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

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: Unknown
• Conditions: Moderate and Severe Plaque Psoriasis
• Intervention / Treatment: Biological: Low-dose UC-MSCs; Biological: High-dose UC-MSCs; Drug: Methotrexate

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: Interventional
• Enrollment (Anticipated): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 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

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	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 Outcome Measures

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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks	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	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

• Sponsor: Tianjin Ever Union Biotechnology Co., Ltd.
• Investigators: 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

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: psoriasis; UC-MSCs
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID 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