A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.
详细描述
Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.
Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.
In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stable psoriasis vulgaris for at least 6 months
- •Baseline Psoriasis Area and Severity Index (PASI) score >= 8
- •Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
- •No other psoriasis management (topical or systemic) during the UC-MSCs infusions
- •Willing and able to comply with all study requirements and provide informed consent
排除标准
- •Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
- •With other disease
- •Systemic treatments within 4 weeks before the baseline visit
- •Topical treatment within 2 weeks before the baseline visit
- •Uncontrolled active infections
- •Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
- •History of severe systemic disease or malignancy
- •Pregnant or lactating females, or willing to have a baby in the next year
- •Cannot be traced on time
- •Any other situations not suitable for this study determined by the investigators
结局指标
主要结局
Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks
时间窗: baseline and 8 weeks
PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks
时间窗: baseline and 8 weeks
DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
次要结局
- body temperature will be monitored for any possible infusion-related toxicities.(up to 3 months)
- blood pressure will be monitored for any possible infusion-related toxicities.(up to 3 months)
- Psoriasis Area and Severity Index (PASI) score(month 6, 9, and 12)
- Dermatology Life Quality Index (DLQI) score(month 6, 9, and 12)