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/NCT05990530</url>
    </required_header>
    <id_info>
      <org_study_id>YD02-2022</org_study_id>
      <nct_id>NCT05990530</nct_id>
    </id_info>
    <brief_title>Allogeneic Transplantation of Expanded Pancreatic Islet Cells</brief_title>
    <official_title>Evaluation of the Efficacy and Safety of Allogeneic Transplantation of Expanded Pancreatic Islet Cells in Patients With &quot;Brittle&quot; Type 1 Diabetes</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 allogeneic pancreatic islet cells&#xD;
        transplantation in patients with &quot;brittle&quot; type 1 diabetes.&#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>Residual β-Cell function (RBCF)</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>Glycemic control (HbA1c)</measure>
      <time_frame>52 weeks post-transplant</time_frame>
      <description>Evaluation of the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment (insulin-independent)</measure>
      <time_frame>12 weeks and 52 weeks post-transplant</time_frame>
      <description>Evaluation of the proportion of subjects who are insulin-independent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment (insulin requirement)</measure>
      <time_frame>12 weeks and 52 weeks post-transplant</time_frame>
      <description>Evaluation of the percentage reduction in insulin requirement</description>
    </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>Hypoglycemia (HYPO)</measure>
      <time_frame>baseline and 52 weeks post-transplant</time_frame>
      <description>Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)</description>
    </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">6</enrollment>
    <condition>Brittle Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>YD02-2022</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>YD02-2022</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>YD02-2022</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntarily sign an informed consent form and agree to comply with the trial treatment&#xD;
               plan and visit schedule.&#xD;
  &#xD;
            2. Age ≥18 years and ≤60 years on the day of signing the informed consent form,&#xD;
               regardless of gender.&#xD;
  &#xD;
            3. Body mass index (BMI) ≥18.0 kg/m2 and ≤35.0 kg/m2.&#xD;
  &#xD;
            4. Diagnosed with T1DM based on the World Health Organization's diabetes classification&#xD;
               (2019).&#xD;
  &#xD;
            5. HbA1c ≥7.0% and ≤15.0% at screening.&#xD;
  &#xD;
            6. Dependence on insulin injection therapy for ≥5 years, receiving a stable insulin&#xD;
               treatment plan for ≥3 months, and injecting insulin three or more times per day or&#xD;
               using an insulin pump.&#xD;
  &#xD;
            7. Postprandial mixed meal stimulated C-peptide level &lt;0.3 ng/mL.&#xD;
  &#xD;
            8. Experienced impaired awareness of hypoglycemia or significant glycemic instability&#xD;
               during screening and in the past 6 months. Hypoglycemic episodes are associated with&#xD;
               impaired awareness of hypoglycemia, extreme glycemic instability, or severe fear and&#xD;
               maladaptive behavior.&#xD;
  &#xD;
            9. Sexually active males who are not surgically sterilized or have partners of&#xD;
               childbearing potential agree to use effective contraception during the entire trial&#xD;
               period and for at least 6 months after the study ends; sexually active females of&#xD;
               childbearing potential agree to use effective contraception during the entire study&#xD;
               period and for at least 6 months after the study ends.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Types of diabetes other than T1DM.&#xD;
  &#xD;
            2. Body mass index (BMI) &gt;35 kg/m2 or weight &lt;50 kg.&#xD;
  &#xD;
            3. Excessive insulin sensitivity and/or insulin resistance (insulin requirement &gt;1.0&#xD;
               IU/kg/day or &lt;15 U/day).&#xD;
  &#xD;
            4. Previous pancreatic or islet transplantation. Severe trauma, severe infection, or&#xD;
               surgery that may affect glycemic control within one month before screening.&#xD;
  &#xD;
            5. History of hypertension with systolic blood pressure (SBP) &gt;160 mmHg and/or diastolic&#xD;
               blood pressure (DBP) &gt;100 mmHg after stable dose (at least 4 weeks) of&#xD;
               antihypertensive medication.&#xD;
  &#xD;
            6. Blood transfusion or severe bleeding within the past 3 months, known&#xD;
               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;
            7. Impaired liver or kidney function at screening: aspartate aminotransferase (AST) ≥3&#xD;
               times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 times ULN,&#xD;
               total bilirubin level (TBL) ≥2 times ULN (excluding Gilbert's syndrome), creatinine&#xD;
               clearance rate &lt;45 mL/min (calculated by the Cockcroft-Gault formula).&#xD;
  &#xD;
            8. Significant albuminuria (urinary albumin excretion rate &gt;300 mg/g) or history thereof.&#xD;
  &#xD;
            9. Uncontrolled or untreated thyroid disease or adrenal insufficiency.&#xD;
  &#xD;
           10. Severe diabetic kidney disease or renal insufficiency, proliferative retinopathy,&#xD;
               diabetic foot ulcers, diabetes-related amputation, and/or severe peripheral neuropathy&#xD;
               at screening.&#xD;
  &#xD;
           11. Active hepatitis B, hepatitis C, acquired immunodeficiency syndrome, syphilis, or&#xD;
               tuberculosis. Even without clinical evidence of active infection, participants with&#xD;
               laboratory evidence of active infection are also excluded.&#xD;
  &#xD;
           12. 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;
           13. 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;
           14. Substance abusers with a history of drug abuse/dependence or drug use within 1 year&#xD;
               before screening.&#xD;
  &#xD;
           15. Received live vaccines within 14 days before screening or planned to receive live&#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;
           16. Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder&#xD;
               disease, pancreatic injury, or other high-risk factors for pancreatitis, or patients&#xD;
               with blood amylase &gt;1.2 times ULN at screening.&#xD;
  &#xD;
           17. Other abnormal laboratory test results deemed clinically significant by the&#xD;
               investigator.&#xD;
  &#xD;
           18. Patients with severe mental illness.&#xD;
  &#xD;
           19. 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;
           20. 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;
           21. 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 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <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/NCT05990530
  org study id: YD02-2022
  nct id: NCT05990530
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells
        transplantation in patients with "brittle" type 1 diabetes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Residual β-Cell function (RBCF)
  time frame: 12 months post-transplant
  description: Evaluation of the magnitude of C-peptide change after transplantation
  measure: Glycemic control (HbA1c)
  time frame: 52 weeks post-transplant
  description: Evaluation of the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events
  measure: Treatment (insulin-independent)
  time frame: 12 weeks and 52 weeks post-transplant
  description: Evaluation of the proportion of subjects who are insulin-independent
  measure: Treatment (insulin requirement)
  time frame: 12 weeks and 52 weeks post-transplant
  description: Evaluation of the percentage reduction in insulin requirement
  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: Hypoglycemia (HYPO)
  time frame: baseline and 52 weeks post-transplant
  description: Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)
  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: YD02-2022
  arm group type: Experimental
  intervention type: Biological
  intervention name: YD02-2022
  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: YD02-2022
  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
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided