Trial | NCT03424629  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    57
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.
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.
Study Started
Jun 01
2018
Anticipated
Primary Completion
Sep 30
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Apr 20
2018

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）.

  • Other names: regenskin

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）.

  • Other names: regenskin

Drug Methotrexate

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

Low-Dose UC-MSCs Experimental

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

High-Dose UC-MSCs Experimental

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

Methotrexate Active Comparator

5-25mg Methotrexate orally

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.
No Results Posted