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Host (likely a diabetes advocate or podcaster)
Hello friends and welcome back to another episode of the Juice Box Podcast.
Dr. Piotr Witkowski
Doctor Piot Witkowski I'm a transplant surgeon and professor of surgery at University of Chicago. As attending surgeon as a Director of Pancreatic Eyelids Transplantation surgeon, I've been doing kidney and pancreas transplant and running clinical trials in eyeless transplantation. Optimizing the procedure at the end of
Host (likely a diabetes advocate or podcaster)
this episode, the doctor will share a website where you can learn more about his trial and if you are eligible, he asked me to let you know that the website is best viewed on a computer or a laptop. Doesn't really work too well on a cell phone. So when you head over there, use your computer, your laptop. Stay off that cell phone. While you're listening. Please remember that nothing you hear on the Juice Box Podcast should be considered advice, medical or otherwise. Always consult a physician before making any changes to your health care plan or becoming or with insulin. Today's episode of the Juice Box Podcast is sponsored by the Contour Next Gen Blood Glucose Meter. This is the meter that my daughter has on her person right now. It is incredibly accurate and waiting for you@contournext.com Juicebox Today's episode is also sponsored by Medtronic Diabetes, who is making life with diabetes easier with the mini med 780G system and their new sensor options which include the Instinct sensor made by Abbott. Would you like to unleash the full potential of the MiniMed 780G system? You can do that at my link medtronicdiabetes.com juicebox I'm Dr. Piotr Witkowski.
Dr. Piotr Witkowski
I'm a transplant surgeon and professor of surgery at University of Chicago. I was educated and trained in Poland as a general surgeon. Then I came to United States to do some research. Initially I was involved in research related to transplantation. Different way to develop the way to transplant organs without immunosuppression. We call it tolerance. I did my research at Columbia University in New York at the same time I was involved in eyeless transplantation. My mentor got a grant and we've been developing eyeless transplantation procedure or operate operation over there. And then after that I accomplished training in surgical training and transplantation Columbia Presbyterian and after that it was 17 years ago when I came to Chicago as attending surgeon as a director of pancreatic eyelids transplantation surgeon. I've been doing kidney and pancreas transplant and running clinical trials in eyeless transplantation, optimizing the procedure. So it's been 17 years at the University of Chicago.
Host (likely a diabetes advocate or podcaster)
How many iterations do you imagine that that procedure has gone through in that time?
Dr. Piotr Witkowski
How many alternations, how many times has
Host (likely a diabetes advocate or podcaster)
it been improved or updated or changed from where you started?
Dr. Piotr Witkowski
So this has been a problem because pancreatic islets, which we isolate from diseased donor organs from pancreas has been regulated in the United States as a drug. So it was 26 years ago when they optimized eyelid isolation technique and eyelets transplantation procedure in Edmonton, Canada, achieving great results. We wanted to adopt it right away, but then FDA said no, you have to test it as any other new drug in control environment and perform phase one, phase two, phase three clinical trials. And when you do clinical trials, you have to do everything the same way because you testing the eyelids as a drug which should be manufactured every time the same way. And it took us over 15, 18 years to accomplish those trials. And over this time we couldn't really modify anything only because it's been regulated as a drug.
Host (likely a diabetes advocate or podcaster)
That time there was you trying to satisfy the FDA's ask, right? Okay.
Dr. Piotr Witkowski
Right. So over this time the islet isolation technique hasn't changed. Actually it hasn't changed for 26 years because we couldn't do it. We have to do it in the one standardized way to satisfy fda. We've been changing and optimizing clinical part, the, you know, changing immunosuppression, replacing one immunosuppression with the other to achieve better results. But we couldn't really optimize. And then because it was still all these years, it was clinical research, very expensive clinical research. The number of the patients which we were enrolling with was low and therefore we couldn't even modify the clinical part much learn I mean change a lot because of limitation in funding and in patient number. So the regulations which been applied in the United States and only in the United States has been not really helping the progress in the field. In other countries, Canada, Europe, Australia, islets has been regulated as any other organ for transplantation. And it means that every procedure is driven by the physicians and, and it can be developed, change all the time, optimize all the time for the optimal outcomes.
Host (likely a diabetes advocate or podcaster)
Are there other people around the world doing this same work and, and able to move and iterate more quickly?
Dr. Piotr Witkowski
Right. So for example, in Edmonton in Canada, they've done over 700 eyeless transplant over the last 20 years. In Europe, they did over thousand transplants and they have this approved in England, in uk, in France, in Switzerland. It's a standard of care procedure based on the results from our clinical trials. And we in the United States still cannot still have it approved because again, it's regulated as a drug and it requires special conditions, validations, funding liability, and it's, it's way beyond capability of, of academic institutions to reach that.
Host (likely a diabetes advocate or podcaster)
I, I mean, I hear how frustrated you are. I mean, did you go back to the FDA and explain to them why and what.
Dr. Piotr Witkowski
Yes. So for the last five years we've been talking, we've been publishing, we've been presenting scientific data and advocating for adjustment in the regulations since for last five, six years. First it was Covid, which was the obstacle. FDA was, was focused on Covid. After Covid, the regulators were not keen on any changes. Despite the fact that there is no transplants as a standard of care, no islets are available outside the clinical trials and there was no progress. So we've been publishing articles, we voice our concerns and there was no really traction until recently when Breakthrough T1D, the major foundation supporting type 1 diabetes, got involved. And now and our patients and social media, and now there is a hope that this, this regulatory adjustment may happen based on current law and regulations. The Secretary of HHS has authority to adjust the regulations himself based on the feedback from FDA and hrsa. But, but it can be done quickly and efficiently. We are ready to work with regulators on proper adjustments which will allow eyeless transplantation to be on the one hand, available to patient as a standard of care, but still safe and an effective procedure. So all the safeguards are, are in place to reassure that it's done in the safe way.
Host (likely a diabetes advocate or podcaster)
If Health and Human Services made that change for you, how would that change what you're doing right now?
Dr. Piotr Witkowski
So the major change would be this, that if islets are regulated as organ based on covered results, we can go to insurance and show them the results. And I know that they like them because I already showed them to several medical directors of the insurance and they said we will pay as long as regulations allows for this, that your product is approved for clinical use. So once the islets are regulated as organ, our product would be approved and then it can be reimbursed. Once it's reimbursed, we can do many more patients. I mean, we can offer this procedure to many more patients and then we can do many more studies and enroll patients faster and learn faster and progress the field. We can test new ways, optimize the islet isolation, optimize the clinical protocols much faster, much more efficient and create progress.
Host (likely a diabetes advocate or podcaster)
So right now you're kind of stuck doing a clinical trial. But if they changed it. You could just start doing the procedures. It would work for people.
Dr. Piotr Witkowski
On one hand, we can start doing the procedure based on our current experience using approved medication. At the same time, we can start continue doing clinical trials and we will be testing new medication. Less toxic, more effective medication is still clinical trials. But only a small fraction of those procedures will be paid by the research and everything else. The core of the procedure, which is standard of care, will be paid by the insurance.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
So for example, with the same funding which we're getting from breakthrough T1D to transplant 10 patients, we can transplant hundred patients with the same funding. So this will be a major, major change.
Host (likely a diabetes advocate or podcaster)
Be a little cynical for a second and tell me why you think it's set up like this and why it hasn't changed.
Dr. Piotr Witkowski
People who we talk to, they were not focused on this. They were always like they, oh, there are so many different problems. We have to focus on something else. I mean, what can I tell you? Yeah, there was no traction so far, but now there is traction. And I think also that what trigger changes now that we testing new medication, less toxic patients are doing much, much better than before. So before was the general feeling is that isleth transplantation, well, they can help some patients, but there is so much side effects of immunosuppression. At the end of the day it's not so beneficial. So people were skeptic about the islet transplant. Now seeing patients with reverse diabetes without side effects patients and people are excited about it. So I think we brought it to the different level of efficacy and safety and this triggers that people are interested into this and see this as a chance for on the path to the cure.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
The ultimate goal is to, to remove the need for immunosuppression. But to get there we have to go step by step. We have to use better medication and then, and then less medication, lower doses and stopping the medication. But it requires, you know, clinical testing before we are completely can can do it without immunosuppression.
Host (likely a diabetes advocate or podcaster)
So is what you're saying is that the, the Tego probart. Is that, how do you say Tego probart?
