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

Phase 1

Completed

• Conditions: Psoriasis; Mesenchymal Stromal Cells; Drug Effect; Drug Toxicity
• Interventions: Drug: Calcipotriol ointment; Biological: adipose-derived multipotent mesenchymal stem cells

• Registration Number: NCT03392311
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2019-07-23
• Primary Completion: 2019-10-23
• Study Completion: 2020-03-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AD-MSCs plus Calcipotriol ointment group	Calcipotriol ointment	AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 2 million cells/kg at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
AD-MSCs plus Calcipotriol ointment group	adipose-derived multipotent mesenchymal stem cells	AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 2 million cells/kg at week 0, week 2, week 4, week 6, week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Improvement rate of PASI(Psoriasis Area and Severity Index)	12 weeks (plus or minus 3 days) after treatment	The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline

Secondary Outcome Measures

Name	Time	Method
PASI(Psoriasis Area and Severity Index)	12 weeks (plus or minus 3 days) after treatment	The improvement in PASI score from baseline after treatment
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.
Relapse rate in treatment period / follow-up period	During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period	Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.
DLQI（Dermatology Life Quality Index）	12 weeks (plus or minus 3 days) after treatment	the Dermatology Life Quality Index
BSA	12 weeks (plus or minus 3 days) after treatment	the Body Surface Area
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

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China