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Regenerative medicine utilizes a patient own cells to restore health, without the use of drugs or surgery. Join expert Amy Lightner, MD as she explains how the process works, identifies current conditions being treated using these techniques and discusses what's on the horizon for regenerative medicine.

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Understanding the Benefits of Regenerative Medicine

Podcast Transcript

Scott Steele:  Butts and Guts, a Cleveland Clinic podcast exploring your digestive and surgical health from end to end. Hi everyone, and welcome to another episode of Butts and Guts. I'm your host, Scott Steele, the chairman of colorectal surgery here at the Cleveland Clinic in beautiful Cleveland, Ohio. And I'm very pleased to welcome Dr. Amy Lightner. Amy, welcome to Butts and Guts.

Amy Lightner:  Thank you. Thank you for having me today.

Scott Steele:  So we always like to start these out by giving a little bit of background about yourself. Tell us where you're from, where you're trained, and how did it come to the point that you're here at the Cleveland Clinic?

Amy Lightner:  So I'm from San Diego, California. I went to undergraduate at Stanford University, and medical school in Boston and then back to Los Angeles for my surgical training, and then to Mayo clinic for fellowship where I stayed on staff for a few years, and I was recruited here for my clinical practice for inflammatory bowel disease, complex surgery, and the stem cell trials and decided to come really when I met the people in leadership.

Scott Steele:  The guy who recruited you must've been awesome.

Amy Lightner:  Yeah, he was pretty awesome.

Scott Steele:  So Amy, we're going to talk a little bit today about this whole concept of regenerative medicine. When people see that, a lot of times it draws up a blank. So let's start really big first and tell us what is regenerative medicine?

Amy Lightner:  So regenerative medicine really is just using autologous products or your own cells or your own tissues to restore function and really regenerate health rather than kind of treat it with a pharmaceutical.

Scott Steele:  And what does that mean on a... Tell it to me on a level that I can understand.

Amy Lightner:  So if you have a problem or you have an illness or a disease and there's not a drug to fix that disease or a surgery to fix that disease, sometimes we can take your own cells or a healthy donor's own cells or a portion of an organ or a scaffold and put cells on it and deliver that to fix the disease.

Scott Steele:  So in lay media, there's a lot of stuff about stem cells. I'm sure that this all fits into that, but what's a stem cell? Even to the point where there's been some questions about ethical issues with stem cells and everything. So what's a stem cell, how does that fit into this entire big picture?

Amy Lightner:  It's a good question. There's actually a lot of different kinds of stem cells. So what we hear about a lot in the media, in terms of ethical issues, are these embryonic stem cells, or cells that are taken very early on and can turn into anything. But a lot of the stem cell trials that we hear about, so trials to treat disease, is actually mesenchymal stem cells, so adult stem cells. So stem cells that come from our fat, from our bone marrow, and they don't differentiate or change to different cell types. They simply just restore the function of your own cells that are there.

Scott Steele:  How does this process all work?

Amy Lightner:  So we don't exactly know why stem cells work, but we think it has to do with communication to other cells. So we deliver mesenchymal stem cells to an area of inflammation. Those stem cells release these little kind of communication factors called cytokines, and they recruit in your body's own cells that would normally be there in larger amounts to heal the area.

Scott Steele:  So we've had guests in the past on regarding inflammatory bowel disease and please see some of our previous episodes on that. We're not going to dig in that today, but how does a process like stem cells fit into inflammatory bowel disease?

Amy Lightner:  So actually stem cells are really being used largely in Crohn's disease. So Crohn's disease, about a third of patients will have this manifestation called perianal Crohn's disease where they havefistulas, significant morbidity with that, a lot of pain, incontinence, loss of jobs, really diminished quality of life. And the problem is we have biologic therapy that we can treat that with, but only about 20% heal with biologic therapy. We have surgical intervention that we can do in certain select cases, but that puts patients at risk for incontinence. So stem cells are actually being used to treat perianal disease, and there's now been over 13 clinical trials. This started all the way back in 2003 with a group in Spain and more than 400 patients treated now with stem cell therapy. It's just a direct injection of cells. No safety issues and treatment efficacy is about up to 85%, so much better than what we had to offer before.

