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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|ClinicalTrials.gov Identifier: NCT04038931|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : September 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Pancreatectomy; Hyperglycemia||Other: Liver biopsy collection|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||June 20, 2020|
|Estimated Study Completion Date :||June 20, 2020|
- Other: Liver biopsy collection
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.
- Confirmation of patients' suitability eligibility to participate in future clinical study [ Time Frame: 1 year post biopsy collection ]Defined by a successful AIPs production from their liver biopsy.
- Evaluating autoimmune response to AIPs [ Time Frame: 1 year post biopsy collection ]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