Dr. Piotr Witkowski
I don't know why they coming with those names. Tego probart. Yes.
Host (likely a diabetes advocate or podcaster)
The understanding that that could be used in your procedure changes the feeling to people. Yes. Taking it from like well sure, we can do it, but you're going to just trade one problem for a different problem. Right, exactly. And now it doesn't feel like that anymore.
Dr. Piotr Witkowski
Right, Right, exactly. So with, with the tacrolimus which is great medication, allowing us to keep the organ transplantation working for many, many years. But the trade off was that there was toxicity to the kidney, to the brain, to the nerves, to causing hypertension, causing diabetes. So there was a trade off, but we didn't have better medication over the last 30 years. And now with take Approbar again, these are the very preliminary results. We have only 12 patients and short observation. But all the patients do not have those side effects. They don't have any side effects so far. And they have eyeless transplant successful and they, they reverse diabetes. So that's why you hear from patients that they feel cured because they don't feel burdened of this therapy so far.
Host (likely a diabetes advocate or podcaster)
Yeah. What is the Tego doing that's allowing it to target this situation without suppressing the rest of your immune system so much?
Dr. Piotr Witkowski
Right, right. So it is still suppressing the rest of the immune system, but the way it's suppressing is it's more selective, it's, it's more accurate, it's not, let's say it's not as global as the other medication. The other medication, they targeting many different entire immune system and many different checkpoints. And then this medication, it's just one, one main, still main mechanism of rejection, but only one, so the other still working and protecting patients and not causing the side effects. So it's much more selective and therefore toxicity is so far it's negligible.
Host (likely a diabetes advocate or podcaster)
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Dr. Piotr Witkowski
So far, right? So far. And again we had to start with something, right. So the liver intravenous infusion is reliable. This is something it's done here in our infusion center. So we know is the liver properly. But moving on, you know the company is already working on subcutaneous infusion. I mean injection by the patients and then the frequency on injection can change the dose. Was. Was just. Was just a. Was. Was actually the dose was just proposed. We using the proposed dose we can, based on experience we can learn that the dose might be too high. Right. And we may go with lower dose. So the dose might be AD or needs to be higher. We'll see. But that's why I'm saying it's just the beginning. But eventually the. There is a good chance that this medication will be given by the patients themselves at home maybe.
Host (likely a diabetes advocate or podcaster)
No differently than how people give them GLP shots.
Dr. Piotr Witkowski
Exactly. Like once a week or once a month. Exactly.
Host (likely a diabetes advocate or podcaster)
What do you think the timeframe is for that? Has that company given you any idea?
Dr. Piotr Witkowski
Now the company is that Eladon, Is
Host (likely a diabetes advocate or podcaster)
that the name of it?
Dr. Piotr Witkowski
Yeah. The company is elegant and they working on this. They know about it. They working on this. They getting ready. It's hard for me to say when but. But it's not far. It's not far, is it?
Host (likely a diabetes advocate or podcaster)
I know that's not your company. But can I ask you, is there a way to, you know, with people have so many different autoimmune issues? Ra, for example, do you think there'll be injections that maybe will be able to more surgically target other autoimmune issues?
Dr. Piotr Witkowski
Yes, yes, as you said, actually this medication was first tested with other immuno als, other autoimmune disease and any immunosuppressant used for autoimmunity we test in transplantation or anything developed for transplantation is tested there because the mechanism is very similar. So definitely very similar. Maybe this way the drug with the same mechanism developed by Sanofi and they testing this for autoimmunity and now they're thinking to come back to transplant. So it's not only Eledon, it's going to be Sanofi with very similar medication. And they already have sub Q formulation.
Host (likely a diabetes advocate or podcaster)
Okay. Oh, do they? Sanofi does, yeah.
Dr. Piotr Witkowski
Yeah.
Host (likely a diabetes advocate or podcaster)
So this could really change like the face of transplantation to.
Dr. Piotr Witkowski
I feel that this is, this is a major change after 30 years. Because this is what I exactly feel comparing when I see patients on tacrolognos on daily basis after kidney pancreas transplant, I see those heart transplant amount of work on us and the patients to adjust the dose. And the patient is frequent blood test to change and control the level of the medication. And then we changing the dose up, down, patient getting confused. And despite those changes, patients experience side effects. It's a lot of frustrated, a lot of work, a lot of frustration. And now in the study with Tego Probarte, there is no adjustment in those. There is nothing. We just shake hands, we hug. How is everything? Everything is fine. From this perspective, it can change less toxicity, less side effects, less work on the patient and physician side to adjust the dose of medication to treat or prevent the side effects. So this will change not only islets, it will change the transplantation. Of course, assuming that nothing bad will happen, right? That there will be no sudden unexpected adverse event. And I can tell you historically, this medication was developed 25 years ago in animals. And the results in animals were amazing. But when it was used for kidney transplant in first three patients, all of them develop blood clots, which immediately the study was closed. And this was something nobody predicted. So it took 25 years for this the same medication to be modified not to cause the blood clots as a side effects. And now we can use it. So this is just example that despite extensive testing in animals, something may happen in humans which we couldn't predict so far. It's good. So we have patient, the first patient, the longest follow up almost two years.
Host (likely a diabetes advocate or podcaster)
Wow.
Dr. Piotr Witkowski
And there is patients beyond two years in the kidney trials. And so far so good for our patients, we will be extending the therapy for the first year for the. And watch them longer to get more experience and learn more.
Host (likely a diabetes advocate or podcaster)
Well, it's a miracle that the company kept going for all that time after the blood clots.
Dr. Piotr Witkowski
Right, right. I mean they were persistent.
Host (likely a diabetes advocate or podcaster)
Somebody really believed in what they saw. Yeah.
Dr. Piotr Witkowski
Yes. And the reason is because we saw amazing things which we never seen before in animals. So that's why we were so excited. And the company and we and others believe that if we overcome the side effects, we can still benefit from this mechanism.
Host (likely a diabetes advocate or podcaster)
And for low toxicity, you get over these humps. Let's just say it's an approved thing and you can start doing as many of them if you want. I mean, how many islet cells are actually available? Like how many people could you actually accommodate if it got to that point?
Dr. Piotr Witkowski
You mean from deceased donors right before the stem cells? Because we still need. Yeah. This is the question where you're going, right, that the limited number of deceased donors, limited number of islets. The goal to have the updated regulation and keep doing deceased donor eyelets transplant is to help the most desperate patients improve their life, reverse diabetes and learn. And learn a lot. And progress the field in order to minimize immuno or eliminate immunosuppression. Now, in the meantime, of course, we want to help patients. Now how many patients we are able to do. I mean, we are limited by the funding and the money. There is a 1000 pancreas transplant done every year in the United States. And they using the best organs. From one perspective, the organs, the pancreas which we use for islets are different than organs used for whole organ transplantation. So it's not competitive. So let's say, I mean, you know, nothing will happen overnight. But like today, we are the only active center. City of hope is another one doing one or two transplant and we do 30 transplants. So today it's like 40 transplant a year in the entire country. But we can do, let's say a thousand. Right. So thousand is much more than 40. It will progress the field extremely. If we can do a thousand, it's not as a solution for every type 1 diabetic.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
But we can sort it out. The way to minimize immunosuppression when the cells, where the stem cells islets are available, we can just combine this new stem cells, islets and which are in unlimited supply with minimal immunosuppression or no immunosuppression, which we will work out using disease on our islands.
Host (likely a diabetes advocate or podcaster)
So to paint a picture for people, if you kind of go back to where the doctor was talking about starting 25 years ago and think of this as a ladder to an eventual cure, which is when people talk about it, you know, in everyday life, that's what they're talking about. They're like give me a pill that shuts this off. And right. And it ends and right. This thing that you're doing right now is huge. It's a big deal. It's amazing at how well it's working. But even if you perfect it, it's just another step on the ladder. Is that right?
Dr. Piotr Witkowski
It's another step on the ladder. But what I want to highlight and this medication in animals we were able to maintain the kidney and eyelids function only with one medication in the Tegaprubar trials. We using thymoglobulin. We're using my fortic additional medication. So that is more than take approval to protect the eyelids. We saw in animals that just go probate can protect it. So there is space to minimize immunosuppression. Now once we stop the group in animals, the organs will keep going for several months. So take a probate. Provides some kind of modulation which may allow for tolerance for no immunosuppression, let's say after a year or two. But in order to. To do that we need develop a new monitoring system of the eyelets graft function. So once we start reducing the dose, we need to know if eyelids are being compromised or not before they gone. We don't want exposed patients to lose eyelids overnight only because we lowered the dose. So in order to do it we, we need more. We need tools to better monitor islets function which we don't have today. But this is the ultimate goal just to do it the way that no immunosuppression in the long term is necessary
Host (likely a diabetes advocate or podcaster)
if there's an eventual end to this. Do you think it's found through medication or do you think it's found through encapsulation? What do you think is the best way to.
