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
About this trial
This is an observational trial for Type 1 Diabetes
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).
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
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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