Leora's Wednesday Wellness Podcast

Unlocking the Secrets of Regenerative Medicine: Stem Cells, Exosomes, and Personalized Therapies with Dr. Randall Feingold and Dr. Tajaz Ozarkar

Leora Acoca Goldberg

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Renowned experts Dr. Randall Feingold and Dr. Tajaz Ozarkar join us for an enlightening journey into the frontier of regenerative medicine. We promise you'll uncover the secrets behind the power of stem cells and exosomes in transforming healing processes and anti-aging therapies. With their guidance, discover how mesenchymal stem cells are the maestros of recovery, directing your body's natural healing abilities, and why their effectiveness wanes as we age.

Our conversation explores the nuanced world of stem cell screening and processing, where the focus shifts from quantity to quality. We'll dissect the meticulous standards required for ensuring the highest quality umbilical cord stem cells, highlighting their potential pitfalls and how superior processing can lead to "superstar cells." Additionally, we'll unravel the truth behind misleading marketing tactics that prioritize cell count over viability, offering insights into why fewer, more effective cells can lead to better outcomes.

Finally, we venture into the future of regenerative medicine, examining its applications in aesthetics and orthopedics. Dr. Feingold and Dr. Ozarkar share their valuable insights on personalized therapies, especially for those over 60, and the crucial role of lifestyle and health factors in influencing treatment efficacy. From PRP to autologous fat grafting, our discussion reveals how these therapies can be harmonized with surgical solutions for optimal patient outcomes, promising a future where innovative science and practical applications are seamlessly integrated.


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Speaker 1:

Thank you for joining Wednesday Wellness. I'm your host, leora Akoka-Goldberg. This is the ultimate podcast for regenerative medicine anti-aging, detoxification, anesthetic medicine. Here we are chatting with experts to uncover secrets about healing, usefulness and overall well-being. Today, our podcast is going to focus on principles of stem cells. We're going to look into application, expectation and safety. I want to thank both of you Dr Randall Feingold, the co-host of this episode. He is the co-founder of New York Breast Reconstruction and Aesthetic Plastic Surgery, and we have Dr Tajaz Ozarkar from the Riordan Regenerative Institute in Dallas. Let's dive first into the introduction for our listeners and viewers what is actually stem cells and exosome and what are the applications?

Speaker 2:

So stem cells are. There are many stem cells in our body. The stem cells that we are concerned with and that we are very interested with in the field of regenerative medicine are mesenchymal stem cells. And so mesenchymal stem cells are the stem cells in our body that can theoretically turn into skeletal tissue or muscular tissue, or bone or certain types of tissue they can differentiate into, or bone or certain types of tissue they can differentiate into. But realistically, a lot of these mesenchymal stem cells which we naturally have all over our body, their primary goal is to act as a general consultant for the rest of the cells. For example, if an adult has 500 million to 1 billion of these mesenchymal stem cells actively roaming their body, when an adult, let's say, gets into a car wreck or has some sort of trauma or injury, and let's say they have a laceration or a big scratch on their forearm, what happens is immediately some of the cells recognize that there's an issue, the platelets start to aggregate, start to build out a clot, then a bunch of cells start producing scar tissue. But after that, when the body's initial response is to stabilize what happens, mesenchymal stem cells then infiltrate that area and they orchestrate a healing response, a reconstructive healing response. Healing response, a reconstructive healing response, so they tell the cells how to organize so that it can turn back into normal tissue. So the stem cells are the ones that are the second phase of healing, where they remodel scar tissue and they remodel tissue that was there meant to hold things together after some sort of injury, and they remodel it to normal tissue again. And of course, as we age, the number of stem cells in our body starts to drop, and so that's why our healing response whether we get a kidney injury or an injury on our skin, everything is just much more difficult to overcome as we age, because A we have less stem cells per kind of square inch of body, and also those stem cells become less and less competent over time.

Speaker 2:

And so the other thing you brought up, which are exosomes, are the secretions of those stem cells and so the majesty of these mesenchymal stem cells. They can read the microenvironment and say, okay, there's a lot of inflammation here, but there's no infection, there's no cancer, there's nothing bad happening. So they start pouring out these secretions to influence all the other cells in that area to say let's be less inflamed and more productive. Alternatively, if there is an active infection, then these mesenchymal stem cells can read the microenvironment and say there is a lot of inflammation here, but there's also evidence of bacterial infection like lipopolysaccharide. Let the MSCs then pour out all of these secretions to engage the immune system, so the immune system can then react and help mount an appropriate response against that infection. So that's the amazing part about these stem cells is that they can read the microenvironment and cue the body in how it is supposed to heal.

Speaker 1:

So what is the difference actually between stem cells and exosomes?

Speaker 2:

So the stem cells, you can consider them the manufacturing site of the exosomes. So the exosomes are just the secretions of those stem cells.

Speaker 1:

And where do you source these stem cells from?

Speaker 2:

Stem cells have tons of different sources. They exist. We have a pretty high concentration of stem cells in our bone marrow. That's where most of these mesenchymal stem cells are born in our body. But we have mesenchymal stem cells in our dental pulp. We have mesenchymal stem cells in our brain. We have mesenchymal stem cells in our liver and kidney and all over the place. The richest source of mesenchymal stem cells, with the easiest access from what we consider autologous, so from the patient, is bone marrow, and there's also a really great source of stem cells banked in our fat as well. So those are the two typical areas where regenerative medicine physicians in the United States at the time of this taping are extracting stem cells from now.

Speaker 2:

Another incredible source of stem cells, from a very young source that is happens to be very ethical, is the umbilical cord, which is the piece of anatomy that connects the mother and baby during pregnancy. So after a healthy delivery, that umbilical cord you're a mother, you've seen some pregnancies and you've been involved with some pregnancies that umbilical cord is no longer useful to you or your baby when the baby is out of the womb and in your arms and so. But that umbilical cord is almost. It's made up of 99.9999% of these healing stem cells, and so that is. It is truly a gift from God, because it is, it gives life to the baby.

Speaker 2:

And after the baby is out in this world, then and it's no longer useful for the pregnancy, we can extract stem cells from it that are very young, that are only eight and a half or nine months old, as opposed to a 60 year old's bone marrow or something like that. So they're young tissue stem cells and they have no purpose after the baby is delivered. And so it's truly kind of a trash into treasure situation. And that's why the founder of my organization, neil Reardon, he pioneered the kind of the translational science of taking the stem cells from the lab and seeing what the potential was in the lab and giving them to humans and seeing what happened. And he's done that since essentially the late nineties. And just for some context, mesenchymal stem cells were first discovered and named in 1991 by the wonderful Arnie Kaplan, who passed last year, but so it's a very young science. So we just learned that these cells existed. We've learned that these cells exist in 1991. And Dr Reardon has been treating other humans with these cells since the late 90s.

Speaker 3:

A few comments there. It wasn't available for all of my children but when our youngest child was born we banked that umbilical cord blood and cryopreserved it and I think many people are familiar with that these days but it wasn't very common 25 years ago, for example. Not that we understood at the time what its utility might be, but whether it's stem cells for regeneration or maybe to repopulate someone who has to undergo chemotherapy for leukemia, for example, who has a source of their blood producing cells, that's a super rich product and I hope everybody has the chance to bank that blood. They should make a worldwide effort to scavenge and preserve and catalog that material because probably so many people could be saved. There could be so many applications because, as you said, that's very high-density stem cells and as we get older that population drifts down.

Speaker 3:

In plastic surgery there were studies done, even when I was a resident in training or an early practitioner, doing fetal surgery to repair cleft lips, doing fetal surgery to repair cleft lips and those births did not reveal scar tissue at the cleft lip repair sites if they were done in utero, as compared to cleft lips that are repaired after birth. So even in that short window of time going from embryo to fetus to a live birth, there's already a change in environment in terms of the power of regeneration and that mature healing after birth it's not regeneration anymore, it's healing with scar tissue and loss of native individual cell capacity and definition. So it makes perfect sense that if we can provide more stem cells to treat injury or damage or disease, that we're going to get back to that miraculous period during fetal development where we've got tremendous regeneration capacity.

Speaker 2:

Absolutely. That's great insight.

Speaker 1:

I want to go back to what you said earlier, dr Ozarkar, regarding once you harvest the stem cells. Can you just tell us what kind of screening medical screening it's going through? And then where is it being stored, in terms of I guess it's going into a lab under certain condition, temperature, sterility and so on?

Speaker 2:

Absolutely so. This is when we're consumers, patients everyone involved has to be a little careful, because some of this is exempt from FDA regulation and therefore the standards can be all over the place, and so sometimes people call it the wild wild west of stem cells, and unfortunately we are in that situation because some of these facilities may not take these steps that I'm about to describe. But if you're a consumer interested in something like this, what you need to know is if that product so first of all, before that umbilical cord even reaches the facility, before it even is accepted into the facility, they should test that umbilical cord for various viruses and also certain bacteria, because there are certain bacteria and certain viruses that can pass through the umbilical cord during pregnancy. Beyond that, you will also need to check for other viral pathogens that may not necessarily pass through the umbilical cord but still may have some exposure because laboring, and so there are certain things that need to be watched out for. So there should be full viral serology testing, and so that would typically include HIV and HSV and HPV Zika now commonly tested for COVID and there are what are called these torch diseases, which are either bacteria or viruses that can pass through the umbilical cord, toxoplasmosis and certain other. There's a long list of viruses and other infectious pathogens that can be transmitted through the cord. So all of those need to be tested before they even get inside of the facility.

Speaker 2:

Then after that the umbilical cord needs to be washed.

Speaker 2:

So typically most facilities like, for example, the product that we work with and the way that we are processed in Panama, we only accept umbilical cords from a healthy C-section delivery, meaning that it can't be emergent.

Speaker 2:

It's not meant to be bloody, it's meant to be untainted umbilical cord that is as sterile as possible when it is harvested and because after that higher cord has to be washed in a very particular way, in a very particular way.

Speaker 2:

And then essentially what we do is at the beginning we measure certain parts of the umbilical cord, for we just want to look at the cell signature, we want to look at what the resumes of these cells are, what their growth factor content looks like, what their surface markers on the cells look like. There are certain things that we are looking for, but so they do some initial testing and once we determine that umbilical cord is viable and meets our certain standards, then we will if it's going to go in the production facility, meaning that we're going to be making these units of umbilical cord tissue, or if we're going to be extracting the stem cells and culture expanding the stem cells out of that, they go in our production facility and so, basically, we identify the cells that we like, we culture, expand them. So, for example, what they do in Panama is we identify each individual cells that we like and this is based on years of outcomes, data, years of practicing in this field. We know the resume that we are looking for these cells.

Speaker 1:

So let me just say I heard Dr O'Neill say that not all the stem cells are equal. Some are better, some are not. So this is the process that you're talking about.

Speaker 2:

Exactly, exactly. So this is all some of the initial steps that we do because we don't want to grow out all these cells just to realize that it wasn't really the type of cell that we were looking for and do all this work. That is not going to be very fruitful. So we have learned through years of hard lessons that we want to identify, because there are certain umbilical cords that are just chock full of really high quality cells, and it likely is related to how the mother, what the mother put in their body during pregnancy and how it's various factors, but a big part of it is a very healthy mother who doesn't have a lot of diseases, and also a mother that was choosing a lot of healthy options, lifestyle options, food, you know, wasn't, you know, consuming a bunch of secondhand smoke the type of pregnancies we would all want for every pregnancy. But we, there are certain pregnancies that create an environment where there are going to be these superstar cells, and so that's what we're looking for. We're just looking for the total superstar cells. But just like when you're hiring someone at your office, just because their resume is perfect does not mean that they're going to deliver the results that you want. And so the other piece of it is, as we go through this processing, as we pluck out the cells, that we like their resumes and we culture, expand them, which basically means we put them in culture, media, we put them in an environment which they love and they just split, divide, divide.

Speaker 2:

And so after we've divided a bunch of these cells, we put them through a battery of tests. So we call that our release criteria. So before they're even released for use, they have to behave. So, for example, we will put them in the presence of just pure inflammation, so we'll just put them in the presence of TNF alpha, which is a inflammatory cytokine that is very high in folks who have autoimmune conditions, for example. And then and we expect them to behave a certain way those cells Then we also put we do another test with them, where we put them with TNF alpha and then we also put them with lipopolysaccharide, meaning that there's a lot of inflammation but there is some bacterial material inside of that of the cell culture.

Speaker 2:

So those cells need to behave a totally different way when they detect bacteria. So we put them through various battery of tests to see if they're up to standard, because just having a good resume, just like humans. It's just not good enough, and so we need to know that they behave in the way that we want them, and then that's how we know that these cells are ready for production, and there are about a. There are a thousand different configurations of how that can be done, and that's what we're learning along the way, because this is still a young science.

Speaker 1:

So when you say production, how, let's say typically, when you take that one type of placenta and you produce the stem cells that are qualified, how many times can you donate these cells to your future patients?

Speaker 2:

So great question. So we we're doing the culture expansion process, meaning that we're taking one cell and dividing we are. One of the things that we're looking for is that we don't want the cells to get exhausted, meaning that because if you keep it, so let's. Let me give you an example of a Xerox copier. So if you take a piece of paper and put it through the Xerox copier and then you keep doing that 70 times over, or you take the page and put it on top of the screen and copy it, copy number 70 is not going to look like copy number one, it's just impossible. It starts to look sloppy and slanted, and that's exactly what happens with cells starts to look sloppy and slanted, and that's exactly what happens with cells. Now, a mark of a weak cell, a cell that we don't want to give another human being, is one that starts to show signs of DNA degradation or DNA mutation very early in their lineage. So we call this cell passage. So the cell passage is how many times we've allowed them to divide.

Speaker 1:

Yeah.

Speaker 2:

So what we're looking for is and what Dr Reardon and his team Signature Biologics and Arugula Sciences have just figured out a couple of weeks ago probably the most prolific cell lineage line. They've turned one cell into 1.9 billion cells.

Speaker 3:

And so it's all.

Speaker 2:

Basically, it's finding that needle in the haystack, that perfect cell that looks perfect on the resume and also does what we want it to in the battery of tests.

Speaker 1:

So let me ask you a question. Yeah, oh, go ahead. Well, I see a lot of high visibility of clinics, whether it's in Mexico or in the Bahamas and everywhere else in South America, and a lot of them are just like using slogans like we inject 150 million, 200 million stem cells. So the question is what is? You're talking about quality of stem cells, they're talking about quantity, so what is the? How do you look at this?

Speaker 2:

and I want our viewers and listeners to understand whether this is important or is just a marketing gimmick when they say that absolutely, and that's such a great point, and it's all we're looking for quality, because over quantity and that's the biggest trick that they have over a consumer is we're gonna give you 300 million cells in a single day. I'm gonna tell you right now, now that if you had 300 million of my cells, that your body would explode. I don't even know what would happen. There can be an inflammatory response after stem cell procedures and if I gave you the numbers that a lot of these clinics are talking about, I don't even want to know what would happen.

Speaker 2:

I don't think that it's unsafe, I don't know what would happen, and it's we can accomplish a lot with. So, for example, in panama, they give you they give 40 million cells through the vein per day for three days, so 120 million cells total. And I've had that treatment before and I can tell you right now, if I got, there are clinics that say they give you 300 million cells in a single day and I just couldn't even imagine that happening, because I really felt, I felt feverish, I felt, you know, I needed to take a nap. After I got that, the results that I wanted, and I had some adverse effects that lasted a day or two, but which is normal.

Speaker 3:

But it wasn't because which? Is normal.

Speaker 2:

It's normal, but we don't need that extra decimal point to accomplish what we need to accomplish. And so the other part of it is that when they're saying that they're giving you 300 million sales or 150 million sales in a single day, likely, it indicates to us that what we think, what us in the, we in the business, when we see that, we immediately know that most of those cells are dead.

Speaker 2:

Because, if I got 150 million cells when I got my IV. I don't even I felt like crap for about 90 minutes afterwards and I don't want to even think of what would happen if I had gotten four or five times what they had given me. And because then it's all downside, then it's all just adverse effects, and because there's also it's like during the pandemic a lot of people moved to Texas. I'm going to give my example that I always give Two people moved into the Dallas area over the past couple of years. These people need trash services, they need cars, they need highways, they need cars, they need highways, they need services. You can't just add 20 million people to the Dallas-Fort Worth Metroplex and it be okay.

Speaker 2:

So that's exactly the same with stem cells. Is that the more you put in, they're now fighting for nutrition. They're now fighting and we're putting them in a diseased area. Right, if we're injecting them into your neck or your back, it's likely already diseased, it's likely already scarred down, there's likely already poor access to blood flow. So now you're just making those cells fight amongst themselves for very limited nutrition. So it doesn't make a lot of sense in a lot of different ways, but what it typically indicates to those of us in the business is that most of those cells are dead and they don't even check to see what they're giving you is alive or not.

Speaker 1:

Yeah, so, when it comes to using it for aesthetic procedures, I know that quite a lot of plastic surgeons are using PRP, including Dr Randall Feingold. Maybe I'll let you talk, Dr Randall Feingold, a little bit about how you've been using stem cells, PRP in your practice.

Speaker 3:

We use products that are derived from a patient's own blood. It's not umbilical cord derived. It is going to involve mature cell products that exist in your bloodstream and whether it's platelet-rich plasma or platelet-rich fibrin matrix as a gel, we use it in limited applications for skin health and for hair growth court services, as Dr Ozarkar is talking about. That's really to treat more pathologic conditions and it seems like that has a very broad systemic effect, not just local environment effects. So we're in the infancy in my practice in terms of regenerative medicine. Hence my interest in this interview, because I want to really understand it, learn it and apply it responsibly and I want to see results that register, that make patients happy, that fix problems and are safe. Our guest today is far more knowledgeable in the hard science of this than I am.

Speaker 1:

Well, dr Ozarkar, I think that you've mentioned, when we met in Dallas, that you were doing some kind of aesthetic procedure to the skin, to the face, using stem cells. Can you just share with us what is your experience with this therapy?

Speaker 2:

Absolutely, and so we typically do just topical application for some of these products. But essentially, you know so there are a lot of applications for aesthetics and they're booming right now. And what I always kind of walk back to to, to kind of dumb everything down, is, with every disease there is a structural component, there is biokinetic component and there's an inflammatory component to a disease process. And regenerative medicine, stem cells, exosomes, prp all of that suite of products are really geared towards the inflammatory side of the pathology. And so that's why it's important for a patient to understand, as they're walking through this, that whether it's for aesthetics, orthopedics or for anything else, there may be structural problems. And and and dr feingold can probably give a better example of this in aesthetics where you know, for example, a facelift, you know I mean there if the tissue is just two centimeters below where it needs to be, then it's not inflammation. Maybe inflammation drove, slowly drove, that tissue to be where it is, but ultimately now it is a structural issue and so it's called gravity issue.

Speaker 1:

It's aging, it's a normal aging process absolutely.

Speaker 2:

I don't say there's nothing wrong with it. When you're dealing with someone like that, then they continue to have this inflammatory component of their disease or their pathology, but they also have the structural component. So we work a lot with surgeons who mitigate or manage or control or fix the structural issue and we manage the inflammatory side of it. And that's what I really see in the future going forward is we need doctors like Dr Feingold who are open-minded, because every single disease process, every chronic disease, ends up being a little structural and a little inflammatory and a little biokinetic, and there's always dysfunction in all three of those buckets.

Speaker 2:

And what we use for aesthetics is typically people who don't have major structural issue in whatever body part, so like, for example, thinning skin can be a really so we don't necessarily even just only use it on the face, we also use it, you know, sometimes we use it in the forearm, sometimes we use it for sagging skin and other areas. But it helps. It makes the tissue more resilient and less inflamed on a cellular level, and so sometimes that outcome is tighter skin and, you know, a more firm look and so. But that's, that's always the part that we want to make sure that the patient understands, because if they really have a surgical issue, then something like a stem cell product for topical use or an exosome product for topical use is not no matter how many applications is not going to give them the results that they want. And so sometimes pairing it or working with a surgeon and saying, ok, the surgeon is going to do the most minimally invasive thing that they can Maybe they wanted to do a long list of things, but maybe they can shorten it and just fix the structural component and maybe we can follow it up with some of these other you know, emerging aesthetics applications to manage the inflammatory component of the disease.

Speaker 2:

And that's exactly how I look at orthopedics as well, and so that's always part of the education process, and so we always I don't do aesthetics and I'm not trained in aesthetics, but we have access to unique products just because we work in this field. We have access to, of course, international clinics that have very unique products, and with that, we always try to work as a multidisciplinary team and say, look, you have to have someone spearheading what we're trying to do, because we want you to have an excellent outcome, long lasting outcome, and the way we do that is by working with someone who really understands this problem and helping and having us all dissect the problem out into those three buckets to understand what stem cells or exosomes or PRP or PRF or any of these products can do for you, versus what a surgery can do for you and how we can all put it together.

Speaker 3:

So when you offer a stem cell based product to one of your patients, is this umbilical cord derived or are you obtaining it by filtration of the patient's blood?

Speaker 2:

So we do a lot of PRP. There are not really stem cells in PRP because they spin out, because the stem cells are large and heavy and so during the spinning process you're basically spinning out all of the very few mesenchymal stem cells that exist in the blood. But yes, we do a lot of blood-based therapies and so we do PRP platelet lysate we do PRF. We use a thrombinator to create a thick gel matrix in certain cases for certain orthopedic procedures that we do. We also use bone marrow, so autologous bone marrow, so we extract bone marrow. We also use adipose in certain cases and what is allowed in the United States is this micro fragmented fat. So I typically take it from the love handle and typically I don't take much, probably 30 to 40 cc's. I typically will put in 30 to 40 cc's of tumescent fluid and then extract like 40 to 50 cc's of adipose tissue out, so on each side, so we can source it from the patient themselves. So that's autologous, so that's either bone marrow or adipose. We also use umbilical cord tissue products. So in the United States umbilical cord stem cells are currently they're considered an unapproved drug by the FDA and so a lot of these products. There are no legitimate manufacturers that I know that sell umbilical cord mesenchymal stem cell products.

Speaker 2:

In the United States we do use exempt tissue products. So there are certain exemptions. It's called PHS 1271, the law that describes essentially transplantation tissue. There is an exemption called the 361 exemption and there are certain exempt products that are derived from umbilical cord and those are not considered unapproved drugs by the FDA. They're exempt from FDA approval. They can have cells inside of them potentially, but they're not MSC drugs. That is what we offer in our international clinics, like in Stem Cell Institute, panama and Grand Cayman.

Speaker 3:

So when you harvest body fat, how do you then apply that in your treatments?

Speaker 2:

So typically we can't extract the cells. The FDA had a large lawsuit with a company called Cell Surgical Network where it was a long drawn out process. Some of your plastic surgery colleagues actually made that company and really popularized the use of adipose cells through a process called SVF. The use of adipose cells through a process called SVF stromal vascular fractionation and that process where you sift out the stem cells in the fat, the FDA considers an illegal, unapproved drug. But if we use the matrix of that adipose tissue, so microfragmented fat for example, then the FDA has cleared devices that help you produce that product and so essentially I use that as a scaffolding agent to inject inside joints, and so I typically will. So if we use the tulip system typically and we extract the fat, we decant it and we put it through these grates as per the kit instructions and then we make it so that it can go through a needle, and so it's basically fat grafting, we make that fatty material small enough to go through a needle.

Speaker 1:

How beneficial is it for a man or woman that are over 60 when we know that they don't have enough stem cells to rejuvenate the site?

Speaker 2:

Great question. This is always something that I bring up with patients. Age is certainly part of it. Age is the number one cause of inflammation. But also, I would rather take a very healthy 60-year-old's own cells as opposed to a 35-year-old who smokes and drinks and eats excess sugar, has all the bad lifestyle choices, and so there are a lot of factors that go into deciding whether or not it's worth using your own stem cells or not, and so I agree with you After the age of 60 in particular, we do see a precipitous drop not only in the number of stem cells, but also the overall competency of those stem cells.

Speaker 2:

They're just not as effective as they were when that person was younger. So then, yeah, we do have to have kind of a discussion about that, and that's why something like fat is a lot more useful for its scaffolding than it is. In particular, there are stem cells that exist in fat, but we're not necessarily after that. We're more interested in the grafting material that comes from the fat, for example, and I don't necessarily do a lot of fat, because the other thing about fat is that it's really only effective for people who don't have very much fat at all, who have a really healthy, healthy BMI and don't have a lot of excess adipose tissue. When you have excess adipose tissue, then the milieu of the environment of that fat tissue is such that it doesn't really help other places in your body that much. So there are a million considerations. It's like playing three-dimensional chess every time I'm discussing something with a patient, because there are a lot of considerations. It's like playing three-dimensional chess every time I'm discussing something with a patient because there are a lot of considerations.

Speaker 2:

Earlier today I had a patient who is super healthy, personal trainer, looks incredibly healthy, is incredibly healthy, but she has lupus that's really well controlled, and so we discussed it at length and she was like I just don't feel comfortable with using my own PRP, my own blood products, because there is, there are inflammatory, there's inflammation inside of her body that her cells are, her immune system is generating as a part of the disease of lupus, and she doesn't want to redistribute that in areas that she hurts in because, to her point there there's some early literature that indicates that it may be, may have a net negative effect overall because you're redistributing all of that inflammatory juice that's running through their body, even though they look like. If you saw this person you would say, wow, she's probably top one percent healthy people in her age group. But that's why we always have to dig a little deeper and try to dissect things out a little further.

Speaker 1:

So do your requires any bloods. Oh, sorry Go ahead, dr.

Speaker 3:

That's why we're all not eligible candidates to be donors when it comes to donating material to help other people, whether it's donating bone marrow or donating solid organs because you have to look at the intrinsic physiology of the donor to find out if it's going to be suitable or if it's going to aggravate the condition. So it's pretty astute on the part of that woman with lupus to say I've got inflammatory products in my blood. I really don't want to concentrate that somewhere. And it's also an important point you made earlier about the high BMI patient that all fat may not be created equally and some people's fat just may not be an appropriate source of therapeutic material. When you use the micro fragmented fat for an injection and you're using it as a scaffold, are there other products that you add to that prior to the injection, or is it the micro fragmented fat only? And then I'll tell?

Speaker 3:

you why I'm asking that question in a follow-up.

Speaker 2:

Oh yeah, that's a great question. I actually only use this micro fragmented fat for people with severe end stage joint disease, primarily in knees and hips mostly knees and I will use it with other products. I will typically that's when we're throwing the kitchen sink at it, because these people are at the edge of a knee replacement and they come to me because they want to try an alternative before they get the knee replacement or the hip replacement or whatever, and so I put the microfragmented fat inside the joint itself. But then I will typically also take bone marrow on the same day and it's convenient because I basically numb at the exact same site because I'm extracting from posterior iliac crest that's where I insert the cannula to extract from love handles.

Speaker 2:

I put the microfragmented fat, sometimes even with PRP, inside the joint or even with umbilical cord tissue, sometimes in the joint, and then I'll use the bone marrow for some of the musculature around the joints.

Speaker 2:

For example, if they have like IT band syndrome, which they commonly do, if they have pes, anserine bursitis, along with their joint disease, I'll use bone marrow for some of those certain other areas and sometimes I'll even inject inside the bone. So we call this an intraosseous injection with concentrated bone marrow, and I'm looking for bone marrow lesions and bone marrow edema on MRI, and so that's our kitchen sink approach. But you're right, we have to be very mindful about where we put things. One of the negatives, the potential negatives, of microfragmented fat and fat in general is that it may cause, if you inject fat into, let's say, your back muscles, your low back muscles, it may actually cause some of those low back muscles to turn into fat. It may accelerate the paraspinal atrophy and sarcopenia that is associated with chronic back pain, and so we always have to be very judicious about where we put things, and so it's always a lot of thinking every time I'm coming up with a plan like this, and also a lot of explaining, because it's a shared decision between me and the patient.

Speaker 1:

So when I see all this advertising in Tijuana in Mexico and all this area where people say I just walked into the clinic, I had an injection, wasn't even painful, and I walked out. I've had stem cells also in my lower back and my hips, so I just know that this is not true. It is a procedure. It's not something that you walk into a clinic and then the next day you're fine.

Speaker 2:

And so, and I'll say you know, about 10 percent of the time people are great, they have no issues.

Speaker 2:

But I'm telling you, if you are, if you're getting a stem cell procedure and if you have like pain relief immediately afterwards unless you're one of the very lucky one out of 10 people who does that I would be if every single patient coming out of a clinic saying says that they feel like a million bucks immediately afterwards, I would be very concerned that they're also injecting something else, like a steroid or something that is going to make you feel good, because, realistically, you as the consumer have no idea what they're doing and, especially when you leave this country, you as a consumer have very little protection and whereas I mean, if you're being treated in this country, it's a very different story.

Speaker 2:

But that's a part of the problem You're exactly right, leora is that these consumers don't even know what they're getting and if you press these clinics, they'll never tell you. They'll never tell you who their manufacturer is, they'll never tell you what the chain of custody was of that product, because they may not know. They'll never tell you what the chain of custody was of that product because they may not know. They're switching manufacturers all the time. They're switching products all the time, and they may be injecting you with stem cells, but they might also be injecting you with something else. That's meant to provide early relief so that you're happy, but it may not give you the long-term outcome that you're looking for, and so you need to go in as a consumer eyes wide open, because you should be very suspect if it's all rosy colored everything at these clinics, because their number one objective is to get you in the door, whether you're a candidate or not, or whether they feel like they can actually help you or not.

Speaker 1:

And I think this plays really a major role in the fear factor. People are concerned and that's where the safety and the clinic that you go to plays a major role, because you want to make sure that this is a very trustworthy medical clinic, because once they put you to sleep, you really don't know what's happening there. And I also want to urge listeners and viewers to ask for the, the surgery or the procedure reports. We should be getting a data reports, not just three sentence, but probably two pages if it's done properly, depending on how many sites are being injected.

Speaker 3:

So I have absolutely a few questions for you as well. There is a commercially available product that's, I think, like a dehydrated adipose tissue matrix for injection as filler material. I don't know if it reports to have anything more than dehydrated adipose tissues, that it's acellular, but it's got some matrix left behind that you rehydrate. Do you see any utility for a product like that? It's very expensive.

Speaker 2:

Yeah, that's what I was going to say is that a lot of these products are expensive and there is there's a very similar product of dehydrated nucleus pulposus material that for disc injections and it is outrageously expensive and just doesn't deliver the results, in my opinion, that some of these other products do.

Speaker 2:

I think that when the prices become more reasonable, I think that, just like the art of plastic surgery has evolved so much, probably in your career, where you say, if we use this local anesthetic instead of that local anesthetic and if we use this product with that product together, and sometimes we get a better outcome I think that as this field of regenerative medicine is massaged, I think there is utility in structural materials that act as a scaffolding and I think that if it's a reasonable price and I think that if it plays well, if we know for a fact that it plays well with other regenerative products, that there's absolutely utility, because the big problem with stem cells is, once we put it in the right spot, it's keeping them there, and so that's what, like PRF, for example, can be really helpful to use as an autologous gel matrix to make that stuff just sit there.

Speaker 2:

But we don't know. There's so much to know Do cells do a better job of engrafting in allogeneic adipose tissue or in other types of tissue? I don't see much utility and I've actually not heard of the product being used for orthopedics, likely because it's expensive and for those who've tried it, it probably wasn't may not have been effective.

Speaker 3:

It has filler material for very small defects but it's super expensive and probably not tenable for most self-paid patients. But autologous fat grafting has exploded in use in plastic surgery in the last 15 years. Initially I used it to treat radiation-damaged tissue in women who had mastectomies, breast reconstruction, chemotherapy, radiation therapy and that radiated damaged skin was empirically noted to improve with autologous fat grafting in terms of color, texture, softening, getting a little bit more of a plush look and feel to it, and that got a lot of plastic surgeons interested in fat grafting. But now we use it for high volume replacement, augmenting breasts, backfilling breasts after removal of implants. A big area of interest for me as a plastic surgeon is how to increase survivability of transplanted autologous fat. Is it based on how we handle the fat, process the fat, the volume of fat we put in? Is it the age of the patient? I myself do not add agents to the fat to improve retention and I don't think you can add medications to it under FDA approvals. But this is overlapping science with what you're doing.

Speaker 2:

Absolutely, because what is commonly done in the regenerative medicine world is using the fat graft with PRP Super common because it's basically just an espresso shot of growth factors, of autologous growth factors, with that grafted material. So I'd be interested to see if some of the literature in the plastic surgery world starts to fold some of that in, because you can take super concentrated PRP and still probably get the consistency of material that you want. It won't dilute it out, so it's super watery or anything. There's other kits now that can take 120 cc's of blood down to 2 cc's of PRP, and so you basically just concentrate all the platelets and growth factors. I'm interested to see. There's so much to learn in both of our fields, so many unanswered questions.

Speaker 3:

In plastic surgery, one thing that many plastic surgeons do when they harvest fat is they filter it, centrifuge it, process it in some way to remove all traces of blood to try to achieve a more concentrated injectate of adipose cells, without considering whether there's any accompanying growth factors in the blood that comes when you harvest the fat. And why wouldn't that be a potential advantage? And they're thinking that's very true. We don't want to add 300 cc's of fat if 150 of it is blood and tumescent, because then it's going to get absorbed and it's not going to look as full as the result we want. My thought process is maybe we need to put it in straight from the tap because we don't know what we want. My thought process is maybe we need to put it in straight from the tap because we don't know what we might be excluding in the associated blood coming out, that fat that may contribute to better viability and retention of those fat cells.

Speaker 2:

I have a very good point and yes, of course.

Speaker 1:

I'm just I want to question if you have ever tried to use a methylene blue. I'm just I want to question if you have ever tried to use a methylene blue, which is a salt that is used as a dye, and I'm just wondering if that's something can be done to draw more oxygen to the site.

Speaker 2:

you know, when it comes to inflammation, We've had plenty of patients use it for as a systemic anti-inflammatory. We've actually had many patients use it as a it as a tool to recover from the injections. So I think that there are a lot of unexplored options, but I don't recommend it formally. But I've had plenty of patients who have sworn by it. They're like I don't want any of the medications that you prescribed after the procedure. I just want to go home and take methylene blue. And they do great, and so something to consider for sure.

Speaker 1:

So I think that I am interested to hear your closing thoughts about the future of regenerative medicine and also how it can benefit other areas in medicine.

Speaker 2:

Absolutely, and, leora, I might have said this to you in a previous conversation. We're just scratching the surface here in terms of stem cells and, like I said earlier, stem cells exist in all human. We're all 99.99% similar, but we all have different things that we're good at and we all have different specialties, and that's exactly what I believe is the case with these mesenchymal stem cells. And so, for example, dental pulp stem cells have an incredible theoretical ability to regenerate nerve tissue. They have an incredible ability to regenerate bone tissue because they sit next to bone, dentin and nerve, which is the root canal nerve for all their lives. And whereas umbilical cord MSCs they're primarily mitigating the mother's inflammatory response, they are building out a bunch of matrix, collagen and fibrin. That's what makes up the umbilical cord, which is really useful for orthopedics.

Speaker 2:

Menstrual blood stem cells, for example, seem to have an incredible ability to mount an immune response. So what I see for the future is that in 30 years from now, when we've exhausted all of our antibiotics and they're all resistant and the bacteria have outsmarted us and are taking us out, I don't think it's unreasonable, for maybe one of us will get a bag of menstrual blood stem cells, so that those cells can never be outsmarted by bacteria and can always mount an immune response, and maybe that's what we're going to be getting. Maybe after you have a heart attack, you'll get bone marrow stem cells instead of umbilical cord stem cells, because they seem to have a better chance of increasing blood flow to areas. Maybe when you have peripheral neuropathy you'll get dental pulp stem cells, or spinal cord injury you'll get dental pulp stem cells.

Speaker 2:

The surface here, and there are so many unanswered questions, but I believe that, especially chronic disease I believe that 90% of chronic disease can be fixed or the solution to their problem can be facilitated with stem cells, and I think that we're going to be folding it into everything that we do. I think that every single doctor, including Dr Feingold, is going to be using stem cells often. I don't think it's going to be far-fetched at all for after Dr Feingold does a mommy makeover, for example, for someone to get a bag of IV stem cells the next day so that they can recover faster and their scar looks better and they have less post-operative pain. I think that all of those things are very realistic and I think that it will just improve all of medicine and all of humanity in general, and so we don't even know. We just need to tug harder on the string and keep marching forward.

Speaker 3:

This all sounds very exciting. We are currently giving our post-operative patients IV nutrition, but it's not nearly as sophisticated as stem cell therapy. I for one would not look forward to being a donor for Dental Pulp, having had root canal in the past, but I guess if it's already processed in existence and I needed it, I'd gladly accept it sooner than give it. Dr Zokar, this has been a fantastic hour talking with you. I've learned a lot, and yet there's so much more that we don't know. That I certainly don't know, and I look forward to having more conversations with you in the future.

Speaker 2:

Likewise. Thank you guys so much for having me and yeah, no, there's a lot to discuss and there's a lot for consumers to learn about, because it is the Wild West of stem cells and you have to be careful.

Speaker 1:

So I want to thank both of you and I want to encourage our listeners to learn more. I'm going to leave below the contact information of Dr Tajas Ozarkar and Dr Randall Feingold, and you're welcome to ask questions in your comments and we'll get back to you. Thank you, guys, and have a good evening. Thank you, leora.

Speaker 2:

You're welcome. Thank you, leora, for inviting me. Thank you so much, you're welcome, take care. Bye-bye.

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