Why is Everyone Talking About Xenotransplantation?

Why is Everyone Talking About Xenotransplantation?

Why is Everyone Talking About Xenotransplantation?

On April 13, CareDx hosted a webinar to explore the future of xenotransplantation. Panelists included Dr. Robert Montgomery, director of NYU Langone Transplant Institute, and chair of the hospital’s Department of Surgery. Dr. Montgomery led the team that did the first human xenotransplant using a pig kidney. He spent 30 years at Johns Hopkins and moved to NYU Langone in 2016. Two years later, he was the recipient of a heart transplant, which gave him a fresh and unique perspective on the transplant journey.

Dr. Montgomery was joined by Michael Curtis, president and head of Research and Development at eGenesis Inc., which is working to scale xenotransplantation to help more patients, and Jim Gleason, National President of Transplant Recipients International Organization (TRIO), which serves as the voice of the transplant patient. Gleason is also a heart transplant recipient who is particularly excited about xenotransplantation because he believes it addresses what he called “the #1 unmet need in transplantation: the organ supply.”

This article is adapted from our webinar conversation, edited only for clarity and length.

Jim Gleason:

As we all are acutely aware, there are a lot of people who aren’t here because they became too sick or died before an organ was available. In fact, about half of the people who are listed for a transplant never make it across the finish line. And that’s what we’re talking about tonight—we’re talking about new opportunities that go beyond what we currently have in terms of organs from other humans.

Both xenotransplantation and perhaps bioartificial organs, which are a bit further away, are renewable sources. I think about them as the solar and the wind of organ supply.

I look forward to a day when there’s no limit to the number of organs that are available to patients and we can begin to transplant some of the 800,000 people who have end-stage renal disease rather than just the lucky few—the 90,000 that actually make it on the list.

And again, remember: only half of those ever get a transplant. I’d like to see us meet the needs of the people on the list but go beyond that and consider xenotransplantation as a very viable source of organ replacement.

Michael Curtis of eGenesis:

We are a company involved in applying modern genetic engineering and molecular biology to creating porcine donors that can address this organ shortage challenge.

I think we have a longer-term goal of can we engineer porcine donors to actually obviate the need or reduce the need for immunosuppression. I think both of those goals are what we’re trying to accomplish: both solving supply issues and reducing immunosuppression.

I come to xenotransplantation as a drug developer. I’ve been in the biotech pharma industry for about 30 years. I’ve been fortunate enough to be involved in taking over 14 products into the clinic. About five drugs that I’ve worked on have been approved to help patients and that’s really the whole point here.

When I looked at the progress in xenotransplantation over the past 10 years, you could see the foundation for a real product. That’s why I joined eGenesis— to turn this idea, this really science fiction idea, into products that can benefit patients.

The hope is that by bringing this experience working with both new products and working with the FDA that we expect to, in the next couple of years, really be prepared to run a formal clinical trial.

For eGenesis, our lead program is for kidney transplant. We have some very encouraging data in monkey models of renal transplant where we now have recipients in the monkey model that are now over 500 days post-transplant, which is incredibly encouraging to us.

We’re preparing to go to the FDA this year to have a discussion with them about what they would need to see to perform the first formal clinical trial. We’re leveraging the pioneering work that Dr. Muhammed Mohiuddin has done at Maryland and that Dr. Jayme Locke has done at UAB with these early pioneering experiments in xenotransplantation. Our goal is to run a formal clinical trial under the review of the FDA.

Dr. Sham Dholakia, Chief Medical Officer at CareDx, Asks Panelists to Share a Brief History of Xenotransplantation

Dr. Robert (Bob) Montgomery:

The concept of xenotransplantation has been around as long. maybe longer, than allo-transplantation or receiving another human organ. It’s faced a lot of challenges. The primary challenges were this response of what we call hyperacute rejection, so if you took an organ from, let’s say, a pig and hook that up to a human by circulating blood through that organ, it would be immediately rejected. The reason why is that there are some sugar molecules that were lost during evolution from pig to human, and we have what are called natural antibodies—a large portion of our circulating antibodies are directed against these sugar molecules because they’re also shared by molecules on the surface of bacteria, so our immune system is primed to fight bacteria, but unfortunately it’s also primed to reject an organ from a pig.

Some of the initial attempts at xenotransplantation were using primate organs because certain groups of primates have also lost those sugar molecules, and so we don’t have that hyperacute response if you use a primate organ in a human. But I think the public perception of using primates as donors is very poor. We all remember, or many of us remember, baby Fae [who lived 21 days after being transplanted with a baboon heart in 1984]. That was a baboon heart that was transplanted and lasted for a while because it didn’t express those sugar molecules. But I think it became clear that because of the scarcity of primates and how close they are to humans and evolution that [primates were] just really not an acceptable alternative.

Dr. Sham Dholakia: Why use Genetically Modified Pigs? 

Pigs—because they have large litters, they’re used as a food source, they’re

relatively easier to genetically modify and they’re less likely to transmit diseases—were chosen. And then there was a concern for a while about a particular retrovirus that is present in the pig genome.

And I think that put a real damper on pig xenotransplantation for a while, even though there’s never been any evidence of transmission into humans, and we’ve lived very closely with pigs for centuries.

And then there was a study to look at all the people—over 200 people who had received cells or skin grafts, islet cells from pigs, and there’s never been an instance of transmission of this disease—but that really slowed things.

So why now is there this sudden flurry? Well, this is often the case with major developments in science and technology. There are people sort of quietly working on these problems, and they often converge at a moment in time where a number of different groups simultaneously make some breakthroughs. So I think that’s why there’s this kind of flurry of activity.

Dr. Sham Dholakia: How Easy is it to Modify a Pig and Genetically Engineer one of the Organs?

Mike Curtis:

It’s a great question and to kind of leverage what Bob was saying: there’s been a lot of evolution and progression in genetic engineering tools to allow us to edit genomes generally. People probably hear about CRISPR-Cas9—it won the Nobel Prize, it’s a huge breakthrough—and our ability to edit genomes. So there’s been several technologies that have allowed us to go into the porcine genome and make edits to address some of the incompatibilities that Bob was talking about like, for instance, when we have these differences in sugar molecules in the porcine donor tissue versus either a nonhuman primate recipient or human recipients that lead to acute rejection. We know what those triggers are so we can go into the genome, we can make changes that really eliminate those sugars.

What Bob and the recent experiments have shown is that by making those changes to the pig genome, we can eliminate hyperacute rejection, which was a huge step—I mean it really can’t be overstated how big a step that was, because if we can’t overcome that, then we have no hope of long-term survival. So now that we’ve overcome that, the pig genome also allows us to make additional modifications. For instance, at eGenesis we make three modifications to improve the consistency or compatibility of the carbohydrates or the sugar molecules. We also add human transgenes to the porcine genome to promote compatibility between the coagulation system or the blood between the recipients and the porcine donors.

The other thing that we do, and Bob talked about this potential retrovirus, is we use CRISPR-Cas9, so this modern engineering tool, to make mutations in the retrovirus to reduce its ability to be transmitted to the recipient. So we reduce the risk of that virus infecting recipients. And the porcine donor is a really ideal donor because it allows us to do all of this engineering.

There’s another technology that we couldn’t do any of this without. If you remember back in the 90s, with the cloning of Dolly the sheep, the way we make porcine donors is a very similar technology. So for us to go from a single cell and then use a cloning technology to make a porcine donor: if we didn’t know how to do that, we wouldn’t be able to make porcine donors. When we think about editing porcine donors to provide sources for organs, it’s this combination of technologies and breakthroughs over the past several decades that have led now to us being able to make porcine donors that eliminate hyperacute rejection, have transgenes that can promote long-term graft survival and give us a chance. We can see this, and when we study this in primates, in transplant, to get long-term graft survival. So when we go into our first clinical trials, we have a reasonable expectation that porcine donors that carry all of these modifications, those organs will last a long time and make a difference for patients. That’s the point. I think all those technologies coming together, as you can imagine, is not trivial and takes a while. But there have been breakthroughs in the past five years that have allowed us to make donors with improved compatibility, by making edits to the porcine genome.

And then the last piece about why pigs as donors is that we obviously know how to make pigs at scale. So we can grow pigs in a way that is pretty unique. From the agriculture industry, we’re making pigs for a long time so we know how to make many of them. The goal here is to produce many organs to help many patients. The pig is almost the ideal species because of the compatibility and the physiology, the ability to edit to improve compatibility and the ability to make them at a reasonable scale.

Dr. Sham Dholakia: With Xenotransplant, Can Organs be Personalized Specifically for the Recipient?

For clarification, is there any human DNA that gets modified in xenotransplant?

When we think at eGenesis about making a donor, most of the folks in the field think the same way. We’re trying to make a universal donor so we’re trying to make a supply of organs that would be suitable for everyone. One of the big questions still in the field is, what are the right types of edits to the genome to get that long-term graft survival. So what is the right combination of taking things out of the porcine genome, putting things into the porcine genome, that’s going to lead to long-term graft survival. We actually don’t know the answer. But we know that what we’re doing now looks promising and has the potential to lead to long-term graft survival.

As far as our edited porcine donor having any impact on the human genome post-transplant, as far as we can tell, we don’t expect any. The biggest thing that we’re focused on, and Bob mentioned this retroviral transmission—is we want to make sure that we produce donors that are clean of any kind of what we call addititious agents, so viruses, bacteria, anything that could come from the donor tissue into the recipient. So we spend a lot of time at eGenesis and a lot of our other colleagues’ space making what we call clean donors. So we produce our porcine donors in really well-controlled clean facilities to keep them free of all of these infectious agents so the recipients don’t receive them. 

Dr. Sham Dholakia: What Barriers and Challenges do You See in Terms of Xenotransplantation?

Dr. Montgomery:

I’d like to speak first of all about sort of more practical barriers, rather than the scientific side. I’m an animal lover. I wanted to be a vet most of my life until my dad got sick with the heart disease that I inherited and then I shifted to taking care of humans.

I think it’s really important to say that the pigs that are being raised for this purpose are treated very humanely. I’ve just been amazed at just how thoughtful the company that I work with and the other companies are about this, and the fact that they provide play and toys and things like that.

For these animals, it’s a really different experience, I think, then, you know, food production, and I think that they’re living their best sort of pig life, if you will, but that’s a really important thing: public perception, transparency, really being very clear about what we’re trying to do here and that we’re doing this in an open way and we’re really considering patients and what can benefit society the most. So those are important barriers, and I think also just getting the attention of the people who make decisions about priorities in healthcare, and you know, the government is a very important part of that, and I think patient advocacy is extremely important.

I mean the reason why we have a treatment for HIV now had everything to do with the early patients who had HIV and how strongly they advocated for a cure.

That’s why the government got together with industry and with investigators and academia and found treatment after treatment for HIV. It was because of those patients making their feelings known and really being tremendous advocates for advances. We need the same thing in xenotransplantation right now.

Dr. Sham Dholakia: What are Some the Technical Aspects of the Barriers?

Mike Curtis:

Whatever products we’re building as a company fit the patients’ needs. The patient voice in the development of what we’re making is super important so when we set goals for durability of survival and what patients are looking for, clearly we’re looking for an organ that you get once and never have to look back. But to get there, we’re going to have to take some baby steps first.

As far as animal modification goes, the field has made a lot of progress in identifying what kind of modifications we need to make to the porcine genome give us long-term survival. So can we turn the porcine donor into a robust durable donor? The verdict is still out regarding how many modifications it will take. Again, I think we’ve had very good results in primate models where I think we’re ready to go to the clinic and ask the question: how do these modified organs perform in transplants in patients? We hope they perform as well, or better, than they have been performing in primates.

But that said, we’re going to learn something from those first clinical experiments that will surely inform what kind of edits we need to make next. So we can keep developing in primates forever, but we need at some point to make that transition into a clinical study to really understand where we are.

With the new technologies, there’s really no limitation to what modifications we can make to the porcine genome, so at some point, we need to be well informed about what those modifications are and what the benefits are going to be for patients receiving these organs.

Dr. Sham Dholakia: As we Think About Patient Advocacy, it’s the Partnership Between Practitioners, Scientists and Patients That Allows Xenotransplant to Move Forward.

Jim, how do you feel about the future of xenotransplant? Do you envision maybe the sickest patients on the list needing xenotransplants? Or maybe the healthiest?

Jim Gleason:

I’m not alone in being very excited. As I approach my next year’s birthday, I’m going to be 80 years old and almost 30 years post-heart transplant. I never thought I would live to see this in my lifetime, to be honest. This is front-page news. [I anticipated] this would be common use maybe seven to ten years from now. In talking with a couple of industry experts since then, they are saying the same thing. Even talking to Mike yesterday, he was actually even more optimistic than I was.

And Bob Montgomery says the same thing, that we’re in the decade where we may see this be a common use. That is very exciting, but at the same time, we need to be patient. Early transplant innovations tend to have a rough history. When you read the history of transplantation, the early pioneers were not well accepted because they had to choose the sickest of patients to use the new technology. And those sickest of patients, while they lived, they didn’t live long. And their own community vilified them for what they were doing—killing patients with their practice. And yet it’s because of those pioneers and those patients who agreed to undergo those initial pioneering practices that we have the results we have today where most organ transplants are getting above 90% survival rates. So as Bob Montgomery exhibits and as the heart transplant down in Maryland does, these are successes. People may say, well, he died: well, we’re all going to die someday. But look what the pioneers have done in giving us hope for the future. In summary, I’m very excited and the people I talked to are equally excited about what’s going on here and I really can’t say enough about the pioneers for making this happen and for CareDx getting this message out so people can see the hope coming forward.

Dr. Sham Dholakia: Patients are Dying on the Waiting List, and Xenotransplantation is Now a Potential Resource.

What is the potential for xenotransplantation to address the organ shortage?

Dr. Montgomery:

People die all along the journey at various time points toward transplantation and unfortunately, a lot of those deaths are not well recorded. Those deaths are sort of silent. As a transplant surgeon, what’s most visible to me and what I see right in front of me are the results of the transplants that I actually do and that my colleagues do. But I challenge my colleagues all the time to think not just about the outcomes of the people that were lucky enough to get a transplant but all the people who didn’t make it to that point and weren’t that fortunate. And I think those lives are just as meaningful and should be just as visible to us as the people who might have died after a transplant. I think that it will be a long time before a pig organ has as good an outcome as a human organ. We’ve been doing human transplantation for a very long time now, and as Jim said, outcomes are extremely good.

It’s going to be hard to reach that level right away. But as Mike said, there are some things that we can do with a pig organ that you just can’t do with human organs in terms of making them more compatible and having them available when you need them, not just when you happen to be lucky enough to be at the top of the list. In providing a transplant earlier in the disease process, you are more likely to have a successful transplant than when you’re really ill.

The organs will be used, probably the pig organs in folks who are less likely to receive a human donor transplant. But then as we get better and better at xenotransplantation, I would see it as an option for any patient. For instance, if you’re a young person and you have end-stage kidney disease, you’re probably going to need several transplants throughout your life. I could see people going back and forth between pig organs and human organs, maybe receiving a human organ early on that is more likely to last longer and then maybe as they get older and are more likely to die from something else, maybe it would be more appropriate a time for a pig organ.

Dr. Sham Dholakia: Where do You see the Future, Especially in Terms of Timelines?

Mike Curtis:

Riffing off Bob’s point about giving options to patients who currently don’t have options, I think that’s where we’re going to start and see how successful we are there. Clearly there’s a tremendous amount of unmet need in patients who will never receive an allotransplant offer. And is the xeno product suitable out of the gate and does it produce a good enough outcome that patients would spend their time on it? That’s our goal in the first trial—at least one-year post-transplant function of the kidney in the kidney program (those [benchmarks] are different in heart and liver).

I think if we can achieve that goal in our first trial, that is a transformational moment in transplant. When you have this kind of option, how will you use it? It won’t be, don’t do allotransplant. No, of course, we will still do allo because it has the best outcomes and that’s still the best option for patients. But how do you get patients to that allotransplant? Right now, kidney patients spend lots of time on dialysis. Could we have a porcine organ that would allow patients not to go on dialysis or that they could spend time on a xenotransplantation while they’re waiting for an allotransplantation? That alone could significantly improve outcomes for patients.

When you bring this product to the field, it’s almost like you don’t exactly know how it’s going to be used because physicians and surgeons have never had this option. Maybe you don’t need a year, maybe six months is sufficient to get you to an allo depending on where you are. So the future is creating this option where it can be a complete transformation of how we think about solid organ transplant—having an option for patients that currently don’t have one.

Dr. Sham Dholakia: What Would You Like to See and What Does the Future Mean to You in Terms of Xenotransplantation?

Jim Gleason:

I would say the word is hope. Today we have over 110,000 candidates for organ transplant currently on the waitlist. Xenotransplantation would be a major game-changer with the potential to drastically reduce that list and save so many lives. The limitation today is the availability of organs. Being able to grow organs through pigs is such a game-changer and brings hope to so many people.

It’s tough waiting on the list, and if you’re a kidney candidate you’re talking maybe five, six, seven years of waiting. This would totally change the field and that’s where the big hope comes in.

Dr. Sham Dholakia: Now on to Audience Questions: Each Speaker has 30 Seconds to get Through as Many Questions as Possible.

Is this something that you think is going to be requested, or is it going to be only for a subset of patients? Will xenotransplant become the mainstream or will it always be potentially for that subset?

Dr. Montgomery:

That’s going to be a moving target. I think in the beginning it’s going to be for subsets; as we get better and better at it, it may be the choice.

Mike Curtis:

I completely agree. We’re going to start in the subset and if we have good success, it will broaden out.

If you can genetically modify the organ to make it more resilient and sustainable, is it possible that xenotransplants could last longer than human transplants?

Mike Curtis:

In theory, it’s possible, I mean the age of a pig depending on when you receive your transplant right we’re talking 15 to 20 years potentially of a porcine organ, which I think is putting us at the long end of allotransplantation. I think we would all agree if we’re at 15 to 20 years post-xenotransplantation, we’re doing pretty well. The other advantage of xeno over allo is the potential to get a second organ because supply again is unlimited, and the genetics are consistent, so you’ll receive a very similar kidney if you receive a second kidney. Your body will already be used to the first kidney.

The patient that had the first heart xenotransplant received a different type of immunosuppression. Do you feel that patients that have xenotransplants will require different medications from those with human transplants?

Dr. Montgomery:

Apropos to the last question and this one, there are groups that are looking at ways of either modifying the genome of the pig or transplanting thymus or cells from the pig to induce tolerance. The hope is maybe we can do things with a pig organ that we can’t do with human organs in terms of modification that would allow us to reduce immunosuppression. But in the beginning, it’s probably going to require more immunosuppression. And yes, you’re right that the recipient of the heart transplant had some additional drugs that you’re probably not familiar with.

A follow-up question to that: is there a chance that xenotransplants increase your risk of rejection compared to a living donor or a deceased donor human transplant?

Based on what we know now, yes, it’s likely that the first-generation xenotransplants will not be tolerated as well as the current allos are so you would probably—if the primate models are predictive—we would expect rejection sooner than you would with a well-matched allo. We don’t know as we go into the first clinical trial just what’s the delta—how quickly will these xenografts be rejected? The hope is they won’t be rejected at all, but the data says they probably will be. The question is how long post-transplant. Knowing what happens in recipients in the first year or so post-transplant is super helpful in figuring out what to do next, as far as engineering, which is why there’s an iterative process here that we’re in the beginning of.

What can parents do to help advocate in kickstarting this movement and moving the science along?

Jim Gleason:

First, get the education that we’re hearing with these webinars so they can be the spokesperson for this technology, which is coming to life, by being educated about the potential by listening to surgeons like Bob and researchers like Mike. This is where you find out what’s really going on and can affect how people react to this concept.

With your hat on as a patient, how would you want patients to advocate for this going forward?

Dr. Montgomery:

As I mentioned earlier, the HIV story is a really good template. Patient groups should look at how HIV patients really affected change. There’s the government, there are the insurers, there are the various branches, you know the NIH, Medicare, CMS—these are the stakeholders. These are the groups that need to be approached, but they need to be approached not as a one-off, one patient at a time, but through advocacy groups. So it’s pulling together, it’s banding together it’s making your desires and your thoughts and your hopes known to the key people. It could be done through TRIO and others. Maybe we need the help of a company like CareDx.

Dr. Sham Dholakia:

Well, we would love to help all the organizations in any way that we can. If there’s anything we can do, we will definitely do that.

Dr. Montgomery:

You know the technology that brought us vaccines and different drugs for the pandemic, it was a top-down thing that came from the President. Xenotransplantation advocacy needs to go in the other direction, it needs to come from the patients and from the researchers and go upward.

What are your thoughts on stem cells to grow organs using scaffolds? Where is the overlap with xenotransplant? Are they competing or is there room for both technologies?

Mike Curtis:

Those are much earlier technologies. When you look at the complexity of a kidney, for instance, and the different cell types inside a kidney, repopulating a scaffold will get you to a certain level of function, but it is really hard currently to recapitulate or reproduce what you see in a kidney that was developed inside a full porcine donor or a human. Similar to the breakthroughs that we’ve been talking about that in the world of xeno, I think the world of repopulating scaffolds needs a few of those similar kinds of transformational breakthroughs to make it a reality. And I think for each organ type, it may have a different probability of success. I think there’s something there, I think it’s definitely worth pursuing, but I think it’s quite a ways off.

How long does it take to modify an organ and how quickly do you see this being able to scale?  What volume could you reach three to five years from now?

Mike Curtis:

Our goal now is from an engineering perspective, the first donors that we are currently studying and have taken to the clinic—it took us about three years to make one donor. We have newer engineering technology that continues to evolve constantly. We can make a new set of genes, we can make a new porcine donor in a matter of about three to four months. In the next five years, if we have good clinical data, we can be talking about producing several thousand donors a year.

That’s the idea, and you look at the unmet need and you say, well, that’s still not enough and it’s not. But if we have some success, investments would be made to start to scale it even more significantly, and the challenge for us as a company is we need to show that the technology is beneficial to patients. If we can do that, then the investments will come.

Is the importance of HLA match or tissue or blood match the same in xeno and allotransplant?

Dr. Montgomery:

It does seem to be different. The targets of the antibodies that we see between humans and pigs are different, and many of them are unknown, whereas a human-to-human is primarily the HLA locus. We know more about that. There are probably more targets between a human and a pig than two humans. But there are things you can do, for instance, the pigs that we used in our first transplant are all blood type O, so you can do things that make them more compatible, so you don’t have to worry about blood type incompatibilities.

When do you think the next clinical trial for patients will be available for enrollment?

Dr. Montgomery:

One to two years.

Mike Curtis:

We have a plan to go to trial in the next two years. if things continue to go well for us, if we have a good interaction with the FDA, if our data continues to look good, we expect to start a trial in the next two years.

Dr. Montgomery:

Remember those initial trials are going to be small. We’re talking about a handful of people.

You’ve done a heart, you’ve done a kidney. Are there plans to do a liver? Is there a plan to do a lung? Where does it stop and will there be one organ that will take precedence over another?

Mike Curtis:

It gets challenging. A lung is more challenging than a heart, which is more challenging than a kidney. The way we do it ranked at eGenesis is kidneys are priority; heart is second; pancreatic islet for type 1 diabetes, and then we have what we call an ex vivo liver perfusion because liver is also very challenging to get compatibility between porcine donors and humans. Those are the four major organ types that we are working with, and they all pose slightly different challenges.

Dr. Montgomery:

Lungs and livers have unique issues that haven’t been overcome, but you could imagine that in these organs that might not last as long, that they could be used as a bridge, because in the case of the liver, there’s really not a good replacement. There’s no dialysis equivalent that is broadly available for people with liver disease, so maybe if the organ only worked for several weeks, that might be long enough to bridge somebody to a human liver.

Could you use xeno for islet transplant?

Mike Curtis:

It’s already been done at some level. A group has already done wild type porcine islets with some success. We have an islet program where we’re using engineered islets to treat patients with type 1 diabetes, so it’s in the mix.

What will we see in xenotransplant over the rest of 2022 and going into next year?

Mike Curtis:

I think there is interest in more compassionate use studies. What the Maryland team showed was the potential benefit. That was a very transformational study for the field that could have potentially been very helpful to Mr. Bennett [David Bennett received a pig heart on Jan. 7, 2022, at the University of Maryland Medical Center; he died on March 8, 2022.]. I would expect that we might see some more of those types of experiments, small single one-offs, before the first real trial starts.

Dr. Montgomery:

It’s hard to know if the regulators have more of an appetite for those one-offs. I think they seem to be very focused on the Phase 1 trials. Now is the time for us to roll up our sleeves and get the work done and for the advocacy work to get the attention of the stakeholders so we are sure that this is going to move along and move at the rate that we want it to.

Jim Gleason:

There are so many patients that are not able to get a transplant today, by age, by any number of factors, so as a last resort, I think you’ve got a lot of patients who would be ready to stand up and take on this challenge. One patient once told me as their lung transplant was failing, even for one more day, I would do this all over again. And so that community of desperate people is going to grab onto this as big hope. And I hope that each one of you will contribute to the long-term success that we’re going to see in the years to come, and I am so excited to hear both Bob and Mike predict trials in the next one or two years. That’s fantastic and then common use sometime shortly thereafter. We’ve got to be patient, but at the same time, you can’t help but be excited.

Dr. Sham Dholakia: Jim, You Close This Webinar so Eloquently.

I can’t really follow that: hope and courage—what a great way to end this webinar.


Disclaimers: This article addresses topics that are still under research and/or in investigational studies and is for informational purposes only. Dr. Montgomery was compensated for his time.

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