Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis

Conditions
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Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity

Intervention / Treatment
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* Drug: Calcipotriol ointment
* Drug: PSORI-CM01 Granule
* Biological: adipose-derived multipotent mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%) 18 to 65 years old written/signed informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Drug: Calcipotriol ointment<br>* The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.<br>* Other names: Dovonex;Drug: PSORI-CM01 Granule<br>* PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.<br>* Other names: Chinese Herbal Medicine;Biological: adipose-derived multipotent mesenchymal stem cells<br>* AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI score improvement rate | PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100% | 12 weeks (plus or minus 3 days) after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI(Psoriasis Area and Severity Index) | The improvement in PASI score from baseline after treatment | 12 weeks (plus or minus 3 days) after treatment | 
| PASI-50 | The proportion of patients who achieve at least 50% improvement in PASI score from baseline | 12 weeks (plus or minus 3 days) after treatment | 
| PASI-75 | The proportion of patients who achieve at least 75% improvement in PASI score from baseline | 12 weeks (plus or minus 3 days) after treatment | 
| Pruritus Scores on the Visual Analogue Scale | Pruritus was assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10. The higer the scores were, the more itching the patient suffered | 12 weeks (plus or minus 3 days) after treatment | 
| BSA | the Body Surface Area | 12 weeks (plus or minus 3 days) after treatment | 
| DLQI(Dermatology Life Quality Index) | the Dermatology Life Quality Index | 12 weeks (plus or minus 3 days) after treatment |