<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/NCT03259256</url>
  </required_header>
  <id_info>
    <org_study_id>Y-03</org_study_id>
    <nct_id>NCT03259256</nct_id>
  </id_info>
  <brief_title>Islet Allotransplantation for Type 1 Diabetic Patients</brief_title>
  <official_title>Islet Allotransplantation for Type 1 Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Guangzhou Medical University</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>
      The purpose of this study is to determine if islet cell transplantation , is an effective&#xD;
      treatment for type 1 diabetes. Study participants may receive up to three islet transplants&#xD;
      and will be followed for five years to monitor blood sugar control, islet transplant&#xD;
      function, and changes in quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 23, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>Phase 3</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>Obtaining an improvement in glycemic control</measure>
    <time_frame>nine months after first and last islet transplants</time_frame>
    <description>The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>normal glycemic control without insulin</measure>
    <time_frame>3 months after graf</time_frame>
    <description>A fasting glucose (&gt; 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>insulin independence</measure>
    <time_frame>One year after the last transplant</time_frame>
    <description>insulin independence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic episodes by HYPO score</measure>
    <time_frame>3 months after transplantation</time_frame>
    <description>Hypoglycemic episodes by HYPO score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degenerative complications of diabetes</measure>
    <time_frame>18 months after transplantation</time_frame>
    <description>degenerative complications of diabetes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Type 1 Diabetic</condition>
  <arm_group>
    <arm_group_label>Allogeneic transplantation of human islet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject may receive 1-3 transplantations of allogeneic human islets we will inject the least dose of 3,000 IEQ/kg body weight of the recipient. Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Allogeneic transplantation of intrahepatic islet</intervention_name>
    <description>Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy</description>
    <arm_group_label>Allogeneic transplantation of human islet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of type 1 diabetes 18 &lt;Age &lt;70 years Evolution of diabetes for more than&#xD;
        5 years Regular patient follow-up (&gt; or equal to 2 visits per year from the same&#xD;
        diabetologist) ABO compatibility with the donor Cross match negative Anti-HLA antibodies&#xD;
        (class I and / or class II) detected by lymphocytotoxicity &lt;20% Accepting patients&#xD;
        effective contraception during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of type 2 diabetes BMI &gt; 28 Need insulin &lt; 28 U per day Pregnancy,&#xD;
        lactation Psychiatric Disorders Inability to communicate or cooperate with the investigator&#xD;
        Lack of therapeutic compliance, including HbA1C &gt; 12% Chronic liver disease Proliferative&#xD;
        retinopathy unstabilized History of cancer, whatever the date, except for basal or squamous&#xD;
        cell skin cancers over 1 year.&#xD;
&#xD;
        Systemic infection Chronic high risk of requiring corticosteroids Need for long-term&#xD;
        corticosteroid, outside that specified in renal transplantation, the patients will be&#xD;
        weaned before transplantation Anticoagulant vitamin K or antiplatelet treatments Platelets&#xD;
        &lt; 100 giga/L and/or neutrophils &lt;1.5 giga/L Chronic intoxication by alcohol, tobacco, or&#xD;
        other substance (abstinence &gt; 6 months required) Active infection by hepatitis B, hepatitis&#xD;
        C and HIV, HTLV-1-HTLV2 Ascites&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ping Xue, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ping Xue, PhD</last_name>
    <phone>0086-020-34153080</phone>
    <email>gyeygdwk@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>xiaofeng Jiang, MD</last_name>
    <phone>0086-020-34153080</phone>
    <email>gyeygdwk@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510260</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ping Xue, PhD</last_name>
      <phone>+86-020-34153080</phone>
      <email>gyeygdwk@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03259256
org study id: Y-03
nct id: NCT03259256
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if islet cell transplantation , is an effective
      treatment for type 1 diabetes. Study participants may receive up to three islet transplants
      and will be followed for five years to monitor blood sugar control, islet transplant
      function, and changes in quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Obtaining an improvement in glycemic control
time frame: nine months after first and last islet transplants
description: The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
measure: normal glycemic control without insulin
time frame: 3 months after graf
description: A fasting glucose (> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months
measure: insulin independence
time frame: One year after the last transplant
description: insulin independence
measure: Hypoglycemic episodes by HYPO score
time frame: 3 months after transplantation
description: Hypoglycemic episodes by HYPO score
measure: degenerative complications of diabetes
time frame: 18 months after transplantation
description: degenerative complications of diabetes
arm group label: Allogeneic transplantation of human islet
arm group type: Experimental
description: Each subject may receive 1-3 transplantations of allogeneic human islets we will inject the least dose of 3,000 IEQ/kg body weight of the recipient. Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml.
intervention type: Procedure
intervention name: Allogeneic transplantation of intrahepatic islet
description: Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy
arm group label: Allogeneic transplantation of human islet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ping Xue, PhD
role: Principal Investigator
affiliation: Second Affiliated Hospital of Guangzhou Medical University
last name: ping Xue, PhD
phone: 0086-020-34153080
email: gyeygdwk@163.com
last name: xiaofeng Jiang, MD
phone: 0086-020-34153080
email: gyeygdwk@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No