Status:
UNKNOWN
Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis
Lead Sponsor:
Tianjin Ever Union Biotechnology Co., Ltd.
Conditions:
Moderate and Severe Plaque Psoriasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
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 mesenchyma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03424629
Start Date
June 1 2018
End Date
December 31 2019
Last Update
April 20 2018
Active Locations (2)
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1
Peking University Third Hospital
Beijing, China
2
Tianjin Ever Union Biotechnology Co., Ltd.
Beijing, China