About this Research Topic
The field of islet transplantation has recently witnessed a significant development with the FDA's approval of the first allogeneic deceased donor islet cell therapy, Lantidra (donislecel), for treating patients with type 1 diabetes (T1D) who experience severe hypoglycemic episodes. However, this approval has sparked debates within the transplantation community, particularly concerning the ethical implications of regulating allogeneic tissue as a commercial drug. The primary concern is the potential for profiting from deceased donor tissue, which is considered unethical for organs, including the pancreas. Additionally, questions have been raised about the quality and safety of the Lantidra islets.
This research topic aims to provide an updated perspective on the status of allogeneic islet transplant therapy following the approval of Lantidra and to stimulate a discussion about the future of this therapy. The objective is to gather diverse viewpoints on how this event has influenced the field of allogeneic islet transplantation. Key questions to be addressed include the procurement of islets by medical research centers, insurance coverage for Lantidra, the quality comparison between Lantidra and islets isolated onsite at medical research centers, and the ethical considerations of monetizing donor cells.
To gain further insights into the implications of the BLA approval of Lantidra and the future of islet transplantation, we welcome articles addressing, but not limited to, the following themes:
- Opinions on the BLA approval of Lantidra
- Strategies for improved islet isolation or transplantation practices
- Perceptions on the future of islet transplantation
- Data comparing outcomes of islet transplantation with Lantidra versus onsite islet isolation
- Policy perspectives regarding the regulation of organs, tissues, and cells
- Comparisons of the regulation of islets in the US versus the rest of the world. Other related topics will also be considered.
This research topic aims to provide an updated perspective on the status of allogeneic islet transplant therapy following the approval of Lantidra and to stimulate a discussion about the future of this therapy. The objective is to gather diverse viewpoints on how this event has influenced the field of allogeneic islet transplantation. Key questions to be addressed include the procurement of islets by medical research centers, insurance coverage for Lantidra, the quality comparison between Lantidra and islets isolated onsite at medical research centers, and the ethical considerations of monetizing donor cells.
To gain further insights into the implications of the BLA approval of Lantidra and the future of islet transplantation, we welcome articles addressing, but not limited to, the following themes:
- Opinions on the BLA approval of Lantidra
- Strategies for improved islet isolation or transplantation practices
- Perceptions on the future of islet transplantation
- Data comparing outcomes of islet transplantation with Lantidra versus onsite islet isolation
- Policy perspectives regarding the regulation of organs, tissues, and cells
- Comparisons of the regulation of islets in the US versus the rest of the world. Other related topics will also be considered.
Keywords: Beta Islet Cells, Type 1 Diabetes (T1D), Islet Transplantation, National Organ Transplantation Act (NOTA), Regulation, Food and Drug Administration (FDA), Biological License Application (BLA), Lantidra (Donislecel), CellTrans Inc.
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
