg body weight of the patient and the second time, after about two weeks, Intrathecally applied in a dose of / 0.5. Millions per Kg body weight of the patient. Intervention 2: Control group: This group will received only a single dose of fingolimod (0.5Milligrams Danelvin capsule , Nano-Alvand Company) daily by the end of the study. Yes - There is a plan to make this available What will be shared: Information about the main outcome will be shared. When: Data will be available six months after the results are published. To whom: The data will be made available to academic researchers and those working in the fields of neurology and MS. Conditions: By contacting the project executives and Contact the project sponsor Where to obtain: 1- Mandana mohyeddin Bonab mohyeddin@sina.tums.ac.ir 2- saeed shahbeigi s_shahbeigi@yahoo.com 3- sinacell info.sinacell@gmial.com How to obtain: The request will first be emailed to one of the addresses. The request will then be processed and the requested data will be sent to the email address of the requestor or the reason for the failure to respond. This process may take about two weeks. Comments:
public Mandana Mohyeddin Bonab
No. 19, First East Ave., 24 meter Blvd., Saadatabad
Tehran Iran (Islamic Republic of) 1997778714 +98 21 2206 6928 mohyeddin@sina.tums.ac.ir Sinacell research and production Company scientific saeed shahbeigi
Loghman HakimHospital, South Karghar Ave., Kamali St.,,
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5541 0044 bmrc@sbmu.ac.ir Brain Mapping Research Center Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 55 years Both 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. G35 Multiple sclerosis Treatment - Other Treatment - Drugs 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 suspended in serum physiology medium enriched with human serum albumin, which is administered twice. For the first time intravenously in a dose of 1 to 2 million per kg body weight of the patient and the second time, after about two weeks, Intrathecally applied in a dose of / 0.5. Millions per Kg body weight of the patient. Control group: This group will received only a single dose of fingolimod (0.5Milligrams Danelvin capsule , Nano-Alvand Company) daily by the end of the study. 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 . 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. Sinacell research and production company Vice-presidency for science and technology Sinacell research and production company Approved 2019-09-03 Ethics committee of Tehran University of medical sciences Poursina Ave. Tehran Tehran Iran (Islamic Republic of) Approved 2019-08-20 Ethics committee of Shahid Beheshti University of medical sciences Velenjak Tehran Tehran Iran (Islamic Republic of)