<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265613</url>
  </required_header>
  <id_info>
    <org_study_id>S2017-01</org_study_id>
    <nct_id>NCT03265613</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis</brief_title>
  <acronym>ADMSP</acronym>
  <official_title>Safety and Efficacy of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of Adipose-derived&#xD;
      Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events&#xD;
      related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse&#xD;
      Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the&#xD;
      improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period,&#xD;
      changes in PASI score and BSA, as well as DLQI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both.&#xD;
      Numerous topical and systemic therapies are available for the treatment of psoriasis.&#xD;
      Treatment modalities are chosen on the basis of disease severity, relevant comorbidities,&#xD;
      patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and&#xD;
      biologic immune modifying agents are recommended, but all of them have some drawbacks or&#xD;
      limitations. Until now, no curative treatment is available. Therefore, it is important to&#xD;
      find new treatment for psoriasis.&#xD;
&#xD;
      Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into&#xD;
      bone, cartilage and adipose cells. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were&#xD;
      isolated from fat tissues and were reported to treat moderate to severe psoriasis vulgaris&#xD;
      and psoriasis arthritis successfully by case reports. For the mechanism of the disease,&#xD;
      involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells&#xD;
      (MSCs) are found to have the function of immunomodulation, migration to skin lesions,&#xD;
      limitation of autoimmunity. Therefore, investigators supposed that the injection of AD-MSCs&#xD;
      could be beneficial for treatment of moderate to severe psoriasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2017</start_date>
  <completion_date type="Actual">November 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (AEs) related to intervention</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The proportion of the adverse events related to intervention in the treatment group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events (SAEs) related to intervention</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The proportion of the serious adverse events related to intervention in the treatment group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement rate of PASI(Psoriasis Area and Severity Index)</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI(Psoriasis Area and Severity Index)</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The improvement in PASI score from baseline after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI-50</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The proportion of patients who achieve at least 50% improvement in PASI score from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI-75</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>The proportion of patients who achieve at least 75% improvement in PASI score from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus Scores on the Visual Analogue Scale</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>Pruritus Scores on the Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>the Body Surface Area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DLQI（Dermatology Life Quality Index）</measure>
    <time_frame>12 weeks (plus or minus 3 days) after treatment</time_frame>
    <description>the Dermatology Life Quality Index</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Mesenchymal Stromal Cells</condition>
  <condition>Psoriasis</condition>
  <condition>Drug Toxicity</condition>
  <condition>Drug Effect</condition>
  <arm_group>
    <arm_group_label>AD-MSCs group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 0.5 million cells/kg at week 0,week 4，week 8 with a duration for treatment for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>adipose-derived multipotent mesenchymal stem cells</intervention_name>
    <description>AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.</description>
    <arm_group_label>AD-MSCs group</arm_group_label>
    <other_name>AD-MSCs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1．moderate to severe psoriasis vulgaris ( PASI &gt; 10 or BSA &gt;10% ) 2．18 to 65 years old&#xD;
        3．written/signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. guttate psoriasis, inverse psoriasis or exclusively associated with the face&#xD;
&#xD;
          2. Acute progressive psoriasis, and erythroderma tendency&#xD;
&#xD;
          3. current (or within 1 year) pregnancy or lactation&#xD;
&#xD;
          4. current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) &gt;&#xD;
             50 or the Self-rating Depression Scale (SDS) &gt; 53, or with other psychiatric disorders&#xD;
&#xD;
          5. With history of primary cardiovascular, respiratory, digestive, urinary,&#xD;
             endocrinologic and hematologic diseases, which can't be controlled through ordinary&#xD;
             treatments. Those who with malignant diseases, infections, electrolyte imbalance,&#xD;
             acid-base disturbance. Patients with clinical test results listed below: abnormal&#xD;
             serum calcium level ( Ca2+ &gt; 2.9 mmol/L or &lt; 2 mmol/L);AST or ALT 2 times more than&#xD;
             normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin&#xD;
             elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia;&#xD;
             Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any&#xD;
             other abnormal laboratory test results, assessed by investigators, that are not&#xD;
             suitable for this clinical study&#xD;
&#xD;
          6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers&#xD;
             or with other organ dysfunction&#xD;
&#xD;
          7. allergy to anything else ever before;&#xD;
&#xD;
          8. current registration in other clinical trials or participation within a month;&#xD;
&#xD;
          9. topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs )&#xD;
             within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and&#xD;
             psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within&#xD;
             12 weeks;&#xD;
&#xD;
         10. medical conditions assessed by investigators, that are not suitable for this clinical&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuanjian Lu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Yao D, Ye S, He Z, Huang Y, Deng J, Wen Z, Chen X, Li H, Han Q, Deng H, Zhao RC, Lu C. Adipose-derived mesenchymal stem cells (AD-MSCs) in the treatment for psoriasis: results of a single-arm pilot trial. Ann Transl Med. 2021 Nov;9(22):1653. doi: 10.21037/atm-21-5028.</citation>
    <PMID>34988162</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Chuanjian Lu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265613
org study id: S2017-01
nct id: NCT03265613
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of Adipose-derived
      Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events
      related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse
      Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the
      improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period,
      changes in PASI score and BSA, as well as DLQI.
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. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were
      isolated from fat tissues 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 AD-MSCs
      could be beneficial for treatment of moderate to severe psoriasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events (AEs) related to intervention
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The proportion of the adverse events related to intervention in the treatment group.
measure: Incidence of serious adverse events (SAEs) related to intervention
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The proportion of the serious adverse events related to intervention in the treatment group.
measure: Improvement rate of PASI(Psoriasis Area and Severity Index)
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
measure: PASI(Psoriasis Area and Severity Index)
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The improvement in PASI score from baseline after treatment
measure: PASI-50
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The proportion of patients who achieve at least 50% improvement in PASI score from baseline.
measure: PASI-75
time frame: 12 weeks (plus or minus 3 days) after treatment
description: The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
measure: Pruritus Scores on the Visual Analogue Scale
time frame: 12 weeks (plus or minus 3 days) after treatment
description: Pruritus Scores on the Visual Analogue Scale
measure: BSA
time frame: 12 weeks (plus or minus 3 days) after treatment
description: the Body Surface Area
measure: DLQI（Dermatology Life Quality Index）
time frame: 12 weeks (plus or minus 3 days) after treatment
description: the Dermatology Life Quality Index
arm group label: AD-MSCs group
arm group type: Experimental
description: AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 0.5 million cells/kg at week 0,week 4，week 8 with a duration for treatment for 12 weeks.
intervention type: Biological
intervention name: adipose-derived multipotent mesenchymal stem cells
description: AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
arm group label: AD-MSCs group
other name: AD-MSCs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chuanjian Lu
role: Principal Investigator
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
facility: 
country: China
citation: Yao D, Ye S, He Z, Huang Y, Deng J, Wen Z, Chen X, Li H, Han Q, Deng H, Zhao RC, Lu C. Adipose-derived mesenchymal stem cells (AD-MSCs) in the treatment for psoriasis: results of a single-arm pilot trial. Ann Transl Med. 2021 Nov;9(22):1653. doi: 10.21037/atm-21-5028.
PMID: 34988162
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Chuanjian Lu
investigator title: Professor
mesh term: Psoriasis
mesh term: Drug-Related Side Effects and Adverse Reactions