| Cerco Medical’s patented thin-sheet immunobarrier system is expected to permit transplantation of cells without immune suppression drugs. Our technology protects the cells from host rejection while enabling nutrients such as oxygen to migrate freely in and enabling cell products such as insulin to migrate freely out through the immunobarrier.
Our first product is the Islet Sheet for treatment of type 1 diabetes.
The Islet Sheet is populated with islets obtained from organ donors that restore the body’s ability to produce insulin that was destroyed by autoimmune attack on the beta cells (insulin secreting cells) in the diabetic’s own pancreatic islets. The cells in the Islet Sheet respond to changing blood sugar levels with the release of insulin in real time, mimicking the normal function of pancreatic islets.
The Islet Sheet is comprised of three components: islets, a reinforcing mesh to give strength and durability and highly purified alginate, which completely encapsulates the other two components. Configured as a thin sheet only 0.3 millimeters thick, with outside dimensions of 4 centimeters x 6 centimeters, the Islet Sheet is expected to be about the size of a business card. A central core region containing islets suspended in alginate and the reinforcing mesh are  surrounded by and bonded to acellular immuno- protective alginate layers. Islets are kept alive by diffusion of oxygen, glucose and other nutrients into the sheet. The sheet is so thin that passive diffusion alone supports islet life and function. Islets in the sheet (figure at right) maintain stable blood sugars by secreting insulin in response to changing blood glucose and other blood constituents including amino acids.
The Islet Sheet surface is mirror-smooth on the cellular scale and made via a proprietary process using highly purified and biostable alginate. The reinforcing mesh is greater than 80% open to allow diffusion of nutrients.
Alginate is derived from sea kelp and is readily available commercially from numerous sources. The Company has developed proprietary methods for alginate purification and processing resulting in alginate gels with the specific properties required for the Islet Sheet, including purity and molecular permselectivy and biostability.
The Cerco Medical thin-sheet device (figure to right)has a central zone with islets (light center rectangle in the figure) and a surrounding cuff for suturing. It incorporates several design improvements over competing approaches which will be evaluated during development studies.
These improvements include:
the sheet is fully retrievable, ensuring
safety
the sheet is replaceable
uniform thinness permits sufficient oxygen diffusion to ALL cells
complete immuno-isolation prevents destruction of islets by immune processes
thin-sheet technology is compatible with many different cell lines
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