NCT03424629

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

Status unknown Phase 1 Last updated 20 April 2018

What this trial tests

Phase 1 trial testing Low-dose UC-MSCs in Moderate and Severe Plaque Psoriasis in 57 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
30 September 2018

31 December 2019

Quick facts

Lead sponsor	Tianjin Ever Union Biotechnology Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	1 June 2018
Primary completion	30 September 2018
Estimated completion	31 December 2019
Sites	2 locations across China

Drugs / interventions tested

• Low-dose UC-MSCs — full drug profile →
• High-dose UC-MSCs — full drug profile →
• Methotrexate — full drug profile →

Conditions studied

• Moderate and Severe Plaque Psoriasis — all drugs for Moderate and Severe Plaque Psoriasis →

Sponsor

Tianjin Ever Union Biotechnology Co., Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with Moderate and Severe Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. MSCs and their exosomes: a rapidly evolving approach in the context of cutaneous wounds therapy.
   Marofi F, Alexandrovna KI, Margiana R, Margiana R, et al · · 2021 · cited 47× · PMID 34863308 · DOI 10.1186/s13287-021-02662-6
2. Small Extracellular Vesicles Derived From MSCs Have Immunomodulatory Effects to Enhance Delivery of ASO-210 for Psoriasis Treatment.
   Zhang W, Lin J, Shi P, Su D, et al · · 2022 · cited 32× · PMID 35359454 · DOI 10.3389/fcell.2022.842813
3. An Update on the Potential of Mesenchymal Stem Cell Therapy for Cutaneous Diseases.
   Li Y, Ye Z, Yang W, Zhang Q, et al · · 2021 · cited 12× · PMID 33505474 · DOI 10.1155/2021/8834590
4. Therapeutic potential of mesenchymal stem cells for refractory inflammatory and immune skin diseases.
   Hua C, Chen S, Cheng H. · · 2022 · cited 7× · PMID 36382475 · DOI 10.1080/21645515.2022.2144667
5. Multimodal Function of Mesenchymal Stem Cells in Psoriasis Treatment.
   Ou J, Li Z, Yao D, Lu C, et al · · 2025 · PMID 40427630 · DOI 10.3390/biom15050737