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
Hi. Welcome to the OneMedicine Podcast. I'm your host, Rob Lutz, and today we're going to be talking about the new frontiers in regenerative health and medicine with a deep dive into the BMP complexes. With me today, I've got two guests, two experts in this topic, Jim Scaffidi, who's the CEO of Regenerative Tissue Science, and Dr. Kim, who's a researcher and expert in BMPs as well. I'd love for you guys to just give a little bit more about your backgrounds if you could, and before we dive into the topic. So Jim, could you just tell us a little bit more about yourself and your company.

James Scaffidi 00:56
Sure. Thank you, Rob, and thank you for the opportunity. So Regenerative Tissue Science is a division of ZyCal Bioceuticals, who's been around about 16, 17, years now. My background is in biochemistry. Played around with a bench for a few years in enzymology. Went in to Big Pharma, sales and marketing, love the business side of it, and the application. Was hired by a bone tissue company and learned about this fascinating protein complex and how it's been used in surgery. And about 17 years ago, we left, a group of us, and set up a natural regenerative tissue science company for bone and joint health.

Rob Lutz 01:32
Awesome. Thank you. And Dr. Kim, can you tell us a little bit more about your background and about yourself?

Dr. Yan Kim 01:37
Sure. I have--my background is in biomedical engineering. Got a Ph.D in medical science, specifically focusing on tissue regeneration. Got involved with BMPs at that point for my scientific thesis work, and eventually got involved and joined, actually, one of the pioneers in BMP development, called the Genetics Institute, which later became Wyeth and Pfizer. Developed--worked on BMP, development of BMP2 for fracture-repair, spine-fusion products, and later also worked on BMP7 development as part of Stryker, which spun off into Olympus Biotech. So, yeah, a lot of BMP development experience for therapeutic development.

Rob Lutz 02:29
That's great. So, you know, I have some questions. I really want to kind of guide this conversation--again, our audience are medical professionals. I want to dive a little bit into the history of regenerative health and medicine, kind of bringing us up to where we are today, and then we'll talk more about BMPs. But I want to throw that question out to you guys. Could you just share a little bit about the history?

James Scaffidi 02:49
Sure. I guess you really have to go way back. I tell people, "Put on a seat belt. The ride gets bumpy." And we're going to jump back to the 1960s. The credit really goes to Dr. Marshall Urist, an orthopedic surgeon, a researcher at UCLA, and actually worked up in Boston as well. And Dr. Urist asked a simple question, "What is it in bone that causes bone to regenerate?" We all know you have a fracture, you set it, and the bone regenerates. And a bone's just an amazing tissue. It regenerates over and over, and it's a fascinating tissue, very dynamic. People think the bones we were born with are the bones we die with, but they don't. Every eight years, our body completely changes every tissue and cell on our bone. So, very dynamic tissue, interesting, and what Dr Urist discovered by removing all the mineral and cells is there's a protein complex that, when he mixed it with certain stem cells, turns into osteoblasts and chondrocytes that makes new bone and cartilage tissue. And that really spawned a whole industry called osteobiologics in the 1980s, as his discovery really sat around and didn't have applications. As Dr. Kim points out, he was involved in the development of singular BMPs. Urist discovered an entire complex, and we have this in all of our bodies. Any animal, whether it's a dog, a human, a cow, all has this complex in our bones, and it's the complex that signals the stem cells in our body to regenerate, to differentiate into osteoblasts and chondrocytes and make de novo bone and cartilage. And so in the 1980s, this complex was used for spinal fusion and fractures. And then in the early 2000s, where Dr Kim was instrumentally involved, developing singular BMPs, synthetic or recombinant, that could be more targeted, focused, and made for fracture healing. The entire complex is a natural complex containing multiple BMPs. What we now have done is, taking what was used in surgery, a group of us said, "What would happen if we extracted this complex from a food source and ingested it orally?"

Rob Lutz 04:52
Mm hm.

James Scaffidi 04:53
Well, it's a pretty amazing protein complex, because nutrition teaches us proteins are hydrolyzed in the gut, and the way this complex is folded up, this complex survives both enzymatic and hydrolytic degradation in the body. And so we find that there are receptors in the gut, and so we are seeing a pharmacological response in the body. And so when we look at regenerative health and medicine, providing the body the signaling complex is what we're all about. So the body can then go and regenerate, and build new bone and cartilage tissue. And that's what we focus on as a company, both developing products, and as a research company, looking at how this complex and these proteins have application now in the body, for bone, joint, GI. We're learning even in sarcopenia and other applications now in health and medicine.

Rob Lutz 05:43
So it's interesting. So it's something that was originally used in surgery, and now it's something that's much more accessible to folks that might need it for-- they're not having their spine fused, but they've got a broken arm or are having some joint issues. Is that--am I correct on that?

James Scaffidi 05:59
Absolutely, Rob, that's correct. So doctors who are treating patients with--both those who have healthy joints and have problem joints, that want to increase joint health, both joint comfort, symptomatic improvement. And as we look at histological improvement of the body for bone tissue, these are the proteins in our body that naturally signal and turn on both the growth of bone and cartilage. And so yes, applications for healthcare professionals in bone health, those with healthy bone and those who are starting to see bone loss.

Rob Lutz 06:32
Mm hm. Interesting. So anything else to say about the history, or kind of what we've learned along the way?

James Scaffidi 06:38
Let's just talk about what we've--quick, of what we've learned. This complex is ubiquitous across all animals, and so we're able to take this complex, extract it from a food source, certified organic bovine bone, and ingest it orally, because it's from a food source, and it still works in the body. And some of our research, we'll touch upon in clinical trials and case studies we've done, both directly and through CROs, we are seeing pharmacological response. And Dr. Kim can touch upon also as to which of these BMPs out of this entire complex, and how they work in the body, and what that means, and what it's opened up for regeneration in fusion, and now what we're looking at for as a nutritional supplement.

Rob Lutz 07:25
There are a number of BMPs. Is that right?

Dr. Yan Kim 07:27
Yes. To do the oral complex, Cyplexinol has a complex of multiple BMPs that promote bone and joint repair and regeneration. They include BMP2, -4, -7, TGF-beta, among others. So I think the complex is critical in terms of ensuring that, you know, you get the best effect, combination effect that's physiological in dose, promotes the tissue to repair and regenerate.

Rob Lutz 08:01
So rather than just using one of those BMPs, there's benefit to having a complex with a number of different--is that what I'm hearing?

Dr. Yan Kim 08:06
That's correct. That's how the body repairs itself, a combination of these different molecules. And the beauty is that dose is physiological, meaning that, you know, compared to cloned or recombinant proteins, which have super-physiological doses that aid in--promote--side effects, adverse events, our oral complex delivers the BMPs in physiological, lower-dose formulations that mimic the body's natural combination of doses.

Rob Lutz 08:43
So in the form that is in the supplement, it's something that is taken well, from a patient. There's not a lot of side effects, as far as GI issues. Or are there any side effects with taking it for most? Or it's pretty easily--because it's a food basically, right?

Dr. Yan Kim 08:58
Yeah.

Rob Lutz 08:59
That's great.

James Scaffidi 08:59
No side effects. And I think Rob, I want to just echo what Dr. Kim has shared for your listeners out there, the fact that the complex is at physiologic levels in a balance. Because each of these proteins turns on the next one in the body for cellular differentiation. They work together, kind of like a symphony working together. You've got the strings and the brass, and that's what makes the harmony, the beauty, versus just having one string play really loud. That's what a synthetic or recombinant would be like. But what does that mean for us clinically? Safety. We're getting an efficacious product that is safe.

Rob Lutz 09:34
Mm hm.

James Scaffidi 09:35
First question we get is, "Wait, we're turning things on in the body. Any concerns?" No. The specificity of BMPs in our body is only targeted at the mesenchymal stem cell and nothing else. And that stem cell is differentiating into osteoblasts to make new bone tissue and chondrocytes. And something else I just want to touch upon for your audience: you'll hear me say bone tissue all of the time, not--why not bone? Because bone consists of three elements, really: the bone tissue, which is the collagen matrix; the cells, the osteoblast and osteoclast; and minerals. And traditional supplements only focus on mineralization of bone tissue, but if you don't grow the bone tissue, the mineral has nothing to stick to.

Rob Lutz 10:18
Mm hm.

James Scaffidi 10:19
So I liken this to a chain link fence and tennis balls, where the tennis ball will be your calcium, and the chain link fence is the tissue itself. And you throw the tennis ball at the fence, and it sticks. That's just like the calcium sticking to the bone tissue. But if the hole--if there's a hole in the fence, it doesn't matter what tennis ball or how many. not until you repair the fence. And so what BMP complexes do for the body, and naturally and as a supplement, is provide the signals so the body can now activate its own stem cells to regenerate the bone and cartilage tissue. Then once you grow tissue, mineralization can occur, but without the tissue growth, the minerals are of limited value.

Rob Lutz 10:59
Yeah. Because, you know, I think--you know, I was going to ask you about calcium, because that's the typical go-to, or what most patients think is the typical go-to. But that example you gave seems to make sense to me, because I've heard that you can take a ton of calcium, but it may not actually help you build bone. Is that...?

James Scaffidi 11:15
That's correct. And go back to 2010, the British Medical Journal of Science did a meta-analysis on high-calcium supplementation in post menopausal women. And I believe there was about a 39% increase in cardiovascular disease, because over-supplementation of calcium, it precipitates out of serum and then adheres to coronary arteries, which is just like having atherosclerosis. And so we built up these plaques and hearty arteries due to the over-calcification. And so you have things like menaquinone, MK7--K2 has come into vogue in the last 10 years--to help keep calcium soluble in the serum, which is great, but if we grew the bone tissue, the calcium would have a place to leave the serum and adhere to the bone. So we're really getting to the root cause of, how does bone grow in the body?

Rob Lutz 11:16
Yeah.

Rob Lutz 12:07
So would you still take a calcium supplement with this? Or is that not even necessary?

James Scaffidi 12:12
It depends upon the nutritional status of the patient.

Rob Lutz 12:15
Right. Of course.

James Scaffidi 12:16
So that's what supplements are really for. If you have a young, healthy person who is having a good diet, eating yogurt and other green, leafy vegetables, they may not need the calcium. They--certainly a BMP complex like ours would be of value, but if you get older patients that are not eating much, and maybe they're not missing their milk and their yogurt, well then absolutely, a calcium supplementation could be warranted there.

Rob Lutz 12:45
Mm hm. Makes sense. Dr. Kim, was there something else that you wanted to say about that?

Dr. Yan Kim 12:49
I mean, calcium would be supportive, but the real active would be the BMPs. That's the whole cascade of stem cell proliferation and differentiation into downstream tissues that actually are de novo tissues, like bone.

Rob Lutz 13:06
Thank you. You know, Jim, you mentioned a little bit about the history and the surgical use. Is there anything more you want to say about that that relates to what we're talking about?

James Scaffidi 13:15
There's a couple of things, and I had just a few years of experience in the surgical business where I was learning about these proteins and just fascinated. The safety of the complex is fantastic. Every time we do a webinar, somebody asks about cancer and--let me put the regulatory hat on. We're not advocating for use in cancer. We have no studies. I always say, "Treat the cancer first, and then we'll come back."And maybe most of the time, patients get corticosteroid-induced osteoporosis. Deal with the cancer, then we could talk about bone health afterwards, secondarily. But I worked personally with an orthopedic oncologist who would excise a bone tumor and then backfill with a BMP complex--again, surgical grade. And I asked him, "Bill, are you worried?" He said, "Not at all. The specificity of the proteins of these BMPs is to the mesenchymal stem cell." And so again, when Dr. Kim is sharing about in physiologic levels, that's so critical, because the body needs this balance at these right levels. And we don't have to go super high, as you do with those synthetic or recombinant versions.

Rob Lutz 14:20
So it's not turning on everything, and it's out of control. It's really just going to focus right on that very specific mechanism, right?

James Scaffidi 14:26
Cool.

Rob Lutz 14:27
Yeah. That's why.

James Scaffidi 14:27
Becase when you look forward, Rob--going forward, where is the pharmaceutical surgical companies? And this really takes off from Dr. Kim's research and development. The two synthetic BMPs available, number two and number seven, are now being investigated even further for therapeutic options on injectable. And so we know our pharmaceutical cousins are looking at, "How do I take a synthetic singular BMP, inject it to grow cartilage and other areas?" Again, there's side effects and challenges. That's a pharmaceutical, but as we look at the future of regenerative health and medicine, what BMPs mean for clinical practitioners--sure, down the road, there'll be synthetic BMPs, but today, to be able to take an oral complex, survives the gut, has physiologic response, and provides support in a unique way for bone and joint, that's what's available today.

Rob Lutz 15:23
Mm hm.

James Scaffidi 15:24
And I have to speak about support to be compliant with FDA, FTC, but I want to talk one moment for your audience about stem cell activation. Every batch of Cyplexinol, which is our BMP complex, and where we own the patents on this--every batch we produce in our FDA-audited facility goes through a 45- to 60-day animal model study. Every single batch--injected in a live animal into the muscle and proven to turn on stem cells. This is the gold standard. This is what every surgical company that produces the surgical grade has to use to sign off that it can turn on stem cells. We hold ourselves to that same standard. So when your audience hears about regenerative therapies or regenerative health, there are lots of modalities that claim that. We back it up with a guarantee. Every lot has to be tested by an independent laboratory, confirmed via histology. So this animal, 60 days later, the muscle is taken out, excised, looked at under a microscope--and yes, de novo bone and cartilage tissue was growing. There is nothing else that can do that. And that's what makes this complex so amazing.

Rob Lutz 16:39
That is amazing. You know, a question, maybe just a point of clarity, I would love to hear your definition, regenerative health and medicine. When you hear that, what do you want people to understand? What is your definition or your take on that?

James Scaffidi 16:52
I'll give you mine, and then I'll let Dr. Kim give you his. I look at, what does regenerative health and medicine mean for a clinical practitioner today? And this is where we took BMPs. Medicine would be the surgical grade, the synthetic individual BMPs. They come with challenges. We understand that, and that's medicine. There's always risks. When we look at regenerative health, the body is an amazing instrument. We all know that. To be able to regenerate our bones, our gut, stomach lining--every eight days, that stomach lining is turning over to all the acid. To be able to have a nutraceutical with true pharmacological response, that's regenerative health to me. Sure we could augment the body with calcium and say, "Well, we grew bone," using a very loose term for growing. You know, calcium fortifies bone tissue. It's not turning on stem cells and growing de novo bone. It's not signaling all these nutrients for gut health that help in inflammation, like herbs, like turmeric, curcumin. Sure, they help and quell your inflammatory signal, but to be able to activate or be absorbed to the various GI tissues, that's a whole new level in molecular health, cellular health. That's, to me, what regenerative health is all about. Hyun, your thoughts?

Dr. Yan Kim 18:12
Yeah. No, I echo that sentiment. No, I think regenerative health certainly is when you can improve human health with a complex of signals that nature intended to, not--versus not an exogenous amount of super-high physiological dose that, you know, imposes additional side effects and risk, safety risks. And this is clearly observed in the surgical and injectable products, the recombinant versions of these BMPs that are in the marketplace or being developed, where you know, delivery is an issue for for these modalities. And you have to use a dose that is incomprehensible and unacceptable to the human body, where you know, you're implanting milligram amounts of these proteins so that you can have some remaining BMPs that have activity at the local site of action. And this is primarily due to the very short half-life of BMP--exogenously delivered BMP, the systemic circulation or at the local site. Thereby, you know, you have--you're hoping for some of the BMPs to be left at the local site to have activity. And the initial delivery shocks the body and causes the body to react to it in a negative way, whether that's forming ectopic bone, like a shell, like a bone that's unwanted outside of the local area, or downstream effects on safety, like inflammation and swelling elsewhere. So really not a great modality there. But our--the beauty of this Cyplexinol complex is that, you know, you're delivering it orally, and at lower, much lower, doses that's physiological. And we have demonstrated that these are absorbed by the gut tissues and have downstream effects the way nature intended to be, so that it promotes gut health, but also crosses the gut barrier into the systemic circulation and has downstream effects in promoting bone and joint health, as well as other tissue systems. So it's not only bone and joint, but you know, it certainly seems to improve kidney health, muscle health, and so.

Rob Lutz 20:44
Without the side effects of the injectables and the synthetic forms?

Dr. Yan Kim 20:48
Correct.

Rob Lutz 20:49
Yeah, right. That's great. James, you look like you might have had something else to say on that.

James Scaffidi 20:54
There's so much to talk about. I'm always like a kid in a candy shop, and where Hyun is always getting papers from me at one o'clock in the morning or midnight, and found something new. The level of research going on around the globe is fascinating. When I came into this space, 17, 18 years ago, there was about 11,000 papers published worldwide on bone morphogenetic proteins. And I'm going to throw another term in for your audience, not to confuse the situation. The surgical grade is called demineralized bone matrix, because it's taken from human bone. So if one were to look up in PubMed bone morphogenetic proteins, the complex demineralized bone matrix, about 11,000 papers. We're over 32,000 papers worldwide. And what's exciting is--and Dr Reddy, who's, or the experts in the world on these proteins, they said, "We need to rename these. They're not bone morphogenetic, they're body morphogenetic proteins." Because just in as early as 2017, 2019, new studies are coming out that tell us that BMPs are instrumental in energy metabolism, sarcopenia, kidney health, and so in a host of areas in our body, anything with this rapid turnover and tissue regenerate, including GI health, we're seeing now. And so the field is just really, really expanding significantly, that we're now seeing all of these other applications. And that's what comes back to your original question of, "What does regenerative health mean?" To be able to provide a level of a natural substance that can have a physiological response and an enrichment of life by providing real value physiologically and then clinically. And what's the clinical benefit? And we've seen many, in many studies that we've done, clinical benefits seen depending on bone, joint, very, very fast.