Scott Steele:  So wait a second, you're telling me that there's no downside and the fact that you have an 85% in a very high risk group like perianal Crohn's, why isn't this more widespread?

Amy Lightner:  Largely due to the ability to make cells. It requires a good manufacturing practice laboratory, which is a big infrastructure at each institution. That's one reason. And the other is cost. So it's quite expensive to produce these cells, and if a lab does produce the cells, it's difficult to transfer them to multiple other labs or other hospitals and locations because the cells only have a shelf life of about 24 to 48 hours. So there's a lot of logistics with delivering cells.

Scott Steele:  So where are we at in our program here?

Amy Lightner:  So in our program here, we actually have a lot of clinical trials that we're starting. We have a trial for perianal Crohn's disease, we have a trial for rectovaginal Crohn's disease, we have a trial for patients with pouches that have fistulas that would otherwise need a big reconstructive operation, and then we're also starting a trial looking at arterial delivery. So delivering these cells right to the intestine. So patients that have intestinal disease, usually at the end of their small bowel in the ilium, we can deliver the cells to the artery to treat that disease rather than doing surgery.

Scott Steele:  So before we go forward, let's look in the past. You mentioned that this has been around now for 15, 16 years. And so how did this come about and what took it so long to get to the point where we're at? Was it the cost or was it... What was it?

Amy Lightner:  So it all started in 2003 with Damian Garcia-Olmo, he had a group in Spain that was doing research actually on mice, and then they eventually treated their first patient and they had such good success that they then did several phase one and two trials and treated 20, 40, then 100 patients and they saw this was working really well.

Simultaneously in the United States there were a lot of labs looking at stem cells, so a lot of laboratory work and mouse work. And then there were some initial clinical trials in other disease states that were passed by the FDA and it takes quite a bit of time for the FDA to pass a trial. They're working on increasing the speed of regulating and passing trials, but it takes time, and that's largely for patient safety. So it's a good thing that it takes time. So the United States caught on to this and has since been doing trials and then there were certain groups that started doing the trials in Crohn's disease.

Scott Steele:  I know that you said earlier that there's really not been much safety issues, but no downside at all? There's no downside to patients? And you also mentioned that you can use other people's stem cells to do this. How does that all work?

Amy Lightner:  Yeah, so really no downsides. There's actually a large phase three trial of over 200 patients that were treated and that was a randomized trial. So some patients got normal saline or just an injection of normal fluid. The other's got cells and there were no difference in the rates of pain or abscess formation, infection, anything. So it really does appear to be safe and that's really reassuring for patients.

Scott Steele:  So does regenerative medicine involve more than just stem cells? What's the bigger picture with regenerative medicine?

Amy Lightner:  It definitely involves more than just stem cell. So there are certain groups that are growing whole organs. There are groups that are working on scaffolds that we can put cells and organs onto so that we could transplant them. So in transplantation, solid organ transplantation, there's definitely not enough donors for the number of patients that need a new organ, so that's also very promising. We could potentially grow liver, grow bladder. So a lot of things that are happening in regenerative medicine.

We're also working on therapies that aren't the whole cell, but are portions of cells that we can deliver in larger quantities and possibly at a lower cost. So we're working on therapies that are lower cost, easier to deliver to more patients, stable at room temperature, that can be given to multiple hospitals, that can sit on a shelf, and then be administered as a drug.

Scott Steele:  So who's the team that's involved in a regenerative medicine program?

Amy Lightner:  So a huge team of people with regenerative medicine. They're scientists in the lab that are working on products. There's good manufacturing practice laboratories. There is people that work with the FDA in terms of regulation and getting all these things approved, study coordinators, and then our own team. We have surgery, we have the gastroenterologists, we have radiology, interventional radiology, and pathology. So a big team of people would make this happen.

