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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275024
• Other study ID #: S2016-05-02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: February 3, 2021

Study information

• Verified date: August 2023
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 3, 2021
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Effect
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Mesenchymal Stromal Cells
• Psoriasis

Intervention

Drug:
• Calcipotriol ointment
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
• PSORI-CM01 Granule
PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.

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

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI score improvement rate	PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%	12 weeks (plus or minus 3 days) after treatment
Secondary	PASI(Psoriasis Area and Severity Index)	The improvement in PASI score from baseline after treatment	12 weeks (plus or minus 3 days) after treatment
Secondary	PASI-50	The proportion of patients who achieve at least 50% improvement in PASI score from baseline	12 weeks (plus or minus 3 days) after treatment
Secondary	PASI-75	The proportion of patients who achieve at least 75% improvement in PASI score from baseline	12 weeks (plus or minus 3 days) after treatment
Secondary	Pruritus Scores on the Visual Analogue Scale	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	12 weeks (plus or minus 3 days) after treatment
Secondary	BSA	the Body Surface Area	12 weeks (plus or minus 3 days) after treatment
Secondary	DLQI(Dermatology Life Quality Index)	the Dermatology Life Quality Index	12 weeks (plus or minus 3 days) after treatment