Rob Lutz 22:49
That's excellent. So, you know, we talked--I understand the bone, you know, how I think loosely, how it works. But you mentioned joint health as well. Can you just talk about maybe a patient that a typical practitioner might see that this would be a good solution for them.

James Scaffidi 23:04
Sure.

Rob Lutz 23:05
Regarding joint health.

James Scaffidi 23:06
Sure. In our joint products, we take the Cyplexinol complex and we'll blend it, maybe with some herbs like a curcumin. Or we've just made a new product called--and our joint product is called Ostinol 5x, now with Maxicuma. And the Maxicuma is a different formulation of curcumin. So these herbs work synergistically with the Cyplexinol complex, because BMPs naturally downregulate IL-1, IL-6, and even IL-8. What does that mean clinically for your practitioners? You downregulate those pro-inflammatory cytokines. Things like matrix metalloproteinase, catabolic enzymes, go down. Clinical benefit to the patients? They're feeling better, right. Now, you can do that with herbs. You don't need this, but to be able to provide the signal for the body, that herbs cannot do.

James Scaffidi 23:57
Here's one of the most amazing pieces of research. Back in 2006, just as we were coming into this, the Journal of Arthritis Research Therapy published findings for the first time that people with osteo- and rheumatoid arthritis have decreased levels of several of these BMPs, number four and five, in the synovial fluid. Now this is exciting, Rob, because this changes our understanding of the pathogenesis of osteo- and rheumatoid arthritis. Why did two people go out and run, and the 220-pound guy is fine, but the 98-pound woman is struggling in her knees? It's nothing to do with the activity--that may compound it further--but we're learning now that for some reason, the body turns off the genetic expression of these proteins. So our--the stem cell that lives in the synovial fluid, the mesenchymal stem cell, requires BMPs to turn it on and become a chondrocyte. That's the cell that absorbs nutrients like glucosamine, chondroitin, MSM and turns it--literally stitches it--into proteoglycans to keep our joints healthy. That goes on every day. If the signal is turned off or missing, the stem cell sits in the synovial fluid going, "What would you like me to do?" And so, in a very colloquial sense here, we are looking at a change that is happening. We don't know why the genetic expression is turned off or downregulated. Is it genetics, nutrition, epigenetics, stress, viral? We don't know. What we do know is we're now seeing a correlation in new research just in the last 20 years that says these signaling proteins are critical to keeping our joints healthy. And so in our clinical research that we've done, both in double-blind, placebo-controlled trials, university level, crossover double-blind trials, when giving the product Ostinol with Cyplexinol as an ingredient, we're seeing rapid improvement in joint health. At a double-blind placebo controlled trial at university just two years ago, within two weeks, significant improvement in joint health. We've done now--blended our ingredient, the Cyplexinol BMP complex, with other herbs, and seen even faster onset of action.

Rob Lutz 23:57
Mm hm.

James Scaffidi 24:11
How is that being measured, as far as, or determined that, you know, there's an improvement for the patient? Is it--can you talk about that a little bit? What's the criteria?

James Scaffidi 26:20
So in those--in that particular study at the university, they did biomarkers, they looked at range of motion. And so whether we use a WOMAC, a VAS. those are looked at. In other studies that we've done previously, where we'll look at using the WOMAC to then assess. It is not always what's interesting--and Dr. Kim touched upon it--very, very short half-life of these proteins in serum. So it's not like you can go and look for them and measure after oral administration, because it's not the protein we're looking for, the BMP. It's the downstream activation, that of what it leads to, that whole cascade effect. Because at the end of the day, as a clinical practitioner, right, you've already said that word about it. Can I measure the protein of this? Or is the patient feeling better, and ultimately, is the joint getting healthier?

Rob Lutz 27:06
Yeah. improving outcomes, that's the ultimate goal, right?

