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

NCT ID: NCT03424629

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-12-31

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.

Conditions

Moderate and Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Dose UC-MSCs

Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10\^6 cells/kg in normal saline injection

Group Type: EXPERIMENTAL

Low-dose UC-MSCs

Intervention Type: BIOLOGICAL

Participants will receive 6 times UC-MSCs infusions (each time 1×10\^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.

High-Dose UC-MSCs

Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10\^6 cells/kg in normal saline injection

Group Type: EXPERIMENTAL

High-dose UC-MSCs

Intervention Type: BIOLOGICAL

Participants will receive 6 times UC-MSCs infusions (each time 3×10\^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.

Methotrexate

5-25mg Methotrexate orally

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15).

Interventions

Low-dose UC-MSCs

Participants will receive 6 times UC-MSCs infusions (each time 1×10\^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.

Intervention Type: BIOLOGICAL

High-dose UC-MSCs

Participants will receive 6 times UC-MSCs infusions (each time 3×10\^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.

Intervention Type: BIOLOGICAL

Methotrexate

Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15).

Intervention Type: DRUG

Other Intervention Names

regenskin; regenskin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Ever Union Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunlei Zhang, doctor

Role: STUDY_CHAIR

Peking University Third Hospital

Xin Guan, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Chunting Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Jinzhu Guo, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Wenhui Wang, doctor

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Tianjin Ever Union Biotechnology Co., Ltd.

Beijing, , China

Countries

China

Central Contacts

Chunlei Zhang, doctor

Role: CONTACT

zhangchunleius@163.com

86-13716014425

Facility Contacts

Chunting Li, doctor

Role: primary

Zhengnan Li, master

Role: primary

Other Identifiers

TianjinEverUnion

Identifier Type: -

Identifier Source: org_study_id