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

NCT03392311 | Completed Phase 1 DMC

• 1 other identifier: S2016-04-02
• 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 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)

• Improvement rate of PASI(Psoriasis Area and Severity Index)

  The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline

  12 weeks (plus or minus 3 days) after treatment

Secondary Outcomes (7)

• PASI(Psoriasis Area and Severity Index)

  12 weeks (plus or minus 3 days) after treatment

• Relapse rate in treatment period / follow-up period

  During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period

• 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

Study Arms (1)

AD-MSCs plus Calcipotriol ointment group

EXPERIMENTAL

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.

Drug: Calcipotriol ointment; 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.

AD-MSCs plus Calcipotriol ointment 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.

Also known as: AD-MSCs

AD-MSCs plus Calcipotriol ointment 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

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: phase 1
• 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: January 2, 2018
• First Posted: January 5, 2018
• Study Start: July 23, 2019
• Primary Completion: October 23, 2019
• Study Completion: March 19, 2020
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)