Inside HeartWorks: A New Era in Heart Disease Treatment

Unlock the future of heart care and understand how a revolutionary cooperative platform is reshaping the landscape of congenital heart disease treatment. Join us as we explore the groundbreaking innovations at HeartWorks, a transformative program at the Mayo Clinic led by Dr. Tim Nelson. With heartfelt insights from Erin Borkowski, a dedicated heart mom, and Rachael Gott, an inspiring adult living with congenital heart disease, we delve into the challenges and advancements that are redefining patient care and clinical trial processes.

Meet the pioneers behind the scenes as Dr. Nelson explains how HeartWorks is bridging the gap between research and real-world applications. By harnessing patient-contributed data, this initiative is overcoming the frustrations of traditional clinical trials, making them more effective and timely. Rachael Gott shares her personal journey with HeartWorks, emphasizing the significant impact of ongoing research and patient empowerment in the fight against congenital heart disease.

Discover how HeartWorks is turning obstacles into opportunities through a data-driven cooperative platform. This patient-owned model is not only increasing enrollment in clinical trials, but also creating a collaborative network of institutions across the nation. From engineering heart muscle cells from skin biopsies to making clinical trials more accessible, HeartWorks is revolutionizing the way we think about congenital heart disease care. Tune in to learn how you can support these efforts and contribute to a brighter future for individuals of all ages affected by congenital heart conditions.

Rachael’s episode: Navigating Life with HLHS and Marfan Syndrome: Rachael’s Powerful Story: https://tinyurl.com/393hbmrm

Dr. Tim Nelson’s other “Heart to Heart with Anna” appearances:

Advancements in Stem Cell Therapies and Research for HLHS Heart Warriors: https://hearttoheartwithanna.buzzsprout.com/62761/episodes/494353-advancements-in-stem-cell-therapies-and-research-for-hlhs-heart-warriors

The Use of Stem Cells in Treatment for Hypoplastic Left Heart Syndrome (HLHS): 

https://hearttoheartwithanna.buzzsprout.com/62761/episodes/9949984-the-use-of-stem-cells-in-treatment-for-hypoplastic-left-heart-syndrome-hlhs

HeartWorks Update 2023: https://hearttoheartwithanna.buzzsprout.com/62761/episodes/12191542-heartworks-update-2023

HeartWorks: https://heartworksinc.org/

The Co-Op: https://heartworksinc.org/coop

Sheri Turner is our newest Defender Patron and she also serves as a HUG Volunteer. Thank you so much for your generosity and all you do, Sheri!

Chapters

• 0:00 HeartWorks 2024 The Co-Op
• 13:42 Segment 2
• 23:09 Segment 3

Transcript

Speaker 1: 0:24

So at HeartWorks we say we build hearts and our purpose is to cure congenital heart disease. We like to refer to ourselves as a team of teams, and there's five things that drive us every day.

Speaker 3: 0:46

Welcome to Heart to Heart with Anna. I am Anna Jaworski and the mother of an adult with a single ventricle heart. Today's guests are Dr Tim Nelson, heart mom, eric Warkowski and adult like a CHD, rachel Gott. Dr Tim and he Nelson directs the Todd and Karawanek Family Program for Hypoplastic Left Heart Syndrome at Mayo Clinic. His research focuses on cardiovascular regeneration using bioengineered stem cells to treat degenerative diseases, particularly HLHS or hypoplastic Tert syndrome. As director of the program, dr Nelson and his team are specifically interested in the cause of HLHS and finding ways to delay and prevent heart failure for individuals with HLHS. To better understand and treat this congenital heart disease, the program has taken a multifaceted approach that includes research into stem cells, genetics, imaging tools and the creation of a biorepository.

Speaker 3: 1:45

Dr Nelson has been on Heart to Heart with Anna numerous times to talk about HeartWorks over the years. We'll have links to the other episodes in the show notes. Erin Borkowski is Bella's mom, who was diagnosed with HLHS at 20 weeks. Bella, now 11, has undergone all three scheduled surgeries. Erin's family created the non-profit Beats for Bella and now she works with Dr Nelson at HeartWorks. Welcome back to Heart to Heart with Anna. Dr Nelson.

Speaker 1: 2:14

Anna, it's great to be here, and it's a privilege to be with Erin and Rachel as well today, so thanks for having us.

Speaker 3: 2:20

I'm so excited to have you on the program, and this is really a dynamic team, isn't it?

Speaker 1: 2:26

It's a team of teams, as we like to say at HeartWorks.

Speaker 3: 2:29

Oh, I love that. Let's start by having you tell us about HeartWorks and the new services for the heart community that HeartWorks is coming up with.

Speaker 1: 2:39

Anna. The field of congenital heart disease has been stalled for the last 30 years with products and new innovation in many ways and Partworks born out of our program at Mayo Clinic and collaborating with a network of hospitals across the country is really focused on. Product development is really focused on how do we bring the best science out of labs and get that through an FDA-approved process and develop new products to transform the way we take care of children and adults with congenital heart disease. So at HeartWorks we say we build hearts and our purpose is to cure congenital heart disease. We like to refer to ourselves as a team of teams and there's five things that drive us every day.

Speaker 1: 3:24

First, we're driven by the urgency of CHD families like the ones we have with us today. We're motivated by transformative outcomes, meaning products that can really change the way we do the surgeries. We're undeterred by obstacles because we know there's obstacles in this journey. We're ultimately committed to a self-reliant ecosystem. What we mean by that is how do we do the A to Z product development, get it out of the lab, get it to the marketplace and get it into the hands of families and clinicians, and do that in a way that we're not dependent on anybody else helping us, but we do it in a self-reliant way. And finally, as we're all here today, we're aligned by the shared responsibility that developing products for congenital heart disease is truly our mission, and that's where we aim to partner with all companies, all academics and all motivated entities trying to make it better for congenital heart disease, and one of those products we'll talk about more today is the co-op that we're super excited about of how that's going to revolutionize the way we do product development for congenital heart disease.

Speaker 3: 4:32

Absolutely. I am really impressed with how HeartWorks doesn't just want to find the cause and therefore create the cure, but they're working to help people right now. That sense of urgency, I think we all feel that We'll hear more about that from Rachel, but as a mother of an adult who was initially diagnosed with HOHS and then it was changed to single ventricle, for the last 30 years I have seen so many people growing up with this condition and facing so many different types of problems. We really do need to find a cure, and I'm not sure that everybody really understands how long the process can take to get something from an idea all the way to something that can actually be used in the operating room. And this seems to be something that HeartWorks has decided. It's not fast enough and you're bound and determined to make things happen faster.

Speaker 1: 5:32

Yeah, you're right, anna.

Speaker 1: 5:33

The thing that we've pioneered and perfected at Heart Works is the cell-based therapies for regenerative medicine, and we're committed to developing cell-based products that can regenerate the heart for everybody with congenital heart disease.

Speaker 1: 5:46

But we've learned in the last 12 years that the biggest bottleneck to our progress and our cycles of learning is actually the enrollment and recruitment of patients into clinical trials. In the congenital heart community we don't have a culture, an infrastructure, a process to be able to inform patients which studies are available, which clinical trials are available and how to enroll those patients so that they can be part of the future and they can be part of pushing the boundaries and pioneering. And the co-op, as you'll hear about today, is really designed to directly address that gap and accelerate the way we can enroll patients across the country, no matter what institution you're at, no matter if you're doing well and thriving today or if you're doing poorly and need help today. Even for our families that have lost somebody in the congenital heart community, it's literally open for anybody with congenital heart disease, and everybody together in the co-op is what's going to allow us to accelerate the clinical trials that are so vital for moving this field forward.

Speaker 3: 6:56

I love that. Welcome to Heart to Heart with Anna Aaron. Thanks for having me. Anna, happy to be here. I'm happy to have you here too, because I know that you're working with Dr Nelson at HeartWorks and I'd love to know more about your role in the co-op.