Dr. Piotr Witkowski
Oh no. So yeah, how I gonna put it today? For cadaveric islets they need a lot of blood supply instantly in order to survive any encapsulation, any additional layer separating the eyelids from blood supply. And this is capsules do. It's just killing. It's. It's just compromising their survival. So I Do not believe that encapsulation is the solution because they need blood supply. Now for the stem cells derived eyelets, they might be more resistant, they may need less blood supply. Maybe there are new materials, maybe it will happen. But I know from the theoretical perspective you are doing something opposite that you should. Islets needs a lot of blood supply and you should improve blood supply rather than limit the blood supply. Therefore, I don't believe in an encapsulation immunosuparation. Now genetic modification people are trying to modify them so they invisible to immune system and avoid this. I think it's going to be difficult because we know only small part of biology of human physiology, immunology. We know something, but we don't know everything. And, and we can overcome some obstacles which we know about, but they might be another pathway which we don't know today which will be causing the rejection and destruction.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
For example, today all this immuno genetic modification to make them invisible to immune system is basically targeting the. The rejection but not really helping from, to protect from autoimmunity, which killed the islets at the very beginning. So we're not sure how to what to genetically modify to protect them from autoimmunity.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
So it's not close. It's far in my mind.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
It doesn't mean we shouldn't try.
Host (likely a diabetes advocate or podcaster)
No, no.
Dr. Piotr Witkowski
But that's why I'm focused on. On Tago Pro. But because this is something we can have today and tomorrow to help the most desperate patient.
Host (likely a diabetes advocate or podcaster)
Feels like a more quicker, more direct path to you.
Dr. Piotr Witkowski
Yeah, yeah, yeah. I mean, it's something, something now tangible before the other stuff is developed and
Host (likely a diabetes advocate or podcaster)
good for everybody else doing that other work. But like you said, that if you find a way to protect the cell but don't shut down the immune response, you could just end up with type 1 diabetes again with the new cells. Yeah, yeah. My gosh. Let's shift gears for half a second. I want to ask you more of a kind of a big picture question. Your work is getting shared online a lot right now. And, and I think it's exciting and I love that people are sharing what's going on. But from my perspective, I'm a person who's been making this podcast for 12 years and it's focused on helping people take good care of themselves. I get worried sometimes that people see this and think, oh, it's all done, they fixed it. I don't have to take very good care of myself. It's almost over. I want to know if you have that concern or. And if you can speak to. Directly to those people and tell them what's the realistic timeline between what's happening right now on your bench and that random person who is not having dire health issues right now, showing up in an office getting this procedure, not having to take insulin anymore.
Dr. Piotr Witkowski
No, no, absolutely. Absolutely. Patients should take care of themselves and keep themselves as healthy as possible. That when one day the real cure is available, they will not have problems. Right. They will be still seeing, have a vision, don't have amputations, don't require amputations or heart attacks. So, no, no, definitely. Patients should. Should do the best they can to stay as healthy as possible when the cure comes one day, what we do, I want to highlight, it will help the most desperate patients in a limited number until we get there. And it's still. I'm not saying five years. It might be much longer.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
So, no, this is just what you're seeing and hearing is just impression from patients who feel great. Right. But we can apply it to everyone today. We cannot. We don't have the. The means and technology, and it's not safe for everybody.
Host (likely a diabetes advocate or podcaster)
Right, well, that's what I was gonna say. It's a small group of people from a highly curated group of people, too. Right?
Dr. Piotr Witkowski
Yes, yes, yes. And so the outcomes are better and the patients are happy, but it doesn't mean we can offer this to everyone. Definitely not. And I'm not sure when. And people should stay as healthy as possible.
Host (likely a diabetes advocate or podcaster)
There is even. Even a world where if their health has waned and this becomes easy and plentiful, you could get your health outside of a range where you wouldn't be eligible for it if that was.
Dr. Piotr Witkowski
Yeah, yeah, yeah. And you will not benefit. Even if you get it, you will not benefit, you know.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
The way you could, you know, without secondary complications.
Host (likely a diabetes advocate or podcaster)
What do you consider a cure? Like, what would you be comfortable not saying functional cure or this is better than it was before?
Dr. Piotr Witkowski
I mean, I would think the same way as most people think that, you know, take a one magic pill or one magic injection, infusion, whatever it. It is, and be sure that I will never had diabetes anymore and it will never come back and I don't have to worry about some side effects. Right? So. So in my mind, this is cure. Right. So I'm a surgeon, right. So if I remove the gallbladder, I know there will be no gallbladder disease for 100%. There might be other problems in the disease, but no disease. So. Yeah. No. In my mind, the ultimate Cure is something which can reverse diabetes in the consistent way forever without any side effects. Right.
Host (likely a diabetes advocate or podcaster)
And that's what a cure is to you. Yeah, yeah, I agree, but I'm sorry,
Dr. Piotr Witkowski
but I don't want to diminish what patients are saying, Right. They feel cure because they were diabetic with all the downside of this, and now they don't have diabetes, and today they feel cure, but they fully understand that tomorrow it may come back. Right. So. But they just describing the moment of happiness.
Host (likely a diabetes advocate or podcaster)
Do you think the work you're doing will lead to a broader understanding of the immune system in general and maybe help us to quell it, to keep autoimmune issues down in people in general?
Dr. Piotr Witkowski
Definitely, definitely. We. We can. We can learn how to. How to manage. But to me, it's still hard to comprehend that in 21st century, despite all those things, we don't know why autoimmunity happens. And it's not only type 1, any type of autoimmunity. We don't know why people has Crohn's disease. Why there is theory. There is, you know, this and that, but nobody can pin. Can pinpoint one. One reason. Right. So I think this would be a major breakthrough if somebody will figure out why autoimmunity happens in the first place. Place. Because if we know the reason, we can prevent it rather than, you know, finding a cure, how to reverse it.
Host (likely a diabetes advocate or podcaster)
Yeah, that would be lovely. I talk to a lot of people every. I mean, every day I record with somebody and. And you ask them about other autoimmune issues in their life or in their family line. And you can see it plagues families sometimes, you know, for all different. Yeah, yeah.
Dr. Piotr Witkowski
There is genetic factor for sure, but it's not only.
Host (likely a diabetes advocate or podcaster)
Not only. No.
Dr. Piotr Witkowski
Of course, the best example in my mind is the ulcer, Right. The ulcer in the stomach. For many, you know, thousands of years or hundreds of years, it's been the disease untreatable. And people were saying, oh, you have ulcer stomach because you stressed. Right. Who is not stressed? And people are trying to explain and treat it until the bacteria was suddenly discovered which is causing this. And we treat the bacteria and there is no ulcer disease. Disease. I just hope that there's one thing which can be discovered and removed and we don't have autoimmunity. This is my hope. I know people look into bacteria, viruses and genetics and diet and that, and it doesn't look like it's one single thing, but maybe there is and we cannot see it or find it yet.
Host (likely a diabetes advocate or podcaster)
I mean, it's interesting when you're trying to figure these things out. I find it helpful to remember that we can use general anesthesia to put a person unconscious and that science doesn't understand exactly how it works. That makes me. Puts a lot of things in perspective for me while we're trying to figure this stuff out, you know? Yeah.
Dr. Piotr Witkowski
No, no. And again, I mean, you know, research and medicine and stuff. And the more I'm learning, the more I know that we don't know stuff, the more we don't know.
Host (likely a diabetes advocate or podcaster)
Can I ask you a couple of bigger questions? So you're. How old are you?
Dr. Piotr Witkowski
I'm how old I am. 57.
Host (likely a diabetes advocate or podcaster)
57. How do you set your lab up so that your work continues on after you? Is there a process in place for that? And how much of new AI models are you employing in the lab? Those are kind of my two questions about how you get to the end.
Dr. Piotr Witkowski
So you see, I can't do too many things, right. I have to focus on something. So my focus is clinical trials, execution of the clinical trials, optimizing clinical trials, and patient care, the patients who participate in clinical trials. So I do not work in. In my lab in basic. I don't have basic science research. I don't develop, you know, something completely out of nothing. The thing which will stay, I mean, after me is my experience based on patient treatment and adjustment in pain. We learning every day new things about it. And my role is to, you know, share with others, publish, and so that others can. Can benefit and take it to the next level.
Host (likely a diabetes advocate or podcaster)
You're sort of an artistic mechanic. You take the parts that are available right now in the world, and you go into the machine and do your best to put it back together.
Dr. Piotr Witkowski
Yeah, exactly.
Host (likely a diabetes advocate or podcaster)
Yeah. Yeah. That's interesting. Do you think that there's a way to pass your knowledge on to other people? Do you have, like, people working with you who are learning from you?
Dr. Piotr Witkowski
Oh, yeah, yeah, definitely this, especially in surgery, this is how he's been, you know, traditionally that we learned from our mentors, especially in surgery, because, you know, there's a lot of details which is not in the books, and you have to see and experience and you learn certain way. And it's funny, when I was learning from my mentor during my fellowship how to do the kidney transplant, he was obsessed with the details. And I was always like, come on, we can do it different or easier way. Every time I deviated from his technique, his, you know, elements of the surgery. Every time I got into trouble and I was developing Discovering. Oh, that's why he was doing this way. Right. He already went through this and optimized this procedure. And to me it was that without any sense why he's doing this. Until I learned hard way that this was just based on the experience of. He said personal experience and I guess his memory. Right? Yeah.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
So. So. So I'm going back and I'm teaching my fellows in obsessed way. I'm telling you do this way. You can choose your way, but I'm telling this is better and you can do what you want with that.
Host (likely a diabetes advocate or podcaster)
It's a classic parenting problem. How do I get them to just believe me and move on?
Dr. Piotr Witkowski
They need to get burned at least once.
Host (likely a diabetes advocate or podcaster)
It just seems to be the human way.
Dr. Piotr Witkowski
Yeah, yeah.
Host (likely a diabetes advocate or podcaster)
To the artificial intelligence, do you have a feeling that it can move the understanding we have of how medications work or what we're seeing in labs? Like, do you think it'll speed it up? Is the bottleneck human beings somehow?
Dr. Piotr Witkowski
I think so. I think so. I think it will. It provides additional tool beyond our comprehension. This AI has. Has enormous power better than our brain, so they can discover some connections which we don't see or cannot see. So. So definitely it has potential to. To extend our vision. Vision where we are and where it can be.
Host (likely a diabetes advocate or podcaster)
Yeah. I'm excited for that, really. To. For us to be able to dump the collective knowledge of this kind of thing into one place and have something considerate that is maybe more likely to consider something we haven't figured out before or be able to think it through to a different end or something like that.
Dr. Piotr Witkowski
And there will be always people who will look outside the box and discover something by chance or by mistake. And, and this is great, right? This is. This is the nature.
Host (likely a diabetes advocate or podcaster)
Sure.
Dr. Piotr Witkowski
Or discover something by chance. But having this, this special power of analysis beyond our regular, you know, power. This is. This is amazing. And I think it will be helpful.
Host (likely a diabetes advocate or podcaster)
Yeah. Also not having to eat, sleep, go home, talk to your spouse, take care of your kids, like all the other things, right?
Dr. Piotr Witkowski
Yeah.
Host (likely a diabetes advocate or podcaster)
Yeah. Can I ask you, you said how ex. That it's expensive to do the procedure and you only have so much money to do so many. Is there a way to generally tell me what the bill is on doing one of these for somebody?
Dr. Piotr Witkowski
Yeah, if you count everything.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
Everything. Like if there is a program which want to start doing transplants and support the facility, the personnel with one source of money. Right. It's a lot of money. So. And of course, the more you do, the cost per procedure is lower. Right. Because of the. A lot of common costs. 800,000.
Host (likely a diabetes advocate or podcaster)
Okay.
Dr. Piotr Witkowski
This is the. For one, one patient.
Host (likely a diabetes advocate or podcaster)
And that would cover everything. Super nice.
Dr. Piotr Witkowski
Everything.
Host (likely a diabetes advocate or podcaster)
Yeah, yeah.
Dr. Piotr Witkowski
So if there is a center who wants to start running the program and do 10 transplants, they need 8 million.
Host (likely a diabetes advocate or podcaster)
Jeez. That's something. That's a lot to get going every.
Dr. Piotr Witkowski
Because if you think about it, everything cost and it's not only people, it has to be clinical grade reagents and they cost 10 times more than regular reagents. Right. And then, and then there has to be oversight, quality control, and there is so many elements. Cell processing and then inpatient care and then hospital and then the medication are extremely expensive.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
So this is all adding up. But again, but I'm not saying that this is how much insurance should pay for one transplant. This is not what I'm saying. Because then again, if you do more, the cost is lower and stuff. Right. I'm just saying for somebody who is starting and, and, and, or doing on the small scale, this is how you need this money.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
To do, to do a few patients. Right. To do a few patients.
Host (likely a diabetes advocate or podcaster)
If you want to open up your own McDonald's, this is what's going to start to get it going. Yeah, yeah, yeah. And to do, and to do temptations. Right.
Dr. Piotr Witkowski
So, so your, your, your first hamburgers will cost 100 bucks and eventually you'll
Host (likely a diabetes advocate or podcaster)
get it down to scale.
Dr. Piotr Witkowski
Yeah, yeah. Eventually you can, you can take everything down and. Yeah.
Host (likely a diabetes advocate or podcaster)
You have how many people on the trial right now? Are you on your 13th right now? Are you up to 12?
Dr. Piotr Witkowski
No. So, so we got funding only for 12 patients. We could do more, but the funding was 12 and we transplant 12.
Host (likely a diabetes advocate or podcaster)
Okay.
Dr. Piotr Witkowski
We are waiting for Ethics Committee our IRB approval to start the second trial sponsor of our breakthrough T1D for 10 patients, type 1 diabetes with kidney dysfunction with teguprubar. So today, because of tacrolimus toxicity, nephrotoxicity, we cannot do patients with kidney partial kidney dysfunction because then we will kill the kidney completely. So we cannot help patients with kidney dysfunction today at all. So those poor patients, they have poor diabetes and they have already kidney dysfunction and they cannot get pancreas or eyelets transplant at all. So this will be first time because of no toxicity of tecoprobar that we will be offering this group of patients eyelet transplantation. We hope that the reversal of diabetes will stop the progress of the kidney disease and hope, who knows, maybe it will reverse, maybe the kidney function will improve. It is being suggested by, by Some scientists. Interesting. So this is coming for 10 patients?
Host (likely a diabetes advocate or podcaster)
Yeah, yeah. The first round is about proving it out in relatively healthy, you know, specific candidates.
Dr. Piotr Witkowski
Now you're going to with relatively healthy kidney and other elements, but still with the hypoglycemia, unawareness and severe hypoglycemia, then
Host (likely a diabetes advocate or podcaster)
you move on to a different group of people who have another issue if it works with them and that's even
Dr. Piotr Witkowski
more proo that we can reverse diabetes in consistent way. More consistent than before because before with tacrolimus, depending on the center, 80% of patients were, 60% of patients were completely of insulin. So the benefit was to prevention from hypoglycemia. But once we prove that we can reverse everyone for at least one year, then I think we can offer the procedure to patient without hypoglycemia unawareness, for example, with a 1C over 7 when we know that they have a higher risk of secondary complication and reversing diabetes will be beneficial for them even if there are some potential side effects from immunosuppression.
Host (likely a diabetes advocate or podcaster)
What's the youngest person you've helped so far?
Dr. Piotr Witkowski
We have one patient in Tegu Probar study who is 19 and I have another 19 year old. So the problem with teenagers is that they usually, you know, they not compliant with oral medication. Right. So you do transplant, they're doing fine, you ask them to take pills and then they decide not to do it and they have rejection, they're losing. So traditionally we wait until 26 and older when they're more mature and we can rely on them taking the medication. Now this, this specific patient has a tremendous family support and also what convinced me that this Tega Probart is iv. So I'm, I'm relying that the family will bring, bring the patient to us and the patient will be safe getting the medication in the right way.
Host (likely a diabetes advocate or podcaster)
And if they're not there, you'll know they're not there. You can get them there.
Dr. Piotr Witkowski
Then we know if something is wrong, we alarming patients, parents and, and stuff. So the fact that this is IV and it's a, it's a main medication and there is, you know, a devot parents and the patient is also dedicated, don't get me wrong. But he has the support structure. Right. He's not college student somewhere living in a dorm somewhere alone without supervision. And, and then he may, he may just, just lose it. Right. So. So not yet.
Host (likely a diabetes advocate or podcaster)
As much as that is about their health, it's also about you and your trial and getting back the information you need.
Dr. Piotr Witkowski
Yeah, yeah, no, of course we want good outcomes. But what really pushed me was that this particular patient had no life. He because of a severe hypos and poor glucose control, he had no social life, he didn't go to college, he was just sitting at home with no life. So the life was so severely compromised that I decided to help him and his parents and him.
Host (likely a diabetes advocate or podcaster)
Is the tegoprobart, is it eligible to be used in children like younger or is.
Dr. Piotr Witkowski
I mean. No, no, no. It's still under development. So as a general rule the medications are tested in adults first and once they approve in adults then depending on the profile and risk benefit they can be, you know, considered for children. Testing in children. Yeah, but it's just, it's a separate path, separate testing after approval for Apple
Host (likely a diabetes advocate or podcaster)
and that's a time in the future. But for you personally, have you seen enough to feel comfortable using it in kids or have you not seen enough yet?
Dr. Piotr Witkowski
Not yet, no. I have to highlight that as much as we have great preliminary results is still anti rejection medication. So we don't have toxicity on daily basis which we see with other medication. But there is still potential for skin cancer in the long term. The long term overall immunosuppression side effects which is the skin cancer or the blood disease like leukemia. So no, there is still potential risk in the future and until we don't have real experience and data definitely we shouldn't go to children.
Host (likely a diabetes advocate or podcaster)
Yeah, I ask you some of these questions just so the people listening can understand.
Dr. Piotr Witkowski
People are. No, no, we having you know, emails every day from desperate parents and asking when and how because they desperate. We understand this but, but the message is it's not for children yet eyelets transplantation is not for children because we're using toxic immunosuppression and then it's not justified yet.
Host (likely a diabetes advocate or podcaster)
Taking the science out of it for a second. Can you tell me a little bit personally how it feels to see somebody have this burden lifted from them?
Dr. Piotr Witkowski
Oh, this is amazing. This is what's driving all of us entire our team. You know when we, the best reward is when we can tell patients you can stop the, the pump. And I don't know if you saw the post from yesterday because we stopped the part the, the insulin on, on patients few days ago and every time is the same, is the same excitement when they telling us, you know some patients they, they were one year old, they don't, they don't know life without insulin.
Host (likely a diabetes advocate or podcaster)
Sure.
Dr. Piotr Witkowski
And, and suddenly they can live without. And one of the first patient, when we told her she was like 57, all live diabetic, and we told her she was so, so emotional about this and we were. And then we let her go and she was running on the stairs and she fell and she broke her arm. So we felt so bad about it and we blame ourselves that she was
Host (likely a diabetes advocate or podcaster)
so excited she fell.
Dr. Piotr Witkowski
That she was. Yeah, she was so excited that she fell and she broke her arm and she needed surgery. So we decide to keep the patient in the bed, in the room for some time or tell them over the phone
Host (likely a diabetes advocate or podcaster)
one of those. Is everybody sitting down?
Dr. Piotr Witkowski
Yeah, yeah, yeah, sitting down and then sitting down for a while and not just let them go right away. Yeah, no, no. I mean, on the one hand, telling patients over the phone, it's a safe way to do it, but then we missing the, you know, the celebration and the excitement and it's all. It's rewarding for our entire team because you don't know if you know when we bringing the pancreas. This is a normal pancreas to us. It usually arrives midnight, 1am, 3am, 4am and my team is working usually at night, isolating whole night, eight hours, 10 hours, sometimes two pancreas in a row. So. So there's a lot of dedication in the team and they do on. They do it on weekends as well when the good organ comes. We are 247 and these are the same people. I have only one team, so there's a lot of dedication here. But. But again, it's all stimulated by, by seeing our patients happy. And that's why, that's why we share our joy with others. And what was triggered at the beginning was that I understood that the general perception of eyelids transplant is that they don't work, they just hurt patients and we shouldn't do it. That's why we start posting that this is not true. And it can be helpful and it can be a path for better therapy or cure in the future.
Host (likely a diabetes advocate or podcaster)
I can't imagine how busy you are. You and I have been scheduled to do this since November and it's. It's April 1st and November, December, January, February, March. No, don't be, don't be sorry.
Dr. Piotr Witkowski
Something right?
Host (likely a diabetes advocate or podcaster)
Yeah, no, but I'm just saying there's a varied nature and a. And a hurried nature to what you're doing and it's a lot of effort. I genuinely appreciate it. I'm sure everybody listening does too. Can I ask you, is there something who. People are politically minded. Is there something that they could do or. You need them to do to help with these cells and their availability, or is that being taken care of by the lobbying that Breakthrough is doing?
Dr. Piotr Witkowski
The Breakthrough is doing. Right, but it's not done deal yet. Right. So definitely we've been voicing our concerns to FDA first now to HHS directly. In the meantime, since we didn't get attention, we couldn't get attention. We reach out to senators and Senator Mike Lee responded. But now the, the shortest path is through HHS and there is some attention, but it's just the beginning. So I think, you know, if people can express support for what we asking for, for regulatory adjustments so it can be done safe and effective and available to, to patients, this will definitely help.
Host (likely a diabetes advocate or podcaster)
I see. That's excellent.
Dr. Piotr Witkowski
Because HHS are watching, watching social media, watching what's going on today. We don't live in vacuum. I mean, for me, I knew social media is powerful, but I never thought that this will be the, the breakthrough through social media.
Host (likely a diabetes advocate or podcaster)
You didn't think you'd be a guy being on podcasts.
Dr. Piotr Witkowski
We wrote papers for five years.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
And we were writing about it for five years. And it's like any other news. I mean, nobody's seen it, nobody pay attention. But now there is attention and it's a good moment to, to have it fixed.
Host (likely a diabetes advocate or podcaster)
That's excellent. Well, I want to say that I have been for well over a decade. When people would ask me, why are you supportive of JDRF and now breakthrough T1D, I would always say I am very excited about having an entity with lobbyists in government to know how to get to people. Like, I think that's incredibly important. I'm glad to see I was right because yes, this is fantastic news.
Dr. Piotr Witkowski
Definitely, definitely. There is a gap and they. Filling the gap and they. It's critical. It's critical to have stuff done in the right way. And breakthrough T1D, it's a great advocate for this and we hope that this issue will be also resolved.
Host (likely a diabetes advocate or podcaster)
Can I ask you a question that I'm sure some people listening are asking? Why didn't you just leave America and do it somewhere else?
Dr. Piotr Witkowski
So first of all, we in America have amazing infrastructure. So my advantage over European countries is that I doing this. I have all deceased donors in the country available with, you know, over what, two, nearly 300 million people. I have so many organs available. And living in Chicago, we have infra. You have flights. We can bring the, we have to bring the pancreas within 12 hours. And living in Chicago, I can bring the. Almost from everywhere. Okay, within 12 hours here. So I have huge number of donors which they don't have in the small, small countries. So I can do much more. And you know, infrastructure is here.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
I'm from Poland, so I help my university to develop the program, ILS program in Poland. But they have own limitations. So it didn't really take off.
Host (likely a diabetes advocate or podcaster)
Okay.
Dr. Piotr Witkowski
But they had the chance to do it. So each country has only limitation more. And some of them are more or less successful. But I believe, I mean this is the best place to do it.
Host (likely a diabetes advocate or podcaster)
Okay.
Dr. Piotr Witkowski
Once we have the right frame, we can do it. And we were leaders in the field. When we were doing the trials sponsored by, by NIH and JDRF, we were leaders. We were doing. There were like eight centers in the states doing this. 300 transplants. We've been optimized. I mean we've been doing stuff and we were teaching others. It's just this once the trials will have finished, there was no system for support. There were no reimbursement and no more funding for research. And all the centers just closed. People who had experience in this disappear. And then we lost a lot. We lost not only time, but experience. So now we have to rebuild it.
Host (likely a diabetes advocate or podcaster)
Reel about that again.
Dr. Piotr Witkowski
We will be leaders again. But you just need a chance.
Host (likely a diabetes advocate or podcaster)
I believe that you just said something that has a question in my head. I don't know how much it fits here, but you said the pancreas is often come in late at night. Is that because they're donors and people have accidents later in the evening?
Dr. Piotr Witkowski
Right. Because the organ donation happens in regular hospitals, usually after hours. Right. So first the elective cases goes and then the procurement happens in the afternoon or at night.
Host (likely a diabetes advocate or podcaster)
I see.
Dr. Piotr Witkowski
And then it arrives to us at night.
Host (likely a diabetes advocate or podcaster)
Okay. So if Health and Human Services makes this adjustment to how this thing is designated, you can move forward as quickly as there's nothing standing in your way anymore.
Dr. Piotr Witkowski
So this, I mean we would need to talk to the insurance and you know, show them the data and convince them to pay. The argument from, from medical, Chief medical officer of one of the insurance, when he saw the data, he's like, this is no brainer for me. Patients are not in the icu, stay in the hospital for three days, go home, they back at work after one week without diabetes. Yeah, this is a no brainer.
Host (likely a diabetes advocate or podcaster)
Can you speak to the, to the people out there who would say, well, they don't want us cured because they're selling us insulin and pumps and all this other stuff. Can you explain to them why that's not the Case. Or is the case, in your opinion, the tinfoil hat? Can you. Can you tell them how to take it off? No.
Dr. Piotr Witkowski
No how I'm gonna say it. I mean. I mean, we all know there is a pharmaceutical business. There is pharmaceutical business. How it interacts with political decisions. Yeah. I want to believe that everybody wants the best for the patients.
Host (likely a diabetes advocate or podcaster)
Okay. There's part of me that. That I should be wondering a little bit if this stalling for the last 25 years isn't somebody else's lobbyist being better than our lobbyists. Is that about right? Maybe you're not. That you. Maybe you don't want to say. I'm not sure yet. I mean, we got somebody on our side now, is what I should think.
Dr. Piotr Witkowski
For some reason, we are here 25 later. 25 years later.
Host (likely a diabetes advocate or podcaster)
I see. Yeah. Okay, well, so then the people listening to this, I mean, the call to action here is to contact Health and Human Services and tell them, actually say it again. Tell me exactly what you would need from them to make this valuable for you.
Dr. Piotr Witkowski
So I think, my understanding is that HHS should hear from everybody that this is the right thing to do. Not only us, physicians and experts in the field, from patients, from endocrinologists, from everyone, that this is what is expected. And we all believe that is the right thing to do. And their job is to analyze it and frame it in the proper way that we all will benefit from this.
Host (likely a diabetes advocate or podcaster)
Yeah, the benefit there is to the insurance companies, because if they can get somebody off of all those devices and then they don't have to pay anymore. Yeah. You just have to create a benefit somewhere else.
Dr. Piotr Witkowski
And then my. My message is, is that we not gonna remove need for devices. The insulin pumps, closed loops, get it getting better. And they helping majority of the patients. And we will treat, still treat the minority of the patients. So we're not replacing eyeless transplantation. We're not replacing the CGMs and pumps yet? No, not. Not at all. We offer this today for all those poor, desperate patients who suffer despite using and they don't have, you know, life, normal life despite using.
Host (likely a diabetes advocate or podcaster)
The pumps help the people who are suffering the most. And hopefully we learn something along the way that allows us to help more people easier.
Dr. Piotr Witkowski
Yeah, definitely.
Host (likely a diabetes advocate or podcaster)
Okay. Because the procedure you have right now, even if everybody was out of the way, you're not able to stand up and say, okay, there's 2 million of you out there with type 1 diabetes. Everybody get in line. We're all done. You know what I mean?
Dr. Piotr Witkowski
Absolutely right. Absolutely not right. This is what we hope for. But no, no, no, no.
Host (likely a diabetes advocate or podcaster)
We're not there.
Dr. Piotr Witkowski
I'm telling you, if we do a transplant, a thousand transplants a year, that would be amazing. I would be happy. Right? Of course it may change, right? Yeah, of course it may change. If suddenly we start doing a thousand and we optimize, we develop new technique of isolation, we figure out many different things. It may, it may scale up. Right. But we don't have it today. I can't promise anyone that we will do, you know, unlimited amount.
Host (likely a diabetes advocate or podcaster)
Definitely not something almost unforeseen at this moment needs to change before you can scale like that. Okay. Oh, yeah, yeah, yeah.
Dr. Piotr Witkowski
So changing the regulation is the first step. And then, and then it will be right environment and framework for people to do stuff. Right. And then we'll see. Because if the stem cells therapy comes soon, right. We're not gonna have time to scale up disease donors. The, let's say vertex cells will replace them. They will be better available, more consistent and available right away.
Host (likely a diabetes advocate or podcaster)
Well, that's very. It's valuable and it's important to me to, to be very just transparent and honest with people because like I said.
Dr. Piotr Witkowski
Oh yeah, yeah.
Host (likely a diabetes advocate or podcaster)
I think it's valid, fantastic that people are sharing their stories. I really enjoy seeing it. But for everyone like me who sees it and says that's amazing, I think that's a great step. But we're not. That doesn't mean that three weeks from now it's over for every person. There's a lot more people out there who see that and just think, oh gosh, look at it. It's all done, you know.
Dr. Piotr Witkowski
No, no, no. If you look even this, you know, we're using take approbart in 10, 12 patients. But it is gonna take years again before Take approve Art is approved for everyone.
Host (likely a diabetes advocate or podcaster)
Right?
Dr. Piotr Witkowski
So. And that's on the other thing happens overnight. It's just the beginning and it's a good beginning, sure enough. And the progress, what, what people, I mean, with disappointment comes that they heard that in five years we're going to do this on that or we going to get somewhere. The progress, it's never linear, right. It's not one line going up. It's just like a step.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
You're trying, trying, trying, and then you take a step up. Right. And. But you don't know when is your next step.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
There is a hope that we, that the steps will be, you know, on a regular basis to get to the heaven in five years. But this is not how it works.
Host (likely a diabetes advocate or podcaster)
It's not how it works.
Dr. Piotr Witkowski
Well, and I can't believe it because, you know, I've been, I've been, I've been here in this country and involved in islets for last 26 years and it's like yesterday. Right. So you, you're saying in five years. But how many. Five years? I already, I haven't seen the progress.
Host (likely a diabetes advocate or podcaster)
Sure. Well, they've been telling people, they've been telling people five years for 50 years.
Dr. Piotr Witkowski
Yeah.
Host (likely a diabetes advocate or podcaster)
Yeah. I always imagine it's because the person working on at that time actually really is hopeful and thinks they see an end to it. I also think they probably want their research funded. So you say positive things while you're doing.
Dr. Piotr Witkowski
Oh, yeah, no, this is another thing that, that people and companies, they, they need funding and they sometimes exaggerate.
Host (likely a diabetes advocate or podcaster)
Right, right.
Dr. Piotr Witkowski
And people are reading this, they really think. And one thing just came to my mind, which is also related, is that when in, in 2000, in the year 2000, when Edmonton Group, they describe seven patients of insulin for one year after eyeless transplant, all of them of insulin, right. This is the moment when expectations were like, oh, come on, this is what you say, oh, we have it.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
Oh, now, now we're gonna roll. Right. In five years, everybody. But then the immunosuppression was not sufficient and they were gradually losing the insulin independence. And, and that's. This is when the disappointment came. Few years later, they were not more anymore. Only, only 7% were on of insulin. Right. So people were saying, oh, no, no, you see, I was no work and stuff.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
But this was all about the expectation. The expectations were huge when it happened and then it didn't meet the expectation and then there was a huge disappointment.
Host (likely a diabetes advocate or podcaster)
And sometimes time just has to pass and different minds have to get set on problems and.
Dr. Piotr Witkowski
Right. But setting the expectations is important. Right. So when we talk to the patients, I'm promising that we will work hard to get them there. I can guarantee that we will get them with every patient because every patient is different and some unexpected thing happened. But I'm promising that we will work hard to. And do everything we can to keep them safe and get them off insulin. But sometimes it's too much for some patients. Right. The amount of adjustment and oversight and going to the labs and this and that and experiencing complications. Sometimes it's too much. And they saying, no, no, no, this is too much for me. So we are warning that this is a commitment on both sides and it would require. And you see, even the first patient from Tego Probad, I Don't know if you've seen my presentation. So the first patient was of insulin. And then she decided this is too much for her. Come to Chicago every three weeks and then she decided to switch to tacrolimus, knowing that it's more toxic. But regardless, traveling to Chicago was too much for her, which she didn't know before.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
And you would think, come on, I mean, you are off insulin, you really want to risk being diabetic anymore. But for her it was too much. It was too.
Host (likely a diabetes advocate or podcaster)
And why could you not do the infusion where she was?
Dr. Piotr Witkowski
Because this is experimental medication. It has to be given here for the safety.
Host (likely a diabetes advocate or podcaster)
Okay.
Dr. Piotr Witkowski
In the future, once it's approved, as we discuss, it can be infused at home. It can be given sub Q definitely in the future, but not yet.
Host (likely a diabetes advocate or podcaster)
Not yet. So almost like when I go get an iron infusion, I go to an infusion center. There are people there getting all different kinds of medications at that point, right? Yeah.
Dr. Piotr Witkowski
And then I don't know about the iron, but we have another medication, Bilatercept, which we're using, which is approved medication. And then patients are getting them either in infusion center, as you said, or at home. The nurses come to patient home, put IV one hour infusion. Done.
Host (likely a diabetes advocate or podcaster)
I see.
Dr. Piotr Witkowski
So we have similar medication, Belatacept, which we, which we use as well outside this trial for our different trial. And it's working as well. But the tacrolimus is given just in the lower dose. So this medication cannot replace tacrolimus. I mean, allows to lower the dose and minimize the side effects. So like halfway what the goprobart is allowing for.
Host (likely a diabetes advocate or podcaster)
Are you looking for trial participants right now or do you have your next group?
Dr. Piotr Witkowski
No, no. So, so we look, we're still looking for patients with kidney dysfunction.
Host (likely a diabetes advocate or podcaster)
How can they get a hold of you?
Dr. Piotr Witkowski
So on our website there is, there is a link to the Eledon Dego Probart study and they can follow the prompts to enroll into the study. There is a questionnaire, they can fill up the questionnaire and there is instruction where to send a questionnaire. My nurses are reviewing every questionnaire and they segregating the patients, those with normal kidney function and kidney dysfunction. And we will be inviting patients with kidney dysfunction one after another until all the spots are filled. But we still have open spots and don't lie.
Host (likely a diabetes advocate or podcaster)
They can tell they're going to check.
Dr. Piotr Witkowski
So I mean, again, it doesn't help because if they lie, they come here and the result is here. So we cannot qualify patients with the results outside the range.
Host (likely a diabetes advocate or podcaster)
What's that web address? Is it actually PWA kowski.org yeah, yeah,
Dr. Piotr Witkowski
this is the website.
Host (likely a diabetes advocate or podcaster)
Okay, I'll put it. I'll put a link in here for you, see if we can get you those people. Yeah, that, that would be awesome. Is there anything that I should have asked you about that I didn't? Anything that you'd like to say that I just didn't get to.
Dr. Piotr Witkowski
It was really comprehensive. It was really good and I appreciate everything you're doing promoting, you know, everything for, for patients with type 1 diabetes.
Host (likely a diabetes advocate or podcaster)
Thank you.
Dr. Piotr Witkowski
And giving us a chance to, to tell patients about. About us. I think again, I'm not our patients, they posting what they feelings. It's not moderated by me. I'm not involved. What they saying, I'm not clarifying. I'm not because I don't think it's yet. So they might be, you know, some misunderstandings and stuff. And at the end of the day, you know, we, you know, we are providing comprehensive information. But the bottom line is it is still anti rejection medication. It's just less toxic than everything else we use before. And the patient tolerated tolerating this much better than everybody before. The outcomes are better than every. Everything before. But it's all preliminary. All preliminary and it's not final. So we're still evaluating this.
Host (likely a diabetes advocate or podcaster)
But a lot of reasons to be excited.
Dr. Piotr Witkowski
Oh yeah, definitely. No, no, we are so we are so excited and especially I want to highlight that we as a scientist, we test new things and then often it doesn't work. Right. So there is a lot of stress and disappointment on patient side and our side. But this time we are just lucky that the stuff which we, the approach which we testing is working better than anything else. So this is, this is extremely rewarding, stimulating and I don't know if you, if you've seen the documentary, the. The Human trial.
Host (likely a diabetes advocate or podcaster)
I know of it. I have not seen it, no.
Dr. Piotr Witkowski
Yeah, I highly recommend it to everyone to watch it. It's a documentary about the patients who participate in the Viacyte stem cells eyelids transplantation trial when the stem cells islets were implanted in the plastic pouch and abdominal wall. But the documentary is made by the director who is also type 1 diabetic. Follow with the camera. Not only medical team, but patients that have home. And it allows us to better understand all these emotions and, and everything related to. To be a participant in the study. Sure. And it didn't work. It didn't work. So the, the documentary shows, you know, the the pain. Right. And disappointment. Although they all highlighting the patients and physicians. Yes, physicians told us it may not work. We knew it may not work work. But they still, you know, sacrifice years of loves, of dry, of emotions and, and, and then. And it shows disappointment. It shows disappointment that it may not be successful.
Host (likely a diabetes advocate or podcaster)
People's kindness supports this a lot. I had a woman on one time, I think, was it Veritex, the one pouch or vioci? Maybe. I'm not sure. I remember. She was in a trial, they couldn't even tell her she was for sure getting actual stem cells. They just, they needed to do. It was a blind. It was double blinded blind. So she still did it to help, which I thought was amazing.
Dr. Piotr Witkowski
In this trial, they were not telling them if there is any C. Peptide, if the eyelids are working. They were not telling them.
Host (likely a diabetes advocate or podcaster)
Yeah.
Dr. Piotr Witkowski
So they were guessing. Right. And seeing those emotions like I feel like eyelids are working. Oh, I feel better. I feel. But the uncertainty is still not allowing them to celebrate.
Host (likely a diabetes advocate or podcaster)
Right.
Dr. Piotr Witkowski
And at the end they learned that there is nothing. Nothing works. This was, this was the hard part. Right. So I'm glad that we can tell patients where they are, what's going on and what they're getting and, and we can share it with others and, and go together along the way. So, so this is you.
Host (likely a diabetes advocate or podcaster)
You threw something against the wall.
Dr. Piotr Witkowski
It's stuck. Yeah.
Host (likely a diabetes advocate or podcaster)
That's awesome.
Dr. Piotr Witkowski
I can give you, I can give you another example. So we've been testing the eyeless transplantation into the. The Cernova pouch, which is a new experimental. And we were not sure if it's. If it's going to work. And patients require surgery, implantation, explantation, several surgeries. So we were aware that this requires a lot of sacrifice. So I was able to convince the funding agency and the sponsors to add additional transplant into the liver if regardless if the eyelids in the pouch doesn't work. So they can get the benefit of participation in the study. But being off insulin with the eyelids in the liver. And this is what happened. The results in the pouch were suboptimal and they all received the islets in the liver and most of them are off insulin. Enjoying living without this after the sacrifice. So this is what we learned from this documentary, right. That we should provide patients more benefit rather than just telling them I'm sorry it didn't work.
Host (likely a diabetes advocate or podcaster)
Yeah, no. Living with diabetes is already a lot of mental and physical stress. You don't need extra, you know, especially in this situation. Well, I, I wanted to thank you too. It was Nice of you to say that the conversation was comprehensive, but I want to mention that listeners of the podcast sent in a lot of questions for you. And I synthesized those questions down into the roadmap that we followed today when we were talking and you were lovely to come on, you did not have these questions ahead of time. You're just sitting there listening and answering. And I thought you did such a wonderful job of outlining what all this is and what it isn't. I definitely feel very good about the direction and moreover that you're in charge of it because your passion and time, it looks like it's really starting to pay off. And I can't thank you enough. You don't know this about me. I don't have diabetes. My daughter will be 22 this summer and she was diagnosed when she was two and she has type one.
Dr. Piotr Witkowski
I'm really sorry.
Host (likely a diabetes advocate or podcaster)
Thank you. I appreciate it. She's doing well, but I really do appreciate it.
Dr. Piotr Witkowski
But no, but yeah, we all know how much, you know, how much work and how challenging, how much harder is life.
Host (likely a diabetes advocate or podcaster)
Basically, it really does reshape your life in a way that you would like for it not to have that. That's for certain.
Dr. Piotr Witkowski
But one more thing, if I can share with you, please. So all the patients, when we telling them now, your diabetes free, you're insulin free, go and enjoy your life, right? So they're happy, right? But the next day they come, they're not happy. I'm like, what's going on? Oh, I have problem with my car. I'm like, so, so this happiness, which I thought, gonna stay forever, right? No, these are regular people who has regular problems and they have just new problems, right? And they're manageable problems. Of course they have perspective. Of course they do. Remember how life was miserable before? Actually, many of them are forgetting. And it's funny when I'm, when I'm observing some of the patients, when they, when they're giving interviews, when they being asked how was the lives, they became like, so distant. They're not getting into details anymore.
Host (likely a diabetes advocate or podcaster)
Doctors like, listen, maybe I'm working too hard here. I don't know.
Dr. Piotr Witkowski
One message is that, that, you know, we, you know, everybody has own problems. Eventually, if it's not diabetes, there are other problems. And then people. What I also learned with people with diabetes, they more resilient after. After that. I mean, after being off insulin, that also, you know, the, the regular life challenges are not, not as stressful for many of them. For some of them, they are.
Host (likely a diabetes advocate or podcaster)
Comes right back. I have to tell you, doctor, I feel like I have the perspective of a 200 year old man. Like, you know, seriously, like, having my daughter being 2 years old and being diagnosed was, Was really. It's something else. And for her too, I, she, she sometimes seems to have the wisdom of somebody three times her age.
Dr. Piotr Witkowski
Yeah. And then I can't even imagine how hard it is, you know, having a child with diabetes. It's challenging for adults, but for children and, you know, childhood teenager, I mean, it must be.
Host (likely a diabetes advocate or podcaster)
Well, I'll say this, this podcast exists because I taught myself how to manage insulin and it turned out that it worked really well for her. And then I realized that I had a way of communicating that information that allowed other people to just hear it and then kind of replicate it for themselves. And this podcast over the last 12 years has close to 22 million downloads.
Dr. Piotr Witkowski
Wow. Congratulations.
Host (likely a diabetes advocate or podcaster)
Yeah, thank you. And I'll tell you right now, the feeling you get when you hear somebody say, you know, my A1Cs and the fives, or I haven't been in love. Oh, it's just wonderful. Right. But at the same time, they do disappear. They stop listening, you know? Cause they go back to their lives. And in the end, what I wanted to share with you about it was, was I've come to think of that as like graduation. And I'm happy when, when they're gone. You know what I mean? So.
Dr. Piotr Witkowski
Yeah, yeah, yeah, yeah.
Host (likely a diabetes advocate or podcaster)
If I was you, I'd be thrilled that they're worried about their car and they're upset about it.
Dr. Piotr Witkowski
Of course, of course, of course. It was just surprise to me. But I'm saying it was surprise, which I. I learned that. Yeah, no, this is. And this is all of us. I mean, when you seek, your sickness is the most important. Once you are healthy, you can just have other problems.
Host (likely a diabetes advocate or podcaster)
Yeah. It's nice that they don't have to worry about anymore who, you know, you can't control what happens next. I will say this. This was fantastic. If the people from Eladon are listening, and I'm sure you are, I would love to interview you too. And if you ever want to come back or you have new news, you are, you're welcome back here anytime. You please just let me know.
Dr. Piotr Witkowski
Thank you very much. I really appreciate.
Host (likely a diabetes advocate or podcaster)
Absolutely.
Dr. Piotr Witkowski
I appreciate it will be opportunity to meet again with something exciting to share.
Host (likely a diabetes advocate or podcaster)
Yeah. Will you be at ada?
Dr. Piotr Witkowski
Yes, I think I was invited to give it the update on the study. Yes.
Host (likely a diabetes advocate or podcaster)
I'm going to find you and say hello. I'll be there.
Dr. Piotr Witkowski
Yeah, let's let's, let's meet.
Host (likely a diabetes advocate or podcaster)
That would be lovely. Lovely. Absolutely. Okay, go ahead. I'm sure you have a thousand things you haven't been doing while you were talking to me.
Dr. Piotr Witkowski
Thank you very much.
Host (likely a diabetes advocate or podcaster)
Take care. Having an easy to use an accurate blood glucose meter is just one click away. Contour next.com juicebox that's right. Today's episode is sponsored by the Contour Next Gen blood glucose meter. I'd like to remind you again about the MiniMed 780G automated insulin delivery system, which of course anticipates, adjusts and corrects every five minutes 24 7. It works around the clock so you can focus on what matters. The Juicebox community knows the importance of using technology to simplify managing diabetes. To learn more more about how you can spend less time and effort managing your diabetes, Visit my link MedtronicDiabetes.com Juicebox okay, well, here we are at the end of the episode. You're still with me. Thank you. I really do appreciate that. What else could you do for me? Why don't you tell a friend about the show or leave a five star review? Maybe you could make sure you're following or subscribed in your your podcast app. Go to YouTube and follow me. Or Instagram TikTok oh gosh, here's one. Make sure you're following the podcast in the private Facebook group as well as the public Facebook page. You don't want to miss please do you not know about the private group? You have to join the private group. As of this recording, it has 74,000 members. They're active, talking about diabetes. Whatever you need to know, there's a conversation happening in there right now and I'm there all the time. Tag me. I'll say hi. When I created the Defining Diabetes series, I pictured a dictionary in my mind to help you understand key terms that shape type 1 diabetes management. Along with Jenny Smith, who of course is an experienced diabetes educator, we break down concepts like basal time and range, insulin on board, and much more. This series must have 70 short episodes in it. We have to take the jargon out of the jargon so that you can focus on what really matters, living confidently and staying healthy. You can't do these things if you don't know what they mean. Go get your diabetes defined juiceboxpodcast.com, go up in the menu and click on series. If you have a podcast and you need a fantastic editor, you want Rob from Wrong Way Recording Listen, truth be told, I'm like 20% smarter when Rob edits me. He takes out all the, like, gaps of time. And when I go and stuff like that, and it just. I don't know, man. Like, I listen back and I'm like, why do I sound smarter? And then I remember because I did one smart thing. I hired rob@worldwayrecording.com.
Host: Scott Benner
Guest: Dr. Piotr Witkowski, University of Chicago
Date: April 6, 2026
This episode features a deep-dive conversation with Dr. Piotr Witkowski, Director of Pancreatic Islet Cell Transplantation at the University of Chicago. Dr. Witkowski discusses the evolution and current state of islet transplantation for people with Type 1 diabetes, focusing especially on challenges in the U.S. regulatory environment, promising clinical trial results with a new immunosuppressive drug, and the path towards broader access. The episode unpacks the scientific, clinical, and personal dimensions of islet cell transplantation as both a reality and a hope for the future.
History & Regulation in the U.S.
Clinical Challenges
Emergence of New Immunosuppressants
Impact for Patients & Scope
Emotional Impact
Teaching and Mentorship
"Regulations which have been applied in the United States—and only the United States—have not really helped the progress in the field."
– Dr. Witkowski [04:43]
"We can offer this procedure to many more patients and then we can do many more studies and enroll patients faster and learn faster and progress the field."
– Dr. Witkowski [08:38]
"Now with take Approbar... all patients do not have those side effects. They have islets transplants successful and reverse diabetes."
– Dr. Witkowski [12:18]
"I do not believe that encapsulation is the solution because they need blood supply."
– Dr. Witkowski [25:45]
"Patients should stay as healthy as possible. When the cure comes one day... I'm not saying five years. It might be much longer."
– Dr. Witkowski [29:06, 29:48]
Host Scott Benner:
"What do you consider a cure? ...What would you be comfortable, not saying 'functional cure'...?"
Dr. Witkowski:
"The ultimate cure is something which can reverse diabetes in a consistent way forever without any side effects."
[30:52]
"HHS should hear from everybody that this is the right thing to do—not only us physicians and experts, from patients, endocrinologists, from everyone."
– Dr. Witkowski [56:36]
"This time we are just lucky the approach we are testing is working better than anything else."
– Dr. Witkowski [67:18]
Dr. Witkowski offers both realism and hope: islet transplantation is not a universal, immediate cure, but marks a crucial step forward for those most vulnerable and for diabetes research as a whole. Progress depends not only on science and medicine but also on regulatory reform, advocacy, and collective action.
To help accelerate access:
This summary offers a roadmap for listeners and non-listeners alike to grasp where we are—and where we're headed—on the path to truly bold advances in diabetes care.