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

Last updated: September 22, 2020
Sponsor: Central South University
Overall Status: Active - Recruiting

Phase

1

Condition

Rosacea

Warts

Rash

Treatment

N/A

Clinical Study ID

NCT03765957
2018-MSC/CSU/PS
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.Understanding the whole process of the study, voluntary participation and signed theinformed 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 andresistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(bodysurface area)>10%, PGA≥3 and PASI>10 at baseline; 4. Patients participated in any stem celltherapy within 6 months;

Exclusion

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 xULN(upper limit of normal), AST(SGOT,glutamic-oxalacetictransaminase)/ALT(SGPT,glutamic-pyruvic transaminase) >2.0 x ULN(upper limit ofnormal);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 lesionsand 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 therapyin two weeks;

  4. Having a serious allergic history or being allergic to two or more than 2 kinds offood or drugs;

  5. Pregnant women, or women who ready for pregnancy or lactating; Patients participatedin any clinical trials within 3 months; Other cases which researchers believe that cannot enroll.

Study Design

Total Participants: 12
Study Start date:
February 20, 2019
Estimated Completion Date:
June 01, 2021

Study 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.

Connect with a study center

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

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