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

NCT03424629 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Moderate and Severe Plaque Psoriasis

Interventions

BIOLOGICAL

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）.

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）.

DRUG

Methotrexate

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

Sponsors & Collaborators

  • Tianjin Ever Union Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chunlei Zhang, doctor · Peking University Third Hospital

  • Xin Guan, doctor · Peking University Third Hospital

  • Chunting Li, doctor · Peking University Third Hospital

  • Jinzhu Guo, doctor · Peking University Third Hospital

  • Wenhui Wang, doctor · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-09-30
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424629 on ClinicalTrials.gov