Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
NCT Number: NCT03392311
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.
Other names: AD-MSCs
Time frame: 12 weeks (plus or minus 3 days) after treatment
The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
Time frame: 12 weeks (plus or minus 3 days) after treatment
The improvement in PASI score from baseline after treatment
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
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.
Time frame: 12 weeks (plus or minus 3 days) after treatment
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
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 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
the Body Surface Area
Time frame: 12 weeks (plus or minus 3 days) after treatment
the Dermatology Life Quality Index
Guangdong Provincial Hospital of Traditional Chinese Medicine
Other
Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
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