Courtney Collen (Host): Hi there. Welcome to our medical series Called to Care by Sanford Health. I’m your host, Courtney Collen with Sanford Health News. Called to Care brings forward medical experts who can give fellow clinicians some advice and guidance that they can use in their primary care practice and more information about when it’s time to refer patients and families to more specialized care.
Joining me for these conversations is Joseph Segeleon, MD, who is vice president and medical officer for Sanford Children’s Hospital and a leader in pediatric critical care. He’s here to help us dive even deeper into these topics to provide the best insight and care for our patients and communities.
Welcome, Dr. Segeleon, good to see you.
Dr. Joseph Segeleon: It’s wonderful to be here. It’s good to see you again.
Host: So our topic today really is fascinating focusing on regenerative medicine. Orthobiologics at Sanford Health is treating musculoskeletal injuries through cells from fat, blood, and bone marrow, which can reduce a patient’s pain speed up healing, improve overall recovery. That’s really all I know about this. So I’m excited to dive even deeper with you and with our physician expert, who is joining us, Dr. Donella Herman, who specializes in non-surgical orthopedic conditions, including fractures, arthritis, overuse injuries in endurance athletes and concussions through a variety of treatments.
Dr. Herman, welcome.
Dr. Donella Herman: Hi, thank you so much for having me. It’s a pleasure to be here today.
Dr. Joseph Segeleon: Yeah, I tell you Courtney, I share your perspective on this. When I was prepping for this session, I really came to realize how much I did not know about this subject and so I’m sure our listeners are also quite excited to learn about this. So, Dr. Herman, again, thank you so much for being here. We really look forward to our conversation that’s upcoming.
Why don’t we start off by telling us a little bit about yourself and your training?
Dr. Donella Herman: So I have been working at Sanford Health for the last four years. I kind of took a roundabout way to get into my medical training. I was actually previously an athletic trainer and then did some fetal alcohol syndrome research and then decided I wanted to kind of pursue medical school. I kind of had a natural draw towards sports medicine and research at that point, given my background. So I went to medical school at USD and then I did my family medicine training here in Sioux Falls. After my family medicine training, I did a year fellowship at Duke University in North Carolina. That sports medicine fellowship focused some on research, a lot of ultrasound guided injections, the overall treatment of musculoskeletal injuries, including fracture management, and then also some additional training in the regenerative medicine realm.
Dr. Joseph Segeleon: Great. Well, fantastic. Thank you. We really are so fortunate to have you here in our region. So why don’t we just get to it? What are orthobiologics?
Dr. Donella Herman: So orthobiologics is kind a big fancy word, and it’s an umbrella term that we use in terms of how we can use our body’s own resources in an attempt to provide a better environment for healing. And a lot of times there’s kind of, I don’t know the fancy words that you hear in the news about how we’re going to regrow things and the stem cells. For us, we’re trying to find ways to use cells that we have, that we know are a part of the healing process. Things like platelets, things like mesenchymal stem cells, things that we know help in the healing process when we have an injury and how can we harness that for some of the everyday things that we see in our clinic. So that’s kind of what orthobiologics is as a whole. It’s harnessing the body’s own resources and trying to utilize those to improve an environment and promote healing.
Dr. Joseph Segeleon: So is orthobiologics a part of regenerative medicine or is it different from regenerative Medicine?
Dr. Donella Herman: It depends on where you are. It’s, it’s kind of a regional term more or less. Some people will call orthobiologics regenerative medicine. Some people will call regenerative medicine orthobiologics. I see it more as orthobiologics is a small area under the umbrella of overall regenerative medicine, because we can use regenerative medicine in cancer treatments. We can use it in other diseases as well. The orthobiologics, we are focusing that on musculoskeletal injuries versus kind of whole body treatment.
Dr. Joseph Segeleon: Okay, perfect. That’s very helpful. Thank you. That really clarifies it for me. In thinking about what’s the best way to sort of unpack this, this topic, perhaps maybe we could start with: what kind of patients come to see you for specifically for this technology and then maybe we can drift into the actual technology itself.
Dr. Donella Herman: Absolutely. I see a wide variety of patients in my everyday clinic. When it comes to the regenerative medicine and orthobiologics portion of my patients, it really is people who likely have a chronic injury. Osteoarthritis is one area that we treat pretty extensively with orthobiologics. But we also have things like chronic tendon injuries, whether it be rotator cuff or achilles tendon. With that being said, you can also use some of this for acute injuries or injuries that maybe we have an athlete that has an acute injury to the rotator cuff or to a muscle. Using these products, we can try to expedite healing, you know, get them better, faster, kind of a, of a mentality, but also do it in a safe way where we know we’re promoting maximum healing.
Dr. Joseph Segeleon: Yeah. I was surprised, when I was prepping for this, in 1939, there was a bone marrow aspirate used for a nonunion fracture. So I don’t know if I was doing a crossword puzzle in medical school during period or what happened, but very interesting. So chronic injuries and I know chronic conditions like osteoarthritis affects something like 50 million people, knee osteoarthritis in the United States. What are the advantages and disadvantages of orthobiologics? Or if you’d like to get right into the usages of whether it be plasma, derived products or stem cells it’s really up to you.
Dr. Donella Herman: Yeah. I think that one thing that we’re focusing on and a lot of people focus on with orthobiologics is it’s a non-surgical option. We’re looking for right now. We have steroid injections or we have lubricating injections, or, you know, we have have things that are, are manmade that we can inject and then we have surgical options and there’s not a lot in between. And so these are kind of seen as conservative measures that aren’t quite as invasive as a surgery. Although I will say that bone marrow aspiration is not an un-invasive procedure. It’s kind of something, if we don’t want to go in and surgically intervene or have a joint replacement, we kind of see these as options of that kind of gray area where… it seems like we go from really conservative stuff and then don’t have a whole lot in between that big surgical intervention. For us, this is hopefully going to help bridge that gap. But there, there are different kinds of, of cells that we can utilize to try to bridge that gap.
The less invasive thing to do is to use a blood product. So, you can have your blood drawn. We spin it down in our clinic, we take platelets and sometimes we add some white blood cells in if we’re going into a tendon. But we use those platelets and we inject that into the injured area, whether that be a joint or a tendon. And the hope is that those platelets who are the first, you know, the first cells at the scene of the accident is how, what I always tell my patients, you know, you cut your fingers and the platelets get there first and signal your body what to do.
Well, we anticipate that these platelets, we put them in a concentrated amount, into a joint space or into an injured tissue and they’re going to signal the body, ‘hey, let’s, let’s have you come in here and bring some healing in’ or bring the products we need to, to promote healing. And it’s really about trying to create that better environment for that joint or for that injured area. And so that’s kind of a less invasive way to do it, but then, okay, the next step, maybe we want to do something more with the regenerative cells that we get from bone marrow from fat. And so for those, we have a little bit more invasive procedure, but we also know that the mesenchymal stem cells also have a lot more signaling power than a platelet does. And so we can go in and do a bone marrow aspirate off the back of the pelvis. And then we have a process where we clean the cells and we count the cells. We make sure they’re alive. Most importantly, we see how many we have. We also make sure that there’s not any toxins in there. And we make sure there’s nothing infectious in there. And those four steps are something important because that’s not something everybody does. And so we make sure that we know what we’re injecting and that it’s a safe product to inject. And then we inject it to the injured area. We can also get those same sort of regenerative cells from fat tissue. And so we can go in and do basically kind of what we call a mini lipoaspirate or a small volume liposuction. And so we do that either off the abdomen or the gluteal areas and we take those cells and they have the same different processing standpoint, but we are looking for the same things prior to injection. We want to make sure they’re safe. We don’t want any toxins in there. We want to make sure that we have live cells and that there’s enough of them that we’re actually gonna get a good response from it when using these cells as the same thing, I’m not going to promise you, oh, we’re going to come in and regrow new cartilage. We just don’t have evidence of that yet. But we do know that if we inject these things, people have improved pain, they have improved function. They’re able to do the things that they enjoy more often. But we’re also following that with all of these regenerative cells. We are following our patients so we know how long they’re having relief for, how much activity they’re doing, if they have improvement of pain and motion. These are the things that we’re following and kind of measuring.
Cause right now we just, we don’t have a lot of information. There’s a lot of people doing it all over the country. You can go anywhere and there’s kind of pop-up shops that are, are offering these stem cells are offering, you know, they’re making a lot of promises that we can’t necessarily say they’re delivering on. And so what we’re trying to do is hopefully in five years, people will come to Sanford and say in a patient with this condition, which product works the best? And we’ll have that information. We’ll be able to say, yeah, we’ve done all three products in, in this kind of an injury or this kind of a population. And this product seems to be working the best. So that’s kind of our overall goal with it.
Dr. Joseph Segeleon: I read I read in prepping the stem cells are viewed as the general contractor coordinating the repair job and the plasma rich or platelet rich plasma is supplies added to do the jobs, or I thought that was or supplies needed to do the job. So I thought that was interesting. So most of these treatments are symptom relief, is that accurate?
Dr. Donella Herman: It’s symptom relief, functional improvements. And so we do generally want to see less pain, but we also want to see improved range of motion, improved strength and improved overall function. And so those are all the things that we follow. We have a way of capturing patient reported outcomes for our regenerative medicine orthobiologic patients. And in doing that, we’re hoping to see maybe we’ll again, in five years, we’ll find out that this, this one helps most with pain. So if their primary problem pain, we should probably go in this direction. But if we’re really looking to get back to doing more high level activities, then you know, we’ll, we’ll hopefully be able to steer ourselves in our patients in the right direction.
Dr. Joseph Segeleon: And when you talked about duration of effect, does that vary with product? Does it vary with the injured area? Or can you comment on a little bit of, is there preliminary data that gives you an idea of what the duration of effect is?
Dr. Donella Herman: It’s kind of hard to predict. It’s kind of like the other options we have currently that are widely used, like the steroid injections and the Viscosupplementation. We know that some people get the injection and it may last for years and some people get the injection, it may last for months. And so, it can be a little bit difficult to predict. I think that there’s been some data showing that, you know, six months out people are still seeing improvement with the regenerative cells. I know that there are health systems and health insurance plans that do cover some of the platelet rich plasma injections for joints and they can allow them up to twice a year. And so kind of, again, that six month mark is what we’re kind of seeing for improvement with that being said, anecdotally, I can tell you if people I know that have had the regenerative medicine and orthobiologics and they have had years of relief and have significantly improved their function.
Dr. Joseph Segeleon: Okay. Cause that’s good to know. I know that there are differences with regards to what’s allowed with the cells prepped and the length of time between aspiration and injection. I get the sense that much of this as FDA and legal, that is specific to the United States and then also perhaps different rules or different legalities pertain to outside the United States. Can you comment a little bit on that?
Dr. Donella Herman: Yeah. The FDA has some pretty strong statements in terms of minimally manipulated cells. That’s the term that they like to use. That gives us a window of time of processing these cells and injecting the cells and also what can you mix together and what can’t you. There’s restrictions in terms of, of, you know, taking a couple of products and putting them together and seeing if we mix some, is it better? Well, that’s kind of, we’re manipulating things at that point. And so things have to happen in individual injections. There has recently been some kind of more robust statements from, from the FDA in terms of, they want to restrict kind of the places that are maybe trying to take advantage of the, oh, what’s the word I’m looking for…
The FDA has come out with a lot of some strong statements in terms of one, we obviously don’t want to manipulate the cells. That’s always been the, the rule, but also if you’re doing this, you need to make sure that you’re doing it appropriately, that you’re doing it for the reasons of collecting patient reported outcomes. And, and in ways that the FDA says it’s okay to do that. One interesting thing of the stem cells, of the regenerative cells that we’re utilizing, is that for the fat derived stem cells, we have an FDA registry for that. We’re the only place in the country that has an FDA registry. So really nobody else should be injecting these, these process cells for, for joint pain or for osteoarthritis in the, in the five joints that we have the registry for.
But the reason we have the registry is because it’s something that’s kind of needed right now in medicine, because there are so many other places doing it. We need something that’s controlled, but it’s hard to do a double blind randomized controlled study for every single joint for every single thing. So they’re asking us to kind of start with the registry and then get some preliminary data from that and then see from there, if we can kind of, okay, what can we use for head-to-head studies thereafter, but it’s going to give them a lot of information in terms of what they can be used for in the future. But that also means we have a registry and we’re being watched. And so, you know we have a lot of safety measures in place. We have a lot of rules that we need to follow, especially our processing. This is something that even with the bone marrow derived regenerative cells, you know, we have a window, we want in from the time we start processing the cell to the time we inject it, we want to get that done in less than two hours, because we want to have the highest cell viability. We want as many cells to be alive as possible. We want the least risk of it being, you know, contaminated by something. And so we try to get everything done within a two hour window for the regenerative cells from bone marrow and fat. For the PRP, we inject those within 20 minutes. I mean, it’s a 20 to 30 minutes between when we draw the blood because we do it directly right there in clinic and this blood draw. So it’s a little less invasive.
Dr. Joseph Segeleon: I can certainly see with the huge number of individuals who are affected by osteoarthritis, by injuries, orthopedic problems, I can certainly see where there’s a need for this. And I can also see where there might be some opportunities for people to take advantage of people that are vulnerable and that have chronic pain syndrome. So I’m delighted to hear Sanford is part of clinical trials and really leading the way domestically with this registry. I think that’s fantastic. Let’s talk a little bit about costs and you alluded to earlier that some insurance companies cover this how do most patients afford this or is cost prohibitive?
Dr. Donella Herman: It can be for some patients. I say some health insurance plan, Sanford health insurance covers the PRP injections to the knee. And that’s one of the few that does. They just cover it for knee osteoarthritis at this point but we’re hoping that eventually we’ll be able to expand that to other joints as well. A lot of insurances don’t cover it though because it’s still considered to be an investigational use. And so until we get consistent data and that involves everybody actually collecting the data until we get that insurance companies are really hesitant to cover for it. With us having the FDA registry, we’re not here to make a profit. We can’t make a profit if we have an FDA registry. But, it does cost money to do these. And so for all of the, the orthobiologics procedures, we do what we call cost recovery, which is basically that we have the patient pay for it, but it is basically covering the cost of the procedure and the injection. And so it’s not it’s not anything that is necessarily for profit for Sanford. We’re just trying to cover the cost. If you’re doing it into a joint, oftentimes it requires more than one injection. So we’re doing usually two, sometimes three injections into the joint. So that can add up. For the tendons with the platelet rich plasma, we can generally get by with just doing one. It has a little more restriction afterwards. You know, if we inject into a joint, people usually get back to the regular stuff pretty quickly. With the tendons, we have some restrictions afterwards, but we can generally do that as a one-time injection for the bone marrow aspirate and the, the fat derived cells.
Dr. Joseph Segeleon: Okay. Thank you. I do want to go back a little bit to the physiology and the science of this, if you will. I understand that cartilage – because it has very little blood supply – does not really heal very well. And that’s one of the attractive features of stem cells. Is that correct?
Dr. Donella Herman: That’s one of the attractive selling points for stem cells. I’ll say, I know that there’s been some studies in the past that have shown that there have been cartilage defects that have had improvement after, after stem cells. I don’t think it’s necessarily the same kind of cartilage. You know, we have this, this really robust cartilage at the end of the bones on those weight-bearing bones. We certainly don’t make promises that we’re going to rebuild cartilage because we just don’t have evidence that that’s what it’s doing. For me, I prefer to think of it as we’re just creating this environment where we have these signaling. And, you know, for me to say, if I put a stem cell into your knee is going to regrow cartilage. Well, if I say it can do that, I don’t necessarily think I can say that it won’t turn into an ear. You know, I mean, we have the, if we think that the stem cells can just figure it out that quickly, for me, it’s more that we’re putting the stem cells in there, it’s in this environment and it’s creating a better environment where the body can come in and kind of heal the area. And it’s probably not going to put down this big, robust cartilage, but it may create an environment where there is some protection for where the cartilage has worn through.
Dr. Joseph Segeleon: Okay. Thank you. That’s very helpful. Let’s talk a little bit about what we’re doing here at Sanford. Why don’t we well, let’s just talk about what, what in your practice, what is, what’s your typical day, or how are you applying his orthobiologics to your practice?
Dr. Donella Herman: I love my practice because I don’t have a typical day. But you know, I, I I’ll see a wide variety of you know, young people to, you know, 6, 7, 8 year-olds to 96 year-olds. But when it comes to the orthobiologics a lot of the times the people I’m seeing are people who it’s either a, an athlete who has had an acute injury, and we’re trying to get in there and promote maximum healing quickly, or it is somebody who has had a chronic condition. Who’s looking for a non-surgical option. Generally, what we do, we have them come in. If we need to get some imaging, we do a lot of times they have some imaging. But we kind of look at their underlying issue and talk about all the things that they’ve tried and then kind of talk about the differences in orthobiologics and based on our kind of conversations and their goals and expectations, we decide what the next best step for them is going to be. And whether that’s a regenerative cell or if it’s more of the platelets, we can kind of determine based on, you know, cost. Is that going to be prohibitive? Or is it going to be difficult for you to be laid up for a few weeks if we inject a tendon? Things of that nature. It’s really an individualized conversation with each patient about what their overall goals are expectations and how orthobiologics can assist them in the most meaningful way.
Dr. Joseph Segeleon: I think I heard you say that there were five joints, is that correct? And what are those?
Dr. Donella Herman: Yes. We have five joints that we can utilize. We have the wrist joint, the shoulder, the hip, the knee, and the ankle. When we do the bone marrow derived stem cells. If you have let’s say you have some arthritis in your hand or, or in your midfoot we can utilize those for, for other joints as well. So there’s a little bit broader use for the bone marrow derived cells. We can also use those cells and things like rotator, cuff tears and tendon injuries.
Dr. Joseph Segeleon: Okay. And are these procedures typically same-day procedures?
Dr. Donella Herman: I usually tell people if we’re going to do the procedures for the regenerative cells, either the bone marrow or the fat that you should plan on giving me half of your day. And so we have you come in either early in the morning and we get you out by lunch, or we have you come around lunchtime and we have you out by five. Like I said, we want that kind of short processing window. We don’t want too much time to go by. And so it’s usually kind of an in and out procedure for them.
Dr. Joseph Segeleon: Okay. And what about recovery or the tendon injuries?
Dr. Donella Herman: That’s a little bit longer. We do, we do a little bit more to protect tendons then after the injection, because we create this inflammatory response and we don’t want to start pulling around on that tendon. So for that, I tell people, you know, at six weeks after that injection, we’re hoping to get you back into those higher level activities that you enjoy, or sports specific activities for an athlete. For joints, we tell people, we kind of just, it’s kind of common sense for the first couple of weeks afterwards, just don’t overdo it kind of reduce your impact activities. Or if it’s a shoulder, don’t do a lot of overhead stuff, but if we’re going into a joint, it’s kind of two weeks of, let’s take it easy and not overdo it, and then gradually try to increase your activity after that.
Dr. Joseph Segeleon: Okay. Well, it seems like this field of orthobiologics… I’ve heard so much about it, particularly in the last five years or so. So I’m going to have you do some predictions here. What does the future hold for this field?
Dr. Donella Herman: I’m hopeful that in five years, we’ll be able to say we have other options for people who are either not surgical candidates, cause there’s people with co-morbidities that that just don’t have good surgical options. But that we also, in five years maybe have a better understanding that we’re standing to glean more of that information of: you have this kind of a problem you’re in this age group you’ve, you’ve tried A, B or C … can we start what what’s going to be the best option for you and where you’re at and your life with this condition, I’m hoping in 10 years, we’ll be able to say, you know what, maybe we should be doing this earlier. Maybe we shouldn’t be doing as many steroid injections. Right now, people are getting in as they run out of options. Maybe in 10 years, we’ll realize that maybe this is an earlier option that will kind of give us additional options moving forward. So, that’s what