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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline after treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks (plus or minus 3 days) after treatment
BSA
the Body Surface Area
Time frame: 12 weeks (plus or minus 3 days) after treatment
DLQI(Dermatology Life Quality Index)
the Dermatology Life Quality Index
Time frame: 12 weeks (plus or minus 3 days) after treatment
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