Breakthrough in stem cell activation: The First Oral Protein Complex for de novo Tissue Growth

Rick: Welcome to the “Chiropractic Economics” webinar series for doctors of chiropractic. I’m Rick Vach, editor-in-chief of “Chiropractic Economics.” Today’s webinar, “Breakthrough in Stem Cell Activation: The First Oral Protein Complex for Tissue Regeneration.” It’s sponsored by ZyCal Bioceuticals Healthcare. And as always, our program is being recorded and will be archived at Chiropractic Economics website, www.chiroeco.com/webinar, for one year. Our expert is on board here today to speak to you, and when the presentation is complete, we’ll follow with a Q&A. You can submit questions throughout the presentation by clicking on the appropriate icon on the right side of your screen. Our presenter today is Dr. Jaquel Patterson. She has a doctoral degree in naturopathic medicine from the University of Bridgeport and 11 years of clinical experience in naturopathy. She has specialized training in European homeopathy and biotherapeutics drainage, and is the president of the American Association of Naturopathic Physicians. Dr. Patterson, thank you for taking the time to participate in our webinar, and for sharing your expertise in stem cells, and helping our audience get a better understanding of stem cells and tissue regeneration. At this point, we’ll hand it off to Dr. Patterson. Thank you.

Dr. Patterson: Thank you. Thank you so much for having me. Really excited today to talk about breakthrough in stem cell activation through an oral protein complex. So, we’re going to walk through everything today. And actually, before we begin, I’m going to now share my PowerPoint screen so that we can go through the presentation.

Okay, there we go. So, as you introduced, I am a naturopathic physician. I’ve been practicing for over 11 years and I have a multidisciplinary clinical practice now with 6 other providers based in Fairfield, Connecticut. And my specific area focus tends to be autoimmune conditions, joint pains. Lyme disease is actually another really common condition I see in my office. And like you said, I’m actually the immediate past president now. So as of 2020, I am now the past president for the American Association for Naturopathic Physicians. And I also help integrative providers also build successful businesses. So that’s another component of some of what I do. So I’m excited to talk today about how I’ve used this product specifically in clinical practice. I’m going to go through some information. Also, I’m going to share some of my own experiences with patient cases in using this product in clinical use.

So the key objectives, so we’re first going to go through the main principles of the introduction to osteoinduction. And then it’s going to be followed by epidemiology and pathology, followed by the actual overview of how this protein complex works, so the osteoinductive protein complex. So we’re going to go through its inflammatory modulating effects of what’s called BMPs, which I’m going to refer to pretty frequently throughout the presentation, that’s called bone morphogenetic proteins. I will go through these BMPs and their stem cell signaling pathway, and then we’re going to talk about just principles of bone and cartilage. The last section, which is really my favorite and for most clinicians, will be on literature review and clinical trials. And also, just so you know, if you do have questions, we will be looking at them at the end. Unfortunately, I cannot see them during the time I’m presenting, but I’ll be sure to answer any questions that you have at the end of the presentation.

Okay, so, Cyplexinol is the patented name of the product and its nature is BMP, bone morphogenetic complex. It’s the first of its kind that proven to do two primary things. So one is to activate stem cells and the second is to regenerate tissue. So the complex itself is composed of what’s called bone morphogenetic proteins. And it also has really key growth factors. So TGF-β, which is the transforming growth factor, IGF, which is insulin growth factor, which we know is related to growth hormone. And TGF-β, just going back to that, is specific to cellular function in terms of cell growth, proliferation, differentiation. And then we have what’s called the VEGF, which is the vascular endothelial growth factor, which is responsible for formation of blood vessels, and then bFGF. So these are the components that make up this protein complex, this oral protein complex known as Cyplexinol.

Okay, so let’s go through a bit of the pathophysiology and epidemiology for osteoporosis. So it’s very much multifactorial. There is genetic determinants, there’s hormonal determinants, also also environmental and nutritional factors. So it’s really important in practice to really look at both osteoporosis and osteoarthritis because of many of our patients are going to be coming in with this on a consistent basis. For me, I mean, I’ve got to say, at least half of my patients may have one of these two. Often, unfortunately, with a slew of other condition types, but it’s an area that, in practice, we’re going to just see really a growing rate. And so this is what’s so great about this product is that it also helps to support, you know, a good amount of your patient base and what they are dealing with.

So, 54 million Americans are affected by osteoporosis as well as osteopenia in terms of low bone mass. And as I mentioned, more than half of the total U.S. adult population is currently affected. It accounts for the full medical impact, which is really important to know is it’s accountable for 2 million fractures annually related to osteoporosis, over 400,000, 432,000 hospital visits. And the majority of these visits are hip fractures, which account for 72% of the overall health costs. So I thought this was really interesting in terms of the total number. As in 2025, the expected cost is $25.3 billion.

So we’re going to talk about two things today, it’ll be osteoporosis and then osteoarthritis. So in osteoarthritis, it’s really the most common joint disorder. Nearly 1 in actually 2 individuals by the age of 85 are going to have a symptomatic knee osteoarthritis pain. And oftentimes, these symptoms will begin typically in your 40s and 50s, but progressively, you know, get worse as you get older, as we know. The major triggers for that are three things. It’s tissue damage from actual mechanical injury, let’s say activity, exercise, things like that. Also, transmission of inflammatory mediators, so if your system is more inflamed, this will go through the synovium into the cartilage, which is going to cause issues with osteoarthritis. And then the other piece is defects in the actionability for cartilage metabolism. So, some individuals are deficient in them and they found these two bone morphogenetic proteins, BMP4 and BMP5. There’s tons of BMPs, but these two specifically have been shown to be reduced in the synovium of people with both osteoarthritis as well as rheumatoid arthritis. So this can also be looked at as Cyplexinol for rheumatoid arthritis, specifically in how it downregulates some of these inflammatory mediators. In practice, since I had mentioned I often see autoimmune conditions, I pretty frequently use it as well for my patients with rheumatoid arthritis with additional benefit.

So in terms of the medical impact, it’s the leading cause of disability for U.S. adults for the past 15 years. And in 2011, there were an estimated 6.7 million hospitalizations. Ten percent of all ambulatory care visits, so that’s the total in terms of being admitted for ambulatory care are related to osteoarthritis. So as you can see, it has a huge medical impact, full-on medical impact.

Oops. Okay, so, now I’m going to talk about conventional modalities in terms of treatments that are frequently used to help address bone health, specifically osteoporosis we’re talking about. So pharmaceutical approaches include anti-resorptive. So, we have bisphosphonates, which are things like Fosamax or Reclast. We have calcitonin. We have denosumabs like Prolia as an example of a medication that is used as an anti-resorptive. And then also we have estrogen, which is also used to protect the bone, and then anabolics. In the natural approach world, in terms of nonpharmaceutical, through supplementation, oftentimes, people are using BHRT, the bio-identical hormones, also calcium, vitamin D3 and K2, these all help to include things like boron, which help to fortify the bone. But we’ll see the difference with this is, is it will actually help to not only strengthen it, but also help to prevent in terms of the continuation of things, like if you’re looking at a patient with your DEXA scan in terms of that progressing in, obviously, the direction you do not want it to progress.

So traditional bone supplements only help to fortify the existing bone tissue, which is good and is very much so needed, but the Cyplexinol works in a different form of not only just that piece in terms of fortifying bone. In terms of conventional modalities for joint health, which would be like osteoarthritis or rheumatoid arthritis, also different autoimmune conditions tend to be things that are anti-inflammatory in nature, like analgesics, NSAIDs, DMARDs like methotrexate. Biologics, common ones are Benlysta for biologics or Humira. Corticosteroids are often something they might use initially in treatment. And then in terms of natural and nonpharmaceutical approaches, one of the ones that’s most commonly used in studies is glucosamine and chondroitin. And that actually is also the number one top supplement that people use just naturally, glucosamine and chondroitin. But as you know, and at least I’ve seen clinically practiced, for some people, it does work but, you know, not for all. And so glucosamine and chondroitin is a common one that’s often used for joint health. The other things are just very various vitamins and minerals. Obviously exercise, PT, all those things to help alleviate some of the symptoms that a patient is experiencing.

So now we’re going to talk about Cyplexinol very specifically when I talk about how do we grow de novo bone and cartilage tissue. So, the discovery was made actually over 50 years ago. In 1965, Dr. Marshall List, Urist, I’m sorry, found what’s… He was actually researching to find out what it is in bones that makes them regrow. And what he discovered was an osteogenic protein complex. And this protein complex he found were those two things. He found that it activated and differentiated MSC, which is mesenchymal stem cells. And the specific mesenchymal stem cells that help to activate and differentiate were both osteoblasts and chondrocytes. The second fact was he found that it grows new bone and cartilage. That was found in this osteogenic protein complex. And what he decided to name it was bone morphogenetic protein. So, this was released as first study in the autoinduction of bone in “Science,” 1965. There’s hundreds and hundreds of articles regarding bone morphogenetic proteins, which you can look up on your own, but it was first founded and published in the autoinduction of bone in “Science,” 1965.

So, how do BMPs work? So, it has two unique mechanisms. The first unique mechanism is its immunomodulating effect. It acts actually against interleukin-1 and interleukin-6. There are many interleukins, but this will act against it. So, in terms of their activation pathways and then the downstream effect of these, of interleukin-1 and 6. So, you may know, but if you do not, IL-1 and IL-6 are proinflammatory cytokines and they activate both NF-κB and MMP, which is matrix metalloproteinase. And those factors, also what they would cause, especially NF-κB, in terms of osteoclastic activity, matrix metalloproteinase is on the extracellular area and it could denature protein. And so this BMP helps to downregulate both IL-1 and IL-6, which are the proinflammatory cytokines.

So, I want to discuss it in more length in terms of these inflammatory mediators. So, we have the proinflammatory cytokines, I just mentioned matrix metalloproteinase. So that’s MMP-1, 3, interleukin-1 beta, as well as tumor necrosis factor-alpha, which these are all connected, the cytokines. There’s many cytokines, but these have been connected with the development of joint damage and arthritis, as well as increased expression of COX-2, which obviously causes inflammation in the system. The NF-κB specifically accelerates the breakdown of bone. So it creates a greater breakdown of the bone. It promotes what’s called osteoclastic activity rather than osteoblastic. So it prevents, in terms of the good one, osteoblastic activity to lay down bone. It actually does the opposite in terms of osteoclastic activity. It also contributes to what’s called RANKL. It binds to that and it induces what’s called the osteoclast formation. And it is activated by interleukin-1. So interleukin-1 is one of the things that activates the NF-κB. So, targeting these regulatory cytokines, such as interleukin-1, such as interleukin-6, which increases that breakdown of bone, it’s really promising for allowing you to actually not sustain bone cartilage tissue as well as health in terms of decreasing the inflammatory burden on the body to manage. So, in IL-1, stimulates bone resorption. We talked about that as it pertained to NF-κB. It’s key in osteoclast activation and it exasperates it by actually cooperating with RANKL. And we just said RANKL is part of the osteoclastic activity.

Interleukin-6, increased levels in the synovial fluid circulation has been found for individuals with rheumatoid arthritis. So people with rheumatoid arthritis, with RA, oftentimes have higher interleukin-6 circulating throughout the system, and the Cyplexinol helps to decrease these, downregulate these two inflammatory markers, IL-1 and IL-6. So IL-6, in terms of how it functions, it regulates the osteoclastic differentiation as well. It upregulates what’s called COX-2, as well as the RANKL expression, which causes osteoclastogenesis.

So this is just a quick information on RANKL and how also what it’s known as tumor necrosis factor ligand superfamily 11. As part of that, receptor activation and nuclear factor-kappa-beta ligand, TNF-related active… I feel like this is… TNF-related activation-induced cytokine, osteoprotegerin ligand, and osteoclast differentiation factor. So it’s a member of TNF cytokine family and it, again, binds to the RANK of the cells of the myeloid lineage and function as a key factor for osteoclast differentiation and activation. So medications like Prolia targets RANK, specifically, on the osteoclasts to actually block the bone resorption. So, it works to target that specifically to prevent that issue with bone resorption, which is one of the things that RANKL does.

So BMPs reduce both the interleukin-1 and interleukin-6, and the SMAD, which is basically signaling pathway downstream, of BMP receptors regulates the gene expression. It downregulates the inflammatory mediators. And so what happens is you’ll see this rapid clinical improvement. So, what I’ll see when I’ve used it for patients, especially that have a lot of, like, inflammation, let’s say osteoarthritis or rheumatoid arthritis, is a great thing, is it helps to build those in terms of the tissues and bones. But also what people will often see is, kind of, immediate benefit in the inflammation because of the fact that it blocks the IL-1 and IL-6. So oftentimes you’ll see an immediate improvement because of that decrease in inflammation. Once activated, typically within a few days, at least in my experience, once activated, BMPs begin to downregulate both basal and TNF-induced expression of cytokines such as IL-1 and IL-6. So in each slide, pretty much in a lot of the slides, there’s a reference here on the bottom so you could see this is where this was actually published as well in the immunology journal.

Okay, so Cyplexinol has been 50 years in the making. There it goes. So again, it was founded in 1965 by Dr. Marshall Urist. It was used surgically in over 5 million cases. And you could see the time frames. And then the discovery, you see, was found in 1970, 1980 of the BMPs, of all the bone morphogenetic proteins in terms of the family, and then used later in surgical use. This later, in 2006, 2007, or actually 2007 there was a launch of Ostinol, which contains Cyplexinol as a product. So it’s been 50 years in the making. It had been used as it pertained to orthopedic surgery for bone and spine healing. So basically, it’s essentially rediscovering the discovery, which was, like I said, in 1965, from surgery to actually supplement form. And so this BMP complex works, specifically, like I mentioned, for bone and joint health. I’ve seen it work clinically for all of those different condition types.

And the actual complex, so let’s talk a little bit about the complex. It’s a partially hydrolyzed collagen backbone. It contains BMPs 2 through 10. And then it has those factors we mentioned, transforming growth factor, TGF-β, insulin growth factor, bFGF, VEGF. VEGF helps with the formation of blood vessels. So it helps, it stimulates growth cell differentiation. The two patents that are set up for is for protein extraction and processing as well as for its osteoinductive activity.

So the other thing is the question that comes up often is like, how is this absorbed? How is Cyplexinol absorbed orally? So the structure is very complex, where it allows BMPs from being destroyed in the harsh stomach environment. And actually, I had a chance to visit the plant myself and got to see that process and how it can actually surpass the stomach acid. Receptors, and one of these is receptors for BMPs within Cyplexinol are expressed along the entire GI tract. So it senses receptors for it, it’s expressed along the entire GI tract. It is able to be absorbed and effectively used in the body. And there are several journal references here below that speak to that if you are interested in learning more as it pertains to that piece.

Okay, so now, I want to make sure, I think… Apologize, but I wanted to see, there’s a stem signaling pathway that I think I somehow skipped. Oh, there it goes. Yeah, so I wanted to just make sure to point that out here was that the SMAD, which I had mentioned, 1, 5, and 8. They basically…they go down this way. So we have the BMP, bone morphogenetic proteins, the stem signaling had this transcription factor, which go into here through the nuclear binding factor. So this is just this whole interaction of how this works through the system. So I just wanted to make sure to point out that picture.

Okay, so now we’re going to get into the application, the clinical part, which is really amazing to look at these studies because it really helps to clarify things in terms of how it’s used by clinical response and activity. So, we’re going to first talk about the osteoinductive proteins and osteoarthritis of the hip and knee. This was a randomized controlled study. So in this study, it was a 12-week study, the N was 87. It was for individuals that were 55 and older. In this, the dosage was 150 milligrams of Cyplexinol used in the case studies. And if you see here on the left, this is the placebo because that’s obviously important when you’re looking at any study. And so what you’ll see is that in the first week, this was regarding percent of population with significant decrease in stiffness for what they felt in terms of a decrease in stiffness. So in a week, the study showed 42% had a decrease, reported a decrease in stiffness. At week 6, it went up to 67%, and then at week 12 it was 82%. So you could see, as it progressed along the curve, along the time, there was a significant decrease in stiffness. But what’s also great about this is that people also felt an improvement just in week one. And you can see it definitely surpassed the placebo. And the placebo stayed relatively the same as it went from week 6 to week 12.

And if you look at this, this next slide talks about, this is reported significant decrease in pain. The last one was for stiffness. And this one is for pain. And you can see, if you compare the improvement for decreasing stiffness was really effective. But the decrease in pain was even better by way of what was reported. So, you could see 48%, about 50% of the people in the study had said in the first week they had a significant decrease in pain, week 6. Again, this is with 150 milligrams of Cyplexinol. Week 6 was 87%. So it almost doubled by week six. And by week 12, 90% improvement, reported improvement in decreased pain. The placebo was 14%, so it was a little lower than the last one with stiffness, and, again, you could see it was pretty much the same throughout the timeframe from week 1 to 12.

So quality of life, this is always an important piece when you’re looking at research studies. You could see the improvement to 36%, 75%, and then 90% that was reported with use of the product by week 12.

Okay, so, now we’re going to go over the osteoinductive effects of Cyplexinol in the effective management of osteoporosis. We’re going to go through some specific case studies. So in this case study, it was a 59-year-old female. She was postmenopausal, osteoporotic already. She had osteoporosis. She wasn’t a smoker and she didn’t have any history of chronic disease conditions like type 1 or type 2 diabetes, Paget’s disease. This was all ruled out. Primary hyperparathyroidism, you want to look at that because of calcium. No, she had no history of osteo or rheumatoid arthritis. So that was important for this because we were looking, again, at just the case of osteoporosis. And then she also was not on a bisphosphonate or HRT, no hormone replacement therapy. So in this, she was on a treatment of calcium and vitamin D for 53 months. And during that time, when she was on that supplementation, her DEXA score, lumbar L2 DEXA score actually worsened. So it went from -1.3 to -3.5. And her average DEXA score declined as well, 1.3 in terms of the difference. So -2 to 3.3. So, that was the result on the top here that she had with just the treatment, with the supplementation of calcium and vitamin D. So, the severity of it did increase.

Now this next study shows what happened with Cyplexinol supplementation. The dosage was higher. The other studies we showed was for 150 milligrams. I don’t know, I think my fingers are moving too fast for this mouse. So she was on 400 milligrams for 34 months. And if you look at this, her DEXA score improved, so it went to -1.8. So it reversed. So it went from… Remember, her number, in the beginning, was -1.3 and it progressively worsened to -3.5. So it went from -3.5 to -1.8. Pretty significant improvement. And her average DEXA score went from the -3.3 here to -1.6. So, it was, overall, a 54% of improvement, which is huge as it pertains to her DEXA scan going in the right direction, obviously, preventing her from getting injured and the severity of her osteoporosis getting worse. This here just shows the study, you know, along the graph, which shows…you could see how it was going down in that first 53 months that it was used for the study. And then this 34 months here, as it went opposite, in the direction we wanted to over the course of the 34 months. So it was a 54% improvement. This was published in “Integrated Medicine: A Clinician’s Journal.” And oftentimes, I thought this was interesting when I first started using the product because a lot of times we just focus on, like, stabilizing, that just stays here, you know, it doesn’t get worse. But the awesome thing with this is it’s actually going in the reverse direction and even improving from what the initial number was.

So these are some additional case studies as it pertains to osteoporosis. This one is a 61-year-old male who was diagnosed with polio at 5 years of age. He noticed a determination in bone health, taking calcium and vitamin D, it decreased from -3.9 to -4.2. So it did increase, it wasn’t as significant as the other patient but it did get worse. So in this study, he was given 900 milligrams of Cyplexinol for 4 months. It was a much higher dose for a short period of time and then it was decreased to 350 milligrams for 20 months. And his number improved. It went from -4.2 to -3.3 in terms of the DEXA scan. So you can see that improvement pretty dramatically in that short period of time in that reverse direction. And this was published here, which is the listing, the reference shown there on the bottom.

This is another one with a woman. A 40-year-old woman who had a hysterectomy at 19. She suffered her first fracture at 32 years of age. She adopted a very bone healthy diet at 32 and she did bioidentical hormones between 48 to 50. But, as you can see, over the course of 14 years, her number progressively worsened to -2.7 starting from -1.7. So worsening by a point. And she had osteoporosis by the age of 53. She was given 450 milligrams of Cyplexinol. The DEXA improved from -2.7 to -2.2 in two years’ time. So it did go up. It was going down, as you can see here, and this is what the change was with that supplementation.

This one is here, a 59-year-old woman who was taking medication. So she was taking a bisphosphonate medication and calcium. And what’s interesting, that it relatively was stable, declined by -0.1. For the most part, it was pretty stable. But with that, they, and in addition with the study, they added 450 milligrams of Cyplexinol, and you can see with the adding of the Cyplexinol itself, it went from -1.1 to -0.4. So it improved. So even surpassed, you know, what the use of the medication which kept stable actually had to go in the reverse direction at the negative point for almost being neutral and normal in terms of not being osteoporotic.

Okay, so, I wanted to also share that I’ve had a patient myself when I first started using the product, and she was about 55 years old, female. And what happened was she had no issue, very athletically fit, eating well. And she just slipped and broke her forearm, her whole forearm. And she didn’t understand because it was just a minor step and she broke her forearm. And so when they checked, she had osteoporosis. So I said, “Okay, this is great. This is a great person to use it for.” And so she had done, obviously, the DEXA scan and one of the pieces where we’re trying to figure how to manage and monitor her because some of the results… She didn’t want to be on medication, and so the DEXA scans are usually approved every two years. So she decided to, you know, check in a little bit earlier, a year earlier than the time that she was technically approved for. And so I put her on a high-dose of Cyplexinol, 450 milligrams.

First, we did 900 milligrams for 2 months and then I stepped down to 450 milligrams a day. And what was awesome was she told me, I think about halfway through, she did have an injury where she fell and she said, “Oh my gosh, I fell and I was okay.” And so to her, that was an indicator that her system and her bones might be stronger. But the cool thing was when she went in to test for, basically, a year later, her number had significantly improved, so she actually moved from being osteoporotic to osteopenic. So it was by about 0.7 improvement. And so that was just in the course of a year. And I’m sure she’s stayed on it. And so she’s continuing, I’m sure, to go in that direction, but it was really neat to see clinically the difference in the, you know, going from osteoporotic to osteopenic in terms of going back to “normal.” So that almost, that was a good case and sometimes it takes longer for osteoporosis because you’re not checking, you know, one or two years down the line.

The awesome thing with looking at osteoarthritis or rheumatoid arthritis, which I’ve also used Cyplexinol pretty frequently with patients, is it often will have that immediate improvement in their pain within a week. And I’ve had a couple of patients that they’ve been able to cut some of their medications or get off of it because of the improvement with Ostinol, not needing the same medications that they did before as it pertains to the inflammation they’ve had on their joints.

So the Cyplexinol paradigm shift is a paradigm shift in molecular nutrition. It’s supported by our research and clinical use. It’s been in 50 years of research. It’s been used medically for 35 years in surgical and oral use. And then it’s been, for actually a little over 10 years now, used in supplement use by chiropractors and naturopathic doctors like myself as well as other integrated provider types. It’s supported by research and clinical use. As I mentioned, there’s hundreds of articles on this. And it is the only BMPs…only product, oral protein complex that has bone morphogenetic proteins that are osteoinductive. Cyplexinol is the only one that provides and shown to have a clinical benefit in some of these, helps to downregulate some of these inflammatory mediators and also has the chondrogenic as well as osteogenic effects.

So these are the different forms in which they come throughout the market through Cyplexinol where this can be accessed. And actually, for participating in this webinar today, you do get one free bottle of either Ostinol Advanced 475 or Ostinol Advanced 5X. Me, personally, I love the 5X product because it has Boswellia in it as well, so it helps blocking COX and LOX pathways very much like, I guess, a steroid would do without using a steroid.

My test, when I first used it, I suggest giving it to a patient… I mean, you could do, obviously, for joint health or for bone health, but for me, when I first tested it out, I wanted to do it for joint health for somebody that had inflammation to see how fast that product works. So, I used it, for me, the person who was very… There’s a couple of cynical people in my life who tend to be usually for us, right, our family members. So I used my brother who, he is 46 and he was a former competitive, you know, football athlete, also formally in IFL and jujitsu, has his own jujitsu gym. So he’s been beat up a lot, has had multiple knee surgeries and things like that. And so I know when I gave him the product, I did the, it was in, like, three or four days. He actually forgot about the pain that he was having because he was having pretty significant knee pain which swells, kind of swells, comes and goes. And he had said to my family and friends, you know, “What is this, like, magical stuff that Jaquel had given me?” So that was a good process experience for me because, you know, trying it out with somebody that I knew would be a little bit more, you know, maybe skeptical, it was always a good way to see if it’s working or not, I mean, so much so that he actually had forgot about that acute pain that he had.

So, I personally like the advanced 5X because it has the Boswellia in it, too, which is for inflammation. All of them are great. I have a lot of patients on the Advanced 475 who have osteoporosis and I keep them on that either the 250 or the 475. Oftentimes, I might start off with the 475 and then decrease as time goes, but it’s great that this is an offer. Definitely try to take advantage of it. And I appreciate everyone for being on the webinar now to be able to listen and learn more about this specified Cyplexinol and this specific protein complex and how it works. I’m now free to answer any questions. I know James Scaffidi who is the director and president of ZyCal is also on the call to be able to help answer any questions you may have. So thank you. I’m going to turn it over to the presenters.

Rick: Thank you, Dr. Patterson. That’s really informative. We appreciate it. As you said, we’ve also got James J. Scaffidi, CEO and president with us. Mr. Scaffidi founded ZyCal in February 2006 after working in the healthcare industry for nearly 30 years. Mr. Scaffidi received a BS degree in biochemistry and completed three years of graduate-level research in entomology and protein purification, and is currently working on his doctorate in natural medicine. We’ve been collecting a couple of questions from our audience. First off, how does Ostinol compare to Metagenics, Xymogen, Standard Process, or Designs for Health bone and joint products?

Dr. Patterson: So, it depends. I know a lot of those companies have different bone products. I know Designs for Health, they do have…because I do it directly through ZyCal, but Designs for Health actually does carry that product. It’s called Tissue Regeneration Factor. So they call it Tissue Regeneration Factor, which has that product in it. So I know a lot of the products, the Standard Process ones, for example, have a lot of bone fortifying products within it, like, obviously, calcium, vitamin D. A lot of them have these products that are bone fortifying. However, none of these products have anything that’s going to actually help to stimulate, you know, these mesenchymal stem cells that actually increase the growth of osteoblasts and chondrocytes. They will help to fortify and strengthen, not necessarily to help increase the growth to be able to see like a reverse in something like the DEXA scans or helping with the cartilage directly in that way. They will potentially help with the fortifying. Some of them also help with decreasing inflammation. There’s some like glucosamine and chondroitin people use, Boswellia that will help with the actual inflammation burden your body has, but it’s not really getting to the root of, like, actually healing and repairing it, which is how this product or this specific constituent would be able to provide for. And I definitely have used Xymogen. I actually, very much use many Xymogen products in my office. They definitely have a lot of ones that are, again, fortifying but nothing that has, like, these types of protein complexes.

Rick: All right, thank you. And another doctor asks, “How do the proteins, BMPs survive the gut acid?”

Dr. Patterson: Okay, so I always…I can answer, but I feel like James always answers this much better than I do. So I’m gonna change it over to him.

James: Sure, thanks, Jaquel. And thank you also to Chiro Economics and all the doctors that are participating on the call today. Bone morphogenetic proteins are one of the most unique classes of proteins that we know of that are stable and acid-resistant. It goes back to the tertiary and quarternary structure of the proteins themselves, how they are naturally folded. And because of their folding, this is what resists both enzymatic and hydrolytic degradation. They’re high in lysine and proline which resists HCL. So no concerns at all of the protein being bioactive within the gut environment.

Rick: All right, thank you very much. And another question from a doctor, “Can Ostinol products turn on any other cells or cause any other effects?”

Dr. Patterson: This is another question that comes up pretty frequently and I’ll let James add on if he would like to, but it hasn’t shown to that. I think people ask as it pertains to stem cells. This is not stem cells directly. It does help to stimulate mesenchymal stem cells, you know, and works if you are deficient in these, like the BMP4s and 5s I’ve mentioned for osteoarthritis and rheumatoid arthritis, but it helps to stimulate them. It’s not, you know, like stem cell directly, which I know there is a lot of conversation about that now, which also has, you know, in terms of research, but this has not been shown to do so. And again, James, I don’t know if you have anything to add onto that.

James: So I’ll just dovetail what Jaquel just offered. Our backgrounds before we launched this version as a nutritional supplement, we were the same team that manufactured and marketed this protein complex for surgeons. I personally worked with orthopedic oncologists that would excise a bone tumor and then backfill that bone void with these proteins. It is that safe and that’s because the bone morphogenetic proteins are specific to a receptor on the mesenchymal stem cell, and the mesenchymal stem cell only. So no concerns about turning on or off anything that is unwarranted in the body.

Rick: Wonderful. Thank you. And…

Dr. Patterson: That’s a good question.

Rick: We’ve just had two more questions come in. We’re going to answer these then we’ll come up on our time limit. Question, “Are there any contraindications for taking this product, and what, if any, side effects are there?”

Dr. Patterson: I have had… I know that there’s no known, like, shown contraindications technically. However, as we know with patients, some people are sensitive to some things and not, you know, even if there’s no necessary contraindications with the medication and things that they’re using. I have had… So one thing you should know, they’re bone morphogenetic proteins, so if you have someone that’s, obviously, like a vegan or something like that, you don’t want to put them on that or they’re sensitive or allergic to any kind of product in terms of, like, knee or bone source. I have had to put some vegans on this. I had a 32-year-old that was osteoporotic and she’s vegan and she was totally willing to take it and her numbers are getting better. So I have done that. I assume, I’m trying to think clinically, I’ve used it a lot and I honestly have not had any patient say… Common ones for me are like nausea, or, you know, not feeling well, or dizzy, or headaches. I haven’t had any reports of that. And trust me, I have a lot of sensitive patients, so I hear that all the time from them if there is something. So, there’s no known study but, obviously, some patients could probably get those common things. You could just, if you’re just sensitive to, you know, a product in general.

James: Okay. The only other thing I’d add to that. First of all, we’ve had an independent preeminent toxicology group certify the ingredient and product as generally regarded as safe. So it has GRAS status. But patients that present with osteogenesis imperfecta, that is a genetic miscode. So even providing our product, while it’s not contraindicated, it would not be of benefit. So there’s really no help there. Well, if you do get an occasional patient, these are very rare, that has Paget’s or Paget’s disease, we’re not going to be of any value there. Again, no contraindications because there’s, as Jaquel pointed out, the protein is extracted from organic bovine and these proteins are naturally found in beef. So it wouldn’t be a contraindication but just of no clinical value.

Rick: Wonderful, thank you. And another question from a webinar listener. “How does this product intermingle with stem cell treatment, i.e. bone marrow or umbilical allograft?”

Dr. Patterson: I see that one. I also see there’s another one that I wanted to answer on what effect does it have on OA. So if I can answer that after this. I don’t… I probably, I mean, personally don’t know if I would. You know, if someone’s on stem cell treatment, bone marrow…it shouldn’t be, I guess, necessarily contraindicated. I just don’t know if it would be something you would need to do because they’re getting stem cell treatment specifically, unless it’s for something different. You know, I have patients on stem cell. Obviously, it’s not necessarily for something like osteoporosis. I don’t know, James, again, if you have more with that, specifically, a question.

James: Yeah.

Dr. Patterson: Yeah.

James: We’ve seen some of the challenges with stem cell treatment. So we see right now the medical community doing this, where they’re removing the autologous stem cells or serum or marrow, spinning it. The FDA is looking at this pretty harshly by the medical community and not favorably because many times the patients have to be sent out of the country for reinjection. It is being regulated as a drug. But when we think back, what is it we’re doing in a stem cell treatment? So the stem cells reinjected are not there to mature and differentiate. They’re really there to lyse open and release growth factors. And interestingly, the same growth factors that are being released are the growth factors that are in Cyplexinol, devoid of the BMPs. So you’re really trying to kickstart the native stem cells in that patient. Now as Jaquel shared on this presentation, she has seen firsthand, the research has shown, all of these stem cell activation properties are what is contained in Cyplexinol.

Dr. Patterson: And…

James: I see a question coming up.

Dr. Patterson: And I see the one question I couldn’t answer. It says, “What effect does it have on osteoarthritis?” And so what effect it has, the Cyplexinol, is that it helps to stimulate, again, the mesenchymal stem cells for both osteocytes and chondrocytes. So chondrocytes, and helping to support the cartilage. Also, the other piece for osteoarthritis, so helping with the cartilage repair and also it helps with downregulating interleukin-1 and interleukin-6 with our two inflammatory marker…you know, how that could be highly elevated have been shown to be elevated in individuals with osteoarthritis. So it helps with some of the pain relief as well as the piece as it pertains to the chondrocytes directly.

Rick: All right, I believe we’ve run through our questions. So, at this time, we’d like to thank our sponsors, ZyCal Bioceuticals Healthcare and Dr. Jaquel Patterson for today’s webinar. And thank you all for attending. And remember, this webinar, including our speaker’s PowerPoint presentation has been recorded. We will alert you when the webinar is available online. Thank you again for attending, and we look forward to seeing you next time. Have a wonderful day.

Dr. Patterson: Thank you, everyone.