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Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies

Primary Purpose

Type 1 Diabetes, Pancreatectomy; Hyperglycemia

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Liver biopsy collection
Sponsored by
Orgenesis Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Type 1 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • patients between the ages of 18 and 70 years old, inclusive.
  • For T1DM - Patients with history of established T1DM undergoing an elective abdominal surgery with an easy access to the liver
  • Patients undergoing total or partial Pancreatectomy
  • Female patients who agree not to breastfeed during the study up to at least seven days after the study is completed.
  • For T1DM - Receiving multiple daily insulin injections or insulin pump therapy.
  • For T1DM - HbA1c ≤10%.
  • Willing to sign the study informed consent document.
  • In good general health with no infections, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.

Exclusion Criteria:

  • Received any investigational product within 30 days of admission into this study or plan to participate in any other clinical study during the conduct of this study.
  • Received methotrexate or other rheumatoid disease modifying agents within the last 6 months.
  • Administration of a live vaccine 30 days prior to screening.
  • No evidence of liver Cirrhosis or Nonalcoholic Steatohepatitis (NASH, grade 3 and above) within the last month.
  • Patients diagnosed with liver viral infections such as HBV, HCV, HIV
  • Patients diagnosed with CMV (defined by IgM positive).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Confirmation of patients' suitability eligibility to participate in future clinical study
    Defined by a successful AIPs production from their liver biopsy.
    Evaluating autoimmune response to AIPs
    Defined by Mixed Lymphocyte Reaction (MLR) assay based on the patient's PBMCs isolated from whole blood samples and following in-vivo subcutaneous implantation into the patients' arm

    Secondary Outcome Measures

    Full Information

    First Posted
    June 3, 2019
    Last Updated
    September 23, 2019
    Sponsor
    Orgenesis Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04038931
    Brief Title
    Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies
    Official Title
    Collection of Human Liver Biopsy and Whole Blood Samples From Type 1 Diabetes Mellitus (T1DM), Total or Partial Pancreatectomy Patients for Potential Use as an Autologous Source for Insulin Producing Cells in Future Clinical Studies
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    June 20, 2020 (Anticipated)
    Study Completion Date
    June 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Orgenesis 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
    In this study, liver samples will be collected, processed and stored in a specialized, clinical grade, cell bank for potential future clinical use. A set of ex-vivo immunogenicity and transdiffrentiation tests will be carried to confirm the ability of this cryopreserved cell batch to be used as clinical grade raw material. Biopsies will be collected during TP or PP with the assumption that some of the patients (especially PP patients will not go through Islets autotransplantation) will develop brittle diabetes, thus Orgenesis therapy can provide them in the long run, a treatment. In terms of T1DM the purpose is to have available clinical grade raw material for cell replacement therapy. The collected liver samples will be proliferated (up to passage 4) for future use. A portion of the stored cells will be utilized in a small-scale process to test possible immunogenicity performed on the collected blood sample. The assay will provide data whether immunomodulation treatment will be required in the future clinical trials. Also the transdffrentiated cells (AIPs) will be tested according to release criteria relevant for clinical IPC production. Liver biopsy donors will be contacted upon approval of the consecutive study and will have study recruitment priority. The donors can refuse to participate in the future study or may not need the therapy, however, their biopsies will be stored for a potential use if required, after the therapy is approved.

    6. Conditions and Keywords

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

    7. Study Design

    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Liver biopsy collection
    Intervention Description
    Liver biopsy collection to Confirm suitability of T1DM, total or partial pancreatectomy patient's liver cells to be used as future personalized cell replacement therapy.
    Primary Outcome Measure Information:
    Title
    Confirmation of patients' suitability eligibility to participate in future clinical study
    Description
    Defined by a successful AIPs production from their liver biopsy.
    Time Frame
    1 year post biopsy collection
    Title
    Evaluating autoimmune response to AIPs
    Description
    Defined by Mixed Lymphocyte Reaction (MLR) assay based on the patient's PBMCs isolated from whole blood samples and following in-vivo subcutaneous implantation into the patients' arm
    Time Frame
    1 year post biopsy collection

    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: patients between the ages of 18 and 70 years old, inclusive. For T1DM - Patients with history of established T1DM undergoing an elective abdominal surgery with an easy access to the liver Patients undergoing total or partial Pancreatectomy Female patients who agree not to breastfeed during the study up to at least seven days after the study is completed. For T1DM - Receiving multiple daily insulin injections or insulin pump therapy. For T1DM - HbA1c ≤10%. Willing to sign the study informed consent document. In good general health with no infections, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor. Exclusion Criteria: Received any investigational product within 30 days of admission into this study or plan to participate in any other clinical study during the conduct of this study. Received methotrexate or other rheumatoid disease modifying agents within the last 6 months. Administration of a live vaccine 30 days prior to screening. No evidence of liver Cirrhosis or Nonalcoholic Steatohepatitis (NASH, grade 3 and above) within the last month. Patients diagnosed with liver viral infections such as HBV, HCV, HIV Patients diagnosed with CMV (defined by IgM positive).
    Study Population Description
    study population comprises of patients undergoing total or partial pancreatectomy or from T1DM patients undergoing an elective abdominal surgery (in which there is an easy access to the liver).
    Sampling Method
    Non-Probability Sample

    12. IPD Sharing Statement

    Learn more about this trial

    Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies

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