Not in humans yet, but in a large animal model and I’d expect human trials to be the next step.
TLDR- They included a microgel with the islet transplant which “resulted in robust glycemic control, sustained C-peptide levels, and graft survival in diabetic nonhuman primates for >6 months.”
Lay press article:
Full article in Science Advances:
https://www.science.org/doi/epdf/10.1126/sciadv.abm9881
Now this is an interesting development. The use of gels to protect Beta cells from the immune system is just great.
Their method includes transferring insulin-producing pancreas cells, known as pancreatic islets, from a donor to a recipient without the need for long-term immunosuppressive medicines.
And -
“A type of apoptosis occurs when a molecule called FasL interacts with another molecule called Fas on rogue immune cells, and it causes them to die,” said Yolcu, one of the study’s first authors. “Therefore, our team pioneered a technology that enabled the production of a novel form of FasL and its presentation on transplanted pancreatic islet cells or microgels to prevent being rejected by rogue cells. Following insulin-producing pancreatic islet cell transplantation, rogue cells mobilize to the graft for destruction but are eliminated by FasL engaging Fas on their surface.”
Interesting approach. Fingers crossed. This is the type of technology solution that would be game changing.
In 5 years??
Sorry, but even though I am type 2, I’ve been hearing the cure in 5 years for what seems like forever. This may actually be of help for those of use T2DMs with worn out Beta cells. I really don’t have much hope for dealing with genetic insulin resistance.
There has been talk of a cure for a century now. Ask the old timers here who have had T1D for 75+ years. But what’s different in this one is that it’s been succesfully employed in NHP (Non-human primates). I believe this is the first such study/research effort that has had success in NHPs. Mice, sure…but their immune system is different than humans, thus, it never translates to humans. But having success in our cousins (who share our immune system) is a huge deal.
My fingers are crossed and yes, I’m not holding my breath, but I’m very hopeful. I even told Liam about the research and he was very excited as well.
Well the 5 years thing is totally worn out by now. The nice thing about this bit of research is a potential solution to the very difficult issue of rejection. i.e. they have been able to transplant islet cells for awhile now, but being able to make such a system work without anti-rejection drugs. Wow, that is a really tough problem to solve. And even if this implant technology doesn’t pan out, the approach will push some cool therapies forward.
As far as this solving cell uptake of insulin, of course it won’t solve that, but for the many diabetics without an insulin resistance issue, this will be a game changer whenever it gets delivered. Which wouldn’t likely be in 5 years anyway.
I was just being snarky about the 5 year thing. This development may really be a game changer for type 1s and for some type 2s like myself. I am probably too old for such a procedure, but it would be nice to get back to dealing with insulin resistance with diet and exercise alone. I would gladly put this pump in my D drawer.
I’d like to think this is great news for the T1s that follow our or the next generation and I hope the study and success continue. Perhaps people like those that came up with insulin and sold the patent for $1, or something like that will recur. My fear, as with many things “corporate” (sorry, I’m sure there are good ones, I just haven’t met them yet) that are run for profit, for investor dividends, or even non-profit CEO’s/similar salaries, it’s great right up to the point one of them buy the tech and suppress it because of the potential impact to their established bottom line, or the likes of a Shkrelli, be it a producer of insulin, CGM, pump, AID(s), or all of the above. Yes, I know I sound like a conspiracy theorist…but its not a lie if you believe it 
…or if they’re really out to get you, I mean your money 
! Free enterprise is a great thing as long as there’s true competition and a choice, but it’s anathema to large corporations and survival (i.e. increased income/dividends/value) is the first law of their environment. Geez, I’m becoming more of a pessimist!
The stuff (islet cells + bioactive microgel) was not even put into the pancreas; rather a pouch was made from the omentum (fatty layer surrounding the guts) to hold it. Apparently one of the standard ways of transplanting islet is to inject them into the portal vein upstream from the liver so that they end up embedded in the liver (those of them that survive the blood), the omental sac has been tested as a way of getting the cells in directly to a place where they can function.
The study seems to have been terminated early:
Animals were terminated with functioning grafts due to coronavirus disease 2019 (COVID-19) pandemic–associated institution-imposed logistical barriers.
The first graft was at 188 days at that point, so that’s 6 months but they had received 3 months of rapamycin. The control animals all rejected the transplant in a month (i.e. they lost glycaemic control within a month.)
Perhaps the most important thing that went unmentioned in the SciTechDaily article:
SA-FasL microgel recipients display no changes in systemic immune cell populations
Which answers the first question that occurred to me; does the microgel do bad things to the immune system in general.
The animals didn’t achieve insulin independence; the authors hypothesize that this is because they only used islet cells from a single donor each time and there simply weren’t enough. Apparently, however, the grafts seemed to function better over time when they came from closely matched animals; the one test pair they had (donor-recipient) that was completely unmatched didn’t show improvement over time. (At least that is what I understand; they didn’t explicitly state this, but the precise numbers imply it.)
They will probably have to repeat the tests to check for long-term toxicity, in particular:
We did not observe any of the reported FasL toxicity (42–44), which we attribute to the form and local presentation of SA-FasL.
But with any luck that can be done on something other than NHPs.
I may be misunderstanding the article but it seemed that the technique achieved immuno-acceptance of the islet cells rather than simple immuno-suppression. I don’t know if islet cells regenerate; I assume they do but not all cells can. To me this is the most interesting part of this; immunosuppression is not necessary if the islet cells have been re-accepted as valuable parts of the cellunity.
Nevertheless if it that isn’t what is happening having an implant in a relatively accessible part of the body would be ok even if it has to be replaced every decade or so. Think pacemakers; the batteries run out and they have to be replaced.
That right there being the biggest part of it!
Not that I’m holding my breath. But I know I would have a surgery every 10 years if that is all it took!
Yeah, well don’t quote me, oh… ok you did, but it’s all down to the Treg stuff in the paper, e.g:
https://www.science.org/doi/10.1126/sciadv.abm9881#F1
and I may be completely misunderstanding that. That said I’m with you on the 10 years. 10 years insulin delivered in one operation of, I think, less complexity than replacing a pacemaker.
Neat. Medicare will probably have been limited to farting, dyspepsia and aphrodysia, but maybe I can get my insulin replaced…
Ok, I went through and READ that article.
And yes, they flat out said that it establishes immune acceptance.
"“This finding is in agreement with studies in diabetic mice demonstrating a pivotal role for Tregs in establishing SA-FasL microgel–induced immune acceptance”"
Obviously 177 days is not evidence of a truly prolonged success, but I think, that in the NHPs over a short duration, they definitely succeeded!
And to be highlighted, these are NHP, not mice. All the testing on mice is basically just a giant tease to us all, as they create such high false hopes it isn’t even funny any more…
It wouldn’t need to be cheap honestly, if it worked as we expect a normal pancreas to work, then it would reduce hospitalizations and deaths significantly in the treatment arm, and would be able to pass the financial hurdles pretty easily. Diabetes is an expensive disease, so even if the treatment is expensive it would be hard to not show a huge favorable improvement, as long as patient selection was paid attention to.
I understand what you are saying, the maintenance is just the tip of the iceberg in the costs. The actual additional care a diabetic gets, pales in comparison to the maintenance of the insulins, and the CGMs etc. The increased risk of cardiovascular disease, the amputations, the kidney transplants, etc would all be added into the maintenance. It really is quite a high number and well above the cost of just keeping a diabetic going.
I fully understood what you said, I just disagree. I have been part of a team gaining insurance coverage for a very expensive treatment, that wasn’t covered prior to putting our product on the market. If you have favorable cost per life year saved data, you can get insurers to cover a treatment even if it costs more than the maintenance. Especially if it improves the quality of life scores of the patients in the study, which this treatment certainly would.
edit - also the pricing strategy the company undertook would absolutely take insurance coverage (by country) into account when they roll the product out.