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

Tianjin Ever Union Biotechnology

Status and phase: Unknown; Phase 1

Conditions: Moderate and Severe Plaque Psoriasis

Treatments: Drug: Methotrexate; Biological: High-dose UC-MSCs; Biological: Low-dose UC-MSCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424629

TianjinEverUnion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Low-Dose UC-MSCs

Experimental group

Description:

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

Treatment:

Biological: Low-dose UC-MSCs

High-Dose UC-MSCs

Experimental group

Description:

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

Treatment:

Biological: High-dose UC-MSCs

Methotrexate

Active Comparator group

Description:

5-25mg Methotrexate orally

Treatment:

Drug: Methotrexate