Back to resultsEfficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
Primary Purpose
Mesenchymal Stromal Cells, Psoriasis, Drug Effect
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Calcipotriol ointment
PSORI-CM01 Granule
adipose-derived multipotent mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Stromal Cells
Eligibility Criteria
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.
Sites / Locations
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
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.
Outcomes
Primary Outcome Measures
PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Secondary Outcome Measures
PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline after treatment
PASI-50
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
Pruritus Scores on the Visual Analogue Scale
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
BSA
the Body Surface Area
DLQI(Dermatology Life Quality Index)
the Dermatology Life Quality Index
Full Information
NCT ID
NCT04275024
First Posted
February 16, 2020
Last Updated
August 23, 2023
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04275024
Brief Title
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
Official Title
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
February 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcipotriol ointment
Other Intervention Name(s)
Dovonex
Intervention Description
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
PSORI-CM01 Granule
Other Intervention Name(s)
Chinese Herbal Medicine
Intervention Description
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
Intervention Type
Biological
Intervention Name(s)
adipose-derived multipotent mesenchymal stem cells
Intervention Description
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg
Primary Outcome Measure Information:
Title
PASI score improvement rate
Description
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Time Frame
12 weeks (plus or minus 3 days) after treatment
Secondary Outcome Measure Information:
Title
PASI(Psoriasis Area and Severity Index)
Description
The improvement in PASI score from baseline after treatment
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
PASI-50
Description
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
PASI-75
Description
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Pruritus Scores on the Visual Analogue Scale
Description
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
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
BSA
Description
the Body Surface Area
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
DLQI(Dermatology Life Quality Index)
Description
the Dermatology Life Quality Index
Time Frame
12 weeks (plus or minus 3 days) after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
We'll reach out to this number within 24 hrs