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

Primary Purpose

Moderate and Severe Plaque Psoriasis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low-dose UC-MSCs
High-dose UC-MSCs
Methotrexate
Sponsored by
Tianjin Ever Union Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate and Severe Plaque Psoriasis focused on measuring psoriasis, UC-MSCs

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University Third Hospital
  • Tianjin Ever Union Biotechnology Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low-Dose UC-MSCs

High-Dose UC-MSCs

Methotrexate

Arm Description

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

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

5-25mg Methotrexate orally

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20
The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI 90) at 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
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 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
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 12,16,36,52
Frequency of Adverse Events and Serious Adverse Events
Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to headaches, allergies, fever and so on
Proportion of subjects who experience psoriasis relapse
The proportion of subjects who experience a psoriasis relapse at any time until week 52. Psoriasis relapse is defined as loss of > 50% of the initial PASI improvement measured at week 7

Full Information

First Posted
December 27, 2017
Last Updated
April 18, 2018
Sponsor
Tianjin Ever Union Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03424629
Brief Title
Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Ever Union Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate and Severe Plaque Psoriasis
Keywords
psoriasis, UC-MSCs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Dose UC-MSCs
Arm Type
Experimental
Arm Description
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10^6 cells/kg in normal saline injection
Arm Title
High-Dose UC-MSCs
Arm Type
Experimental
Arm Description
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10^6 cells/kg in normal saline injection
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
5-25mg Methotrexate orally
Intervention Type
Biological
Intervention Name(s)
Low-dose UC-MSCs
Other Intervention Name(s)
regenskin
Intervention Description
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
Intervention Name(s)
High-dose UC-MSCs
Other Intervention Name(s)
regenskin
Intervention Description
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
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15).
Primary Outcome Measure Information:
Title
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20
Description
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
Time Frame
Week 20
Title
Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 20
Description
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
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20
Description
The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI 90) at week 20
Time Frame
Week 20
Title
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 12,16,36,52
Description
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 12,16,36,52
Time Frame
Week 12,16,36,52
Title
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
Description
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 12,16,36,52
Time Frame
Week 12,16,36,52
Title
Frequency of Adverse Events and Serious Adverse Events
Description
Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to headaches, allergies, fever and so on
Time Frame
Week 0 through week 52
Title
Proportion of subjects who experience psoriasis relapse
Description
The proportion of subjects who experience a psoriasis relapse at any time until week 52. Psoriasis relapse is defined as loss of > 50% of the initial PASI improvement measured at week 7
Time Frame
Week 8 though week 52
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks
Description
DLQI score will be assessed at week 0,1,2,3,5,7,12,16,20,36,52
Time Frame
Week 0,1,2,3,5,7,12,16,20,36,52
Title
Exploring the theoretical basis of stem cell therapy for psoriasis
Description
Analysis the serum cytokine content, immunological subgroup and pathological section to explore the theoretical basis of stem cell therapy for psoriasis
Time Frame
0,1,2,3,5,7 12,16,20,36,52 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlei Zhang, doctor
Phone
86-13716014425
Email
zhangchunleius@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunlei Zhang, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xin Guan, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunting Li, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinzhu Guo, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenhui Wang, doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunting Li, doctor
Facility Name
Tianjin Ever Union Biotechnology Co., Ltd.
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengnan Li, master

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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