psoriasis
Conditions
Interventions
Stem cell low dose group:intravenous inject MSCs
Stem cell high dose group:intravenous inject MSCs
Control:Oral methotrexate
Sponsors
Tenth People's Hospital affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16-70years old male or female; 2. Diagnosed as moderate-severe plaque psoriasis: the course of disease is =6 months, BSA>10% and PASI>10 on baseline; 3. Had received at least one systemic treatment (acitretin, cyclosporine, UV phototherapy, etc.) but had poor efficacy, and the researchers believed that patients are suitable for treatment; 4. Haven't received the therapy of the UC-MSCs in the past 6 months; 5. Patients agree to the therapy of the UC-MSCs and the following examinations and sign the agreement paper.
Exclusion criteria
Exclusion criteria: 1. Other types of psoriasis (drip, erythrodermic, pustular, joint), drug-induced psoriasis or other skin conditions that may interfere with the assessment of the condition; 2. Laboratory abnormalities. Blood routine test: peripheral blood white blood cell count is less than 3.0 *10^9/L or more than 12 *10^9/L, hemoglobin (Hb) is less than 80% of the lower limit of normal value, and platelet is less than 100 *10^9/L. Liver function (ALT, AST, TBil) is more than 1.5 times the upper limit of normal value; if abnormal, a review is allowed. Renal function (serum creatinine sCr) was 1.5 times higher than the upper limit of normal value; 3. Combine severe, progressive, uncontrolled, important organ and systemic disorders (including cardiovascular, liver, lung, and kidney), other autoimmune diseases, malignancies, and investigators believe that the patient is not suitable for this study; 4. Being infected by human immunodeficiency virus (HIV), syphilis, hepatitis B or hepatitis C or other diseases; 5. Have a history of severe allergic reactions; 6. Opportunistic infections occurred within 6 months prior to screening; treated with stem cells within 6 months prior to screening; treated with biologics within 3 months prior to screening or participated in other clinical studies; received systemic therapy within 1 month prior to screening Received topical medication within 2 weeks prior to screening; 7. Pregnant, lactating and women planning to become pregnant within 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| PGA;DLQI; | — |
Countries
China
Contacts
Public ContactYuling Shi
Tenth People's Hospital affiliated to Tongji University
Outcome results
None listed