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

NCT03424629 | Unknown Phase 1

• 1 other identifier: TianjinEverUnion
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Moderate and Severe Plaque Psoriasis

Keywords

psoriasis; UC-MSCs

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20

  The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 20

  Week 20

• Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 20

  The proportion of subjects who achieve a score of 0（clear）or 1（almost clear）on a 5-point Physician's global assessment（PGA0/1) at week 20

  Week 20

Secondary Outcomes (5)

• Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20

  Week 20

• Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 12,16,36,52

  Week 12,16,36,52

• 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

  Week 12,16,36,52

• Frequency of Adverse Events and Serious Adverse Events

  Week 0 through week 52

• Proportion of subjects who experience psoriasis relapse

  Week 8 though week 52

Other Outcomes (2)

• Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks

  Week 0,1,2,3,5,7,12,16,20,36,52

• Exploring the theoretical basis of stem cell therapy for psoriasis

  0,1,2,3,5,7 12,16,20,36,52 week

Study Arms (3)

Low-Dose UC-MSCs

EXPERIMENTAL

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

Biological: Low-dose UC-MSCs

High-Dose UC-MSCs

EXPERIMENTAL

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

Biological: High-dose UC-MSCs

Methotrexate

ACTIVE COMPARATOR

5-25mg Methotrexate orally

Drug: Methotrexate

Interventions

Low-dose UC-MSCs 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）.

Also known as: regenskin

Low-Dose UC-MSCs

High-dose UC-MSCs 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）.

Also known as: regenskin

High-Dose UC-MSCs

Methotrexate DRUG

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

Methotrexate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Ever Union Biotechnology Co., Ltd.: lead

Study Sites (2)

Peking University Third Hospital

Beijing, China

Location

Tianjin Ever Union Biotechnology Co., Ltd.

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Psoriasis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chunlei Zhang, doctor

  Peking University Third Hospital

  STUDY CHAIR

• Xin Guan, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Chunting Li, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Jinzhu Guo, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Wenhui Wang, doctor

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunlei Zhang, doctor

CONTACT

86-13716014425; zhangchunleius@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: February 7, 2018
• Study Start: June 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2019
• Last Updated: April 20, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)