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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424629
Recruitment Status : Unknown
Verified December 2017 by Tianjin Ever Union Biotechnology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Ever Union Biotechnology Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Moderate and Severe Plaque Psoriasis Biological: Low-dose UC-MSCs Biological: High-dose UC-MSCs Drug: Methotrexate Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424629


Contacts
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Contact: Chunlei Zhang, doctor 86-13716014425 zhangchunleius@163.com

Locations
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China
Peking University Third Hospital
Beijing, China
Contact: Chunting Li, doctor         
Tianjin Ever Union Biotechnology Co., Ltd.
Beijing, China
Contact: Zhengnan Li, master         
Sponsors and Collaborators
Tianjin Ever Union Biotechnology Co., Ltd.
Investigators
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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
More Information
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Responsible Party: Tianjin Ever Union Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03424629    
Other Study ID Numbers: TianjinEverUnion
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Ever Union Biotechnology Co., Ltd.:
psoriasis
UC-MSCs
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors