Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 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. |
Drug: Calcipotriol ointment
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
Other Names:
Drug: PSORI-CM01 Granule
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
Other Names:
Biological: adipose-derived multipotent mesenchymal stem cells
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg
|
Outcome Measures
Primary Outcome Measures
- PASI score improvement rate [12 weeks (plus or minus 3 days) after treatment]
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) [12 weeks (plus or minus 3 days) after treatment]
The improvement in PASI score from baseline after treatment
- PASI-50 [12 weeks (plus or minus 3 days) after treatment]
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
- PASI-75 [12 weeks (plus or minus 3 days) after treatment]
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
- Pruritus Scores on the Visual Analogue Scale [12 weeks (plus or minus 3 days) after treatment]
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 [12 weeks (plus or minus 3 days) after treatment]
the Body Surface Area
- DLQI(Dermatology Life Quality Index) [12 weeks (plus or minus 3 days) after treatment]
the Dermatology Life Quality Index
Eligibility Criteria
Criteria
Inclusion Criteria:
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moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
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18 to 65 years old
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written/signed informed consent
Exclusion Criteria:
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guttate psoriasis, inverse psoriasis or exclusively associated with the face
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Acute progressive psoriasis, and erythroderma tendency
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current (or within 1 year) pregnancy or lactation
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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
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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 75.010^9/L; White blood cell less than 3.010^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
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Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
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allergy to anything else ever before;
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current registration in other clinical trials or participation within a month;
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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;
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medical conditions assessed by investigators, that are not suitable for this clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | China |
Sponsors and Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
- Principal Investigator: Chuanjian Lu, PhD, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S2016-05-02