Providing Structure and Support for Cells
What will the BioHub look like? Currently, DRI researchers are focused on two platform approaches for a BioHub - a biodegradable scaffold and a bioengineered scaffold - using the omentum as an alternative transplant site.
Both the biodegradable and bioengineered scaffolds mimic 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 has 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 bioengineered scaffold is a sponge-like disc that is compatible with the human body. These scaffolds are made of only 10 percent silicone. The rest is open space, creating tiny pores that can house thousands of insulin-producing cells of many shapes and sizes.
The DRI also plans to test this silicone scaffold utilizing the omentum as a transplant site. Researchers are in discussions with the FDA about additional preclinical testing that the regulatory agency has required before approval of that pilot clinical trial in the U.S. can be granted.
Learn more about the development of the BioHub mini organ to restore natural insulin production in those living with diabetes.
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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.
The DRI's bioengineered scaffold platform is a sponge-like material that has tiny pores that can house thousands of islet cells of different shapes and sizes.
The above magnified image of the silicone scaffold shows the pores where the islet cells reside.