Ep. 67: PRP, Cell Therapies and Commercial Cell Banking with Drew Taylor of Acorn Biolabs
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Regenerative cell therapy may one day help us all grow our own replacement parts. People with heart failure could get a transplant for an entirely new heart, made out of their own cells. Burn victims, or people who just want wrinkle-free skin, could grow new sheets of the stuff — from their own tissues. Younger cells may provide better raw material for these therapies than older versions, and so a commercial cell banking industry has sprung up to provide the required cryogenic storage for about the price of a Netflix subscription. But is it worth it? To help listeners decide, Medcan Director of Genetics Allison Hazell interviews Drew Taylor of Acorn Biolabs, a Toronto commercial cell banking start-up, with a dissenting opinion from Aaron Levine of the International Society for Cell & Gene Therapy.
LINKS
Visit the Acorn Biolabs website to learn more about regenerative cell therapies and commercial cell banking.
Hazell and Taylor discussed platelet-rich plasma (PRP) and other regenerative therapies for sports injury. A good explainer on PRP. An Acorn Biolabs blog post on PRP and future therapies for sports injuries. A Mayo Clinic primer on stem cell-based therapies.
Learn more about Tel Aviv University 3-D printing that human heart.
Find Acorn Biolabs CEO Drew Taylor on Twitter and LinkedIn.
Here’s a good profile of Drew Taylor. Plus a good synopsis of Taylor’s baseball career.
In this episode, Hazell mentions the International Society for Cell & Gene Therapy’s Statement of Concern speculative commercial cell banking services. Here’s the statement in full.
The ISCT rep who gave the dissenting opinion is Aaron Levine. He’s an associate professor at Georgia Tech. Learn more about his career. Follow him on Twitter.
Want to learn more about your genetic background and gain insight about future disease risk? Allison Hazell’s Medcan Genetics team has many different services for you.
INSIGHTS
Revolution is right around the corner Regenerative cell therapy and commercial cell banking services are growing more popular, but they’re based on technology that’s been around for decades. So why now? According to Taylor, more than 1,000 clinical trials are happening in the field of cell and gene-based therapies. The Acorn Biolabs founder likes to compare it to the Wright brothers. They successfully flew the first powered aircraft in 1903. An aeronautics industry and commercial flight took decades longer to develop. Stem cell science is undergoing a similar curve. [Time code: 7:10]
PRP and 3D printing of human replacement parts Currently, a goal of regenerative cell technology is to concentrate the growth factors and nutrients in platelet-rich plasma (PRP) and put it at the site of an injury. The idea is that this will enhance the inflammatory response in the surrounding cells and encourage healing. It’s used in soft-tissue sports injuries as well as skin-rejuvenation in dermatology. Another potential use for commercial cell banking is the 3D printing of replacement parts for the human body. For example, at Tel Aviv University, they took a biopsy of skin cells, multiplied them and were able to 3D-print a miniature human heart. “It was a major milestone,” Taylor says. [Time code: 9:30]
Taylor’s argument that young cells are better for cell therapies “We need to be thinking about strategies that we could deploy to allow people to actually secure a better cell population to use as a starting material,” Taylor says of his work at Acorn Biolabs. In the past, what he’s found is that adults who are in pain will start looking at regenerative cell therapy. The problem? At that point, the cells and tissues in that area already are in a diseased state. What Taylor wants to help people do is get ahead of these problems by collecting younger, healthy cell samples and storing them for potential further use. “We really need to be thinking about this in advance,” Taylor says. “To be thinking about strategies we [can] do to allow people to secure a better cell population to use as a starting material.” [Time code: 13:55]
Counterpoint Aaron Levine is an associate professor at Georgia Tech and a member of the International Society for Cell & Gene Therapy, where he was a Vice Chair on the Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies. The taskforce concluded that “these companies — that will take your cells and freeze them today for potential use sometime in the future — are too far ahead of the science.” Basically, in Levine’s view, the science is not yet there to justify cell storage. “These companies may be over promising to their customers,” Levine says. “The reality is that the vast majority of these cells will remain frozen indefinitely and never used clinically.” [Time code: 23:15]
Critical thinking Taylor disagrees with Levine's point that cell banking is speculative — he argues that the science is there and will continue to advance. Not all cell-banking services are created equal, Taylor says. Levine’s investigation also was completed before Acorn Biolabs was founded. “There is a massive difference between companies that offer cell-banking services,” Taylor says, adding that it’s likely that certain organizations probably are over-promising. “Personally, I would be mortified to be grouped in with some of them.” [Time code: 26:47]
Practical applications Although you can never make guarantees in science, regenerative cell therapy is already showing real-world results, Taylor says. This type of therapy could help heal athletic injuries, or be used as an aesthetic skincare treatment. But there are bigger potential uses, too. For example, he says, in Canada 24 patients have had keratinocyte and fibroblast cells harvested and leveraged to create sheets of skin, which were then used to treat severe burns. There are also about a dozen people in North Carolina who have had 3D bladders created using their own cells and implanted in their bodies. “We’re already seeing cells being leveraged in some of these therapeutics,” Taylor says. “So I’d push back a little bit” on Levine’s points. [Time code: 27:40]
Drew Taylor, CEO, Acorn Biolabs
PRP, Cell Therapies and Commercial Cell Banking with Drew Taylor of Acorn Biolabs Web Transcript
Christopher Shulgan: Hello, I’m Christopher Shulgan and I’m the executive producer of Eat Move Think. We have a fascinating look at a fast-evolving field of human wellness today. We’re exploring the potential of something called regenerative cell therapies, a part of the biotech industry that may one day take cells from your own body and use them to grow replacement parts.
Christopher Shulgan: So someone with heart failure could get a transplant for an entirely new organ. Have a sports injury requiring a new knee? Rather than surgically implanting one that’s made out of titanium, you may one day be able to have one that’s made from your own tissues. Another use? Lab-grown skin for burn victims, or even plastic surgery.
Christopher Shulgan: Here’s the thing: Younger cells may provide better raw material for these therapies than older versions, and so a commercial cell-banking industry has sprung up to provide the required cryogenic storage for about the price of a Netflix subscription. But is it worth it?
Christopher Shulgan: To help listeners decide, this episode features, as guest host, Allison Hazell, Medcan Director of Genetics. A certified genetic counsellor, Hazell earned her master’s degree in Human Genetics from Sarah Lawrence College in New York. She’s also a co-investigator on the Personal Genome Project Canada, and a past president of the Canadian Association of Genetic Counsellors (CAGC).
Christopher Shulgan: In this episode, Hazell interviews Drew Taylor, the CEO of Acorn Biolabs, a Toronto commercial cell-banking start-up. Taylor has his PhD from the University of Toronto in Biomedical Engineering. He also played professional minor league baseball as a pitcher in the Blue Jays organization until he experienced a shoulder injury — the type of thing that this technology may one day be able to help.
Christopher Shulgan: Finally, this episode also features comments from Aaron Levine of the International Society for Cell & Gene Therapy to provide an objective look at the potential of commercial cell banking.
Christopher Shulgan: One last word before we get to the interview. We connected with Drew Taylor at Acorn Biolabs during a busy work day, which explains the background of dripping water and fans that you can hear in Taylor’s audio — that’s the sound of the biotech future, happening today.
Allison Hazell: Hi, I'm Allison Hazell, Medcan’s Director of Genetics. And my guest today is Drew Taylor, the CEO of Toronto's Acorn Biolabs. Drew, thanks so much for joining us.
Drew Taylor: No, thank you so much — excited to be here.
Allison Hazell: So let's start by talking a little bit about you and your story, because I think the listeners will learn that it's all connected. So your dad was a team doctor for the Blue Jays and you played baseball yourself. How did all that kind of point you in the direction of becoming a CEO in the biotech industry?
Drew Taylor: I grew up around both baseball and medicine. So my father played Major League Baseball for 11 seasons. He played mostly during the ‘60s — he actually was on the 1969 Miracle Mets and the ‘64 Cardinals, both World Champion teams. But I would say my father was definitely much more apt to talk to me about his career in medicine. And, you know, I really wanted to follow my father in pretty much every one of his footsteps. So I ended up playing baseball, competed at a pretty high level here in Ontario and was a prospect. I decided to go to university because I wanted to pursue both education and athletics, and I had the chance to play for the Michigan Wolverines. I ended up being a team captain there my last year, and we won a Big 10 championship that year. It was a fantastic experience, and I was also really focused on education. So after four years in Michigan, I ended up being able to have both my undergrad and master's work done, and was ready to head off to medical school in Michigan. And I was given the opportunity to sign with the Toronto Blue Jays and give a hand at professional baseball. So I ended up saying, “Look, I will defer my acceptance to med school and I'll give a shot at baseball.” And what I decided to do, to not lose momentum towards my education, I very quickly applied to PhD programs. And so I ended up starting a PhD in the offseasons in biomedical engineering at University of Toronto. And that's where I really was exposed to the world of regenerative medicine, and all of these next generation healthcare applications of leveraging our own cells to try to fight off disease.
Allison Hazell: You stopped playing baseball seriously because of a sports injury. Is that right?
Drew Taylor: That is true.
Allison Hazell: So is that somehow related to sort of what you ended up doing? Do you think you would have founded Acorn either way?
Drew Taylor: Yeah, I think probably either way. Although, it is interesting — I ended up having a tear in my labrum as well as my supraspinatus, one of the rotator cuff muscles. I tried to rehab back from that. I ended up playing for another couple of years after the injury, but was never at the same level as what I was before. I definitely lost a few ticks on the fastball. And it was through that process and thinking about some of these therapies and ideas at the time, right? They were not being applied yet, and that really piqued my interest, because many of these were focused on soft-tissue sports injury. So there's actually a group in Canada developing a therapy for soft-tissue sports injuries, leveraging samples of skin cells specifically from the hair follicle, but we'll probably get into all that. And so it was really an example of me kind of, unfortunately, getting injured before some really exciting therapies I feel, down the road, are coming to fruition.
Allison Hazell: There's a saying in technology that the future is already here, it's just unevenly distributed. I think that that definitely applies to the regenerative medicine space. Can you tell us sort of some of the things that are happening today in this world, like what's kind of currently going on?
Drew Taylor: So, yeah, I would say that's true to an extent. We have very strong indications that revolutionary therapies and treatments are possible and around the corner. But the fact is these therapies are strictly regulated and tested extensively before reaching mainstream medicine. That being said, there are groups that, in an attempt to bypass regulatory bodies, do operate outside of countries that do have fully formed regulatory bodies like Canada, the U.S. and others. And by doing so, they avoid the jurisdictions and the oversight of some of these regulatory bodies. A lot of people refer to this as medical tourism. And unfortunately, I think the patients that are choosing to engage with those companies in those therapies are really treading a very fine line between risk and reward. And I do sympathize with them. Some of them are really doing this because they are honestly at their wit's end; they've tried everything that’s available to them. And ultimately, they're searching for a possible solution when faced with a really debilitating or life threatening disease, and they're turning to stem cells. And unfortunately, stem cells do take a while. You know, the patience that patients have to exude is difficult. We’ve known about stem cells for decades, and really only now are we seeing some of these trials explode in numbers, right? There's over 1,000 clinical trials using cell- and gene-based therapies going on around the world right now. That’s an astronomical number. You go back 10 years and it's double digits, maybe. So this is a huge explosion in possibilities that we're seeing. But a lot of people ask the questions, “Why is this available now? We heard decades ago about the word stem cells.” And I try to use an example of the Wright brothers when they invented flight. So the first flight happened in 1906, right in about 100 feet, I believe something maybe 100 meters — 100 feet probably, it happened in the US. So it wasn't actually useful, really. And it would be decades and additional tools in flight that would have to be developed before a commercial plane actually crossed the Atlantic carrying passengers that benefited people. Stem cells are the same thing, right? We may have identified them, and started to characterize them and understood things, like those first moments of flight. But ultimately, to actually see them in real-world applications where they're able to help people, that does take a long time — in fact, decades — to fully come to fruition.
Allison Hazell: So two questions related to that. You said that these things are “around the corner.” In your mind, what is around the corner? Is around the corner a couple of years, is around the corner five years or 10 years?
Drew Taylor: Yeah well, look, cell- and gene-based therapies is a very wide topic, right? In a number of different applications, right? So we have all sorts of different therapies that we can consider timelines around. And we do have ways of trying to predict those things as far as how long they're going to take to develop, because we've seen drugs being developed and other therapeutics, right? Not necessarily cell-based, but others, you know, that have taken — a good ballpark is nine years from the point we start to test something out to see whether it actually makes it into mainstream medicine. These things do take time.
Allison Hazell: Can you give some examples on where you are seeing — just so the listeners have a good sense of PRP, for example, what it's used for now?
Drew Taylor: Yeah, so it's actually used fairly broadly. Ultimately, the idea of PRP is to try to concentrate the growth factors and nutrients that you have in your blood, your blood plasma and the platelets cells themselves that are releasing some of these cytokines and inflammatory response proteins; concentrate that down and put it into a site of injury so that you enhance the inflammatory response to actually target that area with your own body's cells that can heal — like the white blood cells and the various cell types there — as well as provide an influx of growth factors and nutrients that body naturally has and produces. So that it is in that area where you're trying to have that healing happen. So this can happen with soft-tissue sports injuries. It’s actually used extensively for aesthetic things — for skin rejuvenation and things like that. So those are the main two areas that we see it, sports injury and then also in aesthetics. So there's a low complexity things like that. And there's extremely high complexity things, like taking a sample of your cells, and multiplying those cells, turning them into cardiomyocytes, putting them into a bio printer and actually 3D-printing a human heart — which has been done, by the way. So this has been done. We have taken a biopsy of skin cells — and when I say we, I mean the greater scientific community — this actually happened at Tel Aviv University. They took a biopsy of skin cells, multiplied those cells out using a process of creating very potent stem cells — which we can we can talk about if we have time, it’s an amazing, revolutionary tool that we have now — and then turned them into cardiomyocytes and 3D-printed a miniature human heart, about the size of a rabbit's heart. But this is a fully functional heart. It can beat, right? Blood flow can be supplied. And it's a major milestone towards us being able to one day think about the extremely complex scenario of where an individual needs a heart transplant and we are 3D-printing them a heart on demand.
Allison Hazell: Using their own cells?
Drew Taylor: From using their own cells, like in this example. There are 24 patients in Canada right now that have skin that was 3D-printed from a sample of their cells and put back on to treat severe burns. Even more patients that have received skin cells taken from them and put into diabetic foot ulcers and wounds that are not healing properly to try and site that healing. So there are there are examples of this being used today, where it's a very low complexity where you're taking the cell type that you're trying to use, we're trying to refine to get the adult progenitor cells that are present in that population, the adult stem cells, and then applying them to that area to enhance healing and provide benefit. And then you have, you know, the very complex scenarios that I do believe are probably a decade or more away, like 3D-printing human heart and actually implanting that into a human. That being said, personally, I believe that both you and I will see that in our lifetimes.
Allison Hazell: Super interesting. Maybe we can pivot just a little bit to talk about Acorn Biolabs, specifically, and what you're doing there and how it fits into this whole landscape?
Drew Taylor: Yeah, no, absolutely. So I really had the first idea of what Acorn does, right, as a service, when I was at Mount Sinai. And my role in that group was actually translating some very successful animal studies that were done in regrowing cartilage into applying those same techniques and practice with human cells. So actually going into the OR and using biopsies of patients’ cells, taking them back to the lab and attempting to practice to grow out these cartilage constructs and create hyaline cartilage, in practice, so that one day that could be used, instead of what we do now for plastic surgery, which is replace the joint service with metals and plastics. It's a very successful surgery, the patient satisfaction is extremely high. But there's a timeline associated with it — especially if you have this done at a younger age, you're going to be coming in for another surgery and another surgery, and it gets harder and harder each time because of loss of bone and the aging process, in general, and the cells around it. So you end up, unfortunately, probably in a wheelchair. So if you could actually replace your own tissues with new healthy tissue that can respond to sheer forces and stresses, can heal itself, then that could be a lifelong solution for these patients. And so that was really the long-term endeavor of this group that I was working with. It was a fantastic project. And unfortunately, when we translated it into human models, what I learned very quickly was that it wasn't working very well, to put it short. There were definitely some challenges in human cells we weren’t seeing in the animal cells. And the animal cells were — all those studies were actually done in younger animals. So we were actually getting bovine cells from a veal slaughterhouse. And so you have these young adolescent animals that are in the prime of growth and development, and of course, those cells, when we go to experiment with them, are still in that state. In the human example, we were going in at the point of surgery, the point of need where a patient is actually seeking out a hip or a knee replacement, because they no longer have the ability to ambulate without pain, or walk without pain. And so now we're taking cells at their absolute worst, when they have disease, when there's been wear and tear over that patient's lifetime, and asking them now in culture to perform at their best. So age and the onset of disease — how far progressed in the disease state, in this case, mostly osteoarthritis — really influenced our ability to get the most out of those cells and culture and actually be able to create those tissues. So there's this unfortunate limiting factor that is present. And when you think about the future, what I was thinking about at that time in my career was, well, this is a tragedy that's unfolding. We are treating patients when they need something. And they're coming in at the point of pain when their cells and the tissues are not performing properly. Then we're going to take samples from those tissues that already aren't performing properly and try to recreate them? We really needed to be thinking about this in advance because I foresaw a future of us going to patients saying, “Yes, there is an amazing cell therapy that is being used right now to fix your very problem. But unfortunately, you're either too old or your cells are too degenerated for you to be a potential candidate. So I'm sorry.” And that that just wasn't acceptable. And so we needed to be thinking about strategies that we could do and deploy, to allow people to actually secure a better cell population to use as a starting material. And really, that was getting ahead of two things: one aging, and two, the onset of disease. And ultimately, we only get worse as we get older. So the best possible time point to do that for anybody right now is the immediacy to get this done.
Allison Hazell: Interesting. Working in the genetics field, we often will field questions from people about commercial cell banking from sort of the umbilical cord area. And I know, Acorn is using hair follicle cells. Can you kind of give us a bit more detail about how that is similar or different to the type of banking that people are generally familiar with?
Drew Taylor: Yes, absolutely. So at that point in time when I was at Mount Sinai, not to date myself, but it was a little bit earlier than I think the tools had matured to the level where we could actually see our own ability to change cells fate and to leverage cells appropriately. And there's two big discoveries, these two tools that were created. The first one was called iPSCs: induced pluripotent stem cells. And so this is the ability to take an adult cell and draw it all the way back into behaving like that magic moment when sperm meets egg and that cell can become anything, like an embryonic stem cell. That cell has the potential to become any cell type in the body. And so now we can take an adult somatic cell, like a skin cell, and turn it into a pluripotent stem cell that can become anything — take a skin cell, turn it into a cardiomyocyte, take a skin cell turn into a liver cell, kidney cell, you name it. So that is extremely powerful. And it solves two huge problems, right? Cell source, so identifying the sorts of cells that we can have, and then enough of it, because those cells when you actually reprogram them, they can create as many of them as possible, right? So they're immortalized. And so those two issues are huge. When you think about taking a small sample of skin and say, now we need to go create a billion liver cells to recreate someone's liver, that is now possible. So theoretically, we now have the tool to do that. It was discovered in 2008, published in 2009, extensively. The Nobel Prize was awarded for it in 2012. It's the fastest turnaround time of awarding a Nobel Prize in all of history, for very good reason. It has completely changed the game and what we're able to do as scientists with cells. The second one was CRISPR, and so, obviously, that one's actually achieved a fair bit of mainstream news attention — partly because of the competition and the race to try to patent it, and also just the magnitude of this discovery. It really is cut and paste for the human genome. We're able to use this tool to actually go and take a look at a code that may be performing improperly, and actually cut that out and replace it with properly functioning genetic code, thereby eliminating the development of that improper code into a disease. So an amazing tool as well. And these two things combined, right — the ability to kind of edit in and out genes and potentially eliminate disease, as well as creating the number of cells we need and the type of cells that we need — really give us the theoretical tools to treat any disease. And now we're in a period of time where we are, as scientists and doctors around the world in respective areas of expertise, applying those tools into those areas to develop strategies to fight disease. So it is a really exciting time, because we have the ability right now to take a hair follicle — which is an amazing, amazing source of cells and why we target it in the laboratory — and create a population of immortalized konio cells to create cardiomyocytes, liver cells, you name it. The hair follicle also has some really amazing advantages. One, it has multiple cell types in it, right? So it's not just a skin cell, right? You have ended up with very specific keratinocytes, or the active dermal layer, you have mesenchymal cells from the fibroblasts, you have a high population of adult progenitor cells and you've got these amazing cells that are being characterized as half cells — and they have amazing ability and culture to be multipotent on top of the mesenchymal stem cells that are present in the population. So you really are in this amazing mini organelle that is non-invasive collected, right? We've all plucked a wild eyebrow or something, right? It's not too bad. You can access this plethora of cell types that can be both used directly, like we were talking about with skin therapies, or reprogrammed and used in other ways. Or you can actually select for some of the smaller cell populations that are present with the adult stem cell populations and the mesenchymal stem cells to use in other areas, right? Like, we obviously see a lot of mesenchymal stem cell therapies emerging around sports medicine, sports injury and soft tissues. So, really is this power, a mini organelle of potential. The umbilical cord industry has been around for a long time, and there are some absolute uses of those cells. If your child develops leukemia at a young age, it is certainly very useful. And to be clear, I did this before founding Acorn, but my wife and I have three kids here, and all three have cryogenic reserves with their core blood. But I'm also really excited to say all three have had their Acorn cells taken as well and preserved. So I do believe that there are uses for umbilical cord. I do think that some of the limitations around those strategies have been in the cell number. And so while I believe in it, I think that there are limitations in its use, just because they don't expand and you can't create a higher cell number. And so it's really targeting some of the things that come up in childhood, which was more than enough for me to say, I think this is of value, right? And look, it is a small percentage chance of you leveraging those cells, if you look at the metrics that are out there, but I think that there's the potential for that to change over time. Right now, it's a pretty small percentage chance that you're going to leverage them. But let’s say one of those things that they are used for does come up in your child, you're gonna be extremely grateful that you paid the money to do it. It also is fairly expensive compared to thinking about what we do, right? So there's an economic barrier there as well.
Allison Hazell: The idea of using something accessible is sort of a game changer, it makes it available to a much bigger part of the population versus that very limited specific-use case.
Drew Taylor: With Acorn, we're very similar to a Netflix subscription, right? As far as access. So it's interesting from an accessibility standpoint as well, especially being in Canada, where we look at these things as, as a right. It's a right, not a privilege. And so we tried to make it as accessible as possible. And that's definitely part of how we've created the product.
Allison Hazell: That’s very interesting. Okay, so I think, you know, on the other side of this, commercial cell-banking is controversial to the point that the International Society for Cell and Gene Therapy put out a statement of concern about the business. We spoke to Aaron Levine, an ISCT representative about commercial cell-banking. I'll play that tape, and then I'd like to hear your take on it.
Aaron Levine: My name is Aaron Levine. I'm an associate professor in public policy at Georgia Tech in Atlanta. And my research interests over the last 15 to 20 years have focused on the intersection of bioethics and public policy. I originally trained as an undergraduate in biology. And then I did a master's degree at the University of Cambridge working on the Human Genome Project, so it was a really exciting time. But I got really interested in the ethical and policy issues associated with that. And so I went from that master's degree to do a PhD in science, technology and environmental policy at Princeton University. So over the last five or so years, I've been Vice-Chair for Ethics for the ISCT’s taskforce focusing on unproven cell therapies. And we got interested in cell banking a couple of years ago. So the commercial cell-banking industry entails everything from banking of umbilical cord blood, to the banking of hair follicle cells, to banking of the dental pulp from baby teeth, and probably a whole host of other cell types that are out there. And at its heart, it's an industry around freezer technology — cryopreservation is the term of the art, right? It's taking these cells and freezing them so that they hopefully remain viable and useful, many, many years into the future. A couple of years ago, sort of mid-2019, we started to receive just a lot of interest from different sectors across the cell and gene therapy industry of concern, people just asking us questions about cell banking, and the increasing visibility of cell banking, you know, sort of online, and whether this might potentially be harming patients. So the ISCT, led by this taskforce on unproven therapies, undertook an effort to really understand these concerns, to consult with industry, to consult with patient groups, to consult with regulators like the U.S. FDA. And so we lead the development of this statement of concern, drafting it, then circulating it to other scientific societies and patient groups to get their endorsement. And so ultimately, I think we published that in 2019, and it was endorsed by 10 other organizations. The high points of the statement of concern are that cell-banking services — these companies that will take your cells and freeze them, basically, today for potential use sometime in the future — are too far ahead of the science. The current practice is just not, in many cases, justified by the state of the scientific evidence today. And so what that means is, these companies may be over promising to their customers, their customers who are paying hundreds, if not thousands of dollars to have their cells saved for some potential but highly speculative future use. And the reality is that the vast majority, the overwhelming majority of these cells will remain frozen indefinitely, and never be used clinically. So I think that's the first major concern we had, the first concern is about the science. It's not there, and it might not get there in some cases.
Allison Hazell: What are your thoughts on that perspective, Drew?
Drew Taylor: Yeah, so I respect Aaron's viewpoint. But I do have to say that I disagree with the blanket description of cell banking as simply being speculative. I also think that there are massive differences between companies that offer cell-banking services. And personally, I would be mortified to be grouped with some of them. The ISCT came out with the statement before Acorn was in market. And so I don't know if we were a group that was able to be evaluated by them when they were going through this. I know that they have, in fact, endorsed umbilical cord, and have members on the board that have worked in umbilical cord, so they're not against all cell banking. And I think that, if given the opportunity to invite Aaron and others from the organization into our facilities and let them tour what we’re doing, I think they would have a potentially different opinion of Acorn specifically. And I know these are general comments, not about us necessarily, but maybe about the entire industry. And there are absolutely groups out there that are offering services like this and that I would absolutely agree that they are definitely over promising based on what they are doing as a service. I don't believe that Acorn is in that group. I think that we are in a group on our own. That being said, maybe this breakdown of the word speculation that was used. And I think you can definitely use speculation around some of these long-term goals that we're talking about in the scientific community, like 3D-printing organs and hearts on demand for patients. There absolutely is the appropriate use of speculation around terms like that. But when we think about Acorn, we’re actually targeting adult somatic cells that are fibroblasts and keratinocytes. We've seen those cells actually benefit Canadians right now. Right? Like I said, 24 patients, out there are walking around, who have had their keratinocytes and fibroblasts harvested and leveraged to create sheets of skin to help treat some very severe burns. And so that is not speculative. But it's not just the skin example. You know, we've got a dozen people in North Carolina who, at Wake Forest University, they've had bladders 3D-printed and implanted to replace bladders that were not able to actually control their urination. And now they do gain that ability back. And again, their own cells are leveraged to create these tissues. So I think that there's there's a lot of examples out there, including things that help people, but also what I would kind of describe as a near-term application, which is in the world of aesthetics and performance, right? So this is the world of skincare and aesthetics, and also sports injury, where you're talking about performance and faster injury recovery. So in these instances, we're already seeing cells being leveraged in some of these therapeutics, including the very cells that we are harvesting, without layering on modifications to the cell types. So I push back a little bit. And I think that, to be fair, I would love — because I really respect Aaron's work and he made some massive contributions when he was working, prior to his current position, in the Human Genome Project. He's a really interesting guy that I would love to have a conversation with one day and share with him the lengths that we go to, to make sure that our cells are usable.
Allison Hazell: Interesting. Yeah, no, I think that's an interesting point. Okay, so there were two more concerns. I just wanted to get your take on let's go back to Aaron Levine.
Aaron Levine: And then the second major concern is that even if a cell therapy was developed 10, 20, 30 years in the future that use these cells, the type of cells that are being banked today, there's no guarantee that the cells a patient might bank today in 2021 could be acceptably used by a company. Cell therapies are extremely complicated and the sourcing of the material, from you or me or the patient, is a key part of that therapy development. And so we really just didn't see the evidence that there was a feasible clinical pathway. The second is that even if we get there, the technology used to bank cells today may not be acceptable for the cells that would need to be the input into those successful therapies later on.
Allison Hazell: Yeah, so what's your perspective on that, Drew?
Drew Taylor: Yeah, so I actually love getting this type of question. And, you know, this does get proposed a lot, right? Like patients do want guarantees about what's going to be used. And you can never guarantee anything in medicine, any therapeutic is never guaranteed that you're going to be able to cure a patient or help a patient. But, you know, as scientists and clinicians around the world, we try our best to deliver the best care for that patient. But what this question really does is allow me to give the opportunity, right, to talk about the systems and procedures that we've established at Acorn and how proud we are of it. We do have 60 years of data around cell banking and cryogenics, preserving cells by cryopreservation. You know, we've done this in scientific research for decades, even in clinical use back 60 years in the fertility industry, and then even a little bit more recently in the umbilical cord industry, which has been around for over 30 years, right? So we have very good methodologies that have been perfected and refined over time in how to effectively store cells properly. Aaron is absolutely right, not everybody does store them properly. And therein lies the problem. They're not thinking about how the cells are treated prior to in their cryo-preserves. They're not necessarily making sure that the cryopreservation itself, the tanks and the monitoring of those tanks, and the lack of fluctuations and temperatures within those tanks and all of those different things are done carefully enough to make sure that these cells are going to be useful down the road. And I'm really proud to say that we do that, we do that above and beyond.
Allison Hazell: What I'm hearing from you is it's important to look at companies on an individual basis. I think sort of grouping commercial cell banking as one is, you know, there are probably some places that you should avoid spending your money or or storing yourselves.
Drew Taylor: Yeah. He said it much more succinctly and articulated that much better than I but I think that that's absolutely true.
Allison Hazell: Interesting. It reminds me kind of the sort of genetic testing space where you have direct-to-consumer companies that offer pretty garbage products. But you know, to the average person it looks like it's the same.
Drew Taylor: It looks the same, yeah. And that's that's the problem, because differentiating between them is not always easy, right, for somebody that doesn't have a background in healthcare, or medicine.
Allison Hazell: It’s complicated.
Drew Taylor: It is complicated. All we can do is do our best and we're getting there.
Allison Hazell: Okay, so the third argument against this is that eventually commercial cell banking may never be necessary. So by the time we get to a point where these regenerative cell therapies are available on a wide scale, scientists will be able to nudge existing cells into forms that are appropriate for therapies without ever having to rely on bank cells. So let's listen to that clip.
Aaron Levine: Right now, the claim that you ought to have early cells is primarily marketing. I don't think it's justified in most cases by sound science. Maybe there's a time when cell banking makes sense, when we have pathways to make those banked cells viable, usable, feasible. But right now, I don't think we're at that point. And I think the idea that we ought to be preserving early younger cells, in the hopes that they might work later on is, you know, a little bit overly speculative.
Drew Taylor: So I actually agree with a big part of what Aaron is saying. And I think the disconnect may be with where we are approaching this. I absolutely know that having a younger cell is going to be advantageous. And where I agree with him is that we do have the ability to do amazing things with cells in terms of nudging them, reprogramming them, manipulating them into the various different cell types that we want. That is one of the very reasons why Acorn has the opportunity to deliver value to clients by taking a biopsy of their cells non-invasively, from a hair follicle. So this is actually really hand-in-hand with the benefit that we can deliver down the road. Where we differ is, I've seen in the lab myself the effects of having aged degenerated cells, and tried to use them to create tissue constructs and therapies. Aging and disease are severe limitations, right? And they are affecting our ability to use the cells effectively to combat disease in regenerative medicine. And, that was my direct experience. We do have things in the market as well, that are already there that have limited in cap the cells from an age perspective: Bone marrow donor banks will not accept patients over 65. Additionally, studies have shown that the mutation rate in our cells doubles every decade. So having older cells that we are then going to try to use for reprogramming and have an autologous cell source to create these tissues for a patient, and those mutations and all the damage that accumulates in those cells, is a major factor in the success. And look, when I think about the future, I want to be on the side of the group that thought that these things are going to advance and things are going to get better. And I want to make sure that I have the best opportunity to take advantage of these therapies that are certainly coming.
Allison Hazell: So Drew, you've provided our listeners with a really fascinating look at this incredibly cutting-edge area of science and thank you so much for your time.
Drew Taylor: Thank you so much for the opportunity to come on. I've really enjoyed the conversation. Thanks so much.
Christopher Shulgan: That was Medcan Director of Genetics Allison Hazell’s conversation with Acorn Biolabs CEO Drew Taylor. Our expert from the International Society for Cell & Gene Therapy, Aaron Levine, asked for an opportunity to listen to Drew Taylor’s responses. Here’s Levine’s final comment:
Aaron Levine: It’s fair to say that in the world of commercial and speculative cell banking, we see a wide spectrum in how various organizations operate. It can be difficult for consumers, however, to distinguish between these organizations and determine the quality of the services they offer. As a whole, I remain concerned that many of the firms offering commercial cell-banking services today, despite what may be good intentions, are ultimately taking advantage of their customers. Cell banking has enormous potential to improve human health, but how it will advance and develop is uncertain. And so, cell-banking services today with, for example, visions of personalized heart transplants is not, in my view, appropriate. Furthermore, despite the use of high-quality cell processes and cryo-preservation techniques today, these cell banks cannot know if the specific cells they banked, or the approach they used to sample, process and freeze it, will meet future regulatory requirements that would potentially allow them to be used clinically. For these reasons, I caution people from considering banking cells for uncertain and speculative future uses and, in most cases, would not recommend it at the current time.
Christopher Shulgan: That’s it for this episode. Find show notes, links and full episode transcripts at EatMoveThinkpodcast.com
Christopher Shulgan: Eat Move Think is produced by Ghost Bureau. I’m executive producer Christopher Shulgan. Our senior producer is Russell Gragg. Editorial and social media support is from Chantel Guertin, Emily Mannella and Patricia Karounos.
Christopher Shulgan: Remember to rate and subscribe to Eat Move Think on your favourite podcast platform. Follow our host Shaun Francis on Twitter and Instagram @Shauncfrancis — that’s Shaun with a U — and Medcan @medcanlivewell. We’ll be back soon with another episode examining the latest in health and wellness.