James Scaffidi 27:09
Right. And that's really what we're looking for here. And so many of our practitioners that have used our products, that's really what they're looking at: is the patient feeling a difference? And I know a formulation that will work as quickly as one hour.

Rob Lutz 27:21
Wow. Yeah, because I think that is an issue with a lot of products that patients can take is, "Is this working? Is it doing what it's supposed to?" If you're not feeling a difference, what's the point, right? So, anything more that you want to share about, you know, what is the complex? What are we really talking about here? Is there anything else to add to what you've already shared?

James Scaffidi 27:40
Yan, do you want me to take that?

Dr. Yan Kim 27:42
Sure.

James Scaffidi 27:43
So when we look at biochemically what is this BMP complex that nature has developed? And she's really smart, Mother Nature. She put this all together. It's not like we could, as protein chemists, go and put all these BMPs together and have the effect. You couldn't, right? If you look at the spatial, temporal arrangement of the proteins, how the--the dissolution of them, it's all developed by nature. And so we're looking at a very specialized type of partially hydrolyzed collagen with all of these BMPs, 2 through 10, that are naturally present in bone. There are about 22 BMPs in the body. 2 through 10 focus on bone health. And so that's what's in the complex along with the other growth factors that Dr. Kim mentioned: TGF-beta, basic fibroblastic growth factor, vascular endothelial growth factor. It is the combination of all of this in physiologic levels that works. The partially hydrolyzed collagen backbone that the BMPs are naturally bound to is nothing more than the delivery of these.

James Scaffidi 28:46
I liken that to going to buy grapes. We all know when we buy grapes, we have a little piece of the vine in the bag. We're only interested in the grapes. I'm sure the vine has some nutritional value, but it doesn't taste very good and it doesn't make good wine. And so the BMP complex is just like that. The grapes are the various BMPs attached to this piece of collagen. And what we do at our manufacturing facility is take the natural bone and open it up in just the right way to express these BMPs. If you overprocess it, you kill the BMPs and are left with just plain collagen, which many companies manufacture. You need that at about five grams. We're talking about as low as 150 milligrams of the complex. And so it goes back to our processing and expertise understanding tissue and how to produce this complex. And again, then tested. Every batch we produce has to go for about a 60-day histological examination, a live animal. So again, going back to being able to test and say that this is guaranteed to turn on stem cells in a laboratory animal. There's no products that are out there today that can say that.

Rob Lutz 28:46
Mm hm.

James Scaffidi 28:51
Yeah, you can't say that about the collagen powder that people add to their smoothies or--right?

James Scaffidi 30:01
No.

Rob Lutz 30:01
Yeah. Not the same.

James Scaffidi 30:03
You can put a big scoop of that in your smoothy. And, yeah, there's value for collagen. We need it in the body, but--and there are some different types of collagen providing some value, but to be able to give the body those signals, that's what makes this Cyplexinol complex so unique.

Rob Lutz 30:18
Mm hm. All right. Thank you. All right. So, you know, probably what I'd like to spend a little bit of time on, and we touched on it just briefly, but really talk about clinical applications. You know, this is where I think our practitioners really have some interest. We've talked about the science and the history, and that makes a lot of sense. I think we understand a little bit better why this is such a powerful supplement for patients to take. But if we could talk a little bit more about the clinical applications, bone and joint. GI, I think you mentioned, is kind of a new frontier there as well. Could you just speak to that for a little bit?

James Scaffidi 30:48
I'll talk a little about some of our trials and studies, and maybe we could talk a little bit about some of the new research on that Max Energy study that we've just gotten back, and what that suggests here. So as a clinical practitioner, you're faced with patients that are coming in--maybe they have a DXA, maybe they don't. Mostly we're talking post-menopausal women. There's an interesting paradigm, Rob, in medicine today, which--I'm just stymied. Women go through menopause from late 40s to early 50s, and yet we don't do and recommend a DXA until 60. And it is the first five years post-menopausal where estrogen drops precipitously. So do DXA scores. And everybody says, "Well, we'll give HRT." But indirectly, estrogen crosstalks with BMPs in the body. It is the BMP activation that signals the stem cell. So when we look at that--one other thing on that front, we're now seeing research that says women lose as much as 43% of at least one BMP from age 20 to 50, and it's the same BMP that we are now learning is missing in joints of people with arthritis. How many women post-menopausal do your audience see that have both concomitant joint health issues and bone loss?

Rob Lutz 32:04
Mm hm.

James Scaffidi 32:04
It's the same missing BMP in the body. And so this is where you look at holistic, where you're looking at the patient, and what regenerative health is now teaching us. So a woman that presents post-menopausal, some bone loss, we have various strengths of the product. How much support does she need? Are we looking at somebody with just--who wants to be proactive? We've got a 150 milligram. Are we looking at a woman who is within three, four years post-menopause, and estrogen is dropping precipitously? Well, maybe we want to go higher using the Ostinol product with Cyplexinol. Couple of case studies that we published, and I'll go back--one of our earliest ones was a 59-year-old, non-smoking female, otherwise healthy, was on calcium and vitamin D3 for 53 months, and continued to see her DXA scores decline from osteopenic to moderate to severe osteoporosis. So now she went from all the way down as low as a -3.3, okay, and -3.6. That's pretty significant. And within eight months, after using 400 milligrams of Cyplexinol, we saw a stabilization. So for the first time in five years, a bone loss has stopped.

Rob Lutz 33:19
Wow.

James Scaffidi 33:19
That's clinical improvement.

Rob Lutz 33:21
Absolutely.

James Scaffidi 33:22
We all love to be able to see--did the bone DXA score go up? That's great. Did we stop the loss? That's great too. Or did we slow down the loss? And that tells us maybe we need to look at other factors, right? What's the parathyroid levels, vitamin D3, or do we need to up the amount of the BMP complex? So this particular woman, within--she was on 400 milligrams, came back two years later. DXA score improved over 50%.

James Scaffidi 33:49
And those are the kinds of cases--so here we are seeing significant change on the DXA. A more recent case study that was published was a young male. He's a naturopathic physician, partner with a rheumatologist. He--positive family history for osteoporosis on both parents, so pretty rare. He was a strong--genetically, he was at risk. In his late 40s, he developed severe osteoporosis, and he was diagnosed by his partner, a rheumatologist. We used 900 milligrams, and four months later, he went back on the exact same DXA machine, and there was a 9.3% improvement in the DXA. So again, looking at--there is a dose correlation. We'd love to be able to say we could correlate that, but we're not there yet. There's more empirical dosing on what clinicians feel--again, go back to when we talked earlier on safety. Can you go too high? No, not a chance. But, you know, we want to be able to look and say, if I can get an effect with a 300 milligram, then I don't need a 900.

Rob Lutz 33:49
Wow.

Rob Lutz 34:54
Right.

James Scaffidi 34:54
But it certainly can go up.

Rob Lutz 34:55
Yeah.

James Scaffidi 34:56
And we can titrating up and down as needs.

Rob Lutz 34:59
Yeah. That's exciting for someone that has those issues, because what else are they going to do? I mean, what other solutions are out there that you can actually prove that it's been working? And...

James Scaffidi 35:10
Right.

Rob Lutz 35:10
Yeah.

James Scaffidi 35:11
So one other thing I'll share with you on, uh, joint health. We had a naturopathic doctor working with us for a while, who used a lot, a fair amount of PRP, and, you know, talking about regenerative health, and PRP is shown to be very good in joint health. Didn't work so well in surgery. It caused more cartilaginous in-growth, and that's when we realized high levels of platelet-derived growth factor preferentially pushes the mesenchymal stem cell to a chondrocyte, the cartilage growth, versus an osteoblast. And so it fell out of vogue, use in surgery, but now became a good modality in joint health. And so this naturopath noticed that he would use six, seven injections, but when he started adding Cyplexinol complex, the Ostinol product, he was able to cut that down to two to three injections. So that suggests some synergistic effect between the two. Not surprised there at all.

Rob Lutz 36:03
Excellent. One other area, and I think you said there's some new research coming out, is GI health. What can you share about that?

James Scaffidi 36:12
Hyun, do you want to just maybe touch on that a little bit?

Dr. Yan Kim 36:14
Yeah, there's increasing evidence that suggests that BMPs have a central role in, I guess, the repair and promoting gut, GI overall--improving the GI health in people, in humans, who have bowel issues. So you can imagine. kind of, there's a lot of patients out there that have Gi--poor GI health, including even disease-specific like IBD, Irritable Bowel Disease, including ulcerative colitis, and disease. And it appears that BMPs are absorbed within the gut tissue and have some beneficial effects in maintaining the gut morphology, reducing the inflammation that is kind of the hallmark of Gi diseases, and essentially promoting new cells to maintain the GI cellular architecture that translates to--from improved functions.

