Betalin launches new EMP technology that could transform diabetes treatment

Results published in Tissue Engineering Part A

Betalin Therapeutics, a biotech company specializing in tissue engineering for curing diabetes, introduces the Engineered Micro Pancreas (EMP), a novel technology that provides significant levels of glucose-regulated insulin secretion over extended periods of time.

Attempts to treat diabetes by transplants of pancreatic beta-cells have up until now been complicated by the fact that the vast majority of transplanted cells die within two days of transplantation, and therefore about 50% of the patients are still insulin-dependent one year after transplantation, and only about 10% remain insulin-independent five years after transplantation.

Betalin Therapeutics’ EMP is based on the premise that in order for beta cells to properly function, it is necessary to provide an appropriate connective tissue scaffold that ensures the long term survival of the cells. The proprietary platform technology, which was developed by Prof. Eduardo Mitrani, from the Department of Cell and Developmental Biology at the Hebrew University of Jerusalem, is a method to prepare acellular organ-derived microscaffolds that preserve the architecture and the basic composition of organ connective tissue and ensure that no seeded cell will be more than 150 microns from a source of nutrients and gases.

Key findings coming from Prof. Mitrani’s lab and published this month in the journal Tissue Engineering Part A, show that human islets, or beta cells derived from them in EMPs, function in vitro similarly to freshly dissected pancreatic islets. In particular, they continue to secrete insulin in a regulated manner and in levels comparable to fresh islets for over three months, whereas beta cells that are not supported by a scaffold retain functionality for only a few days. In addition to supporting regulated levels of insulin secretion, the EMPs become readily vascularized when transplanted into suitable hosts.

The researchers also report, for the first time, that they can grow and expand beta cells in culture by 3-4 fold prior to incorporating them into EMPs without losing their functionality. The cells are shown to secrete significant levels of insulin in a regulated manner even after several months. This is a significant achievement, since it will enable increasing the number of transplantations by using fewer cells per transplant.

Prof. Eduardo Mitrani of the Hebrew University and Chairman of Betalin’s Scientific Advisory Board, explained:

The micro pancreas aims at solving problems currently associated with transplantation of naked islets. In our system, prior to transplantation, islets are cultured within a biological scaffold that supports their survival, leading to long term functionality of the majority of the cells. This could translate in using a much smaller number of islets, enabling treating a higher number of patients. Furthermore, the fact that we have shown  expansion of beta cells in the laboratory while still retaining beta cell functionality is a significant breakthrough that may allow to utilize even less initial donors’ islets to treat individual patients. Our promising data raise the hope that Betalin Therapeutics will significantly improve on current treatments for people suffering from diabetes Type 1, as well as for people with severe, advanced levels of diabetes Type 2.

Prof. James Shapiro, Medicine and Surgical Oncology, University of Alberta, Canada, added:

We have been collaborating for the past two years with Prof. Mitrani to explore his most promising approach for providing a stable extracellular matrix combined with our highly successful “Edmonton Protocol” islet cell transplant treatment in Type 1 diabetes. If Betalin’s new microscaffold technique continues to demonstrate efficacy in vivo, it has the potential to substantially improve cellular engraftment and survival both for islets and potentially for stem cell engraftment in future for clinical application.

"We are currently in the midst of a financing round to support clinical studies towards the first-in-human trial,” added Mr. Doron Birger, Chairman of the Board of Directors, Betalin Therapeutics, and former Chair of the Board of Directors of Given Imaging. “We are fortunate to have in our scientific advisory board two leading figures in the area of cell transplantation, Prof. Camillo Ricordi, from of the Diabetes Research Institute & Cell Transplant Center in Miami and Prof. James Shapiro from the University of Alberta in Edmonton, Canada. Backed by these renowned scientists, and in addition to promising experimental results to date, Betalin is well positioned to transform the treatment of diabetes for the benefit of diabetic patients worldwide."