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

NCT04275024 | Completed DMC

• 1 other identifier: S2016-05-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenchymal Stromal Cells; Psoriasis; Drug Effect; Drug Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PASI(Psoriasis Area and Severity Index)

  12 weeks (plus or minus 3 days) after treatment

• PASI-50

  12 weeks (plus or minus 3 days) after treatment

• PASI-75

  12 weeks (plus or minus 3 days) after treatment

• Pruritus Scores on the Visual Analogue Scale

  12 weeks (plus or minus 3 days) after treatment

• BSA

  12 weeks (plus or minus 3 days) after treatment

Study Arms (1)

Experimental group

EXPERIMENTAL

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; Drug: PSORI-CM01 Granule; Biological: adipose-derived multipotent mesenchymal stem cells

Interventions

Calcipotriol ointment DRUG

The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.

Also known as: Dovonex

Experimental group

PSORI-CM01 Granule DRUG

PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.

Also known as: Chinese Herbal Medicine

Experimental group

adipose-derived multipotent mesenchymal stem cells BIOLOGICAL

AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe psoriasis vulgaris ( PASI \> 10 or BSA \>10%)
• to 65 years old
• written/signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Psoriasis; Drug-Related Side Effects and Adverse Reactions

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders

Study Officials

• Chuanjian Lu, PhD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 19, 2020
• Study Start: April 1, 2020
• Primary Completion: June 17, 2020
• Study Completion: February 3, 2021
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)