Clinical trial NCT03424629: Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Moderate and Severe Plaque Psoriasis
Keywords: psoriasis
UC-MSCs
Lead sponsor: Tianjin Ever Union Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 study is designed to prove that UC-MSCs is safe and effective.

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 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20
timeFrame: Week 20
measure: Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 20
timeFrame: Week 20
Secondary outcomes:
measure: Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20
timeFrame: Week 20
measure: Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 12,16,36,52
timeFrame: Week 12,16,36,52
measure: Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 12,16,36,52
timeFrame: Week 12,16,36,52
measure: Frequency of Adverse Events and Serious Adverse Events
timeFrame: Week 0 through week 52
measure: Proportion of subjects who experience psoriasis relapse
timeFrame: Week 8 though week 52
Other outcomes:
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks
timeFrame: Week 0,1,2,3,5,7,12,16,20,36,52
measure: Exploring the theoretical basis of stem cell therapy for psoriasis
timeFrame: 0,1,2,3,5,7 12,16,20,36,52 week
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Tianjin Ever Union Biotechnology Co., Ltd.
Study officials:
affiliation: Peking University Third Hospital
name: Chunlei Zhang, doctor
role: STUDY_CHAIR
affiliation: Peking University Third Hospital
name: Xin Guan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Chunting Li, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Jinzhu Guo, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Wenhui Wang, doctor
role: STUDY_DIRECTOR
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