Status:
COMPLETED
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Mesenchymal Stromal Cells
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- moderate to severe psoriasis vulgaris ( PASI \> 10 or BSA \>10%)
- 18 to 65 years old
- written/signed informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04275024
Start Date
April 1 2020
End Date
February 3 2021
Last Update
August 24 2023
Active Locations (1)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China