OneMedicine Podcast

Rob Lutz 00:02
Hello, and welcome to the OneMedicine Podcast with Today's Practitioner. In each episode, we share the expertise of a respected thought leader. Some you'll know, and others you'll probably meet for the first time. We cover topics important to you, always with a focus on improving the health outcomes of the patients you treat, while expanding your understanding of the many healing modalities being used today.

Rob Lutz 00:24
Hello, and welcome to this episode of the OneMedicine Podcast. I'm Rob Lutz, your host and founder of Today's Practitioner. Today's topic is "More Than Calcium and Minerals: Healthy Bone Tissue Is the Foundation of Longevity." And I'd like to thank our sponsor, Regenerative Tissue Science, the distributor of Ostinol, for sponsoring this episode. And we've got three guests today. James Scaffidi is the CEO, and he's been on the podcast before, so we're gonna go a little deeper on the topic, as Dr. Hyun Kim has been with us as well. James is the CEO, Dr. Hyun Kim is on the board of directors, and we also have Luke Bucci, who is the Scientific Advisor for Regenerative Tissue Science. So again, the topic today is "More Than Calcium and Minerals: Healthy Bone Tissue Is the Foundation of Longevity." And James, I think maybe I'll start with you. If you could just give us a little bit more about your background, a little bit of context here, and then we'll have the other two gentlemen share the same.

James Scaffidi 01:19
Came across this fascinating group of proteins we'll talk about today, which are really growth factors, and I've had the great fortune of working with Dr. Hyeon Kim, an expert in this field of BMPs, and Dr. Luke Bucci is an expert in nutrition, and I think we should start first introducing them.

Rob Lutz 01:40
Great. Dr. Kim, would you mind giving us a little bit more about your background and any context for today's conversation?

Dr. Hyun Kim 01:47
Sure, happy to be here. My name is Hyun Kim. I have a PhD in medical science, specifically in tissue engineering and drug delivery, and my thesis was on the development of BMPs. Afterwards, I joined a company called Genetics Institute, where they were one of the first to clone the BMPs for production, manufacturing, synthetic manufacturing. And this was mostly for surgical uses, where I've been involved in development and commercialization of various BMP products, including BMP-2 for open fracture repair, as well as for spine fusion, and then also got involved in some soft tissue repair with other types of BMPs like BMP-12 and -13. And then later in my career, I also worked for Olympus Biotech, which formerly was Stryker, who developed OP-1 implant and putty, that is a BMP-7 surgical implant product for bone regeneration as well. So, happy to be here.

Rob Lutz 02:53
Thank you. Sounds like a wealth of knowledge with BMPs. It's great to have you on the show. Dr. Bucci, can you give me a little bit more about your background as well?

Dr. Luke Bucci 03:01
Okay, I'll try to keep this short, of course, but I was growing up as the kid that kept asking, "Why?" My dad was a pathologist. He drug me in to see autopsies, which is, "I saw dead people," kind of thing, and that was a huge education. It just tells you what not to eat. It tells you to take care of your body. So it got me to asking a question, "Daddy, why did he get like that?" "Oh, he ate like a pig." That kind of stuff. So that got me into science in general, and I went to the University of Texas at Houston Graduate School of Biomedical Sciences--big name for a rather small grad school. In the Texas Medical Center, I've spent most of my time at the world's largest cancer hospital doing biochemistry, and that again kept me asking "Why?" And in that setting, my postdocs were on the effects of chemo- and radiotherapy on normal tissues, especially the testis, but all tissues are affected. So that got me straight into jumping into the supplement world. So, I started off at Biotics Research Corporation--they're still going strong. And I've been in pretty much all the phases of the dietary supplement industry. I've worked for suppliers. I've worked for sellers to professional lines. Health food stores--didn't work in health food stores, but health food store lines--and I pretty much have done it all. Have done a lot of work with, as we're going to get into, digestion. And pretty much a generalist, but I have focused on things, especially the musculoskeletal system. Glucosamine chondroitin was my invention, and I really helped push krill oil to become prominent. And it's another long story, which we'll save for another time. So in other words, I've done just everything you can do in the supplement world, and I'm having a lot of fun helping Jim, helping people to get their musculoskeletal system back in shape with the real signals that control your musculoskeletal system.

Rob Lutz 05:15
Awesome. Welcome everyone. Really glad to have you on the show. James, we had you on about a year ago, and so we do have a resource center that goes into a lot more detail, shares a lot of the science about BMPs. We do have that other podcast episode as well, so if anyone wants to go deeper after hearing the podcast, we'll have links in the show notes, back to the resource center, and some specific articles that I think will really quickly get you up to speed to understand BMPs and potentially how to use those in your practice. So again, some of you are familiar with BMPs. Some of you aren't. I thought maybe we could start with the beginning. What are BMPs, and in particular, how did they transform orthopedic surgery? But what are BMPs?

James Scaffidi 05:57
I'm going to just jump onto that first, and then dovetail over to Dr. Hyun Kim, who's really the expert. But in simple layman's terms, and in clinical application, BMPs are the signal. They are what start the growth, the cellular machinery activation, the differentiation of the mesenchymal stem cell into the osteoblast and chondrocyte. And without them, we don't grow arms and legs as blastocoels, and we don't keep our bones and joints healthy. But let me dovetail over to Dr. Kim, who's the real expert behind this, and maybe he would like to share a little more, as he sees it, of BMPs.

Dr. Hyun Kim 06:35
Yeah, they're basically a family of TGF-beta superfamily members involved in differentiation of stem cells into differentiated cells, and mostly they've been developed for bone and joint applications to convert mesenchymal stem cells into bone osteoblasts, as well as chondrocytes. And that is the key signal required for differentiation and development, as well as the generation of new tissue like bone and cartilage. There are many types of BMPs involved in different types of tissue formations--you can think of other soft tissues, like tendon and ligament in the musculoskeletal system--but also they are involved in maintenance and regeneration of various other organs in the body, such as kidney, brain, GI/gut, and so forth. These are a key family of proteins involved from the outset of development, and we're trying to capture the potency, the power, of this molecule into extending lifespan, as well as health span matters, to improve human health.

Rob Lutz 07:44
And specifically, and I know we're--it sounds like BMPs have applications in more than just bone and joints, but I think we're focused today mostly on healthy bone tissue. And I know that it's--because I've heard this before--but this really all started in surgery. Right? And it's still used in surgery. How did we get from there to, "Now this is something that I can ingest that's going to improve my bone health?" How did that come about?

James Scaffidi 08:08
Over 20 years ago, a colleague of mine called me up and said, "I need you to come into this surgical company with me." I was in brand management in the diagnostic business, and I said to him--his name is John--I said, "John, I know nothing about surgery." He goes, "That's okay. You're smart; you'll learn it. And by the way, in six weeks, you're training the reps. Okay?" So I jump into a couple of cases in bone fusion and surgery, dive deep into the science, just fascinated, and learned about this complex of bone morphogenetic proteins, these BMPs in our body. As Dr. Kim shared, there's 22 known BMPs. BMP-2 through -10--you've heard them allude to several of these numbers--they all work together, and they're concentrated in bone, and other BMPs work in other organs. Those are absolute fascinating fields in surgery. BMPs revolutionized orthopedic surgery, launching a whole new field called osteobiologics. And I found this amazing, but I'm not a surgical person. I like the biochemistry and the pathways, and I thought, "Wait a minute. If we took a BMP complex from human bone and surgically applied it to a fracture and regenerated the bone, what would happen if we took this BMP complex from a food source and it went through the body at a lower dose?" My thinking was it would work on bone-tissue conditions like osteoporosis. And I've had the great fortune in my career work with brilliant scientists like Luke and Hyun, and at the time, worked with a few other scientists, and they showed me and said this would work. And it really goes back to--if I'm going to jump back to the 1960s--Dr. Marshall Urist from UCLA, who gets credited with the discovery, as he discovered this whole complex. And Urist himself, before his death, was working and looking at, "How can we develop an oral BMP complex?" Right. Now, the first thing anyone in nutrition will tell you is, "If you take a protein, it gets hydrolyzed in the gut." BMPs are the most fascinating class of proteins. They defy nutrition. They defy basic protein chemistry. They survive enzymatic and hydrolytic degradation in the gut. What does that mean clinically? Here's a complex that nature created that can survive our hostile environment of the gut and still send its signal, and we'll get into that signal a little bit. And so we thought, "Wait a minute." There's a surgical grade of BMPs, which is extracted from human bone for surgery implant. There are synthetic individual BMPs, which Dr. Hyun Kim shared he was in the development of that, but nobody thought of, "Could we extract this complex from a food source? How would it work through the gut, and what would it do?" And so we really took the concept from surgery to supplement. Several of us left surgical business. Nobody made this, so we put together some smart people. We filed patents, so we had to set up our own manufacturing company and prove that 1) we can extract the complex. That's the easy part. The hard part in biochemistry is, "Can you keep it biologically active? Once you've extracted it, how do you know that complex is still able to do its job?" And that's part of our expertise behind the scenes in our manufacturing facility, keeping it. And what we've done is we entered the nutritional supplement world with a level of biologically active complex and results that you generally only see in pharmaceuticals. But it's natural, and that's the exciting part. And that's what brings us to the table today is to bring forth that academic expertise and excellence that you generally see in big pharma, but in the natural arena, and to stay laser-focused in one area. And for us it's musculoskeletal health with this regenerative complex, and so that's how we got here today.

Rob Lutz 12:08
So, thank you, and just a quick question. So BMPs in surgery are still being used today, right? What type of a surgery do they use BMPs for?

James Scaffidi 12:17
Somebody going in, they've got a compressed--the disc is compressed. The orthopedic surgeon'll either do an anterior or posterior procedure, perform a discectomy, put in a structural construct--either a cage or a bone--and then put down screws and rods--titanium in the lateral gutter. But that's only going to generally last about 18 months, and they'd need to get fusion started. And so BMPs--natural complex or synthetic--are used in those processes. Cervical, lumbar procedures, or in a fracture case where there's a very severe fracture, BMP complexes are used. And they're applied directly on the bone, and the bone tissue will regenerate.

Rob Lutz 12:59
which you wouldn't otherwise, right? Not to that level.

James Scaffidi 13:02
Correct.

Rob Lutz 13:03
Okay. So the thinking was, the theory was, hey, if this works here, how can we create something that you can ingest and will help someone build their bones? Who might be a typical patient that would benefit from BMPs? Who would be a patient that practitioner? Oh, I tell you, this is a good candidate.

James Scaffidi 13:19
Are you talking for the surgical or the oral?

Rob Lutz 13:21
For the oral. Yeah. I was just curious about the surgical, and you confirmed what I thought I knew, but now I'm talking about someone in a clinic. They're seeing their functional MD. And who is a potential candidate for using this product and why?

James Scaffidi 13:36
So, in our nutritional supplement area, there's about 300 supplement companies like us focused on the healthcare professional, and they're all selling wonderful minerals, alright. And Dr. Bucci can share with you some of these companies. Minerals are only half the picture. That fortifies bone tissue, and if you break down bone, you've got the matrix, the tissue, the cells, and the minerals. And our entire industry is focused on the mineralization, but that's only half the picture. How do you grow bone tissue? And so that whole balance between the bone tissue and the fortification, the mineral, is your ideal patient. Any patient that comes into a healthcare professional who needs better bone health. And Luke, maybe you want to comment on our industry and minerals. They're great products.

Dr. Luke Bucci 14:29
Thanks. I think there's three major concepts here. One is that bones and connective tissues, such as cartilage, ligaments, tendons, they are very slow tissues to form and repair. Their time to get back to normal after an injury is months or years, just to get back to where it was. So doing a four- or eight-month study is utterly ridiculous. You won't see anything, and that's where a lot of problems have arisen, that modern medicine says, "All these things don't work. We tried it, and it didn't do anything." Dummies, you didn't go long enough! You didn't look at the half life of the tissue: chondrocytes, two years; bone, a year. In a year or so, you have a whole new skeleton. It takes two years and longer to have cartilage replaced. Your body's always replacing everything, and the faults along the way is how we age. So that's what people need to understand. This is not something you're going to take and feel better, like taking an indocin or an aspirin. You're convincing your tissues to fix themselves normally. That means a certain amount of time. What supplements can do is increase those--or speed up those times to heal by supplying the needed nutrients and signals, especially the signals where the BMPs fit in, to tell these tissues, "Okay, bone. You need to make more bone and stop breaking down as much. Here's what--here is what you need." Calcium has just ruined bone health, especially supplementation. Calcium is the last thing the bone does to harden up and form, the last thing. That's the end result of making bone. You first need to make the tissue that's just soft, like every other tissue. Then you start to calcify that. And cartilage, you just need to make that kind of tissue, that's very similar to the bone tissue but it doesn't have any calcium. But chondrocytes are starved to death. There's no blood vessels inside cartilage. You have millimeters and centimeters of room, and for these cells to get their nutrition from far distant blood vessels, they're very slow. That's why osteoarthritis, the degeneration of cartilage, is so prevalent. Any insult or injury to the blood supply will just starve the chondrocytes, and they can't even maintain a normal amount of cartilage. Then the mechanical forces start to predominate, and it's a big boulder rolling downhill. So that's the kind of mindset we need to do. You need to have nutritional support for a long time, and you want to give the signals and the key nutrients that are actually starting the process, not ending it. By giving too much calcium, you wipe out magnesium, which is super important for both of those tissues to start repair. That's, I think, the basic message that everybody's missing. The second one is the absorption of these BMP proteins. That's a different story.

Rob Lutz 17:40
I'm sure we'll get to that in just a minute. So, my question--so a practitioner might see a postmenopausal woman. Is she a candidate for something like this, because she has osteoporosis? Is it that type of a potential, that kind of a patient? Or a sports injury? Or broken bones? What? All the above? Are there others?

James Scaffidi 18:01
The short answer is, "Yes, all the above." Obviously, with a break, that's an acute condition, and a surgeon's got to set that. But when you look at all of those conditions, whether it's degeneration of the bone tissue or the cartilage, I think one of the--to me, one of the most pivotal pieces of research was published in 2006 in the Journal of Arthritis Research and Therapy, which for me was pivotal. In '06, it changed and challenged our understanding of the pathogenesis of degenerative joint disease, and it found for the first time that several of these BMPs, specifically number 4 and number 5, are decreased in the synovial fluid. Now, what does that mean clinically? As Luke's talking about, signal is--here, I can tell you about how we get the body to regenerate bone and cartilage postoperatively. Having the right signal--the right cells are critical. The stem cell is sitting in the synovial fluid, sitting there doing nothing, waiting for the activation signal, and our bodies naturally produce these various BMPs. Something happens in people with arthritis that the genetic expression of these proteins gets downregulated. Why? I don't think we know yet. But in '06, for the first time, researchers discovered that there's a correlation between a decrease in the synovial of these cytokines and the cellular activation, right, which leads to OA and RA. And so when you say to me, "What kind of person can benefit from BMP supplementation?" There's so many. And so here we are in '06, realizing for the first time we're pumping in nutrients, glucosamine for bone health, all of this calcium, but that's the last stage. All the glucosamine chondroitin, that's the last stage. Until we activate the mesenchymal stem cell to become a chondrocyte--that's that cartilage-building cell--which will absorb glucosamine chondroitin, or hyaluronic acid molecules, and literally stitch them into proteoglycans for cartilage tissue and excrete that, nothing's happening. And so what's exciting here is our understanding of these conditions that are burdening our aging population is not, "Did we get enough glucosamine chondroitin for the joint? Did we get enough calcium?" It's, "Is the cellular process being activated? Is the right signal there in the body?" That's what makes BMP so unique. And that's what transformed orthopedic surgery. I want to go back to that for a moment. And when Hyun was developing these as tools for surgeons, prior to that nothing existed.

Rob Lutz 20:57
Right

James Scaffidi 20:57
Hyun, you want to touch on that a little bit?

Dr. Hyun Kim 21:01
Yeah, certainly. Yeah, prior to development of BMPs for specific bone indications, like for open fracture repair or for spine fusion, there were limited options. I think autograft was one of the options, but that's certainly difficult to harvest tissue from another site. Allograft, there's certainly a concern there for taking tissue from another source. Ultimately, the development of BMPs was a benefit for, kind of, an off-the-shelf product that's used in surgical cases, but certainly that has limitations in that it is a solution to resolve a local tissue repair, like in a spine or spine fusion, or in a long bone fracture. Bone and joint diseases are systemic diseases, and it's not just one site that has deficient bone or joint. It's throughout your whole skeletal system. So I think the benefit of an oral approach is that you do get more of a systemic benefit to improve health, where you do see real benefits on improving bone density, for example, as well as cartilage formation.

Rob Lutz 22:26
Yeah, that was my question. I was thinking about bone density and postmenopausal women, and yeah obviously, you can't do the surgical route and spread BMPs all over their spine, or whatever. So ingesting something, if that's going to signal the bone to regenerate, is that what's happening, basically, is they ingest it, and then there's these signals that maybe had been turned off? Are they--from what you said, there weren't enough BMPs in the system. Now the signal is there, so the minerals and these other things can actually do what they're supposed to do. Is that oversimplification, or am I on track?

James Scaffidi 23:04
Luke, see that one? You want to take that?

Dr. Luke Bucci 23:06
Yeah. I think that's it. It's all about feeding the cells what they want and need. The signals are important for the cells to actually do what they're supposed to, and they respond to mechanical forces, and they take whatever they can from the blood flow they have, which in bone is pretty good. About 1/4 of your heartbeat goes to bones, every heartbeat, so they're well fed, but cartilage, not well fed. My analogy is, "Okay. You're a chondrocyte, cartilage cell, in the middle of cartilage, in let's say your knee. Okay. You need food. You have to go to the grocery store. How far is the grocery store? Oh, about 10 miles, and you have to walk and then come back." So in other words, your cartilage is semi-starved. It has tiny channels to--with motion, which means this is why staying active is healthy. It pushes the fluid through the cartilage, like a very stiff sponge, and from the bones that abut the cartilage. And it's--so, it's really having a hard time getting anything, signals or nutrients. In fact, chondrocytes are--they have the metabolism of somebody that just run a marathon. They are horribly under the gun for creating energy, and then they have to manage and build this gigantic structure around them. They have to make the enzymes to break it down when it gets hurt and put it back together. So that's why it's a two-year replacement time period. So you have to keep taking a supplement for that long. That's what I think is going on is that the BMPs are a key signal for all the musculoskeletal tissues, so when the body needs to fix these tissues, it needs a milieu of these signals, and BMPs are one. There's the start of, "Hey! Wake up! Wake up, cells! Fix this! You need to start making more bone, which means you need to break down the bad bone, put the good bone in." Bone turnover means you're constantly drilling holes in your bone with osteoclast. Don't worry about it. It's okay. You don't feel it. It's going on. It's working. And then you have to fill it back up, and chondrocytes is the same thing, but it's just much, much slower. So that's where the BMPs fit in. They start the whole process, and that's the fun part about it. And they are in such tiny concentrations in your bloodstream and bodily fluids that it doesn't take a lot to actually have a beneficial effect. And that's where the oral supply of BMPs, I think, is a very good idea, because you are starting off that whole signaling process via the gut, and then that circulates back to the bone and chondrocytes and cartilage.

Dr. Hyun Kim 26:09
Yeah, let me add to that a little bit. Yeah, I fully agree with Luke. I think to his point, local delivery of synthetic BMPs, there are tremendous problems. First of all, you're using a massive dose--supraphysiological dose--to account for, kind of, the bioavailability and the half-life issues when actually delivered to the site, and that raises increased side effects like ectopic bone formation--bone formation in sites where you don't want it to happen--because the BMP dose is so high. And the beauty of the oral delivery is that the formulation is developed such that I think the BMPs are delivered at physiological doses, so very low doses. And somehow the oral route is the magic pill that enables BMPs to be protected during transit and act where it needs to act in the gut tissue to have binding and downstream effects of BMP activity in remote organ systems, through these kind of gut-bone or gut-joint axes, pathways. So. I think it's natural to benefit from this formulation to have systemic effects that are real.

Rob Lutz 27:34
It's delivered more in a, kind of, a natural dosage, maybe, similar to what a normal healthy person might have when they were younger, or rather than just this massive blob they put on a broken bone, for an oversimplification. So it's being delivered in a way that the body can really utilize it.

James Scaffidi 27:54
But Rob, I wanted to also just dovetail what other scientists have shared and for your audience out there, clinical practitioners. So what they've just heard is, we've touched upon many applications of BMPs, from the surgical use in a spinal fusion to where the future is now going in these synthetic injectable BMPs, and that's having challenges. It is a future that the pharmaceutical cousins are looking at: to make a singular synthetic BMP injected, but the levels are so high it's causing complications, so it can never be used orally. The other challenge is it's one singular cytokine, right, one growth factor. That's different than having the entire family of BMPs. I liken BMPs to the symphony. You go out. You hear the strings and the brass and everything working together. It's a big beautiful sound, harmoniously. But then you go to the street guy playing just an electric guitar, and it's very loud, but it's only one instrument, and so you have to make it very loud. And so a single BMP is working like that, just one instrument, very loud, but not the complete symphony. And there's key physiological reasons why we need the entire complex, and that's how bone naturally works. So, you're always hearing about surgical applications, the future of synthetic BMPs. And we're right in between there with the natural BMP complex.

Rob Lutz 29:26
Great. Thank you for that clarification.

James Scaffidi 29:29
Sure.

Rob Lutz 29:30
We talked a little bit about expectations and supplements for bone and joint health, and kind of the typical--the calcium and vitamin D, and things like that, but I think what you're saying is it's just not going to be nearly as effective without these signals. Really, the signal is the missing piece, right, for bone regeneration and joint health as well.

James Scaffidi 29:49
That's it, Rob. Oh, we're learning that BNPs are critical for healthy bone tissue, healthy cartilage, many other tissues in the body. Kidney function, nerve--BMPs are being studied in nerve regeneration. We're not suggesting here today that the technology is that if you had a spinal cord injury, it's going to regenerate that. So, as I was sharing, BMPs are quintessential in the body for more than just bone and cartilage, and keeping them healthy. Whether it's nerve function, kidney, energy metabolism, the research is coming out every single day. And that's what's exciting is that we're learning today the importance of BMP signaling across many areas of the body.

Rob Lutz 30:41
I appreciate that. Really, it's just a unique compound or molecule. What would you want to say about that? We talked a little bit about, calcium doesn't really rebuild bone or cartilage, these working together. But is there--really, what makes this unique and what makes you guys unique?

James Scaffidi 31:00
I think, and I'm going to, just from a business perspective, and then I'll let Luke, and Hyun as well, comment as scientists. There are lots of companies out there. Luke's worked with many of them. They've got great mineral products and great glucosamine chondroitin products. What makes us so unique is those products do not address the cellular activation, the differentiation of the stem cell into osteoblasts and chondrocytes. And that's what's needed to grow the tissue. We started this discussion with, "More Than Calcium." There are more than minerals for bone. If you're not growing bone tissue, what does the calcium stick to? And the answer is nothing. If we're not growing the cartilage, if the cellular machinery is not activated, the glucosamine chondroitin molecules don't get utilized properly. And that's really what makes us so different. Luke, from your perspective, you've been in the industry a long time.

Dr. Luke Bucci 32:00
Absolutely right. That's what I was trying to get across is that these--especially cartilage but bone cells, too, the same--certain extent, they have a very hard, tough tissue to have to break down to rebuild or even grow. That's why you have growing pains in the bones, because you're breaking down the bone, and the mechanical stresses are squashing nerves that tell you, "Ouch!" And same for osteoarthritis--from any kind of arthritides--that you're squashing nerves that are outside the cartilage, actually, since cartilage has no nerves. That's because of the mechanical pressures. So that's your body telling you, "Hey, your structure is not right!" The BMPs and other growth factors that are also in the gemitsch, they are the spark that starts the forest fire, so to speak. So, if you don't have any spark or any little fire going--if you don't drop the match--you don't have a forest fire. So, you want to start the fire with the BMP signaling, and that's where they come into play. Now, you have to have all the downstream components. You need all the vitamins and minerals, energy, and then your cells can make the softer connective tissues with glucosamine. And chondroitin is one of those components that built this physical scaffold that fills the gaps, and then it goes to be calcified in bone and make sure that it's not calcified in your cartilage. So that's the sequence, and that's why glucosamine chondroitin works to an extent. If you're still signaling to make more cartilage--if you haven't destroyed your cartilage to the point where it's turned off its metabolism--then it'll feed them, but the spark is the growth factors, especially particular BMPs. And that--getting them in orally is getting them in the right concentrations that they are in the bloodstream, and I think that's the key. So it's just like you're making your bone when you're a kid, it takes a few years to get it to grow linearly, to make the bones grow. And that's what I think that Jim has showed is that in the studies they do, the case studies they have, people are changing their bone density scores. They're getting more bone. Their cartilage are just feeling better. It's hard to measure cartilage and--unless you do a lot of MRIs--and it's very difficult and time-consuming. Even glucosamine and/or chondroitin takes two to three years to see real, measurable thickening effects of cartilage, I mean restoration of cartilage. So that's what happens when you feed them, and--but what Jim has shown is that by giving these tissues the signal, you start the process, and it takes the same amount of time to reverse and restore. So that's the fun part is when you stick with it, it works. And one more analogy here is my wife and I have dogs, and we were part-owners of a dog food company for a while, a dog food store, and its big thing was selling raw foods. Everybody goes, "Ah, no. You're going to kill them. Blah blah blah." No, it's frozen. It's good. That's what they eat normally. Real dogs in the wild eat things raw. So I got into, "Okay. Why is raw food supposed to be so good and better?" First of all, it's fresh. It's not cooked, so all these--guess what?--growth factors that are normally in all tissues are still there. Dogs are eating it, so they are getting orally a bunch of growth factors, including BMPs from raw foods, and raw foods do make a difference. When--it takes a year or so, then you start noticing versus kibble--dry dog food--that, "Hey, coats look better. They don't have the teeth falling out or gum problems as much, and they live longer, happier lives." That really reinforced to me, I keep asking why, right? So, "Why is it? Why is a raw food diet better?" It should be killing them as long as we're not taking care of the food, but it takes--raw food takes care of the dog, because of all those things that are killed off when you heat food. And what do humans eat? We don't eat raw meat.

Rob Lutz 36:24
True.

Dr. Luke Bucci 36:24
How are we going to get any kind of growth factors, mammalian growth factors, in our diet? We're not. That's what Jim has put back into our diets.

Rob Lutz 36:36
That's great. A patient or practitioner might still, along with the BMPs, Ostinol, still recommend glucosamine and calcium and those types of things. It just can be much more effective than it would be without. Is that--am I getting that right?

Dr. Hyun Kim 36:53
Yeah. I've answered that.

Dr. Luke Bucci 36:54
Yes, I think so. You need the signal, but after that, there's still a lot of things that have to happen. And the signal makes it start, but because with aging, you lose blood flow and blood supply, which means that you have a slower rate of making the parts that turn into cartilage and into bone, so you give those things that the bones and cartilage are made out of: glucosamine and chondroitin and minerals. Then you speed up the whole process, and if you don't use too much calcium, then the other minerals are very important in bone to make the osteogenic part that's not mineralized. Then mineralization is the last step. And vitamin K2 MK-7 has been very helpful for a part of the missing link, because it helps calcify things. So now we have a sequence of events, and if you start with the signals and the raw materials, then you're going to have the best options. Vitamin D3 is one of those signals as well. And so, that's putting back--so you're getting back to a young growing situation that's still under control, so you don't make too much bone or too much cartilage.

James Scaffidi 38:06
Luke, thank you so much for that. And again, Luke is just, to me, a walking encyclopedia when it comes to nutrition, and there are many other additives that we need in our diet, but it all comes back to the first step. As Luke said, and Hyun understood, if the signal's not there, the cellular process just is not happening right and growing bone. Couple of things I'd like to touch on: 1) Can BMPs--how are they being metabolized or absorbed in the gut? Very unique complex. We will have more information coming down the road. Here, I've concluded some studies just this past year of BMPs and GI absorption, and so this is a first of its kind that we're seeing this. And so, something I said at the beginning of this discussion: extracting the complex is one thing; ensuring that it stays biologically active is critical. And every batch of ingredient we produce is tested in a live, in vivo model certified to turn on stem cells and grow new bone and cartilage. That's how powerful these signals are. That's what BMPs do. That's how we batch test our ingredient. That's the same surgical companies do before they can surgically implant these BMP complexes. They have to certify that every batch is going to turn on the stem cells and grow bone and cartilage. That's just who we are as a company. We're good prime manufacturing. That test alone takes us two months to confirm every batch, okay. And so Luke also touched upon some of the case studies we've done and clinical trials, and those are available online.

Rob Lutz 39:57
And I think that's a good point is if you guys are testing to make sure this stuff actually does what it's supposed to do. I think that--I'm not gonna say it's completely unique in the dietary supplement industry, but I probably can count on one hand ingredients that have that level of scrutiny, just to make sure that it's going to do what you say it's going to do. This is a signaling thing. You need to know that it's actually going to work; otherwise, it wouldn't be very good for your patient. Where would you say this is all headed? I know--so there's been developments from when it was first used in surgery, and there's synthetics, and now there's an oral form. What other applications might we be expecting coming down the pike?

James Scaffidi 40:36
Things that Hyun shared with you about where is BMP technology heading. Our pharmaceutical cousins are making synthetic BMPs. They're at super-high physiologic levels. There's problems with it. We are just at the beginnings of regenerative health, nutrition, and wellness, and medicine, and it's a growing field, with stem cells coming into vogue, PRP. Again, all of this is focused on signal, and our product, Ostinol, delivers a BMP complex. BMPs have been proven since 1965 to be the only growth factors that can turn on and differentiate stem cells. And so we're really at the beginning of this ride, of this change in nutrition, in medicine today, and BMPs are leading that. Every single week, Rob, there's dozens and dozens of papers published on BMPs around the world, not just in bone and joint now. We're seeing application in GI health, application in kidney health, energy and metabolism, and we're learning that this signaling complex is quintessential to keeping all of our tissues that are regenerating healthy. It is the signaling molecule for all those tissues that have to regenerate. Luke talked about it earlier. Our bones naturally take eight years to regenerate in our body through remodeling. Cartilage takes a very long time. Our GI/gut every eight days is generating. All of these tissues require BMPs, and we're finding out that they are the linchpin now and leading the forefront in regenerative health and medicine.

Rob Lutz 42:17
That makes sense. So, we're talking about the foundation of longevity, healthy aging, health span, lifespan. And if BMPs are the thing that signal your body to regenerate, and that's not happening as you get older, and that's why we're seeing osteoporosis and joint problems and GI issues and things like that. If BMPs can solve that or help with the regeneration of those tissues, it would be pretty revolutionary in my mind.

James Scaffidi 42:44
It really is. I'll leave your audience with one additional stat. In the last several years--it was published in the Journal of Orthopedics--we're finding that postmenopausal women can lose up to 43% of at least one of these BMPs from age 20 to 50, and so BMPs now even will be able to revolutionize menopause, because as women are going through menopause and dropping estrogen, BMP levels are dropping, but unfortunately we don't do a Dex until they're 60. And so if we could change healthcare and medicine and bring the BMP complex into perimenopausal women, that might open up a whole new way of helping women through menopause and keeping their bone tissue healthy.

Rob Lutz 43:34
That's great. Gentlemen, thank you very much for your time and information that you shared with the audience, and I really appreciate you being on the episode with me. Take care.

James Scaffidi 43:43
Thank you so much for having us, Rob.

Rob Lutz 43:45
Thank you.

Dr. Hyun Kim 43:46
Thank you.

Dr. Luke Bucci 43:46
Thank you.

Rob Lutz 43:49
Thanks for listening to the OneMedicine Podcast, I hope you found today's episode interesting and came away with a few insights you can apply to your practice. If you're looking for the show notes, they can be found in the link below. If you want to go deeper on this topic or anything else, please visit todayspractitioner.com and consider registering for our weekly newsletter as well. Thanks again, and I hope you'll join us next time.