Clinical trial NCT03765957: Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Official title: Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Psoriasis
Keywords: Mesenchymal Stem Cells
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel

Detailed description: 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.

Eligibility criteria: 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:

1. 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;
2. 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;
3. Patients who have received systemic therapy within recent one month or topical therapy in two weeks;
4. Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs;
5. 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.

Primary outcomes:
measure: Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
timeFrame: Month 6
measure: Number of Participants Achieving a Physician Global Assessment (PGA) of (0, 1)
timeFrame: Month 6
Secondary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Month 6
measure: Adverse event
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Xiang Chen, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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