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Moderate and Severe Plaque PsoriasisPhase 1NCT03424629

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

A Phase 1 study testing Low-dose UC-MSCs, High-dose UC-MSCs and Methotrexate in people with Moderate and Severe Plaque Psoriasis, run by Tianjin Ever Union Biotechnology Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Moderate and Severe Plaque Psoriasis
What is being tested?
Low-dose UC-MSCs, High-dose UC-MSCs and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesChina
Study dates
1 Jun 2018to 31 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 .
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Chunlei Zhang, doctor contact

86-13716014425

zhangchunleius@163.com

China2 sites

  • Peking University Third Hospital

    Beijing

    Chunting Li, doctor

  • Tianjin Ever Union Biotechnology Co., Ltd.

    Beijing

    Zhengnan Li, master

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Low-dose UC-MSCs, High-dose UC-MSCs, Methotrexate
Keywords
psoriasis, UC-MSCs
Medical subject headings
Lymphoma, Follicular, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose UC-MSCsBiological

    Also called regenskin

    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-MSCsBiological

    Also called regenskin

    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）.

  • MethotrexateDrug

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

Study groups in NCT03424629
Study groupRoleWhat they receive
Low-Dose UC-MSCsExperimentalUmbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10^6 cells/kg in normal saline injection
Receives: Biological: Low-dose UC-MSCs
High-Dose UC-MSCsExperimentalUmbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10^6 cells/kg in normal saline injection
Receives: Biological: High-dose UC-MSCs
MethotrexateActive comparator5-25mg Methotrexate orally
Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

    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

    Measured: Week 20

Secondary outcomes (5)

  1. 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

    Measured: 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

    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

    Measured: 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

    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

    Measured: Week 12,16,36,52

  4. 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

    Measured: Week 0 through week 52

  5. 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

    Measured: Week 8 though week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start1 Jun 2018 (estimated)
  3. Primary completion30 Sep 2018 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424629
Sponsor's protocol ID
TianjinEverUnion
Status last verified
Dec 2017
First submitted
27 Dec 2017
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low-dose UC-MSCs, High-dose UC-MSCs and Methotrexate in people with Moderate and Severe Plaque Psoriasis, run by Tianjin Ever Union Biotechnology Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chunlei Zhang, doctor (86-13716014425, zhangchunleius@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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