Providing Structure and Support for Cells
What will the BioHub look like? Currently, DRI researchers are focused on a biodegradable scaffold using the omentum as an alternative transplant site.
The biodegradable scaffold mimics the native environment of the pancreas - providing islets with the spacing and support structure that allows oxygen and other nutrients to efficiently reach each cell. It also prevents islets from clumping together and choking off the critical oxygen supply for all of these cells.
Researchers can also insert helpful agents into the scaffolds - such as oxygen promoters - that are vital for islet health and function. The scaffolds are in various stages of testing and already have shown promising results, achieving insulin independence in study models.
The biodegradable scaffold uses the patient's own plasma, the liquid part of the blood that does not contain any cells, together with thrombin, a commonly used, clinical-grade enzyme. When combined, they create a gel-like substance that sticks to the implantation site (the omentum).
This "sticky" substance provides a platform onto which researchers can place islets with the optimal spacing they need. Once in place, the area is folded over the islets and stitched to create an omental "pouch." Over time, the body will absorb the gel, leaving the islets intact, while new blood vessels are formed to support their survival and function.
The DRI has received approval from the Food and Drug Administration (FDA) to proceed with a Phase I/II clinical trial that will test islets transplanted within a biodegradable scaffold inside the omentum.
The biodegradable scaffold is made using a patient's own plasma together with thrombin, a clinical-grade enzyme. When combined, they create a "sticky gel" that holds the islets in place. The area of the omentum is then folded over and stitched, creating a protective "pouch" around the scaffold mixture.