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

Primary Purpose

Mesenchymal Stromal Cells, Psoriasis, Drug Effect

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Calcipotriol ointment
adipose-derived multipotent mesenchymal stem cells
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stromal Cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AD-MSCs plus Calcipotriol ointment group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline after treatment
Relapse rate in treatment period / follow-up 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.
PASI-50
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
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.
BSA
the Body Surface Area
DLQI（Dermatology Life Quality Index）
the Dermatology Life Quality Index

Full Information

First Posted
January 2, 2018
Last Updated
August 23, 2023
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03392311
Brief Title
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
Official Title
Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD-MSCs plus Calcipotriol ointment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcipotriol ointment
Intervention Description
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
adipose-derived multipotent mesenchymal stem cells
Other Intervention Name(s)
AD-MSCs
Intervention Description
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.
Primary Outcome Measure Information:
Title
Improvement rate of PASI(Psoriasis Area and Severity Index)
Description
The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
Time Frame
12 weeks (plus or minus 3 days) after treatment
Secondary Outcome Measure Information:
Title
PASI(Psoriasis Area and Severity Index)
Description
The improvement in PASI score from baseline after treatment
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Relapse rate in treatment period / follow-up period
Description
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.
Time Frame
During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Title
PASI-50
Description
The proportion of patients who achieve at least 50% improvement in PASI score from baseline
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
PASI-75
Description
The proportion of patients who achieve at least 75% improvement in PASI score from baseline
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Pruritus Scores on the Visual Analogue Scale
Description
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.
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
BSA
Description
the Body Surface Area
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
DLQI（Dermatology Life Quality Index）
Description
the Dermatology Life Quality Index
Time Frame
12 weeks (plus or minus 3 days) after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%) 18 to 65 years old written/signed informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

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

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