Islet Transplantation
Islet transplantation has become a feasible cell therapy procedure that aims to achieve normoglycemia in diabetic patients. Currently, one of the greatest challenges in this approach is early islet cell death. The natural microenvironment is lost during islet isolation, resulting in β-cell dysfunction and often death. Therefore, the importance of extracellular matrix (ECM) for islet viability and function has been repeatedly documented. Specifically, interactions between β-cells and the basement membrane of the vasculature are important for correct function. Tissue and organ engineering recognizes the need for a complex supportive stroma and thus several approaches use natural decellularized scaffolds derived from natural tissue or organ.
Micro Organ Matrix Technology
Islet transplantation has become a feasible cell therapy procedure that aims to achievenormoglycemia in diabetic patients. Currently, one of the greatest challenges in this approach is early islet cell death. The natural microenvironment is lost during islet isolation, resulting in β-cell dysfunction and often death. Therefore, the importance of extracellular matrix (ECM) for islet viability and function has been repeatedly documented. Specifically, interactions between β-cells and the basement membrane of the vasculature are important for correct function. Tissue and organ engineering recognizes the need for a complex supportive stroma. Thus, Betalin developed a unique micro organ scaffold that uses natural de-cellularized ECM, derived from natural tissue, to support the long term function of β-cells.
Key points from our latest paper
Indeed, EMPs with human islets secrete higher levels of insulin than “naked” islets in a glucose- regulated manner.Moreover, EMPs continue to secrete quantities of insulin similar to freshly isolated human islets (day 0) in a glucose- regulated manner for more than three months, while “naked” islets survive less than 7 days with constantly decreasing functionality. Diabetic mice receiving subcutaneous transplant of EMPs, with a human islet dose of 500 IEQ, were normoglycemic throughout the study period. At 35 days post-transplantation, upon retrieval of the implanted EMPs, the mice reverted to hyperglycemia (see graph below). In contrast, the control animals, which did not receive EMP transplants, had high blood glucose levels that increased rapidly causing hyperglycemia and leading to animals’ death within 5 to 8 days. Thus, our proof of concept of the EMP was pre-clinically validated, facilitating diabetes reversal in a mouse animal model. These exciting findings lay the foundation for Betalin Therapeutics’ solution and are the basis of development towards clinical application.
Successful pre-clinical trials
Betalin is currently raising capital to further optimize the therapy and complete submission of the New Drug (IND) application to the FDA and proceed to clinical trials. Learn more about how we can revolutionize diabetes treatment today