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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 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 |
|---|---|---|---|
| AD-MSCs plus Calcipotriol ointment group | Experimental | AD-MSCs(adipose-derived multipotent mesenchymal stem cells ) intravenous injection at a dose of 2 million cells/kg at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of PASI(Psoriasis Area and Severity Index) | The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline | 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 |
| Relapse rate in treatment period / follow-up period |
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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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| 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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Relapse can be defined only for patients who achieve PASI50,and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.
| During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period |
| 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 |
| 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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