Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis
UCMSCs
1 other identifier
interventional
5
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis. Any adverse events related to UCMSCs infusion will be monitored.The primary outcome is the improvement rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after UCMSCs infusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 9, 2021
January 1, 2021
12 months
November 15, 2018
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
12 weeks (plus or minus 3 days) after treatment
Secondary Outcomes (7)
Psoriasis Area and Severity Index(PASI)
12 weeks (plus or minus 3 days) after treatment
Relapse rate in treatment period / follow-up period
During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
PASI-50
12 weeks (plus or minus 3 days) after treatment
PASI-75
12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
12 weeks (plus or minus 3 days) after treatment
- +2 more secondary outcomes
Study Arms (1)
UCMSCs group
EXPERIMENTALUmbilical cord mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg at week 0,week 2,week 4,week 6,week 8 with a duration for treatment for 12 weeks.
Interventions
Umbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg.
Eligibility Criteria
You may qualify if:
- ．moderate to severe psoriasis vulgaris ( PASI \> 7 or BSA \>10% ) 2．18 to 65 years old 3．written/signed informed consent
You may not qualify if:
- guttate psoriasis, inverse psoriasis or exclusively associated with the face
- Acute progressive psoriasis, and erythroderma tendency
- current (or within 1 year) pregnancy or lactation
- current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) \> 50 or the Self-rating Depression Scale (SDS) \> 53, or with other psychiatric disorders
- With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ \> 2.9 mmol/L or \< 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0\*10\^9/L; White blood cell less than 3.0\*10\^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
- Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
- allergy to anything else ever before;
- current registration in other clinical trials or participation within a month;
- topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
- medical conditions assessed by investigators, that are not suitable for this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2018
First Posted
November 19, 2018
Study Start
August 31, 2021
Primary Completion
August 28, 2022
Study Completion
December 31, 2022
Last Updated
February 9, 2021
Record last verified: 2021-01