Rob Lutz 37:20
Could be a solution for leaky gut--you know, potentially is that? Would that be one area as well?

Dr. Yan Kim 37:26
I think so. Certainly, we're hoping that this has huge impacts on customers who are facing GI issues in that as well as some of these other, colitis or...

Rob Lutz 37:26
Mm hm. So, this is a newer area of research. It more has been on bone and joint health, and now you're starting to see some research focused on GI health with some promising results. That's what it sounds like.

Dr. Yan Kim 37:52
Absolutely. And I--and you know, some of our physicians have experienced this improvement in their practice for patients who have--are experiencing bowel symptoms.

Rob Lutz 38:03
Which is so common.

Dr. Yan Kim 38:04
Yeah.

James Scaffidi 38:05
Yeah. And I think Rob, just to dovetail on that, anybody that's using any physicians involved in integrative functional medicine, using supplementation, augmenting prescription, knows that things like Boswellia is well known in the literature to help with the inflammatory process in the gut. Again, I always go back to, there's some real value in some of the herbs and supplements that are out there, addressing symptomatic conditions, but to start to address the underlying etiology, the behind the scenes of, "Why is this happening?" That's what BMPs, and that's what makes us a whole new frontier in regenerative health and medicine, because BMPs are the signaling molecule. I mean, if you go way, way back, we thought these were just involved in embryology, with little blastocells, signaling buds for arms and legs. In the last 50 years or so, the research has been phenomenal to tell us, "No. BMPs are manufactured constantly in the body and critical to keeping so many organs and tissues healthy." And that's really what makes it different than saying, "Well, I could just grab some curcumin or Boswellia and address the symptomatic." Sure. I can always do that, but are we able to really affect that patient's long-term health and the tissue health? And that's what BMPs are important for.

Rob Lutz 39:25
That's great. So really getting more into the root cause, not just fixing the symptom, which is nice to do, I think, if you're having some challenging symptoms, but if you could get to the actual cause of it all and resolve that.

Dr. Yan Kim 39:37
Right.

Rob Lutz 39:37
That's the ultimate goal. I think. Yeah.

James Scaffidi 39:39
Absolutely.

Rob Lutz 39:40
Well, is there anything else that you want to make sure that we're covering? I think we've covered a lot here, but this is really interesting stuff and really unique for a lot of the things that we talk about here on the podcast. This is a very different and unique supplement compared to others that are out there. But any other pearls or things you just want to make sure that we're communicating and sharing with the audience, before we wrap things up?

James Scaffidi 40:02
I think I would share this. One, today as a regenerative tissue science company, we sell a product, Ostinol. Doctors can get that today. That's where we have the BMP complex Cyplexinol. But as a parent company behind the scenes, ZyCal Bioceuticals, we're the manufacturer of the ingredient, we're the researchers. We represent for physicians, I think, what they've been looking for for a long time, that in between the pharma and a supplement, where we can certainly bring the rigor of Big Pharma and the scientific expertise--somebody like Dr. Hyun Kim, who's developed drugs--and look at what natural medicine and natural supplements can bring, and bring that same level of research to healthcare practitioners on the front lines. And what we do behind the scenes, we are continually doing research, both preclinical and clinical trials. Some of the work we just shared today in GI is research that we're embarking upon with other organizations. And so, you know, we would hope to be able to, in several months, bring you new updates in this field. We are constantly investing in where BMPs can take us and help, just as our pharmaceutical cousins are investing in where the singular BMPs--again challenges, and that'll be on the medical side, but still exciting and cutting. This is who we are. This is our DNA. We're only about BMPs and about regenerative health. So to your audience that may have questions or interests, reach out to us. We're not a broad spectrum. There's plenty of great supplement companies that sell everything under the sun. We go a lot deeper than just those kind of companies--focused in one area, and it's our mission to stay focused on the research, because that's what's really going to change the forefront of health.

Rob Lutz 41:49
That's great. And just to let the audience know on the show notes. I'll have contact information for James. We also have a number of articles that we're starting to publish on BMPs on the site. I'll include links to those as well, but I really thank you both for joining us today. This was really informative and I think really unique. I think it's a unique solution that I'm sure we're gonna hear lots more about in the coming years. So thank you so much for the work that you guys are doing.

James Scaffidi 42:14
Thank you.

Rob Lutz 42:15
I appreciate you being on the show. Thanks so much.

James Scaffidi 42:17
Thanks for the opportunity. Bye-bye.

Rob Lutz 42:20
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.