US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?
Lorenzo PiemontiAxel AndresJohn CaseyEelco de KoningMarten EngelseRobert HilbrandsPaul JohnsonBart KeymeulenJulie Kerr-ConteOlle KorsgrenRoger LehmannTorbjörn LundgrenPaola MaffiFrancois PattouFrantisek SaudekJames ShawHanne ScholzSteve WhiteThierry BerneyPublished in: Transplant international : official journal of the European Society for Organ Transplantation (2021)
Allogeneic islet transplantation is a standard of care treatment for patients with labile type 1 diabetes in many countries around the world, including Japan, the United Kingdom, Australia, much of continental Europe, and parts of Canada. The United States is now endorsing islet cell treatment for type 1 diabetes, but the FDA has chosen to consider islets as a biologic that requires licensure, making the universal implementation of the procedure in the clinic very challenging and opening the manufacture of islet grafts to private companies. The commercialization of human tissues raises significant legal and ethical issues and ironically leads to a situation where treatments developed as a result of the scientific and economic efforts of academia over several decades become exploited exclusively by for-profit entities.
Keyphrases
- type diabetes
- single cell
- primary care
- glycemic control
- cell therapy
- gene expression
- rheumatoid arthritis
- stem cells
- endothelial cells
- quality improvement
- stem cell transplantation
- bone marrow
- insulin resistance
- low dose
- risk assessment
- combination therapy
- drug administration
- palliative care
- skeletal muscle
- decision making
- human health
- smoking cessation