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Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis (UCMSCs)

Primary Purpose

Mesenchymal Stromal Cells, Psoriasis, Drug Effect

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical cord 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 focused on measuring Psoriasis, Umbilical cord Mesenchymal Stem 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 > 7 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

UCMSCs group

Arm Description

Umbilical cord 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.

Outcomes

Primary Outcome Measures

PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%

Secondary Outcome Measures

Psoriasis Area and Severity Index(PASI)
The improvement in PASI score from baseline after treatment. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
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 scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
Pruritus Scores on the Visual Analogue Scale
Pruritus Scores on the Visual Analogue Scale
the Body Surface Area (BSA%)
the Body Surface Area
the Dermatology Life Quality Index（DLQI）
the score of Dermatology Life Quality Index. Dermatology Life Quality Index (DLQI) is a self-administered 10-item questionnaire. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, and Treatment.

Full Information

First Posted
November 15, 2018
Last Updated
February 5, 2021
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03745417
Brief Title
Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis
Acronym
UCMSCs
Official Title
Efficacy and Safety of Expanded Umbilical Cord Mesenchymal Stem Cells On Patients With Moderate to Severe Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2021 (Anticipated)
Primary Completion Date
August 28, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators
Peking Union Medical College Hospital

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 Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis. Any adverse events related to UCMSCs infusion will be monitored.The primary outcome is the improvement rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after UCMSCs infusion.
Detailed Description
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Numerous topical and systemic therapies are available for the treatment of psoriasis. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and biologic immune modifying agents are recommended, but all of them have some drawbacks or limitations. Until now, no curative treatment is available. Therefore, it is important to find new treatment for psoriasis. Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into bone, cartilage and adipose cells. Umbilical cord Mesenchymal Stem Cells were isolated from umbilical cord matrix and were reported to treat moderate to severe psoriasis vulgaris and psoriasis arthritis successfully by case reports. For the mechanism of the disease, involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells (MSCs) are found to have the function of immunomodulation, migration to skin lesions, limitation of autoimmunity. Therefore, investigators supposed that the injection of UCMSCs could be beneficial for treatment of moderate to severe psoriasis.

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
Keywords
Psoriasis, Umbilical cord Mesenchymal Stem Cells

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
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSCs group
Arm Type
Experimental
Arm Description
Umbilical cord 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.
Intervention Type
Biological
Intervention Name(s)
Umbilical cord mesenchymal stem cells
Other Intervention Name(s)
UCMSCs
Intervention Description
Umbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg.
Primary Outcome Measure Information:
Title
PASI score improvement rate
Description
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Time Frame
12 weeks (plus or minus 3 days) after treatment
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index(PASI)
Description
The improvement in PASI score from baseline after treatment. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
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. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
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. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Pruritus Scores on the Visual Analogue Scale
Description
Pruritus Scores on the Visual Analogue Scale
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
the Body Surface Area (BSA%)
Description
the Body Surface Area
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
the Dermatology Life Quality Index（DLQI）
Description
the score of Dermatology Life Quality Index. Dermatology Life Quality Index (DLQI) is a self-administered 10-item questionnaire. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, and Treatment.
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: 1．moderate to severe psoriasis vulgaris ( PASI > 7 or BSA >10% ) 2．18 to 65 years old 3．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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanjian Lu, PhD
Phone
+8620-81887233-31223
Email
luchuanjian888@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danni Yao, PhD
Phone
+8620-81887233-35934
Email
yaodanni1984@163.com
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, PhD
Phone
(8620)81887233
Ext
31223
Email
luchuanjian888@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Zehuai Wen, PhD
Phone
（86）13903008091
Email
wenzehuai@139.com
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, Doctor
First Name & Middle Initial & Last Name & Degree
Danni Yao

12. IPD Sharing Statement

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Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis

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