Overview

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

Status:
Enrolling by invitation
Trial end date:
2021-12-24
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Treatments:
Calcipotriene
Criteria
Inclusion Criteria:

1. moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)

2. 18 to 65 years old

3. written/signed informed consent

Exclusion Criteria:

1. guttate psoriasis, inverse psoriasis or exclusively associated with the face

2. Acute progressive psoriasis, and erythroderma tendency

3. current (or within 1 year) pregnancy or lactation

4. 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

5. 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

6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers
or with other organ dysfunction

7. allergy to anything else ever before;

8. current registration in other clinical trials or participation within a month;

9. 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;

10. medical conditions assessed by investigators, that are not suitable for this clinical
study.