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

April 18, 2018 updated by: Tianjin Ever Union Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-Dose UC-MSCs
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10^6 cells/kg in normal saline injection
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
Experimental: High-Dose UC-MSCs
Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10^6 cells/kg in normal saline injection
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
Active Comparator: Methotrexate
5-25mg Methotrexate orally
Drug: Methotrexate
Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20
Time Frame: 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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Week 12,16,36,52
Frequency of Adverse Events and Serious Adverse Events
Time Frame: Week 0 through week 52
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
Week 0 through week 52
Proportion of subjects who experience psoriasis relapse
Time Frame: Week 8 though week 52
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
Week 8 though week 52

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks
Time Frame: Week 0,1,2,3,5,7,12,16,20,36,52
DLQI score will be assessed at week 0,1,2,3,5,7,12,16,20,36,52
Week 0,1,2,3,5,7,12,16,20,36,52
Exploring the theoretical basis of stem cell therapy for psoriasis
Time Frame: 0,1,2,3,5,7 12,16,20,36,52 week
Analysis the serum cytokine content, immunological subgroup and pathological section to explore the theoretical basis of stem cell therapy for psoriasis
0,1,2,3,5,7 12,16,20,36,52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Ever Union Biotechnology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chunlei Zhang, doctor, Peking University Third Hospital
  • Principal Investigator: 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
  • Study Director: Wenhui Wang, doctor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TianjinEverUnion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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