Moderate and Severe Plaque Psoriasis Clinical Trial
Official title:
A Randomized, Positive Controlled Trial That Assess the Safety And Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cells in Moderate and Severe Plaque Psoriasis Patients
This is a study in patients with moderate to severe chronic plaque psoriasis.All the participants will be randomized into three groups, high-dose UC-MSCs, low-dose UC-MSCs, or methotrexate group.This study is designed to prove that UC-MSCs is safe and effective.
Psoriasis is a chronic, incurable, immune-mediated dermatological disease, and it is
considered that immune system dysregulation is the important cause of the disease.Umbilical
cord derived mesenchymal stem cells (UC-MSCs) have be proven safe and effective for the
treatment of various intractable autoimmune and inflammatory disorders because of their
distinct immunomodulatory properties.
Patients will be randomized into three groups.In one group patients will be treated with
1x10^6 cells/kg in 0,1,2,3,5,7 week, in the second group patients will be treated with 3x10^6
cells/kg in 0,1,2,3,5,7 week,in the third group patients will be treated with 5-25mg
Methotrexate from 0 to 15 week In this study, researchers will determine the safety of
UC-MSCs that a patient can tolerate without causing side effects. Moreover researchers will
also be assess the efficacy and sustainability of UC-MSCs in 52 weeks.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00885196 -
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
|
Phase 2 |