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

Moderate and Severe Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03424629
• Other study ID #: TianjinEverUnion
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 27, 2017
• Last updated: April 18, 2018
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Tianjin Ever Union Biotechnology Co., Ltd.
• Contact: Chunlei Zhang, doctor
• Phone: 86-13716014425
• Email: zhangchunleius[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate and Severe Plaque Psoriasis
• Psoriasis

Intervention

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).
• 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).

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	Tianjin Ever Union Biotechnology Co., Ltd.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Ever Union Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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