Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it explores the expectations of patients for the treatment of traditional Chinese medicine combined with stem cells and their expectations to participate in this study. The trial would provide preliminary data for large sample clinical randomized controlled trials.
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 Mar 2021
Typical duration for phase_1
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
February 28, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 24, 2023
August 1, 2023
3 months
February 28, 2021
August 23, 2023
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% PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.
12 weeks (plus or minus 3 days) after treatment.
Secondary Outcomes (7)
PASI (Psoriasis Area and Severity Index)
12 weeks (plus or minus 3 days) after treatment.
Relapse rate in treatment period / follow-up period
12 weeks (plus or minus 3 days) after treatment.
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 (2)
PSORI-CM01 group
OTHERExpanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 \^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times. PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
Gu Ben Hua Yu group
EXPERIMENTALExpanded Allogeneic Adipose-derived multipotent mesenchymal stem cells(AD-MSCs) will be administered by intravenous drip at a dose of 2×10 \^ 6 cells/kg at week 0, week 2, week 4, week 6, week 8 with a total of 5 times. Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs.
Interventions
PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs
Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs
AD-MSCs (adipose-derived multipotent mesenchymal stem cells) will be infused intravenously at a dose of 2 million cells/kg
Eligibility Criteria
You may qualify if:
- patients with psoriasis vulgaris(PASI \> 7 or BSA \>10%); 2.18 to 65 years old; 3.written/signed informed consent.
You may not qualify if:
- The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
- 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)
Study Officials
- PRINCIPAL INVESTIGATOR
Chuanjian Lu, PhD
Guangdong Provincial Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 28, 2021
First Posted
March 5, 2021
Study Start
March 17, 2021
Primary Completion
June 17, 2021
Study Completion
September 30, 2024
Last Updated
August 24, 2023
Record last verified: 2023-08