Cell therapy developer and manufacturer Orgenesis received IRB approval to collect liver biopsies from patients at Rambam Medical Center in Haifa, Israel for a planned study to confirm the suitability of liver cells for personalized cell replacement therapy for patients with insulin-dependent diabetes resulting from partial pancreatectomy. The cells be managed in a biobank for future clinical trials.
Based in Germantown MD and Publicly traded, (ORGS) Orgenesis includes its MaSTherCell subsidiary, a global contract development an and manufacturing organization. Orgenesis also develops its own proprietary cell therapies. Through its subsidiary Orgenesis Ltd it pioneers the process of Transdifferentiation (Cell reprogramming).
The Rambam Medical Center and Oregeneis study entitled “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.” Its goal is to confirm the suitability of the liver cells for personalized cell replacement therapy, we well as eligibility of patients to participate in a future clinical study as defined by successful Autologous Insulin Producing (AIP) cell production from their own liver biopsy.
Another study objective is to evaluate the Rambam Medical Center patient immune response to AIPs based on the patient blood samples followed by subcutaneous implantation into the patients arms which would represent the first human trial. As reported in the press release the sponsor will collect live sample during the study and thereafter process and store in specialized, clinical grade tissue banks for possible medical use. With a plan of enrolling 20 patients, the study will start this May 2019.
Orgenesis Chief Scientific Office Professor Sarah Ferber commented “we believe that this study, our first human trial, will allow us to better understand the autologous immune response following AIP cell implantation in different patient populations (autoimmune or not), ex-vivo and in-vivo, as well as the potency of transdifferentiation as a novel precision medicine platform to predict treatment success.”