Liveyon Pure Cast – Exosome VS. Stem Cell Therapy. (E19)

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Episode 19 – Liveyon Pure Cast – Exosome VS. Stem Cell Therapy

Dr. Gaveck: Welcome back to the Liveyon Pure Cast Podcast, I’m Dr. Gaveck, Director of Medical Education and I’m very honored to have with me today Dr. Rafael Gonzalez. Welcome.

Dr. Gonzalez: Thank you very much for having me, appreciate it.

Dr. Gaveck: Dr. Gonzalez, you’re very well known in the regenerative medicine field and stem cells, exosomes, and pretty much everything in the cellular world. Give us a little idea about your background.

Dr. Gonzalez: Sure, absolutely. So I was fortunate to work at the University of California Irvine where originally I’m actually from the spinal cord injury sector. I started off doing actually immune interactions with the spinal cord and by default, I actually ended up in the stem cell world by being part of a team that was the first embryonic stem cell research done on spinal cord injury, and they were later gone into clinical studies with Garon Corporation. That later ended up actually dissolving, not coming to fruition, and then from there I just went full steam ahead… this was back from starting in 2,000… full steam ahead actually into stem cell sector, all of it. You know, anything you can think of, adult stem cells, almost any type od cell you can think of.

Dr. Gaveck: You’re pushing 20 years in the stem cell field, which is like a lifetime for this industry.

Dr. Gonzalez: It’s coming up to that, and with all the different cells that I’ve worked at, it feels like a lifetime.

Dr. Gaveck: What we want to talk about today is exosomes big buzzword in the industry, right. Exosomes this, exosomes that. What does that really mean? I mean, what are exosomes?

Dr. Gonzalez: The interesting thing about an exosome is that an exosome basically is, I would consider just like a mini cell, but it’s a mini cell that doesn’t have all the functions of a cell and it has a wall around it, and it’s an information packet. It’s a method of a cell to communicate with another cell, or believe it or not, a cell to communicate actually with itself. This thing is actually 1/1,000th of the size of an actual cell.

Dr. Gaveck: I see the term is like a micro vesicle-

Dr. Gonzalez: Correct.

Dr. Gaveck: … full of this nontranscribing microRNA that wants to talk to everything around it.

Dr. Gonzalez: Correct. yeah, so it’s a method of… a protection method, basically for the cell. Before it’s actually an exosome, it’s inside of a cell. It’s called the endosome. The cell makes this and manufactures this, and then this stuff is actually excreted out, and if the same cell needs it again it’ll take it back in, or if that cell want to communicate, which is the vast majority of the time is with another cell to make a change or to do something, then it actually just transferred it over. It’s a protective mechanism. This way nothing’s degraded, nothing is, you know, changed in it with that exact message inside of it.

Dr. Gaveck: So we know pretty much what they are, kind of what they’re composed of. Can you go into that a little bit. I mean, we know they’re some microRNA, but what’s the working stuff?

Dr. Gonzalez: There are micrRNAs in there, which can make changes and then there are also proteins in there. There’s various different, just sort of this distinctive information. Whatever a cell needs and if it’s neighbor. because remember cells communicate together, and they give each other this information, and they feed off of each other, and they say, “Hey partner, I need this. Can you make me this?” Then this other guy with actually perform, make this, manufacture it, and packet it, and then spew it out of a cell, secrete it out, and then it actually goes to let’s say it’s neighbor or somewhere else. It could actually… it can go far away also.

Dr. Gaveck: Are there specific types of cells that create exosomes or do all cells create exosomes?

Dr. Gonzalez: Virtually, every single cell in the body basically produces exosomes.

Dr. Gaveck: So it creates the package inside the cell. Ones called an endosome and when it’s secreted out, excreted out it becomes an exosome.

Dr. Gonzalez: Correct. It’s in an exosome at that time, so it’s a little different at that point.

Dr. Gaveck: This big buzz in the industry, like oh exosome this, exosome that, I have two billion exosomes in my product. What are they supposed to do?

Dr. Gonzalez: The concept is basically to make a change, and in this type of industry, regenerative medicine, we’re talking about making a change for the better. You know, to repair something, to heal something, to make functional changes in the body. There’s quite a bit of pre-clinical work that’s out there that has actually shown that these things, these exosomes serve really well more than anything else, believe it or not, in the neurological sector. It can increase blood flow to the brain, can help heal specific neurological disorders in animal models. In wound care, can actually help heal wounds. This is based on, for instance, in specific miRNAs that are actually in these packets, that can actually make changes. What’s out there right now is a little bit of a… for me personally, I think it’s a misnomer because it’s not… everybody discusses exosomes and pure exosomes, but I don’t think very similar to the stem cell sector that’s what’s out there right now, when a bone marrow is small fraction of stem cells, very small fraction, and umbilical cord blood is a small fraction of stem cells, stromal vascular fraction, small fraction.

Dr. Gonzalez: It’s really, really similar to what I’m seeing out there, is that these products are not pure exosome based product. To actually do that, you have to do what’s called an ultracentrifugation. You have to do a specific isolation of just the exosome. These products are more… they contain exosomes, but the problem is people are calling them exosome… you know, exosome might be a fraction of what’s actually in the product.

Dr. Gaveck: It sounds like you’re pretty comfortable with the exosome field. How long you been working with exosomes?

Dr. Gonzalez: I’ve been working in this field for about five years, and those of us that’ve been working for awhile in this… We actually just call this supernatant, or the byproduct of media. It’s actually recycled product of cells, of food. These exosomes, you can obtain them from any cell type, for instance, from cancer cells. Cancer cells excrete out these exosomes that actually cause more cancerous cells to grow, so depending on the condition that you put these in is what they are gonna do.
Dr. Gaveck: How do you make them exosomes? We know how the body does it, but when you make… you’re making a product, to sell as a regenerative product, how do you make that?

Dr. Gonzalez: We basically… for instance, in the product that we’ve been working with for years, and we’ve done some outside independent studies on and everything. We basically take a pure umbilical cord mesenchymal stem cell. This is a culture-expanded culture. A system, basically in a Petri dish, or we call them actually cell stack systems. We put the cells to grow in the optimal formulations. We’ve run various formulations to see which one is the best, and then at certain points, once these things are happy as happy can be, they have their tight junctions, and their cell-cell contact with each one. We then at that point change the condition completely, drastically. We put them into somewhat of a starvation mode, it depends on what we want them secrete. We have various different methods to make them secrete different things. What transpires though, is everybody’s focused on the exosome. The exosome is secreted out, but besides the exosome, there’s other things that are secreted by cells. You know, proteins, extracellular matrix in abundance, because cells do not survive without extracellular matrix. We talked about collagen before, we’ve talked about hyaluronic acid the most abundant proteins in your body.

Dr. Gonzalez: These things are also secreted and for instance, the product that we have it has these things in there, and these things are needed for protein survival. These things are needed for the transport of these vessels from one location to another location.

Dr. Gaveck: What they’re talking about is using this in regenerative medicine, so you’re building this in an artificial environment, a perfect environment-

Dr. Gonzalez: Yes.

Dr. Gaveck: … until you know, that they get all perfectly together, then you put them under stress so that you create this, and then you take that exosomal product, and then put it into the body. Does it act the same way? I mean, as in that perfect environment that you’re dealing with?

Dr. Gonzalez: Remember the body is under, depending on what’s transpiring in the condition, you can coerce a cell to secrete out whatever you need. If you put just a straight stem cell, you know, a pure stem cell in a condition that all of the sudden you starve it, it’s gonna go into survival mode, and survival mode is actually gonna require that it secretes out specific survival cues. Whether they’re proteins, whether they’re extracellular matrix, whatever is needed to survive. When you put that into a body for instance, you’re basically putting possibly something in and this is hypothetically speaking, because we don’t really know. Clinical studies have not been done on this, we don’t really know. You put it into a condition that possibly… maybe it works, maybe it doesn’t work but the concept is is that you’re putting something in to activate your own system because that’s what this stuff is spitting out. Activate your own system to heal and to repair. Whether it does that, it’s still to be known. We don’t know.

Dr. Gaveck: That’s probably why you are working on developing a product to see if we can bring online at Liveyon but it requires some studies, more studies to figure out exactly what it’s doing. It’s in some immature stages but you’re getting that very rapidly.

Dr. Gonzalez: Yes, we’ve done a lot of studies on there, so I mean, we’re going on five, six years of studies with this already to identify various, different methods of production, production in a GMP manner. How do you make sure most importantly, is you have a consistent product, that it consistently has the same exact thing, because one day or another even though you grow up a cell in a specific condition, it’s hard to dictate, you know, you got the same exact day, you gotta do collections of the media, and then also the reagents that you’re using, everything has to be according to GMP, testing the actual products, testing large batches of it. It’s not easy and that’s why we’ve spent a lot of time and effort in research and development, and going the correct route, what we wanna do.

Dr. Gaveck: Well, I think we’ve hit what we really wanted to talk about today. You know, where they come from, what are they, what do they do, what do they have the potential to do. If you’d be willing to, id like to bring you back at some other time and really talk about the research that you’re doing, what you’re looking for, what you’re really looking for it to do in the body. Maybe when we can have an idea, when we can see some of this stuff in the market place, other than what we already see, but see your product coming out in the market place. We’d really like that.
Dr. Gonzalez: Yeah, that would be great and that would be amazing to discuss. Just real quick, real quick touches. Remember that these things come from cells-
Dr. Gaveck: Yes.

Dr. Gonzalez: … and cells have to be spewing this out on a consistent basis, and people don’t quite understand that. They have such a big buzz for exosomes-

Dr. Gaveck: Yes.

Dr. Gonzalez: … and they’re discarding that the exosome is what’s actually doing the work. The exosome is not the exosome without the cell and you know that, and I know that, because this is what produces it.

Dr. Gaveck: Right.

Dr. Gonzalez: That’s why cell therapy is a much higher caliber-

Dr. Gaveck: That’s why live cells work, you’re right.

Dr. Gonzalez: That’s why live cells work, yep.

Dr. Gaveck: Hey, another great episode of the Liveyon Pure Cast. Please join us next time when we will again be with Dr. Rafael Gonzalez. I’m Dr. Gaveck, and we’ll see you


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Medical Professional Viewing Only (Disclaimer)


This site was intended for education purposes only and strictly for use by medical professionals. The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.
The FDA has stated:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
This site is not intended for consumers.
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult the national health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.