Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis - EMMES

Banc de Sang i Teixits0 个研究点开始时间: 2014年1月10日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•Patients with MS (McDonald 2010)
•Clinical course of patients with relapsing-remitting MS or secondary progressive (Lublin and Reingold 1996)
•Age between 18 and 60
•Patients in whom is not indicated or are not in a position to begin treatment with drugs that modify disease available for MS, after the researcher has been informed of their benefits and potential adverse events, or who do not respond adequately to standard therapy or can not tolerate
•EDSS < o = 6.5
•At least nine T2 lesions
•Active MS, defined by: At least one outbreak in the last year or At least one Gd-enhancing lesion in the last 6 months
•Have signed the informed consent for participation in the stud
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients pre-treated with:
•- Interferon beta or glatiramer acetate 3 months prior to screening
•- Natalizumab or fingolimod in the 6 months prior to screening
•- Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
•- Experimental treatment within 3 months prior to screening
•MS attack in the 4 weeks prior to randomization
•Serum creatinine> 2.0 mg / dl. If serum creatinine is> 1.2 mg / dl, measure glomerular filtration rate. Patients were excluded if the filtrate is <60 ml/minuto/1, 73 m2
•Infectious disease active or uncontrolled
•Fertile patients who are not using a suitable method of contraception (at the discretion of the investigator). If the patient is postmenopausal or sterile must be documented in the medical record.

发起方