Research study islet cells

Type 1 and LADA
1

So I’m looking into another study. I qualify for it and they asked me in to talk about going forward.
It is an encapsulated islet cell transplant. Little pouches stuck under your skin. Producing insulin after a week or 2.

Half the people will get some drug to prevent rejection half will not.
But the encapsulation kind of prevents immune response so it’s a weird thing

I considered doing the full on transplant last year where they inject the cells into your portal vein, but I decided it was a little too invasive.
This one seems much less scary and after 2 years it’s removed completely.
Anyone else considered this or had it done?

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I would do it! I so WANT to do all the studies, but I live in the middle of nowhere. Pouts

I keep hoping with everything going virtual, they’ll open studies up to long-distance participants. Of course, that wouldn’t work for something like this.

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If it is a Viacyte study, then I would do it as long as I didn’t need to be on immunosuppressants.

I’ve been hoping that the PEC-Encap project would yield good results, but I think they had trouble getting people’s bodies to vascularize around the devices (enabling blood/oxygen to get to the encapsulated cells). I think Viacyte recently partnered with GORE to fix this. That may mean that the next trial works out better.

Anyway, you probably already know all of that.

If they were recruiting in my area, I would sign up.

However, I wouldn’t be surprised if - even if the cells work - they don’t produce enough insulin to cover everything. That could make it difficult to estimate how much insulin you need for both basal and bolus. Just something to think about.

I feel like this is the most promising route to a functional cure. It is hard for me to not get my hopes up.

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If this is Viacyte I’d be in on it. I really think it’ll be the next big thing to happen to the point I think it may be a thing before any new real advancements in APS (commercial, not DIY) systems.

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i have applied for three of these. But have never qualified. I woudl in a heart beat.

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It is viacyte and they will be implanting several different size inplants to see what works best. The idea is to implant enough to cover TDD. But no one knows if they will survive or produce enough.

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The implants with likely contain alpha cells too, so you may have some protection against lows :blush:

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It is billed as stem cells. And the differentiate and mature after implanting. Not really sure the details yet, not sure where they get the cells, but I will find out before I gonfoward

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That seems really interesting.
I assume you don’t get to decide (or even know) if you’re on immunosuppresants or not. That seems like a big downside and I’d want to know more about it.

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Awhile back I spent a lot of time listening to Viacyte representatives speak about their product. My understanding is that when the stem cells mature, they don’t just mature into beta cells. They also mature into other pancreatic cells - such as alpha cells. I didn’t say that very clearly in my last post.

Of course, that was awhile back. Things could’ve changed.

Anyway, I’d be interested to hear about your experience if you decide to participate in the trial. Hopefully immunosuppressants aren’t necessary.

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That part is the double blind part of it. Participants get immuno suppressants or placebo. Then they compare the two sets.
So it’s randomized. I need to decide if I’m willing to do that

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For me the question would be what will be the effect of two years of treatment with the immuno-suppressant they will be using. If they can promise little or no damaging effect I would go for it.

It would surprise me if they are willing to expose anyone to known lasting harm for the sake of research. I suspect that to do so would be unethical.

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Well just as a point of information I have used immuno suppressants for 21 years and except for the arm growing out of my forehead, I feel OK and look wonderful. Shirts are sort of hard to find, but I have a wonderful tailor.

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Speaking of third arms, I had a client ask me to knit him a sweater with a third sleeve coming out of the chest. He didn’t have an arm to put in said sleeve but had wanted such a sweater ever since seeing one like it on The Adams Family as a kid. He has been known to use the third sleeve as a scarf on occasion.

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15

actually the biologic I use has been a God send. I would not hesitate one bit to take one in order to suppress immunity and get my Beta cells back. More than a fair trade.

I assume this biologic is ACTEMRA a very safe immuno suppressant that is used in several disease types. Currently it is being tested as a biologic that is being used in trialnet to prolong the life of beta cells in people with the antibody profile but not yet diagnosed.

I would have no hesitation.

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16

I’m not sure what I would do in your position. As Gary indicated, I would want more information about the potential side effects of the immunosuppressants (long or short term).

I’ve never been on immunosuppressants before, but it seems problematic that you wouldn’t know if you received them or not. Don’t you have to take extra precautions against getting sick when on immunosuppressants? Given the pandemic, it is not the best time to have a suppressed immune system.

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Nearly all credible clinical research nowadays is “double blind”, because it’s too easy for the researchers to skew the results if they know who’s getting the placebo. Meaning, even the researchers don’t know who’s getting what. At least not the ones with any patient/data contact.

Whatever safety protocols are in place for those taking immunosuppressants would also apply to those on the placebos. Every single person is subject to the rules.

Whether or not one should be taking immunosuppressants during a pandemic is a valid concern, though, and I would assume largely part of why @Timothy posed the original question.

This has been studied, and hospitalized covid patients taking immunosuppressants do not fare any worse than those who are not. The most serious side-effects of Covid-19 are actually caused by our own immune systems attacking the virus, and our own cells where the virus lives. Thus, slowing down immune response might mean it takes longer to fight off the virus, but one should not be (more?) seriously ill while doing so. Of course, with all things Covid-related, prevention in the first place is still the best medicine.

There are quite a few other concerns that might be deal-breakers when it comes to the possibility of taking immunosuppressants, but Covid alone shouldn’t top that list.

Remember too, researchers cannot ethically (or legally for that matter) expect you to continue any experimental therapy if you’re experiencing severe side effects. They might ask you tough out minor pain, nausea, and the like, but treatment can be discontinued at any time if you’re experiencing severe distress of any sort. You can even voluntarily drop out of the study if they don’t choose to stop treatment themselves.

This would be top of my further questions… What have previous outcomes and side effects looked like. Prevalence of side effects, minor and major, and how comfortable are you knowing that’s the likelihood you’ll experience the same… and what criteria they have for aborting treatment. Also, if there is compensation for participation, what penalty is there for voluntarily dropping out. Payments are often incremental. What happens if you’re forced to drop out because of side effects? Do they remove the capsules of stem cells? Can you switch to the other therapy option? (Would invalidate your results, but maybe there are side effects to NOT taking the immunosuppressants and you’d fare better with them afterall)

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Anecdotally, I’ve heard it can go both ways which is part of what makes COVID so difficult to treat - should the doctor try to boost your immune system to fight off the virus or suppress your immune system so it doesn’t attack your own cells? I haven’t seen studies that have established what you’ve said as scientific fact at this point. Certainly some of the serious side effects are caused by our immune system- but all of the most serious side effects? Would be interested to read any study that says that definitively.

I responded with things I would consider which includes COVID. There are a lot of unknowns- I still don’t understand why two young relatively healthy people I know are still experiencing side effects from having the virus months ago. How long they’ll experience them or why they are is still unknown.

There is certainly a lot to consider.

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Definitely! Unfortunately, there’s no such thing as “all” in science. It’s all questionable theorums until new evidence comes to light.

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I participated in an islet cell transplant program many years ago and it didn´t go well for me. (I had two transplants, late 2010 and early 2011). The immunosuppresants made me so sick and fatigued that I finally had to stop taking the drugs and just reject the cells. I think I got all the complications possible to get, lost more than 30 pounds and my kidneys started to fail. I participated in a trial where the participants had to be healthy and have no complications from diabetes to qualify.

Eight years after quitting the immunosuppresants I´m still struggling with recurring side effects and fatigue to the extent that I no longer can hold a job or do any physical activity. This just to tell you that it can go wrong and that a “worst case scenario” may exist.

I know this study is not that invasive, but get all information available beforehand so you are sure you can give an informed consent if you decide to participate.

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