Approval of Lantidra, a beta cell therapy derived from donor pancreatic islets, came despite transplant surgeons' concerns about FDA regulating these cells as biologics rather than transplanted organs.
, and abdominal pain. Most of the participants experienced at least one serious adverse reaction related to the method of infusion and/or the use of immunosuppression. Some of these reactions required discontinuation of the immunosuppressive medications, resulting in the loss of islet cell function and return to insulin dependence.
They also wrote to members of Congress. On June 22, 2023, US Senators Mike Lee , Ted Budd , and Marsha Blackburn ,"We were really happy about the introduction of the islet bill. Now, we're concerned about negative downstream effects of granting a licence to a private company for distribution of the cadaveric islets."
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