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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03745417
Recruitment Status : Unknown
Verified January 2021 by Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mesenchymal Stromal Cells Psoriasis Drug Effect Drug Toxicity Biological: Umbilical cord mesenchymal stem cells Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Expanded Umbilical Cord Mesenchymal Stem Cells On Patients With Moderate to Severe Psoriasis
Estimated Study Start Date : August 31, 2021
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: UCMSCs group
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.
 Biological: Umbilical cord mesenchymal stem cells
Umbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg.
Other Name: UCMSCs


Outcome Measures
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Primary Outcome Measures :
  1. PASI score improvement rate [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%


Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index(PASI) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    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.

  2. Relapse rate in treatment period / follow-up period [ Time Frame: 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.

  3. PASI-50 [ Time Frame: 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 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.

  4. PASI-75 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    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.

  5. Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    Pruritus Scores on the Visual Analogue Scale

  6. the Body Surface Area (BSA%) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area

  7. the Dermatology Life Quality Index（DLQI） [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745417


Contacts
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Contact: Chuanjian Lu, PhD +8620-81887233-31223 luchuanjian888@vip.sina.com
Contact: Danni Yao, PhD +8620-81887233-35934 yaodanni1984@163.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510000
Contact: Chuanjian Lu, PhD    (8620)81887233 ext 31223    luchuanjian888@vip.sina.com   
Contact: Zehuai Wen, PhD    （86）13903008091    wenzehuai@139.com   
Principal Investigator: Chuanjian Lu, Doctor         
Sub-Investigator: Danni Yao         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Peking Union Medical College Hospital
More Information
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Responsible Party: Chuanjian Lu, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03745417    
Other Study ID Numbers: S2018-11
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine:
Psoriasis
Umbilical cord Mesenchymal Stem Cells
Additional relevant MeSH terms:
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Psoriasis
Drug-Related Side Effects and Adverse Reactions
Skin Diseases, Papulosquamous
Skin Diseases
Chemically-Induced Disorders