Overview

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

Status:
Not yet recruiting

Trial end date:
2021-06-01

Target enrollment:
50

Participant gender:
All

Summary

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

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Central South University

Treatments:

Methotrexate

Criteria

Inclusion Criteria:

1. Diagnosed according to Classification criteria for Psoriasis vulgaris for more than 6
months;

2. Body Mass Index (BMI) between 18.5-35;

3. Resistance to phototherapy, systemic therapy, or a combination of these therapies

4. BSA(body surface area)>10%, sPGA>3 and PASI>10 at baseline;

5. Understanding the whole process of the study, voluntary participation and signed the
informed consent.

Exclusion Criteria:

1. WBC(white blood cell count ) <3.0x109/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) >2.5 x ULN(upper limit of
normal);

2. Pregnant women, or women who ready for pregnancy or lactating;

3. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions
and the history;

4. Patients suffering from malignant tumor;

5. Patients suffering from any acute or chronic infectious diseases;

6. Mental disorders, history of alcohol abuse, drug or other substance abuse;

7. Patients participated in any clinical trials within 3 months or any stem cell therapy
within 6 months;

8. Having a serious allergic history or being allergic to two or more than 2 kinds of
food or drugs;

9. Patients who have received systemic therapy within recent one month or topical therapy
in two weeks;

10. Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B
virus-antibody ) or syphilis antibody is positive;

11. Other cases which researchers believe that can not enroll.