Study of Safety, Feasibility and Efficacy of Autologous Mesenchymal Stem Cells in Multiple Sclerosis - SEAMS

Department of Biotechnology0 个研究点目标入组 15 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Clinically definite MS based on Revised McDonaldâ??s criteria.
•Relapsing Remitting MS:
•a. Patients who have a fixed EDSS of 4 (not during a relapse)
•b. Unresponsive to one or more approved first or second line therapies (interferons, glatiramer acetate, natalizumab, mitoxantrone, methotrexate, azathioprine for more than one year defined as:
•more than 2 relapses in the preceding one year of therapy.
•Persisting enhancement on MRI done within last one year.
•1 point increase in EDSS over one year.
•c. Failure or Intolerance to first line DMTs (interferon beta and glatiramer acetate).
•d. Inability to afford DMT and failure to respond to oral immunosuppressive therapy with methotrexate and azathioprine.
•Secondary Progressive MS not responding to approved therapy and evidenced by progression of the disease with moderate to severe relapse with an increase of EDSS of 1 point if baseline EDSS less than 5 Or 0.5 points if baseline EDSS more than 5 at baseline within a year; and or worsening MRI lesion load (equal to 2 enhancing lesions in the last 12 months.
•Primary Progressive MS: 6 months to one year of active disease progression as documented by worsening EDSS of of 1 point if baseline EDSS less than or equal to 5 OR 0.5 points if baseline EDSS is more than 5 at baseline within a year
•Expanded disability status scale (EDSS) score of between 3-7 at screening evaluation.
•Able to give written informed consent.

•active infection
•immunocompromised states
•neoplastic diseases
•history or laboratory results indicative of any significant cardiac, endocrinological metabolic hematologic and immunologic diseases.
•Patients who have received natalizumab or fingolimod within last 3 months
•Patients who had received glatiramer acetate orinterferons within last two months
•Female patients with known pregnancy or at risk of being pregnant

发起方

Department of Biotechnology