A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework

Biomaterial-assisted strategies to improve islet graft revascularization and transplant outcomes

“…Table 1 provides an overview of the potential transplant sites considered, along with their respective advantages and disadvantages. Currently, only the liver has the clinical approval as a site for islet transplantation (through hepatic portal vasculature) 5 . Being a transplantation site, the liver offers various benefits, such as the use of minimally invasive surgical techniques, convenient infusion methods, and a reduced risk of bleeding and thrombosis.…”

“…Recent groundbreaking news revealed that CellTrans has gained global marketing approval for Lantidra, the first allogeneic islet cell therapy, further underscoring the promising outlook for islet transplantation in treating T1D and providing substantial encouragement for related research endeavors. 5 However, the broader implementation of islet transplantation therapy is still hindered by the limited availability of donors and the loss of islet cells caused by the unfavorable graft microenvironment for islet survival. 6 Donor islets need to be isolated and purified before transplantation, while the isolation process refers to the removal of the dense vasculature as well as the specialized extracellular matrix present in the native islet environment.…”

“…Recent groundbreaking news revealed that CellTrans has gained global marketing approval for Lantidra, the first allogeneic islet cell therapy, further underscoring the promising outlook for islet transplantation in treating T1D and providing substantial encouragement for related research endeavors. 5…”