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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

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date February 9, 2021
Estimated Study Start Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)		 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%
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)		 Improvement rate of PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • the Body Surface Area (BSA%) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • 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
  • 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.
  • 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-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
  • 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
  • the Body Surface Area (BSA%) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area
  • the Dermatology Life Quality Index（DLQI） [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the score of Dermatology Life Quality Index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis
Official Title  ICMJE Efficacy and Safety of Expanded Umbilical Cord Mesenchymal Stem Cells On Patients With Moderate to Severe Psoriasis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mesenchymal Stromal Cells
  • Psoriasis
  • Drug Effect
  • Drug Toxicity
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Biological: Umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)		 5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745417
Other Study ID Numbers  ICMJE S2018-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Guangdong Provincial Hospital of Traditional Chinese Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Peking Union Medical College Hospital
Investigators  ICMJE Not Provided
PRS Account Guangdong Provincial Hospital of Traditional Chinese Medicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP