Recorded: June 25, 2:00 p.m. EST Speaker: Mike Carberry, DC
Rick: Hello, everyone, and welcome to the Tuesday webinar series, “Chiropractic Economics Webinar for Doctors of Chiropractic.” I’m Rick Vach, editor in chief of “Chiropractic Economics.” Today’s webinar, “Regenerative Medicine Basics” is sponsored by Advanced Medical Integration. 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 his presentation is complete, we will follow with the Q&A period. You can submit questions throughout the presentation by clicking on the appropriate icon on the right side of your screen. Our presenter today is Michael Carberry, Doctor of Chiropractic. Michael and his physical therapist wife Coleen founded AMI, endeavoring to create the healthcare model of the future. He will cover the types of regenerative medicine opportunities with regenerative medicine, including better patient outcomes and profitability and more. Dr. Carberry, thank you for taking the time to participate in our webinar. Before we get started, would you please give me a brief background on yourself and your work with AMI?
Dr. Carberry: Okay. I graduated undergrad school in 1983 with a BS in marketing, and it was through an injury I went back to school after being helped by a chiropractor. And I graduated from Life University in 1991. I started my practice in Pennsylvania and working with, you know, lots of patients. We had a very high-volume practice when we started thinking, “What could we do to help our patients even more?” Being married to a physical therapist, I wanted to have a multi-discipline practice with chiropractic and PT and found out that in Pennsylvania I could not refer to a physical therapist because I was a chiropractor. So we eventually integrated in 1996, and we’ve been working with the medical community ever since. AMI was actually…we were asked to teach our model of integration about six or seven years ago, and we’ve grown to the largest consulting company in integration in our space. So, that’s our background with Advanced Medical Integration. I just authored a book, “The Death of American Healthcare,” and, you know, we’re just trying to get people educated about healthcare and various modalities.
Rick: Very good, and thank you for that background. And now Dr. Carberry will begin his presentation.
Dr. Carberry: Okay. Thank you. I wanna start off by saying that I’m not a researcher. I’m not a medical doctor. I’m not the most advanced expert in this field, but because regenerative medicine is something that is very interesting to a lot of people in healthcare and it has gravitated into the physical medicine space, I had to educate myself on it. And in the process of doing that, I learned lots things, and I found that there’s a lot of confusion and what we call the Wild Wild West when it comes to talking about regenerative medicine.
So what I wanted to do was just share today a little bit of basic information so that people who are interested in it in working with it as a clinician or in their clinic model can have a bit more understanding of the science and the basics of, you know, marketing and so forth. So with that being said, let’s start to take a look at regenerative medicine basics.
So, the word stem cells has become a buzzword in our healthcare industry today because a lot of people hear about stem cells and, “I wanna do stem cells,” and, you know, stem cells are good. Stem cells are not so good. It’s a lot of information. But regenerative medicine is the use of your body’s systems of healing, and particularly, stem cells is a part of that. Excuse me. So, I’d like to explain a little bit about what a stem cell is and how they occur naturally in a human body.
So what happens is when you’re first conceived, you have a cell from your mom and a cell from your dad come together, and that’s in the fertilization process. And they start to reproduce, and what you get initially is a cell mass called a zygote that continues to multiply. And in just a few days, about four or five days, you have what’s called a blastocyst, and that’s usually about 500 cells. The majority of those cells are stem cells, and they adhere to the uterine wall. So, this all happens very, very quickly in the first five days.
And what those cells can do is they can differentiate or change into other cells to form the tissues of the baby that is developing inside the mom, and they can become just about every organ, every tissue, every, you know, skin, muscle, tendon, ligament, bone, nerve, organ. So that’s how the body is formed. It starts with these two cells joining together and starting to multiply, and you process down that line. And that’s where stem cells come from. Stem cells are a category of these cells. So let’s take a look at it in a different way.
If you look at this chart that I have on the screen right now, you have the fertilized egg, and basically, it’s a totally unspecified or unspecialized type of entity that is being formed. And you start to form cells along the way, and they’re called totipotent. So what totipotent cells are, it means total. These cells that are the beginning of this whole process can turn into any type of cell. So that’s why they’re called toti, meaning total.
That’s the zygote and the morula. These are tissues when the first conception takes place, and these cells can develop into almost any type…they can develop into any type of cell that is needed to develop the baby. Then what you have is they form, they come a little bit more specialized, and these are called pluripotent cells. And pluripotent cells is what forms the blastocyst.
These pluripotent cells are more specialized, and they can actually develop into other cells. The pluripotent would be the three germ layers that can form in the developing fetus. These are embryonic stem cells. Totipotent and pluripotent cells are embryonic stem cells. If you were to try to get those involved in regenerative medicine, it would mean sacrificing the baby. So that’s not the type of cells we use.
What pluripotent or these blastocyst cells change into is multipotent cells, and this is where you start to see your different specialized type of cells. They’re more specialized, for example, hematopoietic stem cells. These are cells that can form blood cells, neural stem cells. These can form nerve tissue. Mesenchymal stem cells. These can grow into all types of connective tissue, including bone, cartilage, muscle, fat. In the orthopedic world, these are the types of stem cells that are sought in trying to help people repair damaged tissue.
So, if you notice on the slide that I have here, there’s a little on the left side of the screen, isolated pluripotent stem cells from an inner cell mass and cultured pluripotent stem cells. And there are people that argue that these are the best source of stem cells because they can turn into anything, but because of the huge ethical issue, stigma of working with aborted babies, and, you know, there’s only two ways to get those cells. You either abort the baby, or you fertilize in vitro, and then you take those cells, which means if you fertilize in vitro and life is conceived, you’re sacrificing your baby or fetus or embryo there. So there’s a lot of people that wouldn’t wanna work with that, and I fall into that category. I would not wanna work with tissues that came from aborted babies.
But when you get on the other side of that channel, then you got these stem cells that actually are present even when the child is born and throughout life. This is the way humans repair. It’s the way they fix their bodies, using these cells. So we’re gonna talk a lot about that in this presentation, the multipotent stem cells and how they can be used and sources of them and so forth.
So, there’s another one I wanna talk about, and that is induced pluripotent stem cells. And this is where you take cells, and you can introduce a few genes into the cells, into the specified cells, which can cause them to possibly revert back into a pluripotent stem cell. And this can be done. It’s not actually science yet. It’s what’s being pursued. So this is not something that’s actually happening, but it’s what a lot of people think the future of stem cells are. And that’s where you could take stem cells from a healthy adult or even a compromised adult and then manipulate the genes to get it to go back into a pluripotent cell, but that is not fully specified yet.
And researchers claim that they have actually grown organs in a lab doing this already. When modern medicine looks at stem cells, a researcher would look at this, that’s the area they’re gonna look at. A pharmaceutical company, if they decide they wanna get into the stem cell market, that’s where they’re looking at because, by manipulating the genetics of the cell, you come down with a patentable process, and then all of a sudden, that is now a pharmaceutical or a drug and it’s patentable, and it can be very, very profitable for the company. We’re not gonna talk about that so much in this presentation. We’re gonna talk more about the cells that can be found in the average human, and that would be the mesenchymal stem cells and the hematopoietic stem cells and so forth.
So, to understand this better, I’ll just tell you a quick little story. I heard somebody explain this one time, and it made a lot of sense. Stem cells are a lot like a young child when they’re little and they have any possibility in their future. They haven’t decided on what they wanna do. They just know that someday they’re gonna grow up to be great. They’re gonna be a pilot. They’re gonna be a policeman. They’re gonna be an astronaut or whatever. And then they start to make decisions in life that direct them down that path, and that would be where they start to go into different schools and pursue different educational activities so they can learn how to do that. And the further along that path they go, the more specialized they become until, eventually, they get so far down that path that they can’t change or would not be willing to change to go back and start all over again, or it would be rare that that would occur.
That’s similar how a stem cell develops from a totipotent all the way up into a multipotent or even a unipotent, which we don’t have on the slide here, whereas a unipotent, all they can do is produce another identical cell of the same type, whereas say a multipotent cell, a mesenchymal stem cell can change into cartilage or change into bone or whatever is needed at the time. So, that’s how they actually are classified, to understand that. So there’s different types of regenerative medicine. Understanding those classifications, let’s take a look now and see where we can get cells to help somebody.
So what happens is there are autologous cells. When you’re born, it’s estimated that 1 in every 10,000 cells in your body is a stem cell, and then as you get older, that number starts to decrease. So, when you get to about the age of 80, now it’s estimated that only 1 in 2 million cells is a stem cell. So they drop off dramatically. So, there are authors and a lot of people, and I believe this as well, think that that’s one of the main reasons why people have a harder time healing as they get older. If you look at a young child, say it’s a baby or maybe a toddler, a one or two-year-old falls down and breaks their arm, right? The healing time for that could be as little as two weeks. People believe that’s because of the abundance of stem cells in that young person’s body. If you take a 15-year-old, it’s gonna be like 4 to 6 weeks. If you take a 40-year-old, it’s gonna be like 6 to 8 weeks. If you take a 60-year-old, it could be 8 to 12, and if it’s an 80-year-old, it might be 12 or longer because of the amount of stem cells that are available in the body. That’s the theory.
But you get the idea, the more stem cells you have, the better you heal because what stems cell do once you’re born is they are attracted to different areas in your body through different cell signalers, which we’ll talk about in a little bit, and they’re called to an area to help repair damaged tissue. That’s how your body actually repairs itself. So, for example, if somebody broke an arm, the stem cells would be called to the area due to the release of certain cell signalers called cytokines, and then the stem cells and the growth factors and all the different enzymes in that area that are for healing would go to work in repairing that tissue. That’s a healthy person and that’s what would happen. So, if you get cells from somebody’s body, these would be services like protein-rich plasma or platelet-rich plasma, which we’re gonna talk about in a little bit, also known as PRP, or bone marrow aspirate. You can get stem cells from somebody’s bone marrow, and we’ll talk about that as well. Or you can get stem cells from somebody’s adipose or fat tissue, which we’ll talk about that as well. So these are autologous.
There are some people that argue this is a better source of stem cells because they’re from your body. There’s no chance of rejection or reaction to the tissues because they’re not from your body, because these tissues are from your body. There are other problems where people argue that the older you are, the less you have, and the less this type of regenerative medicine works on somebody because you’re older. So, that’s one source of these. Let’s take a look at some of them.
So, for example, PRP or platelet-rich plasma, it’s basically in your bloodstream. You draw blood out from the patient, and you spin it down. And usually, you do a double spin, and there’s a certain technique to it. But you’re trying to separate the platelets and the serum from the blood cells, and what happens is you end up with this. If you see that picture all the way to the right, it’s a clear or semi-clear fluid like a yellowish color, and that is after the blood has been spun down and the red blood cells have been drawn off or separated, you’re injecting a platelet-rich portion of that. And the theory is, when it’s injected into an area, the enzymes in that platelet-rich plasma will stimulate healing to occur in your body. So, it’s a substance that’s thought to promote healing when injected. Plasma is a component of your blood that contains factors or proteins that help your blood to clot, but they also could contain things that support cell growth.
And researchers have produced PRP by isolating the plasma from the blood and concentrating it. So, in this type of treatment, which is a treatment from your own body, you’re using somebody’s own blood and you’re spinning it down, you’re trying to utilize that to help heal that person and get that body to heal. The idea by injecting PRP into damaged tissues, nobody really fully understands exactly how it works, but they do know that people get results from this. And I’ve talked to a lot of people who’ve done it. We’ve actually done…we do this in our office in our clinic in Chattanooga, Tennessee. But what it does is it helps to stimulate your body into a healing mode in that area to grow new healthy cells and promote healing. And the tissue growth factors are more concentrated in this preparation. So, when it’s injected, researchers think that the body’s tissue may heal faster.
Now, although this treatment hasn’t been definitively proven, and the FDA doesn’t say, “Well, this is an approved treatment,” that doesn’t mean you can’t do it. It’s just that the FDA doesn’t say, “This is a valid treatment.” They haven’t given that stamp of approval, but clinicians are allowed to do this. And where it got its real big boost is athletes like Tiger Woods and Rafael Nadal have used these things to help heal up injuries and get back onto the playing circuit very quickly and did very well after they did that. So, using PRP is sometimes a good form of regenerative medicine that can help somebody to heal.
Let’s take a look at some other ones, bone marrow aspirate. This picture here is a physician drawing bone marrow out of a patient’s hip, and the way this is done, you use what’s called a trocar. And a trocar is a way to punch a device, a sharp device into the bone into the marrow of the bone and to help draw out bone marrow. And then what happens is in this bone marrow, there are cells. And so you’re pulling the cells out. And, you know, I don’t exactly know how they do this, because I’m not a surgeon. I’m not a medical doctor. I haven’t done it. But they pull the cells out. They help to concentrate these cells, and they inject them back into the patient.
And there’s different claims about what kind of cells are in there, but, you know, most likely there are mesenchymal stem cells in there. There’s also hematopoietic stem cells in there. And when you inject them back in, the idea is you put this in an area that is damaged and maybe not healing as properly as you’d like it to, and it’ll accelerate the healing process. So that’s the purpose of it. Some of the drawbacks of this is the older the patient, the less likely that this type of treatment is gonna be effective. It’s also that people report that it’s painful. You’re actually punching into a bone and trying to get to the marrow. There’s a possibility of infection. But it is a way to help stimulate a natural healing process. And I have friends that are surgeons and friends that are anesthesiologists that actually do this method.
One friend of mine is a SWAT doctor in a major city, and that means what he does is he trains with the SWAT team. And he goes in with the SWAT team with a shield in a doctor’s bag, and he carries a gun on his hip, and he actually has to…if any of the officers get injured during the encounter, he has to treat them, and then he also treats them when they get injured in training. And he said the most common thing he’s treating is not quite as dramatic is when they’re breaching a home or taking a suspect into custody. But it’s when they practice, these SWAT officers are jumping off a truck with lots of armor on, lots of weaponry, sometimes a heavy mallet. These guys are physically fit. They’re big guys. And sometimes it could be 400 pounds landing onto that lead knee, and what he treats most commonly is torn meniscus. This was his treatment of choice, using bone marrow aspirate, and he did very well with it.
What he found is that the officers over 40 didn’t seem to work as well, and so he started realizing he could augment that by using a younger source of stem cells, which we’ll talk about in a little while, and that would be from a product called Wharton’s jelly, which we’ll talk about. And so what he found was when he did that, these officers responded better, the older officers responded better.
There are some clinics that do this. It’s a very valid treatment. It definitely has merit. But the biggest issue is the health of the patient. So, what we found is that if you take the cells out and then you cultivate the cells in a growing environment like an incubator, you can actually increase the number of cells. And if you did that for a number of weeks and injected it back in, well, then it might be more potentially potent. The problem is, in this country, that is illegal. The FDA says you cannot cultivate cells and then inject them back into the patient later. In this country, whatever you take out of the patient that day has to go back in in that same visit.
So there are clinics that actually have clinics overseas. And when you go in, they tell the patient this is the way they’re gonna do the treatment. And then they tell him, “Because of your age, you’d be better if you let us cultivate these. So you’d have to fly down to our clinic in Panama,” or it’s Mexico or in the Bahamas or wherever it is, “and have these injected back in in 8 to 12 weeks.” But what we hear is the cost of that is very, very expensive. Sometimes these people are charging tens of thousands of dollars for that procedure to be done. But, you know, there is definitely merit to it. So that is another form of regenerative medicine.
In this slide, we’re talking about…oh, the one slide they didn’t talk about was adipose. Adipose tissue is where you can extract adipose through, like, a liposuction-type procedure, and you take this adipose tissue, and there are lots of stem cells in that adipose tissue. So what you do is you would have to go through a process to separate the stem cells from the fat, and that involved sometimes a solvent and some vigorous mechanical like centrifuging, spinning, and so forth.
And in their position paper in November of 2017, the Food and Drug Administration made a comment about adipose tissue, and basically, what they said was this is exceeding the minimal manipulation rule that follows the tissue transfer. So, they have rules on how you can take a tissue out of one body and put it in another body. And one of the rules is it has to not be minimal…exceeded more than…manipulated more than a minimal amount. What the FDA says, if you manipulate it more than a minimal amount, then that constitutes like making a drug, and it would fall under the regulation of drug manufacturers. So, the rules that the FDA follows here, they assign numbers to them. Not to get you too confused, but they have a 351 rule and they have a 361 rule. 361 means that what you’re injecting is not a drug. It’s a tissue transplant. It’s an allograft. That’s another term for other tissue. But you’re extracting this tissue from whatever source, and then you’re putting it back into the body to heal it. It helps the body to heal, and there’s certain rules you have to follow. And as long as it’s not overly manipulated, then it’s not considered a drug, and it would follow the 361 rule.
What the FDA has ruled is they said, “If you do adipose, we think that it’s exceeding the minimal manipulation rule, and that constitutes being a drug,” which would fall under the 351 rule, which is where you need a pharmaceutical manufacturers license to do that, which is a very, very, very expensive proposition. You have to put it all through the clinical testing, animal testing, human testing, and it can take years to bring that product to market. And it just made it not practical for people to do this. So there’s not many clinics left in the country doing this, and I think in a short time, there will be none. So there’s the three types of regenerative medicine you can get from your own body.
When you look at allogeneic, which is on this page, allo means other, and that means tissues from another source. So, there are tissues from other sources that you can use that are much biologically younger. Say, for example, if you get tissues from the amniotic tissue of the placenta, say a mom carries a baby to term as a healthy baby and then the placenta is the afterbirth. Then if you take the amniotic side of that tissue, it’s a good source of regenerative medicine enzymes and cytokines. There’s argument is there any stem cells in there, and according to the definition by the International Society of Cellular therapy, which is the authority on stem cells, they’ve actually outlined a definition of what it takes to be able to claim that you have stem cells in a tissue. That means the presence of three factors and the absence of five other factors that they’ve identified, which would be there or not there if you actually have stem cells. And they’ve determined they have not found these factors to be compliant with the definition of the presence of stem cells in amniotic tissue. However, amniotic tissue has a lot of benefit.
Then you also have cord blood. So if you look at this picture here, it’s a cross-section of an umbilical cord. And you can see that the dark blue is cord tissue and then the red vessel in the middle is artery and then the purple vessel is a vein all carrying throughout the umbilical cord. And then you have this blue latticework-like matrix, and that is what’s called Wharton’s jelly, and that is the protective layer and structure around these veins and arteries to protect them. These tissues have been determined to have stem cells and regenerative tissues in them. So like, for example, cord blood. If you extract cord blood from a healthy born baby and you have the placenta and a cord, and you save that cord blood, they know there’s hematopoietic stem cells in there. Hematopoietic stem cells are stem cells that make blood cells.
The Wharton’s jelly has a lot of mesenchymal stem cells, which is the stem cells that would be used for connective tissue. So, you can extract stem cells from these tissues and use them in a regenerative medicine treatment. So you just have to understand when you get these sources, you know, there’s issues you have to find out. Who’s providing the source? Are they compliant with how they’re gathered? Are they gathered in a clean environment? Are they preserved and frozen in a proper technique? So you have to understand these things. And then what type of stem cells are in your product and what are you trying to accomplish with it?
So, you know, this is where the regenerative world has gone to a lot of these tissues. There’s a couple things you have to understand. The biggest complaint about these types of tissues is people say, “Well, it’s from another body. You’re putting a foreign tissue in your body from somebody else, and you’re gonna have reaction.” Well, what’s been determined, if you look at the next slide, here’s a picture of a baby in utero, and you can see that thin white line surrounding the baby. That’s the amniotic sac, and it’s a portion of the placenta. If you see where it says placenta, the outer part of it, the red part, that is a chorionic part of the placenta.
The chorionic part of the placenta contains immune cells from the mother, but the amniotic side is the barrier between a mom’s immune system and the baby. These tissues are called immune privilege, meaning that they wouldn’t cause a reaction because they haven’t quite determined for a specific person’s body yet. This is where a lot of the tissues are coming from that help this baby to grow the tissues it needs to make its body. So this is where the source…you can see the cord is inside that amniotic membrane, and that’s why these stems cells in there are considered immune privileged, and they’re very, very safe.
We have clinics all over the country that are using these cells in various ways, and it’s a very, very safe procedure. We’ve been doing them in our clinic in Chattanooga, and we haven’t seen people have allergic reactions to these tissues. In fact, we see the opposite. We see when we use them, people start to…it stimulates their healing process, and, you know, we have a very high percentage of people, 95-plus percent say, “Yes, I started healing in areas where I wasn’t healing before when they put these tissues back in my body.” These are coming from healthy born babies. So the baby is not sacrificed in an abortion. It’s a healthy born baby, and these are immune privileged tissues.
They get nine months to check out the mom to make sure that she doesn’t have any diseases. They screen them from their social background as well. For example, if somebody’s gotten a tattoo within the last 12 months, they’re not allowed to donate the tissues. They’re not allowed to sell these tissues at all because they don’t wanna create, like, a stem cell factory business. So, these have to be donated by the mom, and they have to be checked out and quarantined and tested by the companies that are supplying these tissues. And that’s where we get them. So, we’re gonna talk about these types.
So if you look here, you see the Wharton’s jelly layer. This is just another angle of the cross section of umbilical cord. You can see the umbilical cord artery and the umbilical cord vein. And the Wharton’s jelly layer is like a connective tissue to support all these structures, the artery, the vein, and so forth, and they are laden with mesenchymal stem cells. It’s the largest source of mesenchymal stem cells in the human body.
So, this is a chart that was supplied to me by a vendor who’s in this space. I like this chart because it lays out the different types of regenerative medicine that we’ve talked about, and it shows the human cellular tissue products and the landscape and what type of products are derived from them and what are the tissues, what do they contain, what don’t they contain. If you look here, on the left side of the chart, you can see the different categories. So the characteristics, is it autologous, which means it comes from you. Then it would be checked off in that line. And if you look under peripheral blood, that is an autologous source because it’s coming from your body.
If you continue down the PRP, the peripheral blood, then you see an area called cytokines, general cytokines, growth factor cytokines, scaffolding, homeostatic. So, that next category is what type of factors, what type of cytokines are in there? Can this help? So if you look at platelet-rich plasma, they do have a lot of growth factor cytokines, which is good, in general cytokines. They have homeostatic cytokines, but they’re missing scaffolding cytokines, which is actually what you would wanna have if you were trying to repair connective tissue in a joint that had a lot of shearing effect. So like, for example, a knee. A knee has a lot of shearing effect because there’s a lot of torque on a knee, a lot of pressure on a knee.
So, PRP may work. The younger the person is, the better it would work, but there is some drawbacks from using that. If you look down at the last category, viable mesenchymal stem cell counts, it’s absent in peripheral blood and all the studies that they found. And it’s not a biologically young source. It’s as old as the patient is because it’s an autologous source.
If you look at the next category over, that is a category for placental tissue, and you have amniotic fluid, amniotic matrix, and amniotic membrane. And if you look at those categories, again, this is from others, so it’s not an autologous but an allogeneic source, they do have general cytokines. If you look, the amniotic fluid has more general cytokines than the other two categories.
But if you’re looking for something like growth factors, the amniotic matrix would be a better choice. If you’re looking for scaffolding cytokines, so where you wanna have something to help set up structure so that the tissue that’s gonna grow has a stronger resistance to a shearing effect, then scaffolding cytokines would be something you want present. So, these types of tissues have those, and they also have the homeostatic cytokines. Whereas if you look at the amniotic fluid, it doesn’t quite have so much of that, but the matrix and the membrane do.
So, we like to use product that are some placental products. Well, if somebody has a knee problem, we’re gonna probably look at putting amniotic matrix into their knee, and then we might also put in a source of mesenchymal stem cells as well. So, you know, you can look at these factors, and, you know, a lot of clinicians use this chart to figure out, “What type of joint am I trying to help repair? What type of repair am I trying to do? What type of cytokines am I gonna want?” And they can actually figure out what’s the best formula to use.
The company that sends these things out cannot mix them. The FDA says they do not want mixed components, but certainly, a clinician could say, “Hey, I’m gonna give this person an injection from amniotic matrix, and I’m also gonna give them an injection of Wharton’s jelly, a product derived from Wharton’s jelly because it has mesenchymal stem cells in it.” If you look underneath the placental category, they do not contain mesenchymal stem cells. Based on the definition of the International Society for Cellular Therapy, the three-positive factor is present and the five-negative factor is not present. So they do not fit that definition. They are a biologically young source, because you are getting it from placental tissue.
If you look into the next category over, now we’re talking about umbilical cord tissue. And if you look, there’s umbilical cord blood and umbilical cord matrix. These two were lumped into the same category for years, and a few years back, the FDA realized they’re very different and so therefore, they separated them into two different categories. So if you look, this is not an autologous source. This is an allogeneic source. It’s from the cord blood of the baby or it’s from the umbilical cord matrix or tissue.
If you look at the cytokines, the umbilical cord matrix has much more of those cytokines than the umbilical cord blood. And the umbilical cord matrix does have the factors for mesenchymal stem cells, and they have viable mesenchymal stem cell counts. Whereas the umbilical cord blood does not. They’re both a biological [inaudible 00:33:53] source. There’s a big debate going on in healthcare now. Some people are using cord blood, and they’re saying, “Hey, I took a cord blood product. I injected it into a patient’s knee, and their knee got better.” You have to remember, this whole science has not been completely figured out yet, and there’s a possibility that some of those cells could revert backwards, become pluripotent to come down the chain again as a different type of cell, or it could be that the cells in the tissue would attract your stem cells to the area.
Nobody really knows exactly how this healing takes place. They just know that they’re very safe, and they have a positive effect on healing in a very large percentage of the time. Clinically, that’s what we see, very low risk and very high improvement in the patient’s condition. So what we like to use is we like to use umbilical cord matrix because it does have the viable counts of MSCs, mesenchymal stem cells, and then also it does have the presence that meets the definition according to the International Society for Cellular Therapy [inaudible 00:34:57] having the presence of mesenchymal stem cells.
If you go to the last two categories, you have the bone marrow. Bone marrow is an autologous source. It’s from you. It does have some cytokines in it. It does have growth factor cytokines in it. It doesn’t have a whole lot of the scaffolding cytokines. It does have homeostatic cytokines, and it does have the presence of mesenchymal stem cells, but less when it comes to a viable count, especially based on the age of the patient, which is where we talked about earlier where clinicians would like to sometimes cultivate these cells, which is not legal in the United States.
So, when you talk about these cytokines and you talk about these cells…you know, let’s talk about cytokines for a minute. The word cyto means cell, and the word kine means movement. And the definition of a cytokine is they are cell-signaling molecules that aid in cell to cell communication. They kick into activation with immune responses, with healing, with inflammation, directing and controlling inflammation and fighting infection or in response to a trauma. So, these cytokines are important part of the factor.
So, when you look at these different tissues, you go across the board, you go, “Okay. So we have bone marrow aspirate. We have umbilical cord tissue, umbilical cord blood, placental tissue or PRP.” They all have their benefits. But what happens is what you’re really trying to do, or in my opinion, you’re trying to get the mesenchymal stem cells into the area, and we don’t know if those stem cells are gonna change into the patient’s tissue or not or if they’re gonna signal your own stem cells.
Nobody really quite knows what’s going on, but we do know, and we’ve known this for a long time, for decades, that when people use these things, their healing improves. You know, when I interviewed Tim Grover who was Michael Jordan’s personal trainer, and he worked with a lot of athletes, a lot of different athletes, I asked him how many of them were getting regenerative meniscuses when they got injured. His answer was all of them. So, this is something that’s been in the sports world for a long time. The first time I was introduced to regenerative medicine was by a former pitcher for the Chicago Cubs, and he was basically saying that, you know, when people got injured, we couldn’t afford, in the baseball world, to not heal quickly. So we were using regenerative medicine to get healed up quicker.
So, if you notice, I didn’t talk about the last category, and that’s the adipose. The reason I’m not talking about that is pretty much the FDA has labeled that that is a drug, and, you know, most people that were doing that before are no longer doing it. But it was an allogeneic…I’m sorry, autologous sources, which means your body. It did have general cytokines and growth factor, it did have homeostatic cytokines, and it did have a source of stem cells, but that’s pretty much not really a player in the game so much anymore.
So if you take a deeper look at this, this is looking at more detail in the cytokines that are present. And so remember, they’re signaling molecules, and when you look at some of these sources of cells, placental tissue can have a lot of these cytokines, and if you look, specifically scaffolding cytokines, which if you’re doing a lot of orthopedic work, you’re gonna want that in there, which is why a lot of times, we’ll do an injection of a placental amniotic matrix or amniotic membrane product. And then we’ll also do an injection of the umbilical cord matrix for the Wharton’s jelly, because if you look down on the column for the bottom, the mesenchymal stem cells, the umbilical matrix does have viable MSC counts, and it’s a biologically young source.
So, all of these services, all these types of treatments, they do have merit. I don’t wanna say any of them are better than others. We use the autologous source…I’m sorry, the allogeneic source because we like the idea that they’re biologically young that they’re immune privileged and that they can stimulate healing. A lot of times when patients need assistance in healing, it’s because they’re older, and using their tissues won’t always work. I’ve had a lot of people tell me, “I went and did regenerative medicine, and it didn’t work.” And I’d ask, “What kind did you do?” “Well, they took them from my fat,” or “they took them from my bone marrow,” or “they took them from my blood, and it didn’t work.” And some of those same people got treatment in our office, and then it did work because we we’re using them from the sources that I’ve just mentioned. So, you have to understand these different sources.
Anybody who says they know everything about all of this and that only one of these ways works better than others is usually somebody who’s limited in their ability to grasp new knowledge. They all have their benefits. They all have their place and time. And so that’s why we use more than one source. We use multiple sources because we want the best outcomes for our patients.
So if we look now, we’re gonna look at opportunities with the regenerative medicine because, you know, you’re probably asking, “Why are so many chiropractors bringing this into their practice?” Well, let’s take a look at the opportunities with regenerative medicine. What we did even before we started doing regenerative medicine, when I first started doing integrated practice, it wasn’t for stem cells. In fact, I didn’t even know anything about them back in 1996. But there was a lot of services that medical practitioners along with chiropractors and along with rehab could provide together in a joint service that would make a better outcome for the patient. So, they also would provide income to the practice. So, people get in trouble, though, if they just follow the wrong rules. So we have a priority for our rules, and this is them.
Number one, if we do any service for our patient, number one rule has to be it’s a better outcome to the patient. If you’re in business and you’re in business just to make money, you’re gonna have a very rough time in business because it’s not about just making money. Any business, I don’t care what it is, it’s about solving a problem in your society or in your community. So, in this case where you’re treating patients, it would be a better outcome to the patient. If you can’t get that from the service, it’s not worth doing it.
Number two, we’re in a bizarre industry where there’s third-party people weighing in about what should be done and there’s boards. There’s different boards. There’s medical boards. There’s nursing boards. There’s chiropractic boards. There’s physical therapy boards. So you have to be compliant. You have to follow the rules of the game. The rules are there, and if you don’t follow the rules of the game, you can get in trouble, and they could put you out of business. And then thirdly, it’s gotta be profitable for the clinic, because if you go out of business, you can’t help anybody.
So let’s look at these. Better patient outcomes. When you’re marketing, you have to be careful on how you promote these things. So, unless you have research that you actually are fully aware of and you actually participated in. You know, you have to be careful of the research things you’re quoting. So what you’re safe in quoting is what is your patient’s experience. When you put these services in your office, what happened with your patients?
And we have a very high percentage of clinical satisfaction. I say 90%, to be conservative, but easily, 95% of our patients say it was totally worthwhile. This is what they got out of the service, and the product that was put in their body was better than what they spent for it. It doesn’t happen overnight. Sometimes people get instant reactions, but mostly, it’s a slower process because it’s a healing process. So we tell people it could take three months before you start to see improvement, but a lot of our people see it before then.
But it’s a very high percentage of clinical satisfaction. There’s a very low incidence of complication or adverse reaction. So, that’s one of the things we really like about it. This is a very safe product. Is there absolutely no risk? No, that’s not true. There’s a risk with everything you do, especially if the person doing the procedure makes mistakes. They could do things that could get you in trouble. Like, if they’re using a poor technique where it’s not very, very sterile, they could create an infection. And that could be a very, very bad thing for somebody.
So, you know, they are safe if you’re following, you know, pretty good logic, and people ask me what about protocols, and it’s hard to find protocols because if you’re getting these tissues from a company, those companies are not a drug company. They’re an allograft, meaning it’s a tissue transfer. So they’re not allowed to give you protocols. If they did, then it would constitute being a drug, and it would change the ruling from a 361 to a 351 rule.
But you can get a lot of information by looking at different sources. For example, one great source of studies is the book “Cartilage & Nerve Regeneration: Research and Review.” The issue I had was 2015 to 2016. This is by Dr. Russ Schroder and Dr. Jinaan Jawad. So “Cartilage & Nerve Regeneration: Research and Review” has lots and lots of studies about things, including lots of studies about stem cells. So, my suggestion is if you’re gonna get into this business or if you’re in this business, read up on a lot of those studies.
But when you’re looking at the instance of complication, you know, look at the company you’re getting your tissues from. Have they been inspected by the FDA? If they were, what was the outcome? I know the company that I use. They had a surprise inspection last year. Five days, the FDA was in their office poking around and checking things out, and they ended up getting the highest level of approval that the FDA gives, no action needed. Whereas other companies, if you look around, some of the bigger players in this market have had problems with contamination. You know, getting contaminated with hepatitis tissue and getting contaminated with E. coli. So, you have to understand, you know, it’s your responsibility to vet the person who’s providing you the cells, and you should do that. You should do as much research as you can to find out that those are safe.
I know the company that we use has looked at 60,000 injections. They followed 60,000 injections, which is a large number of products. It was over the course of, I think, one year or two years, and they had no reactions that could be attributed to the product. There was 18 complications out of that 60,000 injections. And all 18 of them turned out to be not very clean technique by the clinician. And it caused, you know, the most common thing was an infection, which can be fought, but then you have to fight that infection, and that’s not really what you wanna do to your patients.
But if you compare that to things like hospital procedures, well, that rate of infection was tremendously lower and not as bad as it would been had you gone into a hospital and got a procedure done. So what you’re looking at is something that has a high percentage of clinical satisfaction and a very low risk. It’s utilizing natural repair mechanisms and not, you know, something like an opioid, which is highly addictive. There’s no downtime, and it’s usually one procedure. Sometimes we do a follow-up, and we’ll do an additional procedure a month or two down the road. But usually, it’s one procedure.
So number two, compliant. We talked a little bit about what I call the 351 rule versus the 361 rule. When doctors, when clinicians, chiropractors, and nurse practitioners get into this game, they have to understand there’s rules to the game. And the FDA made a regulatory considerations for human cell tissues and cellular tissue based products minimal manipulation and homologous use, which is a guideline for our guidance for industry and Food and Drug Administration staff. This was from November of 2017 put out by the U.S. Department of Health and Human Services. I suggest you get a copy of it and you read it, and it talks an awful lot about the rules that keep you listed as a 361-type tissue versus a 351-type medication.
So if you don’t wanna have to get into the system or the situation of trying to get approved the drug which would cost you millions and millions and millions of dollars, you have to follow the rules of a 361. So, this was started with the Biologics Control Act of 1902, which was originally started because of vaccine safety guidelines. When vaccines first came out, a lot of people got very sick and injured by them, and so they created the Biologics Control Act of 1902. That was changed to the Public Health Service Act or PHSA in 1944, which fell into the establishment of the FDA rule. In 1993, the FDA established a rule for human cellular tissue products for transplant. So that’s when they first started to look at this and look at these rules.
They updated the rules in 1997. So, 351 versus 361, it provides authority to the FDA to regulate marketing for traditional biologics in human cellular tissues and products. So this would fall under the 361 rule. The FDA says, “You cannot claim that you will cure diseases or treat diseases or grow tissue back using these products.” It sounds a little strange, but they say, if you claim that, you must be a drug, therefore, you must go and go through the process of the 351 rule, which is much more stringent.
So, you know, if you wanna stay clean in this model and you wanna just be able to explain to patients, “Hey, we’re not doing stem-cell therapy. What we’re doing is regenerative medicine. We’re using either an allogeneic or an autologous source, depending upon what you’re using, and we’re not gonna try to claim that we’re gonna fix anything. What we found is when we use these, they’re very safe, and for some reason, when our patients use these, the vast majority of them start to improve their healing process.” So that’s how you have to market it. That’s how you have to explain it. You can’t say, “Hey, we have stem cells, and we’ll grow your joint back.” That would be, according to the FDA, false advertising or false marketing, and you could get in trouble for that.
So you have to follow the rules. You have to make sure that what you’re doing is not violating that. And different states have different caveats to that. Like, for example, I think in Ohio, you’re not allowed to use the word stem cells in your marketing. So you have to check that out. So, three rules published by the FDA since 1987. You have provisions for the scope and purpose of human cellular tissue products, and established them under the 361 rule. Then they also have to be minimally manipulated. We talked about that earlier. So, you don’t wanna be using drugs or solvents or, you know, major chemicals to try to separate these things, and you don’t wanna change it and manipulate it so it’s no longer homologous.
Homologous means it has to be used for the same purpose in the recipient as it was in the donor. So if we go back to, say, the Wharton’s jelly, Wharton’s jelly is connective tissue designed to protect the arteries and veins of the umbilical cord. So it’s got cushioning protection in structure. So you would wanna use that type of stem cell if you were trying to improve anything that had to do with cushioning structure support, because that’s what they did in the original use. So if you put it in somebody’s knee, you know, if it helped that person to heal the knee, it’s a similar use. So it has to be a homologous use. If it does not meet these three requirements and it falls under the 351 rule, it requires what’s called a Biologics License Application, BLA. And that’s where you apply for the ability to manufacture a drug, and that’s when you get into millions of dollars of expense.
So, you have to get your tissues, which is called an allograft, it means other tissue, from a reputable company. Check their history with the FDA in compliance. You can’t make wild claims about what you’re doing and about curing disease or even growing tissue back. Some people have noticed that, you know, when they do a wellness treatment, if they do that, you know, that would involve doing like a intramuscular injection, or some people say they wanna do them with an IV. Technically, the FDA says they should not be used for systemic use. So, if you’re trying to put them into an IV to cure disease and you’re stating that, you’re gonna get in trouble because you’re not allowed to say that. But some people, for wellness purposes, have used some of these tissues in an IV environment where they’re putting it intravenous or in intramuscular. And some amazing things have happened when people have done that and they’ve seen things respond.
Like, you know, if…I don’t wanna make any claims here. I’m just telling you. If you start saying, “Hey, it’s gonna help your ability to process oxygen in your lungs with a pulmonary obstruction or a pulmonary disease, you’re gonna get in trouble for saying that. There are some pretty wild, amazing stories, and there are people that have amazing testimonials because of things they’ve had happen to them when they’ve utilized these types of tissues. But you’re not really making these claims because, if you do, you’re gonna get in trouble. So, what we do is we’re talking about orthopedics and we’re just talking about, “Hey, clinically, what we see is when we use these, the large percentage of our patients, 95% or so, tell us that their joint started functioning better. They had better ability to utilize that joint. They had less pain and less inflammation, and it was safe.” So, that’s what we recommend how you’d market these as well.
And also make sure your patient signs a good consent to treat and that you’re explaining that consent to treat when they sign it. We like to do follow-up for the patients. We don’t just inject them and let them run off. Some doctors do that. Some doctors figure, “Well, I just wanna sell the stem cells, and when I’m done, I’m out of there.” In fact, we’ve even heard of some cases where people were going to dinner talks to explain the stem cells and bringing a nurse practitioner with them and stem cells in a cryotank and injecting patients right at the dinner talk.
Well, I think that’s extremely unprofessional, and I wouldn’t wanna get treated by somebody who was following those guidelines, because there is no guidelines there. I’d rather be treated in a clinic where I was assessed by a medical clinician who determined, yes, they have a problem, yes, this is appropriate, and it’s not gonna be a conflict. So just look at who’s offering you the stem cells or the regenerative medicine and look how they’re presenting themselves. This cannot be something where a chiropractor determines, “Yes, you need to get this done.” It’s a medical service. It has to be determined by a medical clinician.
So, when you do this, you gotta make sure that the clinician is acting appropriately and evaluate the company that you’re looking at if you’re a patient. And if you’re looking to do this in your own clinic, just look and see how are you gonna do it. If you’re a chiropractor telling a nurse practitioner, an MD to inject people, you’re basically practicing medicine without a license. And then thirdly, is it profitable? If you go broke, you can’t help anyone. So, we look at this as a win-win because it is cheaper for the patient.
If you look at surgical cost, you know, the number one reason for personal bankruptcy in the United States is just unpaid medical bills. And I ask people all the time, “When you go to get surgery, when do you find out how much you’re gonna have to pay?” And the answer is usually 12 weeks after surgery. So, even with insurance coverage, 72% of the people who filed bankruptcy for personal bankruptcy for unpaid medical bills had insurance. So when you start looking at this, you go, “It’s a cash service,” but, you know, $5,000, a lot of times, that’s cheaper than it would be with the out-of-pocket when you have coverage for the surgery. And so it is less expensive for the patient. It does work on not just covering up the symptoms, but actually helping to rebalance the joint, get the joints to function better.
You know, when we look at X-rays eight months later, and there’s increased space there, you know, who knows what that is? But the patient’s telling us they can now run up and down steps, which they couldn’t do for years. That’s a good thing. To me, I say that’s a very good proposition to a patient. It’s worth the cost of the treatment. It’s also profitable for the clinic, excuse me, because of the margins involved with stem cells. You know, to get the stem cells in your office, it could cost anywhere from $400 to $1,000, but that’s not your only cost. There’s marketing costs. There’s cost of the practitioner, the cost of the storage and the inventory, and everything else.
So what we do is we charge roughly about $5,000 for the first injection, but if the patient’s getting multiple injections, then the second, third, fourth, and fifth goes to $2,500 because we’re making it more affordable to them because we’re not incurring that cost over and over again for each injection. You can do whatever you want, but that’s what we do, and it seems to work very well in our practice. Also, because insurance isn’t involved, there’s no insurance audits, but that doesn’t mean the FDA can’t look at what you’re doing.
So being profitable is good for you and your business, because if you go broke, you can’t help anyone. But the problem is, don’t put rule number three in front of the other two rules. People who do that, you know, it’s not good for their business in the long run. They might be going for the money, but what’s gonna happen is they’ll be branded as somebody who’s only involved in the healthcare because of the money. And what you really want is to get somebody well.
My personal opinion is the stem cells definitely help with the healing of the joint, but whatever caused that joint to degenerate prematurely is probably still gonna be there. And it’s the chiropractic, it’s the rehab, and the other services that help to repair that joint. And if you’re not doing that, you’re only doing part of the game. But that’s basically how we look at this. And what I’ve tried to do is share with you the different sources of stem cells and the different things that people are facing now in this environment. So, that’s my presentation, and I think there’s some questions coming in.
Rick: Thank you, Dr. Carberry. This has been an extremely informative and fascinating subject, stem cells. We’ve been collecting some questions from the audience, and we’d like to get to…we have time for one or two. If you did submit and we don’t get to your questions, we’ll be including them with answers in the transcript to the seminar. Our first question, a doctor asked, “Why is there so much conflicting data on regenerative medicine?”
Dr. Carberry: That’s a good question, and that’s because it’s a new science. And so when there is a new science involved in anything in healthcare, you know, if you wait until everything has been proven all the way out to the nth degree, you’re talking about a couple decades from now. We do know they’re safe, we do know they’re effective, but we do call it the Wild Wild West because a lot of people have been popping up into this space to cash in on the…you know, people are reaching for it. You know, with the internet and with people getting amazing results and phenomenal results, word spreads and people are looking for it around the country. That will attract some unscrupulous people who just wanna get something to market to cash in on it, to cut corners on the science, which is why I tried to do so much research. I know that information can be dry, but I try to do the research on the science.
You know, I mean, you have to do your homework. So, that’s why there’s conflicting information. And there’s people out there that are trying to market their product, and to do that, they think they have to discredit everybody else’s product. And if you get somebody that’s saying, “Absolutely, this is the only way to do it, and all other ways are false,” you gotta question the intentions of that person. That’s why we like to present all the different avenues and that’s why we use more than one source of cells or tissues.
Rick: Thank you. And we’ll get one more question in here. In regards to systemic treatment, a doctor asks, “What can you tell us about systemic treatment with regenerative medicine?”
Dr. Carberry: I know the FDA does not want you doing systemic treatment, and they said it’s not intended for that. However, when a tissue or a product is approved for use, a clinician can determine how to use it. That’s why it’s called practice of medicine. So, for example, it might be an off-label use, but if they decide to use something that, then it can be helpful. If you start advertising systemic treatment, you’re gonna get in trouble. But I have heard some amazing, amazing stories, and I could tell you one that it still blows my mind. A patient who had been diagnosed with stage 4 pancreatic cancer, and, you know, that’s a death sentence for pretty much anybody.
And what happened was, though, as he got treatment, he did the traditional treatment with the chemotherapy and radiation, but in between the chemo treatments, he was getting a systemic infusion of stem cells. And he kept saying that he felt horrible after the chemotherapy, but then when he did the stem cells, it’s like he came back to life. And after doing about five rounds of that, and this is from pretty reliable sources that I know, the patient was given a clean bill of health, which I’ve never heard of that before, ever. You just heard on the news recently that Pat Sajak from…I forgot the game show is that he did, but he was diagnosed with stage 4 pancreatic cancer about three, four months ago, which, technically, he should be dead by now. And just a couple weeks ago, he released the statements that he’s in remission, which I’ve never heard of anybody being in remission with pancreatic cancer until this one patient that I just told you about. So I’m starting to suspect probably that Pat, that game show host, may have done a similar thing.
So, you know, the future is there for people to figure out. I think this is gonna be the biggest breakthrough in healthcare in any of our lifetimes. Of course, there’s gonna be people trying to cash in on it and make false claims, which gives the ability for people who aren’t in this business and competing against it, like the pharmaceutical industry, to shoot arrows at this whole industry, which is why we try to get as much information out there as possible. Do your homework. Learn about this and understand how it works.
When you market it, market it in compliance with the FDA’s guidelines. But, yeah, the potential there, I mean, I could tell you, if I face any serious disease, I would be looking for…I would include this type of treatment in my therapy, personally, because of what I’ve seen and what I’ve heard. So, the world is wide open to the future of this. That’s all I can say about systemic use of stem cells. I cannot tell you to do it because, if I do, I’ll be not compliant with the FDA. But I can just tell you, there are people that are doing it.
Rick: Thank you, Dr. Carberry. And I understand you have a special offer for those attending today’s webinar.
Dr. Carberry: Yep. You can see on this screen right now in mydoctors.com/course. If you log into that or google that, you’ll come up…we have an offer for a course that we’re putting together, much more depth of what we covered today on stem cells and their marketing and the science and so forth, and they can give you information about that. So, go to that website, and you’ll be able to figure out…they’ll help you with getting signed up for that course if you have interest in that.
Rick: And at this time, we’d like to thank our sponsor, Advanced Medical Integration and Dr. Carberry for today’s webinar. That was wonderful.
Dr. Carberry: Thank you.
Rick: And thank you all for attending. Remember, this webinar, including our speaker’s PowerPoint presentation, have been recorded, and we will alert you when the webinar is available online. Thank you again for attending, and we look forward to seeing you next time. And to our presenter and our audience, have a wonderful day.
Dr. Carberry: Thank you.