Initially, the researchers will implant the BioHub in the omental pouch, an area in the lining of the abdominal cavity that connects the stomach to other abdominal organs. Once there, the BioHub would sense changing blood-sugar levels and would release insulin when needed.
Inverardi said one of the biggest advantages to the BioHub is that researchers will easily be able to find the best site to transplant islet cells, because if a site doesn't work well, the device can be easily retrieved.
Inverardi and Ricordi both expect this phase to go well, and expect the BioHub with the transplanted islets to begin producing insulin.
Eventually, the researchers hope to develop and test immune suppression that is only in the area of the islet cells, instead of affecting the whole body. One possible way to accomplish this, Inverardi said, is to encapsulate the islet cells in a material that allows the cells to breathe and exchange insulin, but will repel any immune attack. At this point, there is no timeline scheduled for clinical trials of this portion of the BioHub.
The researchers also hope to find alternative sources for islet cells to use in the BioHub. Possible avenues of research include living, related donors; islet cells from pigs; and stem-cell-produced islets.
"We're excited about this research," Greenstein said. "This is an incremental step that indicates progress, but, until we get rid of the need for chronic immunosuppression, the use is limited to those with severe [low blood sugar] unawareness."
Learn more about type 1 diabetes from the Diabetes Research Institute.
SOURCES: Camillo Ricordi, M.D., director, and Luca Inverardi, M.D., deputy
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