Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- PASI score improvement rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.
详细描述
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.
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
- •moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
- •18 to 65 years old
- •written/signed informed consent
排除标准
- •guttate psoriasis, inverse psoriasis or exclusively associated with the face
- •Acute progressive psoriasis, and erythroderma tendency
- •current (or within 1 year) pregnancy or lactation
- •current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) > 50 or the Self-rating Depression Scale (SDS) > 53, or with other psychiatric disorders
- •With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ > 2.9 mmol/L or < 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
- •Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
- •allergy to anything else ever before;
- •current registration in other clinical trials or participation within a month;
- •topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
- •medical conditions assessed by investigators, that are not suitable for this clinical study.
研究组 & 干预措施
Experimental group
AD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks.
The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks.
干预措施: Calcipotriol ointment (Drug)
Experimental group
AD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks.
The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks.
干预措施: PSORI-CM01 Granule (Drug)
Experimental group
AD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks.
The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks.
干预措施: adipose-derived multipotent mesenchymal stem cells (Biological)
结局指标
主要结局
PASI score improvement rate
时间窗: 12 weeks (plus or minus 3 days) after treatment
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
次要结局
- PASI(Psoriasis Area and Severity Index)(12 weeks (plus or minus 3 days) after treatment)
- Pruritus Scores on the Visual Analogue Scale(12 weeks (plus or minus 3 days) after treatment)
- PASI-50(12 weeks (plus or minus 3 days) after treatment)
- BSA(12 weeks (plus or minus 3 days) after treatment)
- DLQI(Dermatology Life Quality Index)(12 weeks (plus or minus 3 days) after treatment)
- PASI-75(12 weeks (plus or minus 3 days) after treatment)
研究者
Chuanjian Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine