In 2023, the FDA approved the first allogeneic deceased donor islet cell therapy for the treatment of patients with type 1 diabetes (T1D) who experience severe hypoglycemic episodes. The therapy known as Lantidra (donislecel) is regulated as a biologic drug following a biologic license application (BLA). While the approval of Lantidra may expand access to allogeneic islet therapy, some members of the transplantation community do not agree with the regulation of allogeneic tissue as a commercial drug. This is because profiting from deceased donor tissue is considered unethical for organs, including the pancreas. Furthermore, concerns have arisen regarding the quality and safety of the Lantidra islets.
The goal of this Research Topic is to provide readers with an update on the status of allogeneic islet transplant therapy after the approval of Lantidra (donislecel) and to facilitate a discussion regarding the future of this therapy. We hope to obtain a variety of viewpoints on how this event has shaped the field of allogeneic islet transplantation. Questions of discussion include, but are not limited to:
How will medical research centers obtain islets going forward?
Will insurance providers provide coverage for Lantidra (donislecel)?
How does the quality of Lantidra (donislecel) compare to islets isolated onsite at medical research centers?
How consistent is the quality of Lantidra given the differences in organ quality from donor to donor?
How will long-term outcomes of islet transplant with Lantidra compare to islets isolated onsite?
Should other organs, cells, or tissues be regulated as drugs?
Is it ethical to monetize donor cells?
The scope of this Research Topic includes:
- Opinion pieces 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 perspective regarding the regulation of organs, tissues, and cells
- Comparison of the regulation of islets in the US versus the rest of the world
- Other related topics will 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.
In 2023, the FDA approved the first allogeneic deceased donor islet cell therapy for the treatment of patients with type 1 diabetes (T1D) who experience severe hypoglycemic episodes. The therapy known as Lantidra (donislecel) is regulated as a biologic drug following a biologic license application (BLA). While the approval of Lantidra may expand access to allogeneic islet therapy, some members of the transplantation community do not agree with the regulation of allogeneic tissue as a commercial drug. This is because profiting from deceased donor tissue is considered unethical for organs, including the pancreas. Furthermore, concerns have arisen regarding the quality and safety of the Lantidra islets.
The goal of this Research Topic is to provide readers with an update on the status of allogeneic islet transplant therapy after the approval of Lantidra (donislecel) and to facilitate a discussion regarding the future of this therapy. We hope to obtain a variety of viewpoints on how this event has shaped the field of allogeneic islet transplantation. Questions of discussion include, but are not limited to:
How will medical research centers obtain islets going forward?
Will insurance providers provide coverage for Lantidra (donislecel)?
How does the quality of Lantidra (donislecel) compare to islets isolated onsite at medical research centers?
How consistent is the quality of Lantidra given the differences in organ quality from donor to donor?
How will long-term outcomes of islet transplant with Lantidra compare to islets isolated onsite?
Should other organs, cells, or tissues be regulated as drugs?
Is it ethical to monetize donor cells?
The scope of this Research Topic includes:
- Opinion pieces 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 perspective regarding the regulation of organs, tissues, and cells
- Comparison of the regulation of islets in the US versus the rest of the world
- Other related topics will 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.