Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Improvement rate of PASI(Psoriasis Area and Severity Index)
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
- •18 to 65 years old
- •written/signed informed consent
Exclusion Criteria
- •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.
Arms & Interventions
AD-MSCs plus Calcipotriol ointment group
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.
Intervention: Calcipotriol ointment (Drug)
AD-MSCs plus Calcipotriol ointment group
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.
Intervention: adipose-derived multipotent mesenchymal stem cells (Biological)
Outcomes
Primary Outcomes
Improvement rate of PASI(Psoriasis Area and Severity Index)
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
Secondary Outcomes
- PASI(Psoriasis Area and Severity Index)(12 weeks (plus or minus 3 days) after treatment)
- Pruritus Scores on the Visual Analogue Scale(12 weeks (plus or minus 3 days) after treatment)
- Relapse rate in treatment period / follow-up period(During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period)
- DLQI（Dermatology Life Quality Index）(12 weeks (plus or minus 3 days) after treatment)
- PASI-50(12 weeks (plus or minus 3 days) after treatment)
- BSA(12 weeks (plus or minus 3 days) after treatment)
- PASI-75(12 weeks (plus or minus 3 days) after treatment)
Investigators
Chuanjian Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine