Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis: a Pilot Study for a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 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 and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it explores the expectations of patients for the treatment of traditional Chinese medicine combined with stem cells and their expectations to participate in this study. The trial would provide preliminary data for large sample clinical randomized controlled trials.
详细描述
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and biologic immune modifying agents are recommended, but all of them have some drawbacks or limitations. Until now, no curative treatment is available. Therefore, it is important to find new treatment for psoriasis.
As current experience and cases of AD-MSCs in the treatment of psoriasis are still relatively small, and it is unknown about their safety and efficacy combined with traditional medicine in the treatment of psoriasis.
This study designed a randomized controlled trial to compare PSORI-CM01 formula vs Guben Huayu formula combined with expanded allogeneic adipose-derived mesenchymal stem cells in the treatment of psoriasis. The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it also aims to determine the feasibility and the potential of the protocol for the full-scale randomized controlled trial (RCT).
Therefore, 16 subjects will be enrolled in this study and their expectations for the treatment of traditional Chinese medicine combined with stem cells and their experience to participate in this study will be interviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •1.patients with psoriasis vulgaris(PASI > 7 or BSA >10%); 2.18 to 65 years old; 3.written/signed informed consent.
排除标准
- •The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
- •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
PSORI-CM01 group
Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.
PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
干预措施: PSORI-CM01 formula (Drug)
PSORI-CM01 group
Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.
PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
干预措施: adipose-derived multipotent mesenchymal stem cells (Biological)
Gu Ben Hua Yu group
Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.
Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
干预措施: Gu Ben Hua Yu formula (Drug)
Gu Ben Hua Yu group
Expanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 ^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times.
Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
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% PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.
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.)
- DLQI (Dermatology Life Quality Index)(12 weeks (plus or minus 3 days) after treatment.)
- PASI-50(12 weeks (plus or minus 3 days) after treatment.)
- PASI-75(12 weeks (plus or minus 3 days) after treatment.)
- BSA(12 weeks (plus or minus 3 days) after treatment.)
- Relapse rate in treatment period / follow-up period(12 weeks (plus or minus 3 days) after treatment.)
研究者
Chuanjian Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine