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.

Vice-presidency for science and technology0 个研究点目标入组 120 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Vice-presidency for science and technology