Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
- Conditions
- Mesenchymal Stromal CellsDrug EffectPsoriasisDrug Toxicity
- Interventions
- Drug: PSORI-CM01 GranuleBiological: adipose-derived multipotent mesenchymal stem cells
- Registration Number
- NCT04275024
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
- 18 to 65 years old
- written/signed informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental group Calcipotriol ointment 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. Experimental group adipose-derived multipotent mesenchymal stem cells 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. Experimental group PSORI-CM01 Granule 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.
- Primary Outcome Measures
Name Time Method PASI score improvement rate 12 weeks (plus or minus 3 days) after treatment PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
- Secondary Outcome Measures
Name Time Method PASI(Psoriasis Area and Severity Index) 12 weeks (plus or minus 3 days) after treatment The improvement in PASI score from baseline after treatment
Pruritus Scores on the Visual Analogue Scale 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
PASI-50 12 weeks (plus or minus 3 days) after treatment The proportion of patients who achieve at least 50% improvement in PASI score from baseline
BSA 12 weeks (plus or minus 3 days) after treatment the Body Surface Area
DLQI(Dermatology Life Quality Index) 12 weeks (plus or minus 3 days) after treatment the Dermatology Life Quality Index
PASI-75 12 weeks (plus or minus 3 days) after treatment The proportion of patients who achieve at least 75% improvement in PASI score from baseline
Trial Locations
- Locations (1)
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China