Speaker 3: 7:15

I have always been inspired by the team at HeartWorks and Tim mentions the team. It truly is and it's incredible the dedication from the physicians, clinicians, everybody that's a part of HeartWorks to solve this problem and help find a cure for CHD. And I'm always very moved by people who are not directly impacted and still dedicate so much of their time and energy and heart and soul to finding a cure for congenital heart disease. And as far as the co-op goes, my role with the co-op is to help families understand the power of this platform, to educate them and to inspire them to become members. We live in a world now with Bella that is a wait and see and this is something that we can do just by simply donating her data and by helping educate the teen different symptoms that she might be having, but sharing the goals of the co-op with families and helping them feel inspired to share their voice and help change the future.

Speaker 3: 8:23

I love it that you're coming at this as a heart mom like me, because we have that sense of urgency, don't we? We want our children to live happy, productive lives. Yes, 100%. I get very frustrated by the slow-moving world we live in sometimes and totally understanding that research takes time and trials take time. But as her mom, I want things done yesterday. I want a plan for the next 20 years. I'm just happy to be a part of this team and do my part and share my passion. I love that. I know.

Speaker 3: 9:01

When Hope was young, I just kept praying that medical technology would stay a step ahead of her. And she is now 30 and it has stayed a step ahead, but just barely. But I think HeartWorks can be a game changer and I'm looking forward to seeing how we parents can help this organization. And there's so much more for us to learn there is. Heartworks is the only one that I know doing what they're doing the work, the research, the team, bringing families, physicians, clinicians, patients together to change your future. That's the power here. Right, exactly so. Dr Nelson, you were talking before about the main reason for developing a co-op is because of that bottleneck. Can you talk to us a little bit more about that and how, discovering what the problem was, led to this revolutionary solution.

Speaker 1: 9:59

Yes, we've done five INDs with the FDA since the beginning of our program, and an IND is the permission that the FDA gives you to do world's first clinical trials for patients with congenital heart disease. And as we've done that, we've learned that we've always enrolled patients far more slowly than what we intended to. So we get the study approved from the FDA, we get the study approved in the local IRB and then we go try to find the patients and recruit them to be part of these, first in human clinical trials, and it ends up taking us four times longer than we expected it to take, and that becomes really frustrating for everybody Everybody on the team our clinicians, our scientists, our manufacturing team, our researchers and especially our families. Our families get very frustrated by the fact that it takes much longer than we'd hoped for. So, after doing this for 14 years now, we finally have figured out a way that we think we can change that, and not only for HeartWorks and our technology, but for literally the entire field of congenital heart disease.

Speaker 1: 11:07

So, rather than designing studies that we think are perfect, fit for families, what if we could have all families with congenital heart disease donating their data to a platform and then using that donated data, we can build the clinical trial for the patients that have the highest unmet need, the patients that have raised their hand and said I need help, I want to be part of something, and we design clinical trials for those patients in need. Imagine how much easier it is for those patients to sign up for the clinical trial once it's developed. So they raise their hand, they donate their data, we design the clinical trials for them and then we go back to them and say we heard you, we listened to you and we now have a clinical trial that's open for you. This is a game changer and we're super excited to be able to make this available to the whole CHD community and go well beyond the products that we have at HeartWorks.

Speaker 3: 12:07

What I love about this is you're continually assessing the data that you get, and you may end up creating products or studies completely different than you would have otherwise, because the data that you're getting will be so rich that that will tell you where that basic need is.

Speaker 1: 12:30

Yeah, that's right, and keep in mind that this is fundamentally different than the registries that have been built over the last decade. There's great work being done in many registries that collect data in a de-identified way and look at best practices and standardized cares across institutions. That's wonderful. Best practices and standardized cares across institutions that's wonderful, really important work. Our mission is to transform the way we take care of kids and adults, going forward, developing new products, and to do that, we need to identify the right patients at the right time to be part of these clinical trials. So it's fundamentally different in a patient-centric way, listening to the voice of the patient, interacting bidirectionally with the family and with the patient to educate us on what we should focus on and then educating back to the families what is currently available for clinical trials across the country. This is the platform that is fundamentally unique to any of the other registries, and so we encourage everybody in the congenital heart community. Whether you are a warrior or an angel, you can donate your data and make this process go much, much faster.

Speaker 2: 13:48

Heart to Heart with Anna is a presentation of Hearts Unite the Globe and is part of the Hug Podcast Network. Hearts Unite the Globe is a non-profit organization devoted to providing resources to the congenital heart defect community to uplift, empower and enrich the lives of our community members. If you would like access to free resources pertaining to the CHD community, please visit our website at wwwcongenitalheartdefectscom for information about CHD, the hospitals that treat children with CHD, summer camps for CHD survivors and much, much more.

Speaker 3: 14:22

Rachel Gott is an adult who was born in 1988 with hypoplastic left heart syndrome, or HLHS. She to date has not had any major corrective birth surgeries. She has had 13 cardiac ablations along with two device implants. Rachel is an advocate in the congenital heart community and a former nurse. She's passionate about helping others on their old CHD journeys. My loyal listeners will remember Rachel from earlier this summer when she was on the program, and the link to that episode will be in the show notes. Welcome back to Heart to Heart with Anna Rachel, thank you for having me.

Speaker 4: 15:01

I'm super blessed to be here.

Speaker 3: 15:04

Well, I'm super excited to see you, and I wish everybody else could see you too. You're wearing your HeartWorks hoodie. You've got your HeartWorks water bottle. Why don't you tell us a little bit about your connection with HeartWorks, Rachel?

Speaker 4: 15:19

You're absolutely right. I became fully a member of HeartWorks after the virtual dinner last year when Dr Nelson and Greg Olson talked about the co-op program that was involving and I was super excited. I didn't give it another thought. This is such an awesome program for people like me who have been misdiagnosed as a baby and haven't had corrective surgeries. I am super excited to be a part of this clinical trial to get help.

Speaker 3: 15:52

Absolutely. You are the only person I've ever met who was born with HLHS and has survived to adulthood without some kind of corrective surgery, so I'm very hopeful that HeartWorks will be able to help you, because I don't think there are many people out there like you.

Speaker 4: 16:09

I came across a very small handful and by handful I'm talking two or three people that have had maybe one surgery but not all three, or just haven't had any corrective surgeries altogether. So I am very much amongst the rare population HLHS, uncorrected, and it's all God. I'm very blessed to be here. He's paved the way, he's kept me safe and I'm very thankful for that. And I'm thankful for what the future holds and working with Dr Nelson and seeing what we can do.

Speaker 3: 16:40

Absolutely so. What do you think the benefits will be for you working with HeartWorks?

Speaker 4: 16:48

I'm very excited about the whole process with stem cells and trying to regenerate the valves All my valves are leaking generate the valves All my valves are leaking. So I'm very excited to dive into that process and see what may or may not amount out of it for myself.

Speaker 3: 17:06

Okay, that's good. You have a very specific focus, then, that you're interested in. And, as a nurse, what do you think about this co-op? Have you ever experienced anything like this before in your medical career?

Speaker 4: 17:21

I have not and I'm very excited that they put together the matrix. I feel like it's a great opportunity to have a central hub database for different patients, then different types of issues, then just one great day central resource center. I'm super excited they did it and I hope this podcast will educate more people about the co-op, because a lot of people I know are very intimidated by it Exactly.

Speaker 3: 17:50

I think there are a lot of people who are intimidated by it. I think that currently in the United States anyway, there's so much fear regarding identity theft, and I'm sure I'm not alone in having had to get new credit cards periodically because some person or entity has stolen my credit card information. It's so frustrating, and it seems to be happening so much more today, that the thought of sharing our very private medical information with somebody else is scary, because we know that something could go wrong. Did that concern you at all before you joined the co-op?

Speaker 4: 18:29

Absolutely not. I figured with it being professional with a medical institution and company that my data would be saved. I know it is through my chart and so that was not a negative factor in my mind. It didn't weigh me one way or the other. I was on board from it from the second I heard about it. I love that.

Speaker 3: 18:50

As a former nurse and now a CHD advocate, what advice would you have for other adults with HLHS, or parents of children who have HLHS, regarding participating in research studies or taking part in something like the HeartWorks co-op? Ask?

Speaker 4: 19:06

your questions. If you have an unsure feeling about something, ask, because nine times out of ten, somebody else out there has the same question that you're wanting to ask. That's the only way you're going to get over your fear. Always ask, because I'm sure somebody has that same question. And Dr Nelson and his team they're fantastic about getting to the bottom of things, making it all comfortable and safe.

Speaker 3: 19:33

You've dealt with EPIC as a nurse. Maybe not everybody who's listening to this program knows what EPIC is and can understand why having dealt with something like that would make you feel more comfortable with the co-op. Can you explain a little bit about that to us?

Speaker 4: 19:49

Okay, and so with EPIC, obviously, HIPAA laws are in place Depending on the hospital institution. They've got great software security about the Huffville institution. They've got great software security and your information is 100% safe, secure and protected. I hadn't came across any issues with patients' information getting leaked out there. That's what fueled my mind to do the co-op program, because I know if my information and app is protected as a patient, that it would still be the same throughout the Matrix program with their co-op.

Speaker 3: 20:22

Not everybody who listens to my show is from the US and they may not know what Epic is. My husband uses Epic at the hospital where she works as well. It kind of streamlines the data that all of the nurses and doctors put in across the hospital. The hospital my husband works at is the biggest hospital for over 100 miles in radius in Texas and there are lots of little satellite clinics. It's really nice that through Epic, all of the information from the patients can be shared practically instantaneously. It's a way of communicating information very quickly, very accurately and much more detailed than what we probably ever thought would be possible before. You can look at x-rays, you can look at echoes. Dr Nassa, do you want to weigh in on this, how EPIC can be helping the co-op and how, through working with the co-op and maybe some of these other medical repositories, that we can keep medical information safe and yet still have access to some really powerful data?

Speaker 1: 21:29

Yeah, the electronic medical record, which EPIC is one of many and is arguably the largest electronic medical record. Epic is one of many and is arguably the largest electronic medical record. All of our data is electric these days. Right, it's all in the database, it's all available and if you're in one organization or one platform, you can get that data downloaded to you and you can even share it quite easily. The problem is if your data is in multiple systems and multiple providers over a long period of time with different hospitals, it becomes very hard to aggregate that all together.

Speaker 1: 22:03

And that's one thing the co-op does allow us to do is to pull electronic medical records from multiple hospitals and put it into one place under the banner of the HeartWorks co-op. That has a lot of advantages to be able to simplify the medical record back to the patients, but it then also allows us to do something as a community that no one hospital could do by themselves. And that is again the reason why the team of teams at HeartWorks becomes such an important concept, because it allows us to bring tens of thousands of congenital heart families and patients together into one unifying platform, and just imagine what that will allow us to do the safety concerns we take as serious as anybody. We have the same safety protocols that any of the large electronic medical record systems have, and it is a concern for us all. And yet the power of aggregation is such a transformative approach that we have to continue to focus on making it safer and making sure that we educate patients of how powerful this aggregation can be professional medical advice, diagnosis or treatment.

Speaker 5: 23:17

The opinions expressed in the podcast are not those of Hearts Unite the Globe, but of the hosts and guests, and are intended to spark discussion about issues pertaining to congenital heart disease or bereavement.

Speaker 2: 23:31

You are listening to Heart to Heart with Anna. If you have a question or comment that you would like addressed on our show, please send an email to Anna Jaworski at Anna at hearttoheartwithannacom. That's Anna at hearttoheartwithannacom. Now back to Heart to Heart with Anna.

Speaker 3: 23:50

Now we're all in the studio together and I want to talk a little bit about research, because when I was in college studying research, one of the problems that we would see is maybe there were 20 people in the study and that was it, so it was hard to generalize anything from a study with such a small number of subjects. Tell us how this co-op can change that for the heart world yeah, it's exactly right.

Speaker 1: 24:21

We need a large number of patients, a large number of diverse experiences, a wide spectrum of ages, a wide spectrum of good and bad outcomes that people have experienced to be able to get the true picture of what is the reality and what is the opportunities to move forward.

Speaker 1: 24:39

So the co-op allows us to aggregate that across multiple institutions literally any institution because the patient themselves owns their own data and the patient themselves can donate their data to the platform at the co-op. So that donation of their data and participation in this research study is really what allows us to do it at scale. And if it were my son or daughter that was being asked to be part of a research study, I'd be asking is it safe? What do you know? Is this really the right thing to do? And the only way we can get some of those answers that we all need is by aggregating the data together in a unique way. And the beautiful thing about today's electronic medical records is the data is available to be able to be donated and shared and aggregated and as long as we can at HeartWorks, earn the trust of families and patients to be that custodian of the data, to be that agent of change with that data. We believe we can move faster than anybody else with this type of an approach.

Speaker 3: 25:48

Are you also looking for data that's old? For example, my daughter's 30, and she had her surgeries at a different hospital than the one that she is seeing now. Is there any value to her asking if the other hospital where she had her surgeries could send data to you?

Speaker 1: 26:08

Absolutely right.

Speaker 1: 26:09

I mean, this is the beautiful thing to be able to look at the longitudinal outcomes of patients like your daughter over the past 30 years gives tremendous power to being able to predict what's coming in the future, or to be able to identify patterns and trends where patients that may be just like your daughter are going to do great.

Speaker 1: 26:30

But maybe, if they're not like your daughter, maybe they have a higher risk situation that we should be intervening and doing things sooner.

Speaker 1: 26:37

The aggregation of the data in a personalized, prospective way is what makes this platform fundamentally different. Now, the one thing that prevents people and Aaron can speak to this perhaps better than I is that people get worried about how much time and energy is it going to take to get that data, and if anybody's ever signed up for life insurance or had to get medical records from one provider and sent to another, they know how complicated that is and people are tapping out saying I don't have the time to do that. But before you say that, you must realize that the co-op has done something really revolutionary. You must realize that the co-op has done something really revolutionary. With your permission, the system can go, talk to the system, grab the data and pull it into the co-op, so you don't even have to transcribe the data and manually enter the data. There are options to automate this, which changes the level of involvement and time needed to make that work.

Speaker 3: 27:40

But my daughter was born before Epic was created, I think, or at least it wasn't at the hospital when she was an infant. I mean, she has I don't even know how many folders of information at the hospital. Are hospitals taking all of those old-fashioned folders full of information and inputting them into their computers, dr Nelson?

Speaker 1: 28:04

Some are. Some are going back into the medical record and transcribing old data into the electronic medical record, so that is happening automatically in many institutions. But it's also true that not all of that data is going to be transcribed. The co-op is really focused on grabbing the data that is immediately available to us in the electronic medical record. There's always ways where patients can upload the data manually directly, and we would welcome that, but we also recognize that that takes a lot more time and energy to be able to accomplish.

Speaker 3: 28:39

Erin, what common misconceptions have people expressed about the co-op to you? I think that it's just a general understanding because this is something that didn't exist before the co-op at HeartWorks began. So I think that educating families and patients that this is not your typical registry, that your voice is important and that sharing their data is simple I heard earlier that this can seem intimidating, which I didn't feel that way I think that making families and patients aware how secure the system is and that the data is safe is really important. I have heard that from some families simple registering is and becoming a member is.

Speaker 3: 29:39

The more we talk about the Co-op, the more we share the possibilities that will come. The evolution of it will be pretty incredible to see over the years. As we build the database to 500 and 1,000 and 10,000 members, I think that we'll have more soldiers on the street for lack of a better phrase sharing this platform and sharing the story of how to take a hold of your future and help impact the future for CHD care and treatment. I love that, rachel. Do you have any questions for Dr Nelson or Erin about the co-op?

Speaker 4: 30:17

I do, Dr Nelson. How long exactly does the clinical trial last?

