Hello and welcome to the Get to Life podcast where we have conversations about organ tissue and ideonation and transplantation. You can always find us at thegettidlife.org. I'm Roy Steele. I'm Joey Boudreau.
I'm Sarah Blakemore. Coming up on this episode, we are inviting guests back from episode 104 to talk about advancements in reconstruction for breast cancer patients. And we're going to talk about how awe and being in awe of your life can help with your death anxiety. We have lots to get to.
Here we go. The Get to Life. On this episode of the Get to Life, exciting new developments. We invited some friends back.
They joined us on episode 104 to tell us what they were working on. And that was in 2019. We went back and were like, oh, it's been a minute. And they have been working steady and hard.
And it's for the benefit of so many people. And so we invited them back. Yeah, Laurie, we have Nick Passchows here again with us, CEO of Bioesthetics along with Billy Heim, the chief operating officer. So thank you guys for coming on again and look forward to talking to you again.
Thank you very much for having us. All right. So Nick, we'll start with you. I remember on episode 104, you talked about watching Netflix and you have this marvelous idea that you're working on towards your PhD, you've been changed kind of a year and a half and a half years.
So tell us what that idea was and what you started. Yeah. So as I was telling you guys before, I previously was working on whole long regeneration and ended up watching a Netflix documentary pretty late at night, but they were talking about mastectinies and potentially losing an nipple and ariola during that process. So I stayed up all night reading about what mastectomy actually was and how currently the methods to reconstruct nipples are surgical reconstructions where they take skin from a different part of the body, such as a thigh, the arm or even the breast tissue and suit her up a nipple like structure.
A lot of times these lose about 70% of its projection within a year and within five years, almost like completely five-consipations chest where they can have a tattoo which fades and has no depth to it. So going through that process and just learning about it, I thought we could pick the methods of what we're doing to try and regrow lungs outside the human body and transfer over the nipple and ariola complexes. So that's what I did. I walked into my office the next morning and said, hey, what's in my office idea?
I'd like to try to regrow the nipple and ariola complex for women who have had mastectomy to breast cancer. And that's what we've been working on. And I've been pushing forward with it ever since. We've been both working full time and since 2017.
And it's the human-derived nipple and ariola complex product that's used from deceased owners. So tell us a little bit more about that if you don't mind Nick. So you talk about it being a human-derived. Can you tell us about the process of what takes place from the actual recovery and also including the synthesizing part or the additional parts, desalurizing and structure?
Absolutely. So in this case, for breast reconstruction, they currently use products known as allographs, which is essentially what our product is as well or it's exactly what our product is. We are taking human-donut tissue and removing all the cells in DNA and processing as desalurization, which means to remove cells from the tissue. Over-left with is a collagen-rich scaffold in the exact same shape and size of that starting tissue.
In this case, it's the nucalone ariola complex. We've shown in a preclinical, large biological model that we can actually regrow blood vessels and full fitness skin when grafted directly onto a dermal bed. So we're ready to move forward to clinic with it. And Billy, last we talked to Nick.
I know you guys were well on your way with trials on mice, if I recall. And then of course you were looking at more clinical trials later. So how's that going? And can you tell us a little bit about the mice research?
Yeah, so I guess back in last time we talked, Nick had completed some of the research in mice. They were his PhD work at Tulane. And then 2017 when the company became operational, that's when we actually moved it into a large animal, a non-human-primite model. And so I saw very nice results from that.
With the different graphs, we saw that they actually healed within about six-week time frame. And that includes essentially new skin forming within the graft. So the patient's own cells are, in this case, the host, which is the animal. Their own cells migrate into the scaffolds that has been derived from donated tissue and repopulated and effectively created a new layer of skin.
And then we also saw the creation of blood vessels. So it became a living tissue that was integrated within the body. We also saw that from pictures and anecdotally that we saw that the nipple projection was maintained for that six-week period. So those are all very exciting results.
Not often are tissue, desalurized tissues like these and grafts on the outside of the body. So it was really unique to see how well the tissue regenerated using that fascia. So like Nick said, these are all the graphs are used within breast reconstruction, but underneath the skin is a support for the implant. And so within the body, they integrate fairly well.
And it was kind of a new use to use externally. So being able to see how that healed in the animal models allowed us and gave us confidence to now to bring it forward for human use in patients that have had breast cancer. So kind of where we are now is we've been working probably since the last time we talked. I think we've been working on the manufacturing side of things, so making sure that we're producing a consistent product, following quality assurance protocols, and so that it'll be safe for human use and meet the FDA regulations from our large animal studies as well.
We saw that this was a very safe product. And so we expected to be a very safe in human use. And so we're expecting as right now, we're intending to move forward with a clinical study with a university where we'll actually enroll 15 patients and follow them over the course of 12 months. And we'll be looking at wound healing, so making sure the graphs are integrating with the body and then looking at the nipple projection and looking at patient satisfaction.
And we'll also be following the potential for sensation. So those are kind of where we're going. We also expect the product to be available for use outside of the clinical study later this year. So it's been exciting to see the transformation moving from really the research phase and now into the product launch, if you will.
And working with great partners and recovery agency side like Lupa to make this happen has been fantastic. So guys, of course, with organ transplants, the organ recipients are usually in most almost all occasions have to take medicines, immunosuppressants and things for any rejection. Make sure they don't look at the organ as a foreign body and attack it, so to speak. So because this is the cellularized scaffolding, so to speak, does that mean that the 15 patients will not need to use immunosuppressants?
Or are they still going to need immunosuppressants with it? Yeah, that's correct. So patients will not need immunosuppressants. So because we don't have, you know, cells are very little to no DNA left over from the donor, the recipient's body actually sees it as a simply just human protein, as human collagen, as human elastin, and it uses that as a scaffold to allow for the patients own cells to grow into it and reestablish a blood supply and full thickness skin.
So it just becomes part of the body. It did not seem at the foreign entity. And these types of products that are derived from humans have been on the market for probably about 30 years with very nice safety profiles and very low risk rejection. And as Billy said, our preclinical models have all been really wonderful both from a safety and at the PC standpoint.
So we feel very comfortable moving forward and we're excited to start offering this to patients. What's the time frame that you guys from, I guess, from the donor side to what you project for the recipients, what's the time frame that you'll be able to locate someone, you know, I guess the processing and then location of the right potential recipient? Yeah, that's kind of an interesting question on how does it find its way to the recipient. And what we're actually doing is, you know, from speaking with breast cancer survivors and patients with undergone breast reconstruction and also from surgeons, we understand that patients actually have a preference on the size of nipone area that they would like during their reconstruction.
So that's basically how we'll be able to offer the product to them is based off of size preference. So, you know, if somebody would like a smaller one or a larger one, we're able to match that preference. So from the time it's a donor from a donor to a recipient, you're probably looking, you know, about four weeks or so before it can be engrafted by the time, you know, all quality checks are through and processing is all set. And then it's purely just a size preference in there.
Wow, that's pretty impressive, especially for the patients. I'm sure it's going to change their lives. From a donor family perspective, I actually approach family's for donation and have been approaching for nipple area research. And every family that has agreed and consented to this is very excited.
Most people in this country know someone who is affected by breast cancer. So it's very meaningful. It's a very powerful decision. So I just wanted to let you all know that from our side, it has been very well received and very well excited.
The families are excited to be a part of that process. You know, thank you very much for that feedback. You know, as Bill and I have been pushing forward with this, you know, I had the companies since 2017 together. It's been really important to get, you know, the donor family's feedback as well as the organ procurement agencies and tissue procurement because that's absolutely central part without donors.
None of these types of products would ever happen. So it's important to keep them in the loop and also to receive their feedback so that we can, you know, offer that gift to, you know, the patients that need it. One of the things that I remember from our last conversation was the potential to possibly store a patient's own nipples before mastectomy. Is that something that is able to happen or where are we on that?
Yes. That's something we are still looking pursuing. So we would expect it to be from someone that is undergoing a prophylactic mastectomy and has not had any expression of cancer yet. So it would be gene positive.
So they test prechopinitis or something like an angelia and a jelly. And then they elect undergo prophylactic mastectomy. At this point, that's what we feel comfortable with, not with a patient who has had some expression of cancer because the nipple has many ducks. And depending on where the margins are, we just want to make sure things remain safe for the patient at this time until, you know, for the research that's conducted on how the expression of cancers or tumors might, you know, affect the tissue and, you know, something potential in the future.
So as of right now, you know, all the donors that we are accepting are, you know, they have had breast cancer or any skin disease of the breast. And so then we make sure that the tissue is absolutely safe for any recipient down the road. But like I said, for those prophylactic mastectomies, we would definitely be open to, you know, recovering their nipple prophylactically and then processing them and giving them back at a later time. But we haven't had that happen yet.
So we're open to it and hopefully that'll, you know, increase in the future. You mentioned the aerial of ducks and of course now having a new baby, maybe think about it. So from a functionality standpoint, is there going to be a function, you know, with possible use of a baby, you know, with the aerial is or is it purely cosmetic? Yeah.
So, you know, it's actually a pretty complicated question. You know, when Billy and I were really looking at it and seeing the main population of individuals that would benefit from this type of reconstructive surgery, which would be breast cancer survivors who are under gone mastectomies. In most cases, you know, those breast cancer survivors may not have the ability to kind of produce milk moving forward for a baby, especially if most of the breast tissue is removed. So from the standpoint of breast reconstruction, you know, we're not also reconstructing the booster for a stux or, you know, the sort of gland that produced the milk were purely regenerating the inflammation or ill complex.
So it has an absolute massive, you know, self-esteem or other psychological benefits for the patient as well as an aesthetic benefit just at this time. That's really the main population that would be helped. So you know, likely milk or breastfeeding for a baby in a future would not be something that this product would be helpful for currently. That's a good point.
I didn't even, as I'm saying it, I didn't think about it's true, you know, most of the breast tissue is going to be removed so it wouldn't be possible anyway in most situations. So, but you're right, you know, the whole, the self-image part, you know, and of course, and I don't speak to families anymore, but I'm still part of the family support group. And you know, one of the things that they, you know, can connect with is that self-image for those, you know, for their loved ones that have had breast cancer and those image issues that come with the mastectomies. To be able to provide that is such an amazing thing.
You guys talked about, you know, you're working on, you know, the sensation I talked about functionality, but so the sensation, obviously you can't figure that out with the animals, but are you somewhat expecting that to be one of the positives coming out or, you know, high of a confidence level, I guess, that you guys have right now on being able to return that sensation. These questions today, they're, they're great question. You're right. You want to answer this?
Sure. Yeah. So, I mean, in terms of, you know, what we saw in the large animal model and this was going on to healthy tissue, you know, was that we actually in 75% of the graphs we saw within six weeks, we, you know, observed nerves. So, they were present, but whether or not that actually implied or, you know, saturated sensation, we don't know because they're obviously the animals and we don't know.
But, you know, from the human perspective, you know, what we are expectation is that it's going to be very patient dependent and it's going to be highly dependent upon how the mastectomy was done and then how the breast reconstruction was done. So, you know, if, if it's not the, if the mastectomy takes all the breast tissue, most often patients that have that done and have a tissue expanded for reconstruction, have no feeling in their breasts at all. If they're left with a skin sparium mastectomy, even if it's a possibility that they actually have sensation in the breast on the skin of the breast on the loop and those, you know, those nerves potentially migrate into the graft, you know, if they're undergoing a total radical mastectomy and then have an autologous reconstruction rather than a tissue expanded or an implant, or they actually take large skin flaps from the abdomen or the back and reconstruct breasts out of that tissue, you know, those would be likely to highly have quite a bit of innovation. And so then we could potentially think, you know, those nerves would also make it into the nipple at some point, you know, timing of that we don't know, you know, until, you know, we're in patients and, you know, get some of that feedback.
You know, otherwise we do know that there are some groups, one company in particular called oxygen that is working on, as a decelerized nerve product, allergraff nerve product, and they have some studies ongoing for re-innervating the breast tissue for the second patients as well. So there's some of that work ongoing. And so, you know, that could be, you know, it's kind of potential in the future. And, you know, kind of we'll have to see where the research takes us.
So, but what we can say is that from our large animals work, the graft is not in hidden nerve growth, it actually supports it. And then the question is whether or not there are nerves there or in the area to then migrate into it. And then, you know, functionality for sensation, we're unclear, you know, what that means down the road, but it's possible. So I know when we talk about breast cancer a lot, we think about women.
Are there any men who are in your trial who are expecting grafts? Yeah. So we actually also work with a male breast cancer group, the male breast cancer correlation, which is based in Kansas City. And, you know, there aren't too many men that undergo or have breast cancer each year.
You know, it's probably about 26 or 2800 each year. And most of them want to go, you know, on mastectomy and a lot of times that is also removing the non-renewal complex. So that's something that we have been discussing with that group getting feedback from, you know, it's a really, really important, so much smaller population than female breast cancer survivors. Our study is open to anyone who is undergoing a reconstruction.
There are some inclusion and exclusion criteria, of course. Through that study. But, you know, and Billy and I do not know the individuals who are going through that will be included in the study. So as of right now, I don't believe so, but it's not to say that wouldn't be a potential.
And certainly, you know, when it comes to DC Stoners, you know, we are open to both female and male because a lot of times, you know, again, going back to size preference, it really is, doesn't discriminate based off of sex. So, you know, it's definitely something that we could utilize and, you know, offer two male breast cancer survivors as well. So fascinating. We actually talked about this with our volunteers here at LOPA.
So many questions, so many possibilities, so much hope that you guys are providing. So we appreciate you and I just think we're going to have them back on the podcast. So guys, you have a standing appointment whenever you're ready to come back. But we know that our listeners will have questions.
They want to go and see what you guys are doing. Where can we send them? Where do you want them looking, you know, online, Facebook, those types of things? Yeah.
So we have a presence on LinkedIn. We have a presence on Facebook and on our website, which is we just had recently redone actually is bio-esthetics.com. And please feel free to go on there. We have a little link that you can send us a message directly with a email address online as well.
You know, we love to hear from, you know, our families as well as breast cancer survivors and caregivers, you know, for their feedback in general. You know, we couldn't do this without, you know, the DC Stone and Sloeb ones pushing forward with it and offering this for our recipients. So we're incredibly thankful to everyone who's involved and for you guys as well. Thank you so much for having us on today.
We appreciate the both of you, Nick and Billy, keep up the good work and we hope to hear from you again here on the Gift of Life. Thank you. Thank you. Thank you.
Thank you. Here on the Gift of Life podcast, it's time for mental health and we're taking a moment. Yes, Sarah, this was a very interesting one. Coping with death anxiety.
Oh. Interested to hear what you have to say. I'm nervous. Okay.
Don't be nervous. Okay. So essentially people who experience death anxiety, a lot, it could be anyone, but a lot of times it's people who either experience a traumatic death, which could be categorized as a death when you're young, sudden death and your family, friends, something that really disrupted your world. Or a lot of times people who work in death.
So a lot of hospice workers, people who work in Oregon donation, we see a lot of sudden traumatic death, which could give us death anxiety. So just so I can understand that death anxiety would be your own death, anxiety about your own death. Your own death or your family and friends? Essentially it's feeling so anxious and fearful of death that it disrupts your day to day life.
So a lot of times we see this with health care workers, especially when, you know, if they have kids, they're very afraid of what could happen, of death that they could experience because they've seen it daily. So it's very natural. It's very normal to feel afraid of death, but we don't want it to disrupt your life. Right.
So how do we do that? How do we do that? Well, I get nervous if like there's a funeral coming, like am I going to say the wrong thing? Right.
How long do you stay? What are you staying at? Like those things go through my mind just like as there's an event happening. Right.
And you know, I think the one thing that I want to talk about today, which really can help you cope with death anxiety is all. So what I mean by that is being in awe of your life of life in general. How do we do that? We just simply live in gratitude.
We recognize that while death, the reality of death is very scary and it is something that we all will have to deal with, there's still so much to live for. So recognizing the awe of life and pursuing your purpose, your passions, making the most of your time with family and friends can really help reduce the anxiety of death. Live. Live.
Live. Live. Live. In my life, I don't really experience that death anxiety too much for myself, but you know, even just driving here today now with a new baby, my wife has it constantly with baby Blakely.
Right. All right. Make sure you don't talk in text on phone and don't obey all traffic laws. Right.
Like baby, I got it. Right. It's a constant, it is a real anxiety for her right now. Just bringing you know that the baby to my mom's house, for instance, it's like all the babies on the road.
Right. Right. Yeah. I get your wife.
I totally get it on there. Yeah. Yeah. And I've heard a lot of my co-workers have this discussion because we're around death so much that a lot of people can think it's going to happen every day.
And so really, I'm not saying ignore that because denial doesn't work, especially with anxiety and death, but also remember to be in awe of your life and awe of the gifts you have, the family you have. And when you are afraid of death, remember to also be in awe of life and it'll help reduce that anxiety. Enjoy where you are. Mm-hmm.
I like that. You have a topic you want to share to cover? Just email us info at the GiftedLife.org. Lori and our question and answer segment.
Uh-oh. Today's question is for you since I'm the organ guy as some people call me. Yes. So how can so many people benefit from one person's gift of tissue?
What is recovery? Oh, I love this question. And then when we're doing presentations, I love to have these conversations because someone somewhere is connected in some way, shape or form, which is amazing. But local recovers tissues for donation and more than 50 people can be healed by these donations, which is pretty incredible.
You want to list Sarah? Yeah. So right now, this is currently what we recover. These are the gifts of tissue.
We recover eyes, heart for pericardium, bone, vessels, skin, and bone marrow vertebral bodies. And that doesn't count all the countless gifts from research like we talked about earlier in today in our podcast. And you know, these are life enhancing and also life saving. Yeah.
And we work with a donor family. I just love how she put this. Her son was a hero, a donor, and donated his cordias. And so she said, I haven't met.
I don't know. But she said whoever received his eyes, they will see a more beautiful world. And that just gave me comfort, gave her comfort. I just love the way that she phrased that.
And that was her view of cornea donation. I thought that was beautiful. So those are the things that we can do. If you want more, we have a resource page at lopa.org.
We'd love for you to check it out. And we could talk about it all day if you let us on show. Yes, we will. And if you guys have a question, please give us a call.
That number is 504648347. That's 5046483477. In every episode of The Gifted Life, we honor a hero. Today's hero is Chelsea Carrier.
And we learn about Chelsea from her family. Chelsea will always be our angel at Christmas and every day. It was her life mission to help others always. She truly made this world a better place.
She gave specific instructions that she wanted to be a donor when she passed. We are so honored to continue her legacy and honor all of her wishes as we know her recipients are seeing the world through her angel eyes. So now we pause and say thank you to Chelsea for the gift of life. And that's going to do it for episode 156 of The Gifted Life.
Yeah, thank you to Billy and Nick for coming on and sharing those advancements in the nipple aerial complex that they're researching. It's fantastic research, obviously very necessary. And we're so happy at lopa to be just a part of that. Yeah, I love to hear from them and hopefully they'll join us here again on The Gifted Life.
Maybe you're listening and you haven't yet taken that step to register as an organ tissue and I don't know. You can do that anytime. Hopefully you've been inspired to register me. Or in the best place to find us guys, the Gifted Life.
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Thanks for listening. Help us spread the word. Our goal is to learn and to make life happen. And our ask is that you go out and do something you would normally do to help us make life happen.
We're one big team. Until next time. See the Gifted Life is hosted by Lori Steele, Joey Buudrow and Sarah Blakemore. Our executive producer is Kirsten Heis, producer is Shalom Caraway.
Intern is Rebecca Rannam and we are recorded, engineered and mixed in our Covington Louisiana studio by Troy Perez.