Gladden longevity — Episode #54

Steve Reiter: Welcome to the Gladden Longevity Podcast with Dr. Jeffrey Gladden, MD, FACC, founder and CEO of Gladden Longevity. On this show, we want to answer three questions for you: How good can we be? How do we make 100 the new 30? And how do we live well beyond 120? We want to help you optimize your longevity, health, and human performance with impactful and actionable information. Now, here's today's episode of the Gladden Longevity Podcast.

Dr. Jeffrey Gladden: Greetings, everyone. This is Dr. Jeffrey Gladden on the Gladden Longevity Podcast, becoming the Age Hackers podcast. Steve isn't with us today, but I want to introduce you to a conversation we're about to have with Tom Casey. 

Tom is the Founder and, Chairman, Executive Chief Officer for Spectrum Plasma, and he's been involved with harvesting young plasma and providing it to people to utilize it for rejuvenation strategies, if you will. This is going to be a far-ranging conversation. We're going to talk about plasma donation and the health benefits of that. We're going to talk about plasmapheresis, where people remove the old plasma, and the benefits of that. We're going to talk about exchanging out old plasma for young plasma and what are the benefits of that. We're going to talk about the aging process itself. You're going to come away with some really deep knowledge and understanding of the aging process, how it starts, how it's mediated, and how we can potentially go in and reverse it. So, I think you're going to find this conversation really fascinating.

Welcome, everybody, to this edition of the Gladden Longevity Podcast. I'm here today with Tom Casey. This is going to be an interesting conversation. Tom is the Founder and, Chairman, Chief Executive Officer of Spectrum Plasma. He's been involved with blood banking and plasma for a long time. His company is located in San Marcos, Texas. 

I got to know Tom in the context of our LIFE-RAFT trial that we're running because Tom has been a source of young plasma for us. I thought it would be interesting for the audience to hear more about some of the things that Tom can talk about; there are some things that he can't talk about, but some of the things that he can talk about with regard to how plasma is curated and things like that. So, Tom, I want to welcome you to the show here. I appreciate the opportunity to talk with you.

Tom Casey: Well, thank you very much, Jeff. I appreciate the invitation.

Dr. Jeffrey Gladden: Yeah. So, give us a little bit of your background. How did you get involved with all of this? Just let the audience know a little bit more about that, if you would.

Tom Casey: Well, I started out after graduating from the University of Connecticut as an intravenous solution salesman in New England. I guess I did pretty well after my first year, so I was promoted back to a company headquarters in California, and I was made the product manager of irrigation products, IV products, pharmaceutical Admix products, and dialysis products, and really had quite a good experience. It's a company now called B. Braun Medical. Back then, it was called Labs, and it got bought by Baxter, and now it's B. Braun Medical. 

It gave me a real insight not only from the administration of intravenous solutions in the field when I was a salesman but also in the marketing realm. We had a lot of very interesting products, including total parenteral nutrition. It really was as a result of TPN that I saw a need to provide intravenous solutions outside of hospitals. In essence, some people needed the nutrition intravenously, but if they received it, they were healthy. 

I went to the Cleveland Clinic and met a 16-year-old girl, who had been in the hospital for five years because she had an inability to absorb food, but when she got the TPN, she was fine, and there she was locked in the Cleveland Clinic for five years. So, I set up the company, which became known as Caremark. It was to set up compounding pharmacies within all the major states that would compound intravenous solutions, such as total parenteral nutrition, and then teach the patients to self-administer it, even through central lines, and then to deliver it at their homes. It became-

Dr. Jeffrey Gladden: Okay. So, just so the audience understands here, total parenteral nutrition is basically a form of nutrition that's given to somebody. Parenteral nutrition is something that goes through your stomach, but if you're given this bypass, if you will, of the stomach, and given all the nutrients IV, then you're basically trying to provide all the nutrients somebody needs without them having to swallow anything. There are people with conditions that require that.

It can be life-changing for people, but the idea of taking it out of the hospital because usually people are worried about infection and things like that with the intravenous administration, et cetera, so to be able to take that out of the hospital and give people control over their own nutrition again, that's quite a step forward, yeah.

Tom Casey: Well, and in fact, you are correct, there were a lot of people that were very concerned about it, but the Cleveland Clinic stepped up, and they became the first sponsor. The company was bought by Baxter. It's now known as Coram CVS, and it administers 20,000 intravenous procedures per month outside of hospitals. 

Dr. Jeffrey Gladden: Okay. Great. 

Tom Casey: So, it became a huge, huge opportunity for patients to actually receive what they need but do it outside of a hospital environment. So, a lot of the factors really apply to the plasma business as well because back in-

Dr. Jeffrey Gladden: So, after you sold that company, then did you go directly into plasma, or where did you go next?

Tom Casey: Well, I started an infection control company for a Nobel of Sweden and did that. We ended up starting it and selling it. But it was very interesting because the first Nobel Prize in Medicine in 1901 was for convalescent plasma, but I sold that business, and I started the development with a heart surgeon of a pulsatile heart bypass machine.

Interestingly, the software to control it was written by Carnegie Mellon University. So we did, and it was pulsatile where most, as you know, as a cardiologist, most bypass machines are continuous pressure. So, the perfusion, peripheral perfusion, would be much better with the pulsatile machine, but what became a twist in my life we wrote a white paper, and I got a call by the Department of Defense, and they said: "We read your white paper, and we'd like to meet with you." And it became a secret meeting and they sent an airplane to pick me up. They wouldn't tell me where I was going. 

I ended up at the White Sands Missile base and walked into an auditorium where the proctor and the people said that they read my white paper and believed that that algorithm could be used to control weapon systems in following terrained, be it a cruise missiles, be it a bomber, be it a submarine under the sea. 

Dr. Jeffrey Gladden: Interesting. 

Tom Casey: So, it came as quite a shock to me, but they said: "Would you take this software and support our needs?" and that became 24.5 years of my life.

Dr. Jeffrey Gladden: Oh, wow. So, you work with the defense partner, basically writing software to help guide missiles? Is that what we're talking about?

Tom Casey: Well, missiles became bombers, became submarines. So, it was at the very highest levels of the Pentagon. It became quite a big thing. The software itself was inducted at the University of California San Diego into their time capsule to be opened on the 100th anniversary of the university. Then I was invited to join the Chancellor's Advisory Council, where I served. I served there and on a number of boards for approximately ten years. It was back in 2005 when the UCLA Longevity Group discovered, quote, unquote, "adult stem cells" that I started my return back into, let's say, where we are today. I originally was going to do it as stem cells, and I was very, very interested. So, actually, it was an interesting path, but at the end of the day-

Dr. Jeffrey Gladden: Let me interrupt you. Let me interrupt you for one second because I'm curious. When is the 100th year anniversary of the San Diego time capsule?

Tom Casey: I think it's 2064, so I hope to be there.

Dr. Jeffrey Gladden: Yeah, good. All right. Well, we got to make sure you get there. Okay. So, back to stem cells…

Tom Casey: Well, and I kept following stem cells, and I, actually, which was an interesting approach, I have a background part of it because of the military of knowing a lot of the Native American tribes. So, some of the tribes were actually interested in setting up health centers on their reservation under their sovereignty, which I thought might be a very interesting approach for stem cells, but it just continued as I tracked the research, and I was very interested in the heart, and I was following Johns Hopkins and Cedar Sinai, et cetera, but it never really seemed to pan out. 

The pivotal moment for me was on May 4th, 2014, when Nature Magazine presented the parabiosis studies of Harvard and Stanford that were conducted independently, Stanford back to 2005 and actually parabiosis back to the 1950s. Through reading that research, the light bulb went on. It really is the plasma that controls the stem cells that triggers them because we know our bodies produce stem cells throughout our entire life, but they remain incessant. So, they need-

Dr. Jeffrey Gladden: Let me interrupt you again just for a second, just for the audience's sake. So, parabiosis, I think most of you probably are familiar with this, but it's basically the idea of connecting the circulations of a young animal with an old animal, typically with mice or rats. It's heterochronic parabiosis because you have two different ages, young and old. What they found in these experiments, and it's been done numerous times now, is that the older mouse gets young, and the younger mouse gets old. 

So, the question has become: Are there old factors in the old mouse that's aging us? And are there young factors in the young mouse that are providing us with youth? So, that debate has gone on, and the Conboys got involved at Berkeley and did experiments with just replacing half the plasma volume with albumin and its saline and showing that they were rebooting stem cells across all three germ layers, suggesting that removing the old factors took the governor off, if you will, on some of the rejuvenation properties, but then a debate has gone on whether or not that's all the story or whether or not there are actually young factors also that contribute to this. So, just to give you a sense of a backdrop to the story here. So sorry to interrupt, but go ahead.

Tom Casey: Oh, that was very insightful, and a lot of it came full circle in December of 2019 when Stanford released their proteome, plasma proteome report study of more than 5,000 people. They found that our plasma really controls our aging. One of my favorites is we're programmed, the age, and where a gray rat will live five years, a gray squirrel can live 24 years. So, it's not the fundamental biologies necessarily, but it's our own intrinsic program. Stanford showed that our programmed aging is controlled by our blood plasma and that our blood plasma changes so profoundly during our lifespan that they can pull it out and identify your age to an accuracy of three years regardless of your size or race, or sex, and they also-

Dr. Jeffrey Gladden: Tell us a little bit more about that because that's really fascinating for the public to understand that you can have your plasma tested and have it married up to your chronological age. I think people are familiar with biological ages, things like epigenetic ages, being able to predict either chronological age using certain clocks or actually being able to predict biological age of one sort or another, but now we're basically talking about proteins in the blood that are really in a function of DNA expression. 

So, as you go through life, what's really happening is that signals are occurring inside the body that's causing your DNA to be expressed differently. So, when you're 20 years old, your DNA is being expressed one particular way. You can think of it this way. Think about going through puberty. So, when you're a kid, your DNA is being expressed one way. You go through puberty, and all of a sudden, genes get turned on that weren't turned on before. Other ones get turned off. 

So, as you go through life, the same thing continues to happen, whether it's at menopause or andropause or as you go into your 30s. We know that proteomically, there are spikes in aging that occur that's been mapped out now. You're probably familiar with this, one at age 35, one at age 60, and another one at age 78, which is really a massive spike. That's been shown based on the difference in these proteins that are expressed in the blood, which are really a function of how the DNA is being expressed. So, to your point, aging itself is a program that's running inside the body. I've got a couple more comments about that, but it's really fascinating to understand that this is what's happening. So, go ahead. 

Tom Casey: Really, it was very insightful, and we know that plasma has over 10,000 proteins, 5,000 peptides, 45 cytokines, and more than 50 different sex-specific hormones. So, you have 1.84 billion exosomes per mL. So, it's a very, very complex formula, and some of the age identification was based on approximately 400 proteins out of the 10,000 that change significantly with age, but with aging as part of that study identified to commence at 26, as you said, hitting that first peak at 34, 35, really what we're doing is seeing the full spectrum of our life on a program. 

Those practitioners such as yourself who are prescribing young plasma are basically biohacking programmed aging. So, it's a very profound field because what I think a lot of the listeners may not be aware of, 20% of all blood products are donated by young donors. So, we have an infinite resource here that's renewable, hopefully, we will always have young people, and that can really form a therapeutic foundation for our country that we think is going to be extraordinarily beneficial in the future.

Dr. Jeffrey Gladden: So, as we go through this, do you want to talk a little bit about some of these proteins and what they are and what they do and that sort of thing?

Tom Casey: Well, I'm probably more on the opposite end where I look at plasma as an intact organic resource and really capture it, collect it from a healthy young individual between the age of 18, which is just the legal age of consent to the age of 25, and you just sex and age group identify that plasma, and then to knowledgeable practitioners such as yourself, that can be applied therapeutically in the treatment of age-related conditions, which is what the research that has been conducted on young plasma to date has shown us.

Dr. Jeffrey Gladden: So, one of the things that have been interesting we've worked with Shelly Jordan out of UCLA. He's a neurologist out there. You may know Shelly, and he has also picked up on some data that was published showing that there are stem cells in the hippocampus that basically degenerated over time, and they send out exosomes. If I have this correct, they send out exosomes that basically tell us to stay young, but as those stem cells start to degrade, they stop sending out those exosomes that basically instruct us to be young, and we start to get old. So, your point about the 184,000 exosomes per milliliter, I think that's what you said, close to that, or maybe it was more. 

Tom Casey: 1.84 billion per mL.

Dr. Jeffrey Gladden: Sorry, 1.84 billion. I was off by a factor of about a thousand, but anyway, 1.84 billion exosomes. Just so the audience understands what an exosome is, an exosome is basically information. I make it analogous to a letter, right? So, cells send information from one to another, and they do it, they put it in an envelope, which is basically a portion of the cell membrane, and then inside there is a content, which consists of things like messenger RNA, and DNA, and some lipids and some proteins. Then there's also a signature, typically, attached, which is where that exosome originated, right?

So, the exosomes get sent around the body to; basically, it's an internet of communication for the body. So, this is interesting because if this hypothalamic stem cell degradation is part of the process, and it's in the ventral lateral portion of the, I think it's the whichever ventricle that it is in the hypothalamus, they basically are felt to be the controlling mechanism, which then is leading to different DNA expression, which is then leading to this change in protein patterns that are picked up in the plasma, which would be defined by Stanford.

So, it's interesting to start to try to loop this all the way back to what is the originating problem that occurs. One thing we know about those stem cells is that they require melatonin to stay alive. So, melatonin, of course, is an antioxidant, in general, and it has some anti-inflammatory properties, which we've seen with COVID, but it also seems to be critical for maintaining the integrity of those stem cells. 

So, it's interesting that as you think about this, how far back in the chain can you go to try to get back to the origins? So, the question would be also what Shelly is doing is basically trying to rejuvenate those stem cells utilizing focused ultrasound and then sending in exosomes to the brain to try to rejuvenate those stem cells, which is interesting in and of itself, but the situation here is that we're taking out or adding in, could be either, but in our situation, we're actually taking out old plasma and replacing it with young plasma under an IRB approved trial. In that context, looking to see to what extent we can make people more youthful, if you will, and also treat diseases of aging.

So, it's really a fascinating continuum here between the stem cells, the exosomes, and the proteins. They're all in this interplay, but ultimately for the audience, you should understand that your DNA is actually being orchestrated to be expressed differently as you go through life. This is one of the prime drivers of aging. We talk about different hallmarks of aging, which are signs of aging and, of course, shortening telomeres and senescent cells, and all these things are part of that, but this is really a thing that's a primary driver behind all of it. 

So, when you're talking about replacing plasma and putting young proteins back into your blood, it really is dropping youth into your blood on some level with regards to potentially how it impacts the DNA to be expressed going forward because you're also dropping in exosomes and you're dropping in other things in the plasma, right? So now, you're changing the signaling in general. So, this becomes a really fascinating piece to see if this is part of the equation for how we actually stay young.

Tom Casey: Well, I think a very important part of this is the complexity of plasma, which very much, for commercial reasons, gets ignored, and I'll call it Mother Nature versus the magic proprietary molecule. So really, what we've seen is a steering away. Well, let's talk a little bit of history here. Plasma was first used during World War I on the battlefield. During World War II, its use not only continued and expanded, but it became a little more sophisticated when a Harvard Ph.D., Edwin Cone, used a milk churner to develop the apheresis device to separate plasma from the blood. That became the foundation of your treatments, and that became the foundation of all plasma collections. 

Then a couple of years later, Edwin Cone also developed the use of ethanol fermentation to fragment proteins out of plasma. For the listeners who don't know that, the ethanol fragmentation process takes seven to nine months. So, basically, plasma, a hundred thousand donations, men, women, all ages, are put into a vat with ethanol, and it ferments for seven to nine months, completely sterilizing the plasma, of course, but the plasma proteins start separating. 

Of course, we've all been aware in the past, our blood supply was periodically unsafe, and we had a lot of pathogens we couldn't control. During World War II, that was a problem. So, this sterilization of the plasma proteins became a revolution. It formed what is now 20% of all drugs are derived from fragmented plasma proteins, but because of the sterilization of the ethanol, suddenly, some of these proteins, like the plasma's immunoglobulins became IV, administered IV, IVIG, and that is now a 10 billion dollar product. 

It became immunoglobulins from a donor that were rendered safe because of the ethanol. That went on for a very long time, with one of our periods of great stress, with the blood supply being the '80s and '90s during the time of HIV and hepatitis. So, this ethanol sterilization of the plasma proteins became a very, very big business. 90% of all the plasma collected in the United States is for the production of pharmaceuticals, not for use by hospitals. People have very little understanding of this. 

These plasma proteins then come back in the form of very expensive products, biologics, but again, they were lifesaving. Everything shifted in the year 2000. Advanced testing became so sophisticated. For the first time, the blood supply became safe, and it has been extraordinarily safe in the 22 years since.

Dr. Jeffrey Gladden: So, tell us about this advanced test. Is this advanced testing that allowed it to be safe? Are you saying that all of a sudden, we were able to detect pathogens in the blood that we couldn't detect previously and, therefore, we could actually tell if the plasma was clean or not clean? Is that what we're saying?

Tom Casey: Correct. Correct. That was the year 2000. So, HIV, viral particles, and the blood supply are now extraordinarily safe. In fact, plasma itself, the FDA produces a transfusion safety report. So, in the last full year of transfusions, 2.1 million transfusions of plasma were performed in the United States, and there was only one plasma-related but totally avoidable fatality when a male received HLA-positive plasma from a female. Now, we test all females for HLA, and we-

Dr. Jeffrey Gladden: Let's talk about HLA. Let's talk about HLA for the audience here. So, you want to talk about that for a moment?

Tom Casey: Yeah. It's a human leukocyte antigen, and it basically forms in the mother when she has a pregnancy with a blood type incompatible fetus. So, an antibody forms, which if that antibody gets into a man through the administration of plasma, it can be fatal, very, very rare. It is so rare the blood industry is not required to even test for it, nor is the blood industry required to sex identify their plasma. Spectrum Plasma-

Dr. Jeffrey Gladden: So, this would be a situation where the HLA would ... but it's an antigen, right? So, the male would have to respond to that?

Tom Casey: Yeah, it causes a traumatic lung injury, but really, the point of this is to say, out of 2.1 million transfusions, we use 6,000 to 10,000 units of plasma every single day in this country. We had one avoidable fatality. In the following two years, there were none. So, we're talking about millions-

Dr. Jeffrey Gladden: So, the point is plasma is very safe, is what you're saying.

Tom Casey: We're talking about administering millions and millions and millions of units of plasma with no fatal reactions at all. It's extraordinarily safe, which then leads us to the point of if plasma is extraordinarily safe, then its use as a therapeutic could be an extraordinary opportunity for the human race because our ability to collect plasma and our ability to administer it, that infrastructure is in place worldwide. 

All we have to do is understand the biology of plasma and the proteome and sex identity of all donors because males are very different than females. Males should receive plasma from males, females from females unless you have a very extraordinary circumstance, such as maybe a male with prostate issues where you want to avoid the testosterone. I mean, there are some unusual ones, but for the most part, sex identification is very important. 

Age identification, if you're going to use plasma therapeutically, is very important because the Olympic years are 18 to 25, as the Stanford studies showed, and replacing some of those plasma factors that our bodies stop producing as we age has been found to be, by the research that's been conducted, an extraordinary rejuvenating factor. 

So, it really comes down to the removal of the old factors that are keeping you aged, which is what the Conboys and Dr. Kiproff and other people are advocates of, but there's also the other fact of replacement. So, it's removed and replaced because if you replace those youth factors that our bodies no longer produce, it could be hormones, could be proteins, peptides, could be those exosomes.

Dr. Jeffrey Gladden: Exosomes, yeah. 

Tom Casey: The important thing, Jeff, I think with exosomes is it's a signal. So, you have to have someone able to respond to the signal at the other side. So, if a cell doesn't have all the cohorts it needs to regenerate and to respond, that exosome message may go unheated, but the young plasma has the exosomes, but the proteins and the peptides and the hormones and the cytokines, so it's a complete package.

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I think this is a really important point, and this has to do with the fact that I think in the whole world of regenerative medicine, there are people using mesenchymal stem cells and hematopoietic stem cells and people using peptides and people using very small embryonic-like stem cells. Then there are placental stem cells that have basically been developed by Dr. Atala at Wake Forest. Then you have people that go to Panama and places like that to get embryonic stem cells and things like that. 

It's interesting that all these rejuvenation therapies only work well in a conducive environment, and it's been shown that if you put stem cells into old plasma in a Petri dish, they die out fairly quickly. Whereas if you put them into a Petri dish that has young plasma in it, they thrive and do very, very well.

So, one of the key things that we've discovered at Gladden Longevity and is incorporated into the LIFE-RAFT trial is that it's really important to clean up the system before you put the stem cells to work. So, one of the things that we do is we do plasmapheresis to remove the old factors, put back in the young plasma, and then we actually drop in the peptides and the stem cells and the other things that we're trying to get to go to work for us. 

We think that that makes a lot of sense to give them a young environment to work in. Just so people understand that this is a complex symphonic approach to rehabilitating a human being, it's not just: "Oh, well, if I get young plasma, everything's going to be hunky dory," or, "If I just get stem cells or if I just use peptides, everything's going to be fine." There is an entire concert of things happening here that's making you old, and there's an entire concert that has to be played to back that up. I think the young plasma is a piece of that in the orchestra, so to speak. So, it's interesting, really.

Tom Casey: Well, I think it's very important that it is a very complex biologic process, but from the top view, it's incredibly simple. Biohack your age, which is controlled by your plasma, by the introduction of young plasma. So, those benefits are unique. Back to the point, this is a universally available resource. So, because you've brought up the-

Dr. Jeffrey Gladden: So, why do you think it's not being used? Why is it not being used more if it's universally available? I mean, it has to be people are getting young plasma all the time, it sounds like, right?

Tom Casey: Well, I think this gets back to my comment earlier where it's Mother Nature versus the industry and proprietariness. So, it's all about money. So, what really goes on here is plasma, you can't patent plasma because it's a naturally occurring substance. So, they found starting in the 1950s that, when this fermentation of the plasma proteins began, that you could put together non-natural assemblages of those proteins such as IVIG, where it's just the immunoglobulins by themselves, where we know that healing involves hormones. We know that healing involves cytokines, interferons, the cytokine. 

We know that it's very complex, but you can take some proteins like immunoglobulins and IVIG and run it through the investigational biologic process because it's not naturally occurring, so you have to prove it's efficacy. Then if it gets approved, you proprietarily own it. So, the money in the business has been to own all these pharmaceutical drugs. 

So, there are three things that are going on in the health industry, and in the plasma business, people don't see that there's money in the blood banking side and going arm to arm, as we call it, from the donor through testing to the recipient is the most economic and efficient form of treatment and providing therapeutics, biologic therapeutics, but it isn't as profitable. So, the average Plasma Protein Therapeutics Association members produce after that seven to ninth-month fermentation process is approximately $200,000 per year. An annual treatment of the plasma direct from a donor to a prescriber like yourself is 9,500 a year. 200,000 versus 9,500, but the research that I've seen has also shown that the sterile product doesn't have the same efficacy as the biologically intact plasma. 

That's best shown that it takes 130 donors to create IVIG for one patient for a year. One donor creates three doses of convalescent plasma. So, that's a 390 to one-

Dr. Jeffrey Gladden: Ratio. 

Tom Casey: ... disadvantage due to the ethanol. So, these products tend to be very expensive, but now we have the opportunity because the blood supply is safe to go directly from the blood banks to the practitioners such as yourself for therapeutic purposes at an efficacy and an economic value that's unprecedented.

Dr. Jeffrey Gladden: So, tell us a little bit about Spectrum now, which is a blood bank that you're running, and you have ... Tell us a little bit about Spectrum's mission and how you go about fulfilling that mission in terms of young plasma and these kinds of things. So, just walk us through that, so people understand what Spectrum's doing.

Tom Casey: Well, Spectrum Plasma is a fully accredited blood bank. We're a member of the American Association of Blood Banks. We're CLIA Laboratory certified. We're FDA-registered. We're audited by the American Association of Blood Banks, by CLIA, and by the FDA. We set this up to be an extraordinary blood bank and to be very mission-specific. We exclusively collect plasma, and we exclusively collect it adjoining the state Texas State University campus here in San Marcos from 18 to 25-year-old donors.

People that prescribe our plasma, such as yourself, are using it therapeutically. So, we perform more tests than are required to be performed by the blood industry. We mentioned HLA of females earlier because if you're in emergency room and you need plasma because you've been in an accident or in some kind of incident, then you're doing that to save your life. If you're taking plasma therapeutically, then you're electively choosing to do it. 

So, we self-impose upon ourselves a higher standard, so that even if it was only one person out of 2.1 million transfusions that had a fatal reaction to HLA, well, that's not going to happen with Spectrum Plasma. We're going to eliminate that risk because people should not electively get into an environment that may be worse than the problem they're trying to address. So, we went and set up a facility that's state-of-the-art. The FDA said it was an extraordinary facility because they audit all blood banks and said that our commitment to safety and quality was outstanding.

Dr. Jeffrey Gladden: So, tell us about that. What do you do that's the extra mile here, so to speak? You're identifying sex, you're identifying HLA where that's appropriate. Tell us what else you're doing. How are you making sure this is super safe?

Tom Casey: Well, we have all that testing, so you know, at the end of the day, you have a safe product, but it's all about the proteins and the elements within the plasma. So, it's legal in the United States to collect plasma twice a week. You can only collect blood basically once every 59 days, so let's say once every other month. Plasma, twice a week. So, plasma is much more viable, but it's also interesting that around the world, most nations categorize plasma as blood, and they only allow it to be collected once every two months.

So, the reason 90% of the plasma collected in the United States is collected by pharmaceutical companies is because they all come to the United States to collect their plasma because they can collect it twice a week. 

Dr. Jeffrey Gladden: I see. 

Tom Casey: So, the PPTA is Grifols, Takeda, CSL, BPL, all those plasma pharmaceutical companies, but at Spectrum Plasma, it is all about the proteins and the factors. So, we have every donor take a protein electrophoresis test, and then they do that initially, and then they do it every three months. Every time they come in for a donation, they do a total protein test. We have very rigorous health screening. 

