Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
Conditions
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.
Interventions
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.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. moderate to severe psoriasis vulgaris ( PASI \> 10 or BSA \>10%) 2. 18 to 65 years old 3. written/signed informed consent
Exclusion criteria
1. guttate psoriasis, inverse psoriasis or exclusively associated with the face 2. Acute progressive psoriasis, and erythroderma tendency 3. current (or within 1 year) pregnancy or lactation 4. 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 5. 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 6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction 7. allergy to anything else ever before; 8. current registration in other clinical trials or participation within a month; 9. 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; 10. medical conditions assessed by investigators, that are not suitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of PASI(Psoriasis Area and Severity Index) | 12 weeks (plus or minus 3 days) after treatment | The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Relapse rate in treatment period / follow-up period | 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. |
| 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 |
| PASI(Psoriasis Area and Severity Index) | 12 weeks (plus or minus 3 days) after treatment | The improvement in PASI score from baseline after treatment |
| 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 |
| 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. |
Countries
China
Outcome results
None listed