Speaker 1: 30:24

Great question. So to be a member of the co-op, you actually sign a research consent form that's IRB approved and you can withdraw that consent at any time. So our goal is to be able to bring families and patients into the co-op and keep them there for as long as they're willing to participate the longer the better, because it gives us that longitudinal data. But it's also true that if, for any reason, any time, somebody wants to withdraw from the co-op, it's a simple undo if people want to. But this is a living, breathing data collective that brings people together for the long-term.

Speaker 1: 31:01

Now, one exciting thing that has come out of this we have over a hundred patients that have already signed up for the co-op and we had a new clinical trial that became available in the last month, a new clinical trial where we can consent patients to a skin biopsy, get their cells manufactured and prepare for future clinical trials with their stem cells.

Speaker 1: 31:23

And in the co-op there were 28 out of 100 patients that were eligible for this new research protocol with the skin biopsy. We were immediately able to reach out to those 28 people and inform them that because they donated their data, because we had a clinical trial that was available, we then could screen their medical record and who they are and inform them that they may want to learn more about this particular clinical trial that is now enrolling, and then they can reach out to the study coordinators, learn more and do that. We imagine that this is the platform that people will stay in the co-op because as they go forward, as their medical conditions change and evolve, we'll be able to keep them updated on what clinical trials are available anywhere in the country. That value add, I think, is going to keep people engaged for the long term in the co op.

Speaker 4: 32:20

I am happy to say that I was led for 28 participants that you reached out to for the skin biopsy, so I'm very excited to do that and see what happens.

Speaker 1: 32:32

Well, we thank you for being a member of the co-op, because that's exactly what allows us to move so much faster. Is that few weeks when, from a protocol being available to you, being aware of it, to you being able to engage in that? That previously took us months and months and months to figure out. So it's a perfect example, rachel, and we're grateful that you were able and willing to trust the co-op to allow us to do that so much more quickly.

Speaker 3: 33:00

Oh, absolutely, Rachel. Were you surprised that you signed up with the co-op only this year and you already got a call saying that you qualified for one of the studies I?

Speaker 4: 33:12

was surprised. However, the shock didn't last long because I am single ventricle, so I figured I wouldn't again give any takes for this organization.

Speaker 3: 33:22

But this co-op helps you to realize you're not alone. There were 27 other people who got the same call you did, and that's actually a decent number to get started with the study, isn't it I?

Speaker 4: 33:43

completely agree. It's a fantastic starting point.

Speaker 1: 33:48

And I think it's allowing us to get started with something so much even bigger.

Speaker 1: 33:52

Anna and Rachel, I like to think of folks like this as the pioneers.

Speaker 1: 33:58

We need to get back to the day where we were in the 60s and 70s and 80s, where we had a culture and an expectation to pioneer new therapies, new surgeries for these children that we had no options for at that time, and that pioneering spirit is what, together, I think we can reignite. And the technology is available, the science is available, and getting more patients enrolled in clinical trials is a game changer for the future of congenital heart disease. Imagine the day when we have 10,000, not 100, but 10,000 individuals with congenital heart disease in the co-op and imagine how much easier it will be to engage drug companies, device companies, researchers across academia. We will have a patient-owned data set that will drive the innovation that we've so desperately been lacking over the last 30 years. That's why this co-op is a game changer, and these individual stories and these individual examples of how we can do it today is what's really propelling us forward into a much, much bigger and much faster future, and I think that's really motivating for our families.

Speaker 3: 35:14

It seems like in the past, dr Nelson, so many of the research studies that were done were single institution studies, and what you're talking about doing is a multi-institution study. It's only as small as you want it to be. You have the ability once you get information from people in Hawaii or people in Philadelphia or people in Houston. You're getting all this information from people in Hawaii or people in Philadelphia or people in Houston. You're getting all this information from everywhere, and I think that makes it even more powerful.

Speaker 1: 35:43

We're 100% dependent on institutions with their massive skill sets. As clinicians and providers, we need to partner with institutions, and yet the co-op allows us to go above the demands of institutions and be one institution, one community of congenital heart disease, and that's really empowering for families and individuals to realize that it doesn't matter what institution they're at. They can be part of a nationwide, global-wide effort. So, yes, we'll always be dependent on institutions to be our partners to do the clinical trials, but we also, as a community, can help the institutions do more because of this.

Speaker 3: 36:26

You're based at Mayo, so if somebody does qualify for your study, do they have to go to the Mayo Clinic to take part in that study, or will there be opportunities much closer to home where they can still participate in the study?

Speaker 1: 36:45

Well, something we haven't talked about today that we're also very proud of is the consortium of hospitals that we've created.

Speaker 1: 36:51

So, yes, we do a lot of things for the first time at Mayo Clinic, because that's where we're home base and that's where our core team works out of.

Speaker 1: 36:59

But we recognize that we need to make these therapies and these clinical trials available more locally, and we have worked with 11 pediatric hospitals across the country and as we go forward with more adult congenital heart protocols, you will expect to see from HeartWorks a network of hospitals working collaboratively and really, the place that we're going to go with this network is the institutions that have the most patients, the institutions that have the highest density of people in the co-op. That allows us to centralize and focus on the most patients in one location. That's going to allow us to go faster than what on the most patients in one location. That's going to allow us to go faster than what we've been able to do before. So this isn't about one institution. It isn't even about a few institutions. It's about how do we make all institutions allow their patients to be available and participating in research studies, because it's all of us together that's got to move this field faster than what we're doing right now.

Speaker 3: 37:59

Absolutely. So you had this one study going on. Does a person have to be a member of the co-op in order to be eligible to take part in a study?

Speaker 1: 38:10

It's the best way for us to find out if you're eligible for the study is using the co-op, as we talked about. But it's not the only way you can directly reach out to us and we're happy to work with patients one-on-one with our study coordinator team, but the co-op is definitely the way that allows us to streamline it, simplify it and hopefully accelerate it.

Speaker 3: 38:31

I love it, erin. Is there anything else we need to know about the co-op? I encourage people to reach out and connect with the team if you have any questions. I think that it's going to be an incredibly powerful tool for the future. Nothing like it exists today, so I'm excited for what it will do for the adult population as soon as possible. I'm excited for what it will do for babies just being born and tweens like my daughter, bella Advocate. Get involved. That would be my best advice. I love it. Well, rachel, good luck in the study. How long is this study going to take? Dr Nelson, is this something that's going to go on for years?

Speaker 1: 39:17

The skin biopsy study, as you've heard us talk about. Before we take a piece of your skin, we engineer your cells and then we make your beating, contracting heart muscle cells. I've launched that. We have patients in the process of their cells being manufactured. It's a nine-month process to make cells and we will then go on to the next step for the right patients at the right time, to do the transplant for them. So this is always a long process, but we're super excited to scale it and make it available to as many people as possible.

Speaker 3: 39:47

I just love it. I'm so excited and, rachel, we're going to have to have you and Dr Nelson and hopefully Aaron, come back in the future and let us know how things are going. This time has just flown by. I want to thank all of you so much for coming on the program. Thank you, dr Nelson, for bringing us up to speed on what's going on and explaining the co-op even more in depth with us this time.

Speaker 1: 40:09

Well, thanks for being part of the team of teams, and we can't do this without folks like you communicating, so thank you for your time today.

Speaker 3: 40:17

Well, thank you. I'm hoping that this will help my daughter. It's a little bit selfish that I do this to you, because I want to make sure that she has opportunities that are on the cutting edge, just like what you're providing. Erin, thank you so much for coming on the program today. I'm so excited to finally meet you. Thank you, anna. It was great to meet you too, and Rachel, I always love having you on the program. Thank you for coming on today. Thank you for having me. Well, friends, that does conclude this episode of Heart to Heart with Anna. Thanks for listening today. If you want to learn more about the co-op, please check the link in the show notes, and I hope you have a great week and remember my friends, you're not alone.

Speaker 2: 40:59

Thank you again for joining us this week. We hope you have become inspired and empowered to become an advocate for the congenital heart community. Heart to Heart with Anna, with your host, anna Jaworski, can be heard at any time, wherever you get your podcasts. A new episode is released every Tuesday from noon Eastern time.