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A Study of Autologous Induced Islet Body With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
islet body
Sponsored by
Allife Medical Science and Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, 18 to 70 years old (including 18 and 70 years old)
  2. Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:

（1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.

3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.

Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.

Exclusion Criteria:

  1. Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
  2. Patients with Severe bacterial and viral infections
  3. patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
  4. Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
  5. Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
  6. Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2)
  7. Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
  8. patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
  9. Other circumstances that researchers do not consider suitable for research.
  10. Withdrawal from trial, loss of follow-up or death due to other reasons
  11. Incomplete data, affecting effectiveness and safety judges
  12. Researchers believe that the need for termination of the trial is needed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    islet body treatment group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Occurrence of treatment related adverse events as assessed by CTCAE v4.0
    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2018
    Last Updated
    October 31, 2018
    Sponsor
    Allife Medical Science and Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03728296
    Brief Title
    A Study of Autologous Induced Islet Body With Type 1 Diabetes
    Official Title
    Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Allife Medical Science and Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    islet body treatment group
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    islet body
    Intervention Description
    Transplanting islet bodies under the diaphragm
    Primary Outcome Measure Information:
    Title
    Occurrence of treatment related adverse events as assessed by CTCAE v4.0
    Description
    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, 18 to 70 years old (including 18 and 70 years old) Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria: （1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L. 3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan. Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day. Exclusion Criteria: Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc. Patients with Severe bacterial and viral infections patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets) Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit). Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2) Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial; patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years. Other circumstances that researchers do not consider suitable for research. Withdrawal from trial, loss of follow-up or death due to other reasons Incomplete data, affecting effectiveness and safety judges Researchers believe that the need for termination of the trial is needed.

    12. IPD Sharing Statement

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    A Study of Autologous Induced Islet Body With Type 1 Diabetes

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