Scott Steele:  So if I'm a patient at home or I'm a provider that's listening to this podcast and I want to get involved or find out more about this, what is the process? How do I go about that? How do I get in to see you about this thing, and does everybody qualify?

Amy Lightner:  So most anyone with Crohn's disease will qualify. We pretty much will have a trial for any patient with Crohn's. And so they reach out to the clinic, they contact me, and I'm happy to see them and talk to the patient and evaluate them and see if they would qualify for a trial.

Scott Steele:  And so now walk me through what a potential visit would be like if I'm a patient. What happens? They come through the door, they're anxious to see. What's going to happen to them at that visit?

Amy Lightner:  So at that visit we'll talk to them about what their problems are, what their primary symptoms are. We'll do an examination of the area. We'll talk about the clinical trials, talk about what stem cell therapy is, see if they're interested. Because they're in a clinical trial, it does require that there's multiple study visits. So what that means is after they get treatment with the stem cells, the primary issue is safety. So we need to follow them closely and make sure there's no any adverse events or any safety issues. So they would need to understand the followup of coming back to the clinic four or five times.

Scott Steele:  Is this a one shot deal or is it multiple injections or what happens with this?

Amy Lightner:  So one injection and then after three months we check to see if they're healed, depending on the trial. And if they have not completely healed, if they partially healed, we do another injection at three months.

Scott Steele:  So where do you see this entire process of regenerative medicine heading over the next one, three, five and even beyond years?

Amy Lightner:  So I really see this changing medicine. I think right now we have, at least for inflammatory bowel disease specifically, we have a lot of medical therapies, but those are fraught with side effects, and any surgery that we do does have risks. So the fact that we can deliver cells in a minimally invasive fashion, whether it be direct injection or endoscopically or in an artery offers a lot of promising therapy for patients with Crohn's. And we're really seeing that this actually treats Crohn's patients much better than the therapy that we have. So it's really promising, because Crohn's disease, when we do an operation, we are just treating the symptoms. We're not curing the disease. So this offers a minimally invasive therapy that really works better than what we have to offer.

Scott Steele:  And you said that there is other disease processes beyond Crohn's that stem cells and regenerative medicine apply to. Is that also here at the Cleveland Clinic?

Amy Lightner:  There are. There've been trials in cystic fibrosis, there's been trials in osteoarthritis, a lot of trials in orthopedics. They're working on trials in both neuro for glioblastoma as well as heart attack and MI.

Scott Steele:  Well that's incredible stuff. And Amy, we like to have all of our guests just tell us a little bit more. We're going to end with some quick hitters. Number one, what's your favorite sport?

Amy Lightner:  Favorite sport is water polo. I played in college.

Scott Steele:  Yeah, absolutely. What's your favorite meal?

Amy Lightner:  Favorite meal would be a good steak and mashed potatoes.

Scott Steele:  What's your last book that you read or your favorite book that's outside of medicine?

Amy Lightner:  Last book I read was the Michelle Obama book. Very inspiring.

Scott Steele:  And although it's relatively new, what's something that you like here about Cleveland?

Amy Lightner:  One thing, the children's museum. I took my kids last Sunday. It was amazing. Spent almost the whole day there and they loved it.

Scott Steele:  Well, that's great stuff. We're very, very proud to have you leading this unbelievable innovative aspect of regenerative medicine. And for more information about Cleveland Clinic's Digestive Disease and Surgery Institute, please visit clevelandclinic.org/digestive, and to make an appointment with a Cleveland Clinic specialist, please call (216) 444-7000. That's (216) 444-7000. Amy, thanks for joining us on Butts and Guts.

Amy Lightner:  Thank you for having me.

Scott Steele:  That wraps things up here at Cleveland Clinic. Until next time, thanks for listening to Butts and Guts.

Butts & Guts
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Butts & Guts

A Cleveland Clinic podcast exploring your digestive and surgical health from end to end. You’ll learn how to have the best digestive health possible from your gall bladder to your liver and more from our host, Colorectal Surgery Chairman Scott Steele, MD.
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