A Randomized, Positive Controlled Trial That Assess the Safety And Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cells in Moderate and Severe Plaque Psoriasis Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20
研究概览
简要总结
This is a study in patients with moderate to severe chronic plaque psoriasis.All the participants will be randomized into three groups, high-dose UC-MSCs, low-dose UC-MSCs, or methotrexate group.This study is designed to prove that UC-MSCs is safe and effective.
详细描述
Psoriasis is a chronic, incurable, immune-mediated dermatological disease, and it is considered that immune system dysregulation is the important cause of the disease.Umbilical cord derived mesenchymal stem cells (UC-MSCs) have be proven safe and effective for the treatment of various intractable autoimmune and inflammatory disorders because of their distinct immunomodulatory properties.
Patients will be randomized into three groups.In one group patients will be treated with 1x10^6 cells/kg in 0,1,2,3,5,7 week, in the second group patients will be treated with 3x10^6 cells/kg in 0,1,2,3,5,7 week,in the third group patients will be treated with 5-25mg Methotrexate from 0 to 15 week In this study, researchers will determine the safety of UC-MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be assess the efficacy and sustainability of UC-MSCs in 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- •Diagnosis of plaque psoriasis at least 6 months before entering the study.
- •Moderate-to-severe plaque psoriasis(PASI≥10，or BSA≥10% and DLQI score≥10).
- •Failure after conventional therapy.
- •No other treatment for psoriasis during the period of the trial.
- •Willing and able to comply with all study requirements and provide informed consent.
排除标准
- •Other types of psoriasis,such as pustular, erythrodermic and guttate psoriasis).
- •Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
- •Ongoing use of other psoriasis treatments.
- •Ever use of any biologic drug directly targeting IL-17,IL-23,TNFa etc.
- •Active systemic infections during the last two weeks (exception: common cold) prior to initiation of the trial and any infections that reoccur on a regular basis.
- •History of malignancy .
- •Evidence of infection with HIV, hepatitis B or hepatitis C.
- •Pregnant or lactating females, or willing to have a baby during the trial.
- •Can not be traced on time.
研究组 & 干预措施
Low-Dose UC-MSCs
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10^6 cells/kg in normal saline injection
干预措施: Low-dose UC-MSCs (Biological)
High-Dose UC-MSCs
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10^6 cells/kg in normal saline injection
干预措施: High-dose UC-MSCs (Biological)
Methotrexate
5-25mg Methotrexate orally
干预措施: Methotrexate (Drug)
结局指标
主要结局
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20
时间窗: Week 20
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 20
Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 20
时间窗: Week 20
The proportion of subjects who achieve a score of 0（clear）or 1（almost clear）on a 5-point Physician's global assessment（PGA0/1) at week 20
次要结局
- Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 12,16,36,52(Week 12,16,36,52)
- Frequency of Adverse Events and Serious Adverse Events(Week 0 through week 52)
- Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20(Week 20)
- Proportion of subjects who experience psoriasis relapse(Week 8 though week 52)
- Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 12,16,36,52(Week 12,16,36,52)