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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol ointment | Drug | The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chuanjian Lu, PhD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | China |
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| PSORI-CM01 Granule | Drug | PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks. |
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| adipose-derived multipotent mesenchymal stem cells | Biological | AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg |
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| 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 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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