xml: <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/NCT05990517</url>
    </required_header>
    <id_info>
      <org_study_id>YD01-2022</org_study_id>
      <nct_id>NCT05990517</nct_id>
    </id_info>
    <brief_title>Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients</brief_title>
    <official_title>Evaluation of the Efficacy and Safety of Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients With Diabetes Mellitus After Total Pancreatectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Jiao Tong University School of Medicine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the efficacy and safety of autologous transplantation of expanded&#xD;
        pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 22, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>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>C-peptide change</measure>
      <time_frame>12 months post-transplant</time_frame>
      <description>Evaluation of the magnitude of C-peptide change after transplantation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events</measure>
      <time_frame>52 weeks post-transplant</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects who are insulin-independent</measure>
      <time_frame>12 weeks and 52 weeks post-transplant</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage reduction in insulin requirement</measure>
      <time_frame>12 weeks and 52 weeks post-transplant</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glycemic control (MAGE)</measure>
      <time_frame>12 weeks and 52 weeks post-transplant</time_frame>
      <description>Evaluation of the average amplitude of glycemic fluctuations (MAGE) in subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)</measure>
      <time_frame>baseline and 52 weeks post-transplant</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life score</measure>
      <time_frame>baseline and 52 weeks post-transplant</time_frame>
      <description>Evaluation of the quality of life score in subjects</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">3</enrollment>
    <condition>Diabetes After Total Pancreatectomy</condition>
    <arm_group>
      <arm_group_label>YD01-2022</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>YD01-2022</intervention_name>
      <description>Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein.</description>
      <arm_group_label>YD01-2022</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Voluntarily sign an informed consent form and comply with the trial treatment plan and&#xD;
          visit schedule.&#xD;
  &#xD;
          2. Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless&#xD;
          of gender.&#xD;
  &#xD;
          3. Diagnosed with chronic pancreatitis and indication for total pancreatectomy. 4.&#xD;
          Post-total pancreatectomy, experiencing elevated blood glucose levels and meeting the&#xD;
          diagnostic criteria for diabetes (World Health Organization, 2019 edition).&#xD;
  &#xD;
          5. Post-mixed meal stimulation, C-peptide level &lt;0.3 ng/mL at 120 minutes. 6. Sexually&#xD;
          active males who are not surgically sterilized or have partners of childbearing potential&#xD;
          agree to use effective contraception during the entire trial period and for at least 6&#xD;
          months after the study ends; sexually active females of childbearing potential agree to use&#xD;
          effective contraception during the entire study period and for at least 6 months after the&#xD;
          study ends.&#xD;
  &#xD;
            1. History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic&#xD;
               criteria for diabetes.&#xD;
  &#xD;
            2. Previous pancreatic or islet transplantation.&#xD;
  &#xD;
            3. Uncontrolled hypertension, such as systolic blood pressure (SBP) &gt;160 mmHg and/or&#xD;
               diastolic blood pressure (DBP) &gt;100 mmHg despite stable dose (at least 4 weeks) of&#xD;
               antihypertensive medication.&#xD;
  &#xD;
            4. Known hemoglobin-related diseases, anemia (moderate to severe), or other known&#xD;
               hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell&#xD;
               disease).&#xD;
  &#xD;
            5. Impaired liver or kidney function at screening (reference range from the study&#xD;
               center's laboratory): aspartate aminotransferase (AST) &gt;3 times the upper limit of&#xD;
               normal (ULN), alanine aminotransferase (ALT) &gt;3 times ULN, total bilirubin level (TBL)&#xD;
               &gt;2 times ULN (excluding Gilbert's syndrome). Creatinine clearance rate &lt;45 mL/min&#xD;
               (calculated by the Cockcroft-Gault formula).&#xD;
  &#xD;
            6. Significant albuminuria (urinary albumin excretion rate &gt;300 mg/g) or history thereof.&#xD;
  &#xD;
            7. Uncontrolled thyroid disease or adrenal insufficiency.&#xD;
  &#xD;
            8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with&#xD;
               peripheral blood hepatitis B virus (HBV) DNA ≥104 copies or ≥2000 IU/mL (HBsAg&#xD;
               positive with HBV DNA &lt;2000 IU/mL (&lt;104/mL) must receive antiviral treatment&#xD;
               throughout the study; HBcAb positive with HBV DNA &lt;2000 IU/mL (&lt;104/mL) require&#xD;
               regular monitoring of HBV DNA quantification throughout the study); Hepatitis C virus&#xD;
               (HCV) antibody positive with peripheral blood HCV RNA ≥103 IU/mL; Human&#xD;
               immunodeficiency virus (HIV) antibody positive; Active syphilis infection (cured cases&#xD;
               may be included); Cytomegalovirus (CMV) DNA positive; Positive nucleic acid test for&#xD;
               novel coronavirus (COVID-19).&#xD;
  &#xD;
            9. Severe heart disease or a history of cardiovascular disease within 6 months before&#xD;
               screening, including stroke, decompensated heart failure (NYHA class III or IV),&#xD;
               myocardial infarction, unstable angina, or coronary artery bypass grafting.&#xD;
  &#xD;
           10. Previous history of coagulation disorders or requiring long-term anticoagulant therapy&#xD;
               (e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR &gt;1.5.&#xD;
  &#xD;
           11. Substance abusers with a history of drug abuse/dependence or drug use within 1 year&#xD;
               before screening.&#xD;
  &#xD;
           12. Received live virus vaccines within the past 6 months or planned to receive live virus&#xD;
               vaccines during the trial or within 1 month after treatment. Live vaccines include,&#xD;
               but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies,&#xD;
               Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.&#xD;
  &#xD;
           13. Previous history of pancreatic cancer, intraductal papillary mucinous neoplasm of the&#xD;
               pancreas, end-stage lung disease, or liver cirrhosis.&#xD;
  &#xD;
           14. Other abnormal laboratory test results deemed clinically significant by the&#xD;
               investigator.&#xD;
  &#xD;
           15. Patients with severe mental illness.&#xD;
  &#xD;
           16. Participated in a drug or medical device clinical trial within the past 3 months and&#xD;
               received investigational drugs or medical devices; or within 5 half-lives of another&#xD;
               drug before screening (if the half-life exceeds 3 months).&#xD;
  &#xD;
           17. Currently receiving long-term (continuous for ≥14 days) systemic pharmacological doses&#xD;
               of glucocorticoids or other medications that may affect the participant's&#xD;
               consciousness.&#xD;
  &#xD;
           18. Treatment (local, intra-articular, intraocular, or inhalation preparations) for any&#xD;
               other factors or diseases not mentioned above, deemed unsuitable for participation in&#xD;
               this clinical study by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Weiqiong Gu, PhD</last_name>
      <phone>86-21-64370045</phone>
      <phone_ext>671701</phone_ext>
      <email>Gwq10978@rjh.com.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University</name>
        <address>
          <city>Shanghai</city>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Weiqiong Gu, PhD</last_name>
        <phone>86-21-64370045</phone>
        <phone_ext>672701</phone_ext>
        <email>Gwq10978@rjh.com.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990517
  org study id: YD01-2022
  nct id: NCT05990517
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy and safety of autologous transplantation of expanded
        pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: C-peptide change
  time frame: 12 months post-transplant
  description: Evaluation of the magnitude of C-peptide change after transplantation
  measure: the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events
  time frame: 52 weeks post-transplant
  measure: The proportion of subjects who are insulin-independent
  time frame: 12 weeks and 52 weeks post-transplant
  measure: The percentage reduction in insulin requirement
  time frame: 12 weeks and 52 weeks post-transplant
  measure: Glycemic control (MAGE)
  time frame: 12 weeks and 52 weeks post-transplant
  description: Evaluation of the average amplitude of glycemic fluctuations (MAGE) in subjects
  measure: Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)
  time frame: baseline and 52 weeks post-transplant
  measure: Quality of life score
  time frame: baseline and 52 weeks post-transplant
  description: Evaluation of the quality of life score in subjects
  arm group label: YD01-2022
  arm group type: Experimental
  intervention type: Biological
  intervention name: YD01-2022
  description: Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein.
  arm group label: YD01-2022
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Weiqiong Gu, PhD
  phone: 86-21-64370045
  phone ext: 671701
  email: Gwq10978@rjh.com.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: Undecided