Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells

Study Overview
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Brief Summary
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To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel

Detailed Description
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Psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. Psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. In China, there are about 10 million psoriasis patients. Human umbilical cord-derived MSC (huc-MSC) has many advantages for the treatment of immune disease. Because it was demonstrated that huc-MSCs are effective in modulating immune cells and treating diseases and it has low immunogenicity. Furthermore, huc-MSCs do not raise ethical issue for clinical applications. Some experimental results and cases has showed that mesenchymal stem cell (MSC) can prevent or treat psoriasis. This clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.

Official Title
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Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 Years to 65 Years old, Body Mass Index (BMI) between 18.5-35; 3.Diagnosed according to biopsy for Psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(body surface area)>10%, PGA≥3 and PASI>10 at baseline; 4. Patients participated in any stem cell therapy within 6 months; Exclusion Criteria: WBC(white blood cell count ) <3.5x109/L, blood platelet count<100x109/L, hemoglobin<100g/L serum creatinine>1.5 x ULN(upper limit of normal), bilirubin > 1.5 x ULN(upper limit of normal), AST(SGOT,glutamic-oxalacetic transaminase)/ALT(SGPT,glutamic-pyruvic transaminase) >2.0 x ULN(upper limit of normal);Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B virus-antibody ) or syphilis antibody is positive; Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,Patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; Mental disorders, history of alcohol abuse, drug or other substance abuse; Patients who have received systemic therapy within recent one month or topical therapy in two weeks; Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs; Pregnant women, or women who ready for pregnancy or lactating; Patients participated in any clinical trials within 3 months; Other cases which researchers believe that can not enroll.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal Stem Cells<br>The mesenchymal stem cells will be derived from human umbilical cord. After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjects of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. | Biological: Mesenchymal Stem Cells<br>* After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjetcts of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. Besides MSCs, moisturizers such as boric acid ointment will be given to all subjects.<br>* Other names: Human Umbilical Cord-derived Mesenchymal Stem Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline. | Month 6 | 
| Number of Participants Achieving a Physician Global Assessment (PGA) of (0, 1) | The PGA is a physician's determination of the participant's psoriasis lesions overall categorized by descriptions for induration, erythema, and scaling. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects. | Baseline, Month 6 | 
| Adverse event | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Baseline, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal Stem Cells