Sort-of cure for T1D approved by FDA

TLDR Summary
Cell therapy to replace beta cells via a single infusion to reduce insulin needs.
Specifically authorized only for adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education.

The good:
“Overall, 21 patients did not need to take insulin for a year or more, with 11 not needing insulin for one to five years and ten not needing insulin for more than five years.”

The bad:
“…the majority of patients involved in the study experienced at least one serious adverse reaction, some of which required immunosuppressants to be discontinued, leading to the loss of the transplanted beta cells.”


The site the link points to does not allow blocking of cookies; instead it requires us to disable cookies on web sites ourselves.

The site is operated by an organization that describes itself as “product delivery specialists”: About Us - Project Delivery Specialists | PM Group

The site also does not include a link to the FDA approval; the links on the page are to click counters.

Here is the real link:

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So here’s the breakdown from the FDA site (and the words on that page still ring up “marketing” in my brain, my father was a car salesman):

Lantidra is administered as a single infusion into the hepatic (liver) portal vein.

The islet cells end up in the liver where they can, and will, generate insulin in response to BG. The cells need to be protected against our over-active immune system, this is where the invention is. The problem is that in the liver the cells do not turn off the alpha cell production of glucagon; alpha cells require very high local levels on insulin to stop producing glucagon. This is know as the “impaired glucagon response”.

That is not to say that the approach lacks merit. It only takes one trip round the bloodstream (20s IRC, but I may remember wrong) for the glucose the liver releases to be taken up by the liver again (most of it).

Yet I can see why the FDA are taking small steps; beta cells in the pancreas would, even protected against the immune system, really be a cure.

Sorry about that - it was a link from news alerts I get and I didn’t notice the restrictions. Thanks for posting the clean FDA link.

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There is absolutely nothing wrong with posting links; we need to look at them, criticize them and post our own. This way we learn. The other way, where all the links posted are correct (and the gist of yours is correct, just the wrapping lacks merit) if we all agree all the time, well, I’m not permitted to state clearly what happens.

That would be a real cure, but infusion of donor islets into the pancreas is simply not feasible, if that’s what you’re hoping for. I think research is currently heading in the direction of implantation of protected patches of islets.

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Yes, that’s why I’ve seen. Infusion into the pancreas is possible too; same problem as with Lantidra, and one that has curiously has been avoided in the press, mostly:

According to the FDA, most trial participants experienced 1 adverse reaction to the procedure for infusing donislecel and the use of immunosuppressive medications needed to maintain islet cell viability. The FDA also pointed out some serious adverse reactions required discontinuation of immunosuppressive medications, which resulted in the loss of islet cell function and insulin independence.[1]

That’s from FDA Approves Donislecel (Lantidra), an Allogeneic Cellular Therapy, for Type 1 Diabetes

The reference [1] is to the link I posted. So note that the “cure” requires going on immunosuppressants.

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