The Diabetes Research Institute (DRI) at the University of Miami has received approval from the Food and Drug Administration to perform Phase I/II clinical trials to test using the omentum (the inside lining of the abdomen) as a new transplant site. Presently islet cells are placed near the liver. These trials will determine if the omentum is a better home for islet cells than the liver. The research team, led by Dr. Rodolfo Alejandro, has screened hundreds of patients and is now waiting for matching organs to extract islet cells.
The team has also created a biodegradable scaffold consisting of the patient’s own plasma and clinical-grade thrombin – a BioHub platform. Researchers will evaluate the two transplant sites by using the same anti-rejection drug therapy; however, DRI hopes in the future to totally eliminate the need for immunosuppression medication. Researchers will evaluate whether the severe hypoglycemia has ceased and if the recipient is able to maintain an A1C of ≤ 6.5%.