First Stem Cell Therapy Approved

It’s been almost a week and I haven’t heard hardly a peep about the FDA approving the first islet cell infusion treatment for T1, branded name Lantidra. I’m slightly obsessive about medical research, and I’ve never even heard of this CellTrans company who developed it. I never even saw them on ClinicalTrials.org. While other companies are focused on methods that don’t require anti-rejection drugs, these guys ran in and got the dirty method approved while nobody was looking. So, while it’s certainly not the dream we’re all hoping for, it is the first FUNCTIONAL cure for T1 on the market. It’s not “5 years away” anymore… It’s today.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes

It’s indicated for the hypo unaware, who basically might die otherwise from insulin overdose. It seems to me, though, that it’s likely to be used off-label by anyone who’s in dire straights due to their difficult diabetes.

I haven’t been nearly as active here as I once was because I’ve really been struggling with my own T1 the last year or so. For almost 10 years now I’ve had terrible inflammation and a myriad of miserable symptoms that arise from that inflammation . Absolutely no doctor had been able to help or diagnose why. We finally figured out late last year that I’m allergic to the lab gown recombinant DNA insulin we all use. ALL OF THEM. It’s the process by which they’re made I’m allergic to, not any particular ingredient. I have a histamine intolerance, likely caused by mast cell activation, which means I have an allergic reaction to anything fermented/aged with bacteria, amongst a mile long list of other things. And the insulin we use is churned out by genetically-modified, histamine-producing bacteria. Most people can handle histamine… Turns out, I can’t.

So what’s a T1 who’s allergic to the drug they need to survive supposed to??? The FDA banned animal insulins in 2006, and it’s nearly impossible to find in other countries anymore either, because of it’s unpopularity. There’s only 1 company still manufacturing it and it’s simply not an option I can afford. It’s essentially the bespoke Bugatti of the insulin world, even though it’s the oldest formulation. Supply and demand. So basically I’ve just been taking massive amounts of antihistamines, rationing my insulin, and trying to cope with the symptoms. Ironically, the antihistamine diet I have to follow is pretty high in carbs, too. Plain ol’white flour and starches are amongst the safest foods. A1c is up from 5.4 to 7.8. It’s all done a number on my head, as if living with this pain, inflammation, brittle/fluctuating insulin needs, and all the other fun that goes with diabetes wasn’t enough on it’s own… Basically, this incredible, healthy lifestyle I thought I was living before had been killing me!

I’ve been holding out hope that Vertex comes through with something quickly, so that I can start producing my own insulin again! And desperately hoping they don’t get eaten up by Big Pharma and “disappeared”. Eli Lilly just bought Sigilon, another islet cell therapeutic in the works , so I feel like we may be kissing that one goodbye.

Personally, I’m terrified and thrilled at the same time over this new Lantidra. I know most T1s wouldn’t even consider a treatment that requires anti-rejection drugs, but I’m seriously weighing the pros and cons. 100% of the trial participants had severe adverse reactions to the anti-rejection drugs. EVERY. SINGLE. ONE. And some dropped out of the trial because of them. But most of them persisted despite the side effects. Most thought the benefit outweighed the risk. I’m seriously asking myself if I want to risk cancer in the long run to be free of this pain today??? Or do I keep enduring and wait for better? What if Big Pharma never lets better see the light of day?

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Best of luck!

Maybe they’ll come up with a stem cell treatment for histamine sensitivity while they’re at it. We could only be so lucky.

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It’s likely that you are not allergic to human insulin but the preservatives. I had hypo unawareness when I switched off pork insulin. But eventually it came back and I can sense lows again but not until I’m in the 50s. I’m all for trying the new drugs and I came close to doing a vertex study only I backed out because Covid was in full swing. And I didn’t want to take immune suppressive drugs.
I have seen trials for vertex and the other drugs you mentioned but they only take diabetics who are under 40 for those immune studies.

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It’s not human insulin itself or the preservatives. You can’t exactly test the former because it’s impossible to obtain, but my allergist has tested every listed ingredient in Novolog, Humalog, and Apidra (lyumjev and fiasp have extra ingredients added we didn’t bother with, but nothing left out), and I don’t react to them. A little bit to the phosphate, but nothing compared to my reaction to the greater solution. It’s the E. coli bacteria that makes the insulin I’m allergic to. Histamine is one of the waste products of their metabolism.

We’ve already confirmed the histamine intolerance. It takes a lot longer to confirm Mast Cell Activation Syndrome because the tests are done in series.

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This is very exciting! Whats the cost?

I haven’t yet seen anything about cost. Approval and availability are two different things. I assume astronomical without insurance, and quite the battle with insurance for coverage.

I hope you get access. Have you considered a pancreas transplant? I realize that entails a lot.

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In South Florida, a hospital-medical group will be starting transplants of the pancreas and the kidney simultaneously.

I’m so sorry to hear this, Robyn. It sounds like a nightmare.
You have probably already looked at this from every angle, so I apologize for just throwing something out there, but have you tried Afreeza? Maybe it has the same histamines but it seems like it’s in and out of the body pretty quickly so possibly might cause less prolonged inflammation? I really have no idea, but it occurred to me…

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Many thanks for this, I had not heard of CellTrans either until your post.

Oh dear and with great sympathies.
I can see why something that might require anti-rejection meds would still be enticing, at least in theory.

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Robin, I read quit a bit of posting this morning on Reddit regarding the transplanted islet cell studies. They mentioned Vertex also. The postings got a little “in your face” at times. If interested you can read on Reddit: r/diabetes_t1 Just thought I would pass this on to you. This is a sub group I lurk on.

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If I were gonna investigate something like this further, or look for a consult, I might try speaking with someone at the U of WA (state) because I think they are one of the few places that do pancreas transplants for diabetics. I feel like the Mayo is limited in the diabetes space, but they are good with multi-specialty issues. Would anyone at Joslin know something? This is such a tricky one.

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Yeah, that’s really not on my radar. To my knowledge they are rarely ever done alone and usually combined with kidney transplant, and they’re not done much in the US at all. I did have a friend in the UK who received the double transplant due to necrotizing pancreatitis and never recuperated well from it. It’s hard to separate complications of the transplant from complications of the disease, though. Regardless, since my kidney health is excellent, I’m not looking to take in such a big risk, and wouldn’t even be considered eligible. I was initially a little green over my friend’s “fortune” when I heard through the grapevine she was getting the transplant, but I quickly realized how misplaced that thought was.

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@Robyn_H ,
I get how a transplant is a huge deal. I think that taking daily meds to prevent rejection would be scary, though it’s doable for those who have little other choice. I have read a couple of accounts of T1 in the US who have gotten a pancreas transplant on-line in the diabetes community.

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I’m not sure this is really news.

Islet transplants with immune suppression have been done for a long time. They tend to fail after 5 years even with immune suppression, and this doesn’t sound like this method is hugely different. The immune suppression means that the side effects are life limiting, generally available only for people with a kidney transplant who are already on immunosuppressive drugs. Other than the FDA approval, what am I missing here?

Sorry you are having problems, @Robyn_H . I met someone that went through the islet cell transplant almost 20 years ago … the process almost killed her. I know that some (many?) have had issues with immunosuppressants. I guess I am fortunate that I have not had any problems with my experience since my kidney transplant 11 years ago. It’d be interesting to know what immunosuppressants they used. I have been on Mycophenolic Acid and a very low dose of Tacrolimus the whole time since my transplant with no issues whatsoever.

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@Robyn_H This is an interesting piece of new news for me but most of all, I’m struck by the magnitude of difficulties you have encountered, and in spite of that your persistence and courage. Testimony to spirit. Thanks so much Robyn and all the best.

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Robyn, I’m so sorry this predicament has befallen you. My first impression was that you could find an affordable pork-based insulin source. But one thing I’ve learned from personal experience is when a medicine source is whittled down to a few or worse, one, the supply becomes tenuous and unaffordable. Big Pharma cannot control its greedy nature!

It’s hard for me to imagine as I survived on pork-derived insulin for first 12 years of my nearly 40 years of T1D existence. It was ubiquitous back then. The unavailable preferred insulin supply combined with being forced to consume unfriendly carbs is an unimaginable torture to me!

I have taken no hope with transplant tech since the risk with anti-rejection drugs is too much for me. I understand, however, that your calculus is different. I wish you luck in this path.

Do you have any discretion about which carbs you do consume? If you can lean toward the less hyperglycemic triggering end of the spectrum, perhaps that might help. I think the order in which you eat the carbs may help, too. Eating, for instance, the potatoes after the meat or mixed in with the meat might moderate the glucose variability.

I fear that you’ve already considered and tested these ideas. I apologize if that’s the case! I wish you the best.

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