Episode 22: Autoimmune Disorders - There's Hope! With Dr. Rafael Gonzalez And Dr. Keith March

PYP 22 | Autoimmune Disorder

 

Autoimmune Disease is a condition in which your immune system, the one that should be protecting you, starts mistakenly attacking your own body, your lungs, tissues, joints, and much more. Join your host Haylie Pomroy as she sits down with two amazing guests, Dr. Rafael Gonzalez and Dr. Keith March. Dr. Rafael Gonzalez is a biochemist and cell expert who has extensive knowledge in stem cell health. Dr. Keith March comes from the world of cardiology with two decades of research and development in the world of adult stem-cell therapies. Both are doing a scientific trial studying how stem cells can be applied in the autoimmune world. What is more, they are also joined by one of Haylie's clients to share her experience with an autoimmune disease. Follow them in this conversation as they talk thoroughly about autoimmune disease and how to remedy and protect yourself from this disorder.

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Autoimmune Disorders - There's Hope! With Dr. Rafael Gonzalez And Dr. Keith March

I have some power to put on your plate. We are going to tackle the subject of autoimmune disease. I have brought some of the most brilliant doctors and even a mutual patient of ours to the table. I want to talk about, "What is the autoimmune disorder?" It could be something like lupus, dermatomyositis, celiac disease, ITP, MS or Type 1 diabetes. An autoimmune disease is when your body is attacking itself. Your immune system should be attacking foreign invaders but with autoimmune disorders, it attacks your tissue. It could be your lungs, joints or platelets.

One thing that's interesting is that it's a 2 to 1 ratio with women to men that end up having an autoimmune disorder. Most commonly, it happens when we're having some hormone transition. We see it in young people with the onset of periods, sometimes during pregnancy and most commonly, we see it a lot during menopause. In the United States about 24 million people will be diagnosed or will have autoimmune disorders in 2021. In our community, it's all about finding solutions and ideas, being progressive and putting that power in your hand.

That's why I'm bringing some very unique people. There's going to be four of us. It's going to be quite an eclectic discussion because I want to bring up a therapy that maybe a lot of you guys haven't been exposed to. That's what we're seeing in many other countries and now we're starting to see in the United States. That is stem-cell therapy and its effect on re-regulating a body that's suffering from an autoimmune disorder. We're lucky to have Dr. Rafael Gonzalez. He is a biochemist and cell expert who has extensive knowledge in stem cell health. He is responsible for developing several clinical trials, both in the United States and out of the country.

Maybe you've heard of cell therapies for joints or anti-aging but a lot of the progressive therapies are in severe treatment for diseases that we don't have a lot of restorative or reparative drug therapies for. That's why I brought into this conversation Dr. Keith March. He has over 60 worldwide medical patents. Ten million patients have used his patch where it patches the blood vessels after having a stent. He comes from the world of cardiology. He had two decades in development and research in the world of adult stem-cell therapies. He and Dr. Gonzalez had this phenomenal trial that's being started at the University of Florida around how stem cells can be applied in the autoimmune world.

I also have one of my clients. Her name is Karen. She has been a client for a very long time. I have had the pleasure of walking on her journey through being diagnosed with an autoimmune disorder, being given prednisone, Imuran, CellCept, all of the anti-rejection drugs, Mepron and her tenacious desire to accept nothing but getting back to health. Karen is going to share her journey with us and what motivated Dr. March and Dr. Gonzalez, two brilliant researchers in the stem cell world to come together to help give you guys the information to put some power on your plate. Join me while we dissect this complicated concept of being progressive in the world of autoimmune disorders. It's been an amazing journey for myself and I cannot wait to share these brilliant people with you.

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I'm very excited for myself, my clients that I have here and our community. I wanted to bring everybody into my kitchen. This is my classroom. It's been my pharmacy and my own health journey. For us, as a community coming together, it's all about putting power on your plate. When we put power on our plates, sometimes that's in the form of food, success boosters or things that you can do to help enhance your body and immune system. We're going to talk about the power of choice, knowledge and looking at options in your health and wellness. I want to introduce a couple of cherished individuals in my life. I have Dr. Rafael Gonzalez, Dr. Keith March and Karen, who's been a client of mine for many years. Thank you so much for being here. I appreciate each of you.

I wanted to get together and talk about autoimmune disease, autoimmune disorders, why it's happening, why it's prevalent, why many of us are struggling with it and bring some of the brightest minds that I've had the privilege of working with together and see if we can provide you guys with some ideas, options or choices in your particular healthcare. Welcome, everybody. Karen, I would like to start with you. You are a client of mine. With our community, I like to bring in all of our virtual clients, doctor friends and different individuals who incorporate different therapies. Karen, I want to thank you for coming as a client and as a fellow autoimmuner. It's very exciting to have you.

Thank you for having me.

Karen, let me share about how all of us came to be in working together. Karen and I were working together on health and wellness. She had what we would call the perfect storm. Karen, you were dealing with some health issues, everyday things that normal people deal with. Maybe fatigue or working on your health and then you got sick. Can you share with us what happened with that?

Sure. I got sick with an autoimmune disease. I was in my 50s. That's a very common year to get an autoimmune disease and it mostly affects us, women. I had perfect health like I thought I did and then all of a sudden, I became very sick. I thought that, "I go to the hospital, the doctors treat you, give you pills and you get better." That didn't happen to me. Once I got over the initial big inflammation storm that came, they said, "We're going to put you on medication for the rest of your life. We're going to suppress your immune system. You have an autoimmune disease and the only way to treat this is with six medications."

Initially, they started me with prednisone which anybody knows about prednisone. It puts you a ton of weight on, makes you puffy and irritable. They phased me off of that and put me on some other immunosuppression. A year goes by and they said to me, "You might be able to come off your meds." Time went by and they started phasing me down on my medications and the disease came right back. My disease is an autoimmune disease that is called dermatomyositis or polymyositis, which affects the lungs. I couldn't ignore the symptoms that I had because I wouldn't be able to breathe and I would need a lung transplant if I didn't pay attention to medicating myself. I was forced into this medical world that I, as a healthy person, have never navigated before. 

We've been through quite a journey. That is for sure. Karen, I brought on Dr. Gonzalez and Dr. March because they've been very integral in us finding innovative ways to deal with both of our autoimmune disorders. Some of the biggest questions that we get asked on a regular basis are, "What do I do? How do I survive the disease and treatment?" I always say, "How do you thrive in this kind of environment?" Dr. Gonzalez, if I can start with you first and we can talk about, "What's going on in the immune system when we start to create an autoimmune disorder or the body starts attacking itself?"

What we're looking at is there are many different hypotheses as far as what is transpiring in autoimmune but there's no known cause. One of the biggest ones is looking at viruses. A possibility of a virus coming in, integrating with your own DNA and then mimicking something that seems like it's you but it's not you. The body then comes in, targets it and then recognizes this thing as being foreign when it's you. It's targeting you, then killing and destructing tissue. There are many known autoimmune diseases. We all commonly have rheumatoid arthritis and lupus. One of these ones right here is polymyositis and dermatomyositis that we're talking about with Karen. There are some similarities but yet they're different because the targets are different and what transpires over time is different.

I work in the stem cell sector and the cell therapeutic sector. We look at the immune system as a key to health. The most important thing that we can do is maintain immune health. The reason being is because every single disease and every single thing that transpires has an immune component to it. We target and look at that. We're in phase 1 clinical study that I've been fortunate to meet and work with Dr. Keith March at the University of Florida, where we're using a particular stem cell that we have a patented technology on. It's doing a clinical study for polymyositis-dermatomyositis in patients, such as Karen. We've been blessed to meet and speak with both of you to be able to bring this to fruition for many individuals.

One of the reasons is because these cells have properties to modulate the immune system, not do what Karen said, which is, “It keep me in a suppressed immune state,” because then there are secondary effects. If we think of the common drugs that are out there, we suppress the immune system. I now put somebody that's been a suppressive immune system in the probability of getting cancer somewhere later on down the line because the immune system is not functioning properly or many other different disorders that are out there that we come in contact with on a daily basis. We look at modulating the immune system.

PYP 22 | Autoimmune Disorder

I'm going to take a step back for our community. An individual like myself or Karen, all of a sudden, we've been diagnosed with an autoimmune disorder. Mine was early when I was nineteen. Karen shared that hers was in her 50s, which is very common. It's a 2 to 1 ratio for women to men. It's very common when we're going through some hormone transition, either onset of periods, pregnancy or menopause. Those are common. If I hear you correctly, Dr. Gonzalez, what we see in those situations is a dysregulation of the immune system were proinflammatory and our body is attacking ourselves.

You brought into the conversation about using stem cells or cell therapy which Karen and I both had a lot of exposure and experience with as a way to re-regulate the immune system. We're not looking in this situation. Karen, maybe you can share that. With my role in working with my clients, I'm looking for a way for the body to create healthy homeostasis, not necessarily for suppression of what's going on. I want to figure out the why and the how. Dr. March, you have had research working with adult stem cells specifically and leading incredible laboratory efforts. I want to ask you a couple of questions since Dr. Gonzalez brought stem cells into the conversation here.

In my world, I've traveled with a lot of my clients. We have to go out of the country for therapies like this to even be an option. I'm going to back two things up before I give you the punchline of my question. In the autoimmune world, there are a lot of drug therapies that I had shared with my community that I've been exposed to and Karen shared that she has been exposed to. In a lot of other countries, there are different biologic therapies that have been used very successfully in the autoimmune world. The mesenchymal stem cells are one of them. As Rafael said, we're talking about a study that you guys are working on together. In all of your vast research, what is the mechanism that we're hoping to reprogram in the body so that it stops attacking itself?

Thank you for the chance to be here with you and Rafael and Karen. It's wonderful. I like to think of those cells as being the repair stations on the highways of the body, which are the blood vessels. These blood vessels go everywhere throughout the body. These cells line those blood vessels. The particular kind we're working with that Rafael has made is derived from the umbilical cord. The umbilical cord itself has blood vessels within it. It's the ones that line those blood vessels that we're using. These cells throughout the body are importantly involved in regulating and modulating immunomodulation. It's how much access and trafficking there is of the various inflammatory cells, what are called our white cells or leukocytes, which include both lymphocytes and monocytes? How much access do they get and in what way they traffic into the tissues of our body?

I would like to think of these also not only as repair stations but governors of entry and access to those tissues of the body. When there is a dysregulation, meaning an abnormal function of some element of autoimmunity, what we found is that adding the mesenchymal stem cells appear in many different models of disease and also in other countries to be able to down-regulate and modulate that autoimmunity so as to protect the body. What we're using is something that the body naturally does with these lining cells, the mesenchymal stem cells or stromal cells as they're also called but we're providing more of them. We're using a natural protection mechanism to change the immunity for the better.

I'll try to distill this down in my brain. Something has gone awry. Like Dr. Gonzalez said, it can be viral or infectious. I feel like mine was chemical. When I did a lot of different chemical assays as I was going through the autoimmune process, I have ITP. It was attacking my platelets and it was very odd. We did this whole chemical profile and they said, "You have this strong insecticide in your bloodstream. The counts are weird. The values are strange." I had been exposed. They were spraying for medflies. I don't know if you remember, Dr. Gonzalez. In California, they were spraying. They did this whole thing where you had to be inside.

A bunch of friends and I was coming eighteen. We were out and about past curfew and got dumped on. I'll never forget it was this orange spray and we got covered. As I was going through rebalancing or re-regulating my immune system, those levels were both found in tissue and blood as residual. There was also a lot of stress in my life during that time. That was the perfect storm. Karen, I know you've shared or we've talked a lot about what you maybe feel like, was your perfect storm that caused the body to go into this dysregulation?

One of the things you mentioned was chemicals. Mine was potentially a bacterial virus. I got bitten by a tick off my immune system. I had high stress and tons of food allergies. My gut was inflamed. I had heavy metals. That's one of the things that I feel got my immune system off. That's another reason why I'm coming to you. You ripped all my goody foods out of me and whipped me into shape. My dairy, gluten, soy and corn were gone. That all helped calm my immune system and make me able to work the program that we've been going on. My diet with stress reduction has helped get me down. It not solving at all but it helped. It's one of the steps you need.

We've all talked about Karen's case a lot in watching through this process. We had a sudden onset of extreme dysregulation in her immune system. Her hands and knees swelled. She had been bitten by a tick. She already had a lot of food allergies, maybe sensitivities and things of that nature. If you guys could explain to me if you gentlemen don't mind. The option for me was prednisone, Imuran and CellCept. With Karen, it was very similar and then a lot of Mepron on top of it. When the body goes into that status and the protocol or approach is going to be a regimen of autoimmune meds, is there any chance at that point to re-regulate?

Like Karen said, we worked on stress reduction and food and diet, which I think is the foundation for health. One of the reasons why we both sought out stem cells was because we can eat like angels, de-stress and do everything that's possible to try to get on no drugs or as little drugs as possible because of the side effects and issues that being vibrant, bright and brilliant women, we didn't want to experience but we were looking for a way to re-regulate the immune system to get to what I want to call pre-autoimmune disorder. Is that what we're looking for in these trials with the stem cells?

One of the things that we've seen and many others have in the field, including in particular some of the clinical trials that have been done in other countries that we're now looking to expand and extend in this country with FDA authorization, is that it appears when you provide the MSCs, the Mesenchymal Stem or Stromal Cells to the system, it does do a prolonged reset of the immune system. You can provide the cells at one point. The effect that changes the way immunity is regulated over time appears to last for weeks or months after that provision.

It is probably not necessarily permanent. It is highly likely as best as we and others believe that it's going to require re-dosing like almost everything in medicine does. The cells themselves have an impact that is prolonged with regard to changing the cells of the immune system from being very active, the ones that we call effector cells in the world of T-cells towards those that are called the regulatory cells, the ones that decrease the immune reactivity. That can be persistent. It's not like one shot and you have to repeat it every day. It prolongs. It seems like there's a reset.

It's, "I'm taking and I'm going to put a conductor into your immune system. This conductor is now going to regulate what is going to happen in there that I don't allow that strong pro-inflammatory response." Instead of, "If I give you a drug or these drugs that are available out there, I'm going to consistently keep your immune system suppressed to stop this control that's happening right now,” yet there are effects of that. If I can throw that conductor in there and say, "This amount of immune pro-inflammatory response is okay. This amount of anti-inflammatory response is okay. Let's keep our bodies at homeostasis," which goes back to one important thing that you described and Keith said too. This is not a cure, first and foremost. It's therapy but it's a natural therapy which is what makes us strong.

Secondly, if you don't eat right and if nutrition isn't put into the key the right way, you probably have triggers in there that you have gluten sensitivities or whatever it may be that you all of a sudden eat something and now trigger that immune response again. It's like a combination of a package. We work together in collaboration of you get the nutrition and then we give them these cells to hopefully try to help and better their symptoms.

Extending what Rafael said, I thought the conductor analogy is cool. One of the things that you can think about with the way these cells work is that the cells are like repair stations. They have a lot of different tools in them. If you like to use the conductor analogy, the cells secrete a lot of different molecules. Those are their tools. They might be called peptides or small molecules, enzymes, microRNAs or mRNAs. All of these are contained by the cells. That's a scenario in which they're secreting a variety of molecules acts like a symphony.

PYP 22 | Autoimmune Disorder

Instead of with the standard pharmacological approach, which is not biological, you're attacking one particular mechanism, target or set of a small number of targets. Instead, you have a symphony of instruments, which the cells are secreting and all of these tools work together. It's like in the case of a single loud instrument like the tuba, it’s very loud. There's one thing playing. You have a symphony of a lot of things working at a low or moderate level, but it still makes a big sound but they're all working together, which we believe in general will also help the way they work and decrease adverse side effects.

Tell me if this buttons it up here. In my experience, we look at removing the insult, restoring the body and creating a healthy ecosystem through nutrition and natural therapies. In my clinical practice where we started seeking out different types of therapies and unfortunately, until you guys started these studies in the United States, seeking them out in other countries. With autoimmune specifically, we had a heck of a time rebalancing the body. We talked a lot about this in our community. A lot of us with autoimmune disorders live in this world of what we call fear of the flare. What that means is, "Are we going to break through the prednisone? Are we going to break through the Imuran or CellCept? Is the disease going to progress because of having stress that we don't have control over?"

With the cell therapies, I started looking at in my clinic and bringing in different ideas or options for people. We don't do them in-house. I started contacting individuals and Dr. Gonzalez where I started reaching out was because with autoimmunity, there's this rebalancing that felt so elusive. Over the years that I've watched clients go through stem-cell therapies, there seems to be a lot more stability in that rebalancing option. It doesn't seem to be as fragile as it feels in the autoimmune world. Karen, would you say that was the experience that you've had?

Yes, by taking it.

How did stem cells get brought up to you? How did that even come into your world?

I had met some other doctors who had talked to me about saying, "You might want to look into them." I was connected up with Dr. Bendalas. I wanted to find out, "How does this therapy reduce inflammation?" Because my whole problem with autoimmune disease is inflammation to the point that my hands and knees swelled up. I couldn't breathe. I want to know how I'll get rid of this flare and storm. It looked exciting that these stem cells could possibly help me.

I distinctively remember that. You were having visits with your doctors and we were going, "What's next?" We were somewhat stable from an immune perspective but on max doses of meds. We were both very excited about, "What was the plan from here? Now, what do we do? Now, how do we get healthy?" We first were looking at all kinds of different research out of the country. We were looking at some stuff that was happening in Spain, China, Moscow and a lot of different areas. What response did you get when you broached the subject with your rheumatologist and pulmonologist? How did they feel when you said, "I'm thinking about doing something that's outside of the box?"

They thought I was crazy.

I want to take a little step back. We've loosely mentioned that there is a trial going on. Karen, Dr. Gonzalez, Dr. March, you're all involved in it in a unique way. Let's say someone in my community is dealing with an autoimmune disorder and they're thinking like, "I would like to incorporate as many types of therapies that can drive me towards wellness on my wellness journey.” An individual says, "Maybe I would like to try stem cells or maybe I've thought of stem cells." I know that the two of you are working together on a trial with polymyositis. Should we define that? Karen, you can even share some of your personal experience with that disease uniquely. Let's unwrap that one.

What we're doing is a phase 1 trial. Our purpose with the trial is to build on the data and the findings that have been either reported in publications or also anecdotal from other countries so that we can determine here under the FDA-authorized clinical trial rubric how well these cells work and to what extent they work. That's the basic question, "For whom are they going to be effective? Are they effective? How effective? Let's establish that in this country."

The way you begin is to do what we're doing, what's called phase 1. It's the first human trial in this country for this cell type for dermatomyositis and polymyositis. The people who we hope to address are anyone who's eighteen years old or older with a diagnosis of dermatomyositis and polymyositis, either one of those who are definite or probable in their diagnosis. Those patients would typically have either a myositis-associated antibody or we've evaluated their disease process with their rheumatologists to exclude other things that can mimic polymyositis or dermatomyositis.

In other words, we try to understand that they have that diagnosis. We're going to enroll them in this trial, looking for safety predominantly and also some effects in terms of their pain and strength, the release of enzymes that denote muscle damage and all those kinds of things. That's what we're hoping to do in the next period, looking at this first set of deliveries in nine patients. After that, we'll evaluate the safety and any hint we have of whether there seems to be efficacy that we've been able to reproduce. If so, then we'll approach the FDA and move forward to the next stage.

Dr. March, if I have someone in my community who wants to participate in this, it's at the University of Florida. I want to bring this to our community. How would they be involved in this? Would they call you? For those of us who have autoimmune disorders, I feel like sometimes that's what we do while we're in the middle of a fear of the flare. How would they reach out to you specifically?

Specifically, we'll provide you with the phone number that they can call (see below). We can put that up and let it be very clear. Anyone who has a concern about dermatomyositis and polymyositis are the people we want to be able to see, whether or not this might be something that could be helpful. That's the whole purpose of the clinical trial is to determine, "Is this helpful or not?" If it is, we move forward.

I can feel that everybody in our community who is dealing with autoimmune disorders, whether it's lupus, dermatomyositis, celiac disease or ITP like myself, they're going to say, "This is exciting that this trial and study is going forward and that you guys are actively looking for individuals." You guys, if you're out there, feel like you have a diagnosis with dermatomyositis, polymyositis or seem to fit that profile, want to connect with a good rheumatologist to see if that's right and think like myself and Karen, you're wanting to do some therapy that can help regulate your immune system. I know a lot of people are going to be asking, "Maybe I don't have that diagnosis,” but what's next? Why is it important to do this study? How is it going to help people who have something like lupus?

PYP 22 | Autoimmune Disorder

This is going to look at a particular autoimmune disease and its safety of it. Once we have that safety established and some form of efficacy, there's a crossover with many different autoimmune diseases. One of the largest autoimmune diseases out there and the most prominent amount that people have is rheumatoid arthritis. It either goes to multiple sclerosis and lupus. Down the line, Type 1 diabetes is relatively prominent, too. There are many of them that the immune system. Once again, it goes out of balance and attacks the body positive for things. Once we show that this is safe, then us as a company reach them as a company and make a decision which we are making that decision of moving forward with other clinical studies.

The nice thing about this key study is that it gives us the possibility and probability of going into phase 2 for these different autoimmune diseases. Whether it be lupus, rheumatoid arthritis, multiple sclerosis, etc., we go straight into phase 2, where we look at efficacy in this. Another issue is these things cost a lot of money. We need support to fund these studies. Eventually, we have to go to the table and go back, "Help us out whoever had the associations, parties and universities," and try to work together to be able to afford these clinical studies. They run millions of dollars.

It's our goal to move forward with various different autoimmune diseases. We truly believe that this will work for autoimmune disease that it's a natural form of maintaining a quality of life. We would love to build out a portfolio of these exact types of FDA-authorized clinical studies to evaluate safety and efficacy across a range of autoimmune diseases because those are prominent. These cells appear to be effective in doing immunomodulation. We need to see, "What disease? Does that work well then? Which ones are not?" That's what we're about. It's a great synergy of intent that we have among all of us in this discussion.

That could not be said more eloquently, Dr. March. I always say, "It was a struggle." I've watched my clients struggle through all of the complexity of autoimmune disorder and dysregulation that you have both talked about. For any community member who's reading, they could participate in this particular trial or study. The goal there is then to get more studies and integrate this type of therapy into a portfolio of options of care for someone like myself who deals with an autoimmune disorder. Karen, can I ask a personal question? Dr. March talked about the reason why he and Dr. Gonzalez are doing this. What has led you to push forth this therapy in the United States when you could go out of the country and continue with your glorious life?

I decided that I was too young to be living on immunosuppression and possibly getting cancer or other side effects of immunosuppression. It's got to be able to help other people. I feel that with cell therapy, it needs to be legal in the United States. In trials, it's legal. This is an FDA-approved trial and the government has said, "Go ahead and do it. We can take nine people in the trial and for safety," then efficacy, which means, "Does it work?" They can go to phase 2. The exciting thing about this is once this trial goes through and it's approved, they can use it while it's going. They can also authorize use for other things like lupus, diabetes and MS. We have to be the pioneer out there and get it out there. I want everybody else to be able to get the benefits of what I'm getting because I feel a hell of a lot better. I feel healthier. I've been able to reduce my medications. I'm not saying this will happen for everybody. I'm telling you my story and I would like to have other people have the same opportunities.

Karen, you can call yourself a pioneer all you want. I'm going to call you an angel. We have all been fortunate to be on your health journey with you. It's always inspirational, but the thing that has been touching for all of us is that you don't want this for you. You want this accessibility for other people. I know that you have been the driving force in getting everybody together to make this study be able to happen.

I cannot believe how hard it is to learn about trials that are available for your health and wellness. I have almost never seen a doctor outside of a trial and cancer therapy or a drug therapy being recommend one of my clients for a trial. We are constantly scouring and combing databases and knowledge to try to figure out how to get people access to this. We don't have enough time to talk about, Dr. Gonzalez, how we finally got in contact with you. We've been so fortunate since then to get to work with you. If each of you could share with me, what does a person need to do to be able to participate in something like this?

Be proactive, first and foremost. Number two, start off with baby steps as far as nutrition. Nutrition is the most important thing that you can do. Working with individuals such as Haylie and being part of her group and network is the biggest start that you can take. Secondarily, looking at going online and being proactive.

Dr. March, specifically with your trial, Karen wants to have other people realize the same success that she's had. What would you say to a person that's maybe never heard of stem cells or thinking about stem cells? You are the expert in the Regenerative Medicine field. What would you share with them to get them up to speed in this particular type of therapy? Is it injectable or oral? Give me the basics of what would a day in the life of someone participating in a regenerative therapy trial specifically like this?

On a specific trial, after contacting us and then we go through the process of evaluating. Whether they're candidates for the trial as the FDA has authorized it, they would come and visit us. We would start our medical record process and some baseline testing so we would understand where their disease is currently and working closely with our rheumatology faculty here who are our partners. If they agree and want to proceed, we would put them in the context of an intravenous infusion. They would receive an intravenous infusion of these cells, which have been culture-expanded under careful FDA guidelines by Dr. Gonzalez and his co-workers.

They would receive the cells over the period of about an hour as an outpatient. After a short time of observation measured in hours, they would be able to go home. We would follow up with them at several intervals, 1, 3, 6 months out and 1 year out. We would look at the course of their disease, safety profile, changes, any of the kinds of laboratory studies that we had done and most importantly, how they're feeling and whether there has or hasn't been any change. It's very straightforward in a certain way. There is some testing that's on, infusion and then I move forward.

Thank you for distilling that down. It sounds doable. The most important thing that I want to do for our community is to bring the best of the best to the table and share ideas and possibilities. In our community, we share a lot of vulnerabilities. Karen, I can't thank you enough for sharing your story but also wanting to spread your success to other people because this is kind, amazing and incredible. Dr. Gonzalez, maybe someone out there is worried about some of the things that they've heard about stem cells and some of the ethical issues like fetal tissue. Karen, this was a big issue that you and I talked about when we were considering this therapy. Can you explain to me the source of these cells and why this works well in this study?

These cells are from post-birth. Meaning mother is, first and foremost, screened prior to having the baby. For different viruses and in particular with the cell lines that we have, we look for every single virus. One of the most prominent ones in the United States and in the world is Epstein-Barr Virus and cytomegalovirus, which 75% of the patient population suffers from. We look for donors who don't even have this virus. Now, we've eliminated 75% of donors out there. We screen for genetics by doing karyotype analysis and a couple of different things. Once we've obtained the ideal donor after they've had a baby, so post-birth, we obtain the umbilical cord tissue. That's donated to us under informed consent. From there, we start the process of extracting cells, growing them up and making sure that they are the ideal cell source for you. These are post-birth that are adult stem cells.

Dr. March, in all of your experience in regenerative therapies, this for me has been the most exciting because it's promising what I've seen with clients but what I've also seen in trials and studies. What do you think the power of this particular cell is?

These cells have so many different influences depending on the circumstances. In the context of immunity, they have the power to change the degree of inflammation and immune response working by influencing a variety of kinds of white cells or immune cells. That's seen in multiple models and multiple early studies in other countries. What we want to do is test that circumstance and power here. They also have the ability to help with blood vessel growth, providing support to tissues that may not have enough blood flow and helping with cell survival. Maybe when we have another episode, we can talk about some of those other things that these cells might be able to do and how there are clinical trials that are being designed to test those abilities as well.

PYP 22 | Autoimmune Disorder

Dr. Gonzalez, Dr. March and Karen, I can't thank you enough. We'll do this again. There's so much more to talk about. My community is struggling with finding the care that they need. Can each of you give me a little parting word? Dr. Gonzales, if you can start first, what should my community hold onto to know that there are more and more progressive things that are happening that are going to drive us towards wellness?

Number one, there's so much knowledge in nutrition. Haylie, you being one of them who helps out there with it. It's very important besides that supplementation. Before, it wasn't believed that it was that important, but it is important. Understanding that you have the support out there, that there's a ton of support that can help you with anything. Personally, I know Dr. Keith March, Haylie and Karen, that's why I think we feed off each other and there's a lot of respect for each other that we have participation and we want to help. That's the most important thing.

Thank you. Dr. March.

We're looking forward to having the opportunity to help patients enroll in these trials so we can find out as soon as possible for whom what particular therapy will work. I'll build on what Rafael said. We published the importance of the environment and chemicals. One of the chemicals that people encounter, for example, is the chemical found in smoking. You can perturb the soil of your body, which if you want to think of it in a certain way, we're seeding with these cell products, but you can perturb that by chemistry. You can also improve it by the chemistry that's created by good nutrition. Obesity leads to inflammation. Not obesity leads to not inflammation. It's very important to look at the synergy between a healthy lifestyle, nutrition and the potential for cell therapy when needed. That's what we're trying to explore together.

Both of these two doctors lead with their heart and are brilliant. Karen, if you don't mind giving people some hope. I know you have been through hell and back. On that journey, you have dragged a lot of us along with you. I'm so grateful for that. Could you talk to some of my community members and share your always wisdom?

I will tell you that it is a journey. The first thing you have to do is you have to get your diet and nutrition under control. If you have weight on you, you got to get the weight off. You start with the next phase, which we're hoping for another alternative besides drugs but even though stem cells would be considered a drug, they're more natural drugs. That's why it's so important to do this trial so that the rest of the country can get these cells and, hopefully, treat their other autoimmune diseases, as well as dermatomyositis and polymyositis. I hope that you get in touch with Dr. Keith March and Dr. Gonzalez. They can help you take the next step. Thank you.

Everybody, God bless. Be well.

God bless.

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Everybody, that was a lot. Let me distill it down for you. Autoimmune disorders have been treated for a long time with the same immunosuppressive drugs. In many other countries, autoimmune disorders are treated with cell therapies. A lot of the more prevalent research and the more positive outcomes have been around what's called mesenchymal stem cells or MCSS. I wanted to bring these two brilliant doctors. Dr. Rafael Gonzalez has been researching this particular cell line that's available in the study for decades. Dr. March has been the Head of Research and Regenerative Medicine. Together, with one of my clients who have been through it. She has been through the flare of the diagnosis and immunosuppressive drugs.

She and I found the concept of going out of the country and doing cell therapies. I've shared with you that I've traveled out of the country with many of my clients in Moscow, Spain, the Caribbean, Belize and France to seek therapies that aren't available in the United States. Karen, my client, wants to make sure that these therapies are available in the United States. I wanted to bring to you guys the guy who developed the cells, the doctor who's running the study and the patient who insisted that this happen in the United States. I wanted to bring it all to you to make all of these new ideas and concepts an option.

You guys can register for that study if you would like and if you feel like it fits you or one of your family members. You can also use this as an inspiration and a motivation to think outside of the box when you're struggling with something from a health perspective. Nothing but being healthy is an option. Someone once said to me and I love this, "I don't know how you do all that you do." My response back was, "I didn't know that I had a choice." With my own autoimmune disorder, I'm not looking to fear the flare and survive the experience. I'm looking every day at ways to build on my health and thrive despite having this particular diagnosis.

Let's think of it this way. When we have an autoimmune disorder, your friends, family member, loved one and yourself, your immune system is attacking itself. Through nutrition, stress reduction and supplementation, we're looking to rebuild and strengthen our body so that it doesn't feel that it has to operate in this state of dysfunction. Another option that we've looked at for many years is cell therapies, specifically MSCs, mesenchymal stem cells. As always, I'm trying to put even more amazing, incredible ideas on your plate. We'll give you lots of data and information. This is a big one. This is a lot to eat and process. What I want you to know is that there are always ideas, hopes and solutions to whatever is stressing your body. I love you, guys.

Register for the dermatomyositis and/or polymyositis clinical study by contacting:

Sara Long, BSN, RN
Office Phone Number: (352) 273-8933
Directions: Please ask for Sara Long and mention DM (for dermatomyositis) or PM (for polymyositis) for the specific clinical study. Some will answer the phone and get Sara a message if she is not available at the time you call.

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Important Links: About Dr. Keith March
PYP 22 | Autoimmune Disorder
Keith L. March, MD, PhD, FACC, has dedicated his career to bringing new medical approaches to patients. His publications include more than 170 manuscripts. He was the editor of the first book dedicated to cardiovascular gene transfer. Dr. March’s research has resulted in more than 60 worldwide (20+ U.S.) patents, with others pending. He invented the Closer, a widely-utilized patented suture-mediated closure device, used to close the puncture wound in an artery following heart catheterization. This device allows a patient to “walk off the table” after a catheterization without requiring prolonged bedrest. In 1999, Abbott Vascular, an affiliate of Abbott Laboratories, acquired the company that developed this technology; and the Closer approach has been used worldwide to treat more than 9,000,000 patients. He has served as a scientific advisor to numerous pharmaceutical, biotechnology and medical device companies. More recently, he co-founded Theratome Bio, based on a patented platform of technology originating in his laboratory that establishes the therapeutic factors secreted by stem cells as powerful therapeutics for critical medical needs, including degenerative and ischemic diseases of the nervous system. With FDA input, Theratome Bio is pursuing this off-the-shelf approach to markedly reduce stroke and prolong quality life in ALS (Lou Gehrig’s disease), as two near-term goals.
His laboratory focuses on vascular biology, with a particular emphasis on the function and translational study of stem cells found in the adipose (fat) tissue, which his laboratory identified as cells with critical roles in blood vessel growth and control of inflammation. Dr. March is recognized as a leading expert in the field of adult stem cell research, particularly that involving adipose-derived stem cells. From 2008-2012, he was Chair of the National Institutes of Health Data and Safety Monitoring Board that oversees cell therapy trials in the areas of heart, lung, and blood diseases. Since 2012, he has been an investigator in the Cardiovascular Cell Therapy Research Network (CCTRN), involving seven lead centers in the USA working together to conduct NIH-sponsored cell therapy clinical trials. He has spearheaded FDA approval to conduct multiple U.S. trials employing one’s own fat-derived stem cells or umbilical cord lining-derived stem cells, including an ongoing trial (SUCCESS) to test these cells in the treatment of COVID-19, and three cell-based therapy trials authorized by FDA in early 2021, addressing critical medical needs in other pediatric and adult patient populations.
In addition to his research roles, Dr. March has served as the President (2007) of the International Federation of Adipose Therapeutics and Science (IFATS), and on the IFATS Board as well as other advisory committees and boards in the field. He continues to work to advance collaboration as well as public awareness about the significance of adult stem cells, and to provide consultative assistance in obtaining FDA approval for cell-based therapies.
About Dr. Rafael Gonzalez
PYP 22 | Autoimmune Disorder

Doctor Gonzalez obtained his Ph. D and BS from the University of California, Irvine where he studied, and his thesis addressed interactions of the immune system following spinal cord injury. In addition to his expertise in degenerative disorders involving the spinal cord, he has extensive experience in stem cell culture and biology from human embryonic, pre-natal and adult sources. He has extensive knowledge in all aspects of cell biology and health.

Presently, Dr Gonzalez is responsible for the development of clinical stem cell applications for several disease/trauma states. He leads 2 different investigational new drug applications with patented stem cell technology. Additionally, he works on the clinical development of immune based therapies using natural killer cells. He leads our reference laboratory that has tested greater than 12 different regenerative medicine products. Dr. Gonzalez has been in the stem cell field for greater than 18 years and has several scientific publications. In addition, he has taught, spoken and led many conferences nationwide in the regenerative medicine sector.

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