So, even though we're taking college kids in, and 78% of them are on a meal plan, and it's a very, very large, very good university, we still defer up to 40% of our donors, prospective donors. It could be a female coming in who's menstruating, so her proteins are not quite as high as they could be. So, we defer her for a couple of weeks, but it's the end product for us because what people really need to understand is the American Association of Blood Banks was set up in 1947, and it was set up to supply hospitals with blood products. 

So, 98% of the members are nonprofits, 98% of the members are contractually committed to supply hospitals, and they do so for these emergency room purposes and surgical purposes, not for therapeutic purposes. So, the blood industry itself doesn't sex or age identify their donors because they have a volume supply problem. 

Here's another important factor. Pharmaceutical companies are allowed by the FDA to pay their donors. Follow the money. That's where 90% of the donations go. The American Association of Blood Banks and the Red Cross are not allowed to pay donors. So, you can get cookies and a T-shirt. So, the net result of that is we continuously have supply shortages of blood. One is going on right now. Typical over the holidays, be it winter or summer because the association was set up in 1947 post World War II. So, the fact is altruism isn't quite as strong now as it was after World War II. 

We think it would be wise to allow, as pharmaceuticals are allowed, blood banks to pay their donors. They cannot, but you can create some rewards. Basically, what you have is a disparity in the system. So, the blood banking industry supplying hospitals right now can barely keep up with demand because they have a shortage of donors and, therefore, they don't want to give their prescribers, the surgeons, a choice of, "Well, let me have a young person and let me have what the available is." They're lucky to provide the blood or plasma at all or the platelets. 

So, they have made a decision not to sex or age identify their donors because they're in a supply shortage, and they don't want that to be a limiting factor. At Spectrum Plasma, we identify the sex and age group of our donors because our prescribers are not hospital-based, they're private practice physicians such as yourself who are using the plasma therapeutically, and that information is part of what they need.

Dr. Jeffrey Gladden: What about blood type? Does that play into it as well for the audience?

Tom Casey: Yes. Blood type does, but not RH with plasma. So, RH is not a factor.

Dr. Jeffrey Gladden: So RH, is that plus or minus that comes after your O positive or O negative or AB negative or AB positive? That's the RH. That's the antibody that you might have, right? 

Tom Casey: Yes, and it comes from the Rhesus monkey. So, that's where the RH comes from. Really, it's people in the Basque region that don't have it. So, most of us have that connection, but it's not a factor in plasma. So really, it's just the sex and the blood type. Now, with plasma, AB is universal. So, anybody can get AB plasma. Get it? If you're a male, get AB from a male. If you're a female, get AB from a female, but unfortunately, that's the opposite of blood, where O is the universal donor. So, unfortunately, O is the most predominant form, and AB is the one that's the rarest. 

Dr. Jeffrey Gladden: AB is one of the rare. Yeah, exactly. 

Tom Casey: Yeah. So, 1% of the population is a universal plasma donor, and we treat them very nicely when we find them, but we have rigorous screening, and we have healthy students coming in. What's very, very important is as you perform plasma exchanges, as you talked about at, Jeff, cleansing out basically someone's system. Let's say a total plasma exchange therapeutically would be approximately three liters. Donors, when they donate, they donate, if you're smaller, 600, larger, 800 mL, up to a thousand. So, if a donor comes in once a week, at the end of the month, they just achieved the therapeutic benefits of a plasmapheresis exchange.

So, we tell people, if you go to some Southwestern Medical Center, they'll charge you $8,500 to do a plasma exchange. If you come to Spectrum Plasma and donate four times in a month, you'll have achieved that same medical benefit, and we'll have rewarded you to have done so. So, the message we're trying to get out to the students, and it's called ‘the dilution solution’ based upon the Conboys in large measure out of Berkeley, is that frequent donations of plasma once a week for the rest of your life will promote neurogenesis and longevity in the donor.

Dr. Jeffrey Gladden: That's an interesting point too. So, we're talking about young plasma for older people, but actually donating blood has been shown to be a healthy activity for older people.