Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Score of Expanded Disability Status Scale (EDSS)
研究概览
简要总结
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.
Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.
- •Aged 16-65 years.
- •Disease duration≥2years
- •Poor response to steroid therapy.
- •Written informed consent and follow the clinic trail procedure
排除标准
- •Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.
- •Combined Pneumonia or other Severe systemic bacteria infection.
- •Severe drug allergic history or anaphylaxis to 2 or more food or medicine.
- •Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/
- •HIV+, TPPA +， patients diagnosed as HBV or HCV.
- •Tumor Markers +
- •Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form.
- •Coagulation disorders.
- •Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg.
- •Pregnancy.
- •Enrollment in other trials in the last 3 months.
- •Other criteria the investigator consider improper for inclusion.
结局指标
主要结局
Score of Expanded Disability Status Scale (EDSS)
时间窗: 1 year after treatment
次要结局
- Visual Evoked Potential (VEP)(1 year after treatment)
- Brainstem Auditory Evoked Potential (BAEP)(1 year after treatment)
- Somatosensory Evoked Potential(SEP)(1 year after treatment)
- Brain Magnetic Resonance Imaging （MRI） Scan(1 year after treatment)