Clinical trial · Interventional
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
NCT03424629CI-TRIAL-00032620unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate and Severe Plaque Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose UC-MSCs | Biological | — | UNRESOLVED |
| Low-dose UC-MSCs | Biological | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low-Dose UC-MSCs
- description
- Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10\^6 cells/kg in normal saline injection
- interventionNames
- Biological: Low-dose UC-MSCs
- type
- EXPERIMENTAL
- label
- High-Dose UC-MSCs
- description
- Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10\^6 cells/kg in normal saline injection
- interventionNames
- Biological: High-dose UC-MSCs
- type
- ACTIVE_COMPARATOR
- label
- Methotrexate
- description
- 5-25mg Methotrexate orally
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.