- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275024
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
August 23, 2023 updated by: Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis.
Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.
Study Overview
Status
Completed
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis.
Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China
- Guangdong Provincial Hospital of Traditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
- 18 to 65 years old
- written/signed informed consent
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
AD-MSCs: adipose-derived multipotent mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg of body weight at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The basic treatment is oral PSORI-CM01 Granule plus calcipotriol ointment (Dovonex;LEO Laboratories Ltd, Ireland) for topical use twice daily for 12 weeks. |
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
Other Names:
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
Other Names:
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PASI score improvement rate
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
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12 weeks (plus or minus 3 days) after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PASI(Psoriasis Area and Severity Index)
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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The improvement in PASI score from baseline after treatment
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12 weeks (plus or minus 3 days) after treatment
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BSA
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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the Body Surface Area
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12 weeks (plus or minus 3 days) after treatment
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PASI-50
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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The proportion of patients who achieve at least 50% improvement in PASI score from baseline
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12 weeks (plus or minus 3 days) after treatment
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PASI-75
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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The proportion of patients who achieve at least 75% improvement in PASI score from baseline
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12 weeks (plus or minus 3 days) after treatment
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Pruritus Scores on the Visual Analogue Scale
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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Pruritus was assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10.
The higer the scores were, the more itching the patient suffered
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12 weeks (plus or minus 3 days) after treatment
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DLQI(Dermatology Life Quality Index)
Time Frame: 12 weeks (plus or minus 3 days) after treatment
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the Dermatology Life Quality Index
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12 weeks (plus or minus 3 days) after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chuanjian Lu, PhD, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
June 17, 2020
Study Completion (Actual)
February 3, 2021
Study Registration Dates
First Submitted
February 16, 2020
First Submitted That Met QC Criteria
February 16, 2020
First Posted (Actual)
February 19, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2016-05-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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