Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Ever Union Biotechnology Co., Ltd.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Male or female patients ≥18 years old with moderate-to-severe psoriasis.

• Diagnosis of plaque psoriasis at least 6 months before entering the study.

• Moderate-to-severe plaque psoriasis(PASI≥10，or BSA≥10% and DLQI score≥10).

• Failure after conventional therapy.

• No other treatment for psoriasis during the period of the trial.

• Willing and able to comply with all study requirements and provide informed consent.

Exclusion Criteria:

• Other types of psoriasis,such as pustular, erythrodermic and guttate psoriasis).

• Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).

• Ongoing use of other psoriasis treatments.

• Ever use of any biologic drug directly targeting IL-17,IL-23,TNFa etc.

• Active systemic infections during the last two weeks (exception: common cold) prior to initiation of the trial and any infections that reoccur on a regular basis.

• History of malignancy .

• Evidence of infection with HIV, hepatitis B or hepatitis C.

• Pregnant or lactating females, or willing to have a baby during the trial.

• Can not be traced on time.