Status:
UNKNOWN
Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Lead Sponsor:
Central South University
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03765957
Start Date
February 20 2019
End Date
June 1 2021
Last Update
September 23 2020
Active Locations (1)
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1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410000