Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients

  • STATUS
    Recruiting
  • participants needed
    8
  • sponsor
    Guangdong Provincial Hospital of Traditional Chinese Medicine
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Updated on 16 February 2024
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psoriasis vulgaris
calcipotriene
psoriasis
psori-cm01
calcipotriol

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.

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.

Details
Condition Psoriasis, Drug effect, overdose of drug with toxic effect, Breast Cancer - HER2 Positive, Chronic Shoulder Pain, Mesenchymal Stromal Cells
Age 18years - 65years
Treatment Calcipotriol ointment, PSORI-CM01 Granule, adipose-derived multipotent mesenchymal stem cells
Clinical Study IdentifierNCT04275024
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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