2023 Stem Cell Updates Part 1

The research about stem cells is not yet over! Interestingly, we gradually discover more of stem cells' capabilities and benefits. Medical Insider would like to share some good news!

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Intro
Welcome to "The Medical Insider" podcast, where we highlight real-life solutions to your health challenges, encorporate new technology and proven solutions from the past with a healthy dose of common sense while resisting the pitfalls of idiopathic classifications and economically-based medical doctrine. This is your host, Dr. Thomas Santucci. Let's get started.

Dr. Thomas
Good morning. Today, I'm going to do something a little different. I think it's time to make a general statement about what's going on with stem cells, with the FDA, with what's available, with what's being said in the market. We've really come a long way, and I put together a piece, and I'm just going to read it, and I think that will provide a background. And then there's a number of people who follow these things pretty closely, and we can have conversations about it later. So the stem cell update. So the landscape one year later, as most of you know, stem cells were reregulated last June of 2021. Specifically, the relaxed enforcement of drug-designated rules ended, and now stem cells had to be approved as drugs. Labs were then tasked and always had been tasked, just to be fair, with the daunting job of proving that stem cells were safe and effective with large-scale, extensive studies that nobody did. The thinking was that stem cells were so good that there was such good clinical evidence that they wouldn't have to go through the FDA trials. They wouldn't have to do the so-called standard of practice, placebo-controlled, double-line studies. The reality is regen, regenerative medicine probably doesn't lend itself to that. But what's what happened at the FDA level, and it's not at the top level, this isn't a Trump, Biden kind of a thing. It's not even the head of the FDA. It's the head of the group that controls regenerative medicine. And for some reason, a few months before the end of the trial period, that person was replaced. That's a very mysterious thing. It's an interesting coincidence. So the new person comes in, and he's the Food and Drug Administration Administrator, and he's doing what he's trained to do. It's really hard to say that there's malice there. He comes in and says, where's your research? And it seems like a good question on the face of it. It just killed an entire industry. So on June 1st, it became illegal to offer stem cells for anything other than a couple of cancer-related, like leukemia conditions. The reality was, a 110 successful stem cell transplants had happened. 110,000. And with no adverse medical events, stem cell safety record ends up being better than getting your teeth cleaned at the dentist. What's happened now is we've got an across-the-board kind of prohibition against stem cells until they get through the clinical trials. So to obtain stem cells, the harvested umbilical cord from the healthy c-section after birth that were otherwise considered medical waste were now continued to be processed, but not sold. The interesting thing about these cells is there are different levels. And one of the things I want to make it clear is that there's a clear hierarchy of what is good, what is not so good, and what doesn't work at all. So let's just talk about the stem cells in general. And when we're talking about how we prove things, remember, we're using Class-A or level-one research, not the paid-for stuff that we've discussed in the previous research podcast. Stem cells replicate themselves, and probably more importantly, they replicate and replace damaged tissue. When you think about what these cells are, and we're talking about these primary cells, these omnipotent stem cells. They're stem cells that can ultimately break down into five different intermediate types and then ultimately into 120 different kinds of cells. They are the cells that we made our own bodies out of, or our own bodies were made out of, depending on who you think did that. So these are cells that can create an entire human. So coming in and creating some cartilage and a knee isn't that big a trick. When you talk about it, there's a lot of, kind of people sitting there with their arms crossed and going, well, that sounds too good to be true. Well, honestly, human creation is too good to be true. It's amazing what the DNA code can do. And remember, every single cell in your body has the code for every other cell of your body at any stage of life. So hypothetically, if we could get the signaling correctly, we could repair ourselves, and we could repair ourselves with day zero cells. My own cells, now that I'm in my 70th year, are senescent. No matter what I've done to them, which is plenty, the universe has done plenty to them. What's in the food? What's in the air? What's in the EMF? How are cosmic rays affecting us? You know, go on and on and on and on. There's so much conversation about how unhealthy it is to live, and stem cells didn't go through any of that. They're day zero cells. So there's a lot of argument that the lack of senescence or the youthfulness of the cell is an important part. Stem cells are anti-inflammatory, so they convert natural immunity white blood cells to an active anti-inflammatory state. Because cells are naturally attracted, these cells are naturally attracted to inflammation, they can seek out damaged and injured tissue so that a simple IV can conceivably go to 100 places where it's needed in the body. And what would that be? That's rheumatoid arthritis. So you do an injection in a wrist, it goes up to the right atrium, right ventricle, goes to the lungs, and gets oxidated. It goes to the left atrium, left ventricle, and goes to the entire body. Those cells are going to seek out their cytokine directed. They're going to seek out inflammation, and they're going to go to the places in the body that needs it. From a clinical point of view, we know this to be true. It's amazing to me that nobody's done a clinical trial that proves that because it would be fairly easy to use chemical mediators like C-reactive protein or eosinophil sedimentation rate and show that the things that we consider as chemical markers for, first of all, inflammation and second of all, maybe arthritis and some other things like heart disease and cancer is actually being mitigated by these cells. This is so obvious that I've gotten to the point where I just think that either we're only dealing with the groups that are doing the research for their own self-interest, meaning justifying their own products so they could sell it, or there's just an amazing amount of headwind against this. One of the things that we're doing right now is we're talking to one of the high-morality stem cell producers about doing our own research because in our kind of estimation, this would be a fairly straightforward thing to prove that inflammation is quelled with stem cells and it certainly would do a lot of good. Stem cells are anti-apoptotic. This is controversial, but it means that they battle cancer cells, helping the body rid itself of cancer cells, the ones we form every day in life. And, you know, when the research says something and then you say it back to people and they say that that's too good to be true, that's a common human reaction, but it should be quelled by the fact that you have the research in place. This isn't my opinion. This is what the research and not the popular research, the deep research says. So we've got these cells that can replicate themselves, repair things and replicate the tissue that they're repairing, quell inflammation, which, as all you'll remember, you know, is the cause behind most diseases that kill you, kill cancer. And then lastly, stem cells help balance the immune response. So just like vitamin D balances out the Th1, Th2 system in the body and we're all big on that, you know, vitamin D3. Stem cells do it better. Stem cells are amazingly powerful in creating an explosion of, you know, reaction to the explosion of autoimmune disease. I mean, we've got a runaway condition in this country on top of having you know, viruses that we're not very good at controlling. And we've got something that's excellent at coming in and balancing out that scale. You just wonder why of all the things that are being considered at, you know, the very, very top levels and I'm talking about in multiple countries, why stem cells aren't being trotted out as a COVID-19, you know, at least thing to look into. We understand that there is a second-stage COVID-19 stem cell trial, but I also understand it's not going very well. We're looking into that. We're actually talking about helping them with their research. We're talking about, you know, maybe using a more powerful stem cell like the ones we were using before because my personal opinion is that COVID-19 is easily quellable with stem cells. So I know that there's a lot of controversies and there's a lot of claims, but this is, you know, what we've seen. Even exosomes are very, very, very effective at restoring pulmonary function in seriously ill COVID patients. So the applications were widespread and ranged from joint injections that eliminated knee and hip surgeries, IV applications that helped control raging arthritis pain, to internasal stem cells that reverse signs of dementia and Alzheimer's, it was really a golden moment in medicine. Honestly, it was the most productive, the most fun, and really the most important work we've ever done in our clinic when we were doing those three things. In one day, the FDA took that all away and with silence, basically was, you know, here's the new environment. You're now invited to do a million-dollar study that proves this thing that doesn't hurt anyone, doesn't hurt anyone. Nobody really stepped up in any major way. The aftermath of all this was dismal. Unrelated labs at inexpensively cloned live cells were opened up in Mexico, usually staffed by the same doctors from the US that could no longer offer the higher quality stem cells. These cells were multiplied. Interesting terminology, which is really cloning several generations to get the counts in the billions, not millions, as naturally occurred. Multimillion-dollar labs with Ph.D. staffs were now illegal, but a backroom operation in Tijuana was okay. It is now over a year later. This was June, so it's almost a year and a half. It's December now. Stem cells in their pure form are still not available. They're considered to be the stuff of future medicine, to be assiduously researched, nothing to be rushed into. So the advances that are shepherded by the research which will bring these into the mainstream, modified stem cells, which we are really in favor of, you know, they are going to make stem cells that can fix the right atrium valve, you know, that kind of thing, just so spectacular. But those things are a decade away, and they should be researched because they're going to have an almost unnatural effect on the human body. They are going to be what we would consider pharmacologic. Stem cells as they currently exist and as you could get them, you know, today, if the law was different, is much more physiologic, is much more natural. The stem cells are going to do what they're programmed to do in the body. So right now, if you try to get stem cells today, or if you try to do anything from a regenerative point of view, there's a hierarchy. And remember, doctors have been squirting everything from salt water to steroids into joints in hopes of creating either, you know, body healing, less inflammation, or some kind of matrix that would help you know, with cartilage formation or at least form some kind of a pad. What's the first level of that? So Prolotherapy was a therapy developed probably 50 years ago, and that is salt water. It created a scarring. And so you'd put that into a knee or a joint, and it would be, you know, kind of better than nothing. Then steroids came along, and anabolic steroids decrease inflammation. Let's be fair. They do decrease inflammation. But just like the After School Special, there's a big price for anabolic steroids. Anabolic steroids, prolotherapy, and now hyaluronic acid, which is one step above, it does less damage but hyaluronic acid has some matrix in it and actually provides some padding for the synovial fluid in a knee or a shoulder and elbow. But none of those things work very well. The reason that they are used is they are insurance reimbursed. All of those things you can do if you're, you know, the right kind of doctor doing the right kind of billing. Even Medicare will pay for some of those things. So we look at that and we say, what's really driving the market? That's really the lowest level consideration. Honestly, when I was looking through you know, stem cell alternatives, it never even occurred to me to use any of those things because they had such low clinical efficacy. And if they really want to talk about when people are being cheated, who's being cheated in using those substances as in the US government and the patient. And then remember, there are a lot of people who don't take the total cost into consideration as long as they only have to pay their copay. They don't, you know, really understand that the United States government just paid $3,000 for a procedure that was worth about $200. So going on, you know, and we're going to go into, kind of the next level of responsible regenerative medicine is amniotic fluid. And amniotic fluid is the fluid from the amniotic sac. There's a lot of it. Now, in fairness, it has some MSCs, Mesenchymal Stem Cells, which could create a new bone matrix, synovium cartilage, the things we're generally inserted in joints. It just is a weaker version. It's not bad. So it's, I think, on par with PRP, which is Plasma-Rich Protein, which is your own blood spun down. It's not a bad thing. If we were in Hill in Oregon and there weren't any hospitals, we would use PRP for a lot of joint injections. But we're not. We're in America and there are labs. So PRP and hyaluronic acid and amniotic fluid are kind of lower-level things. Again, they're used mostly for economic reasons. They're used because they're cheap and because the margins on them are extreme. People that are doing them are making a bunch of money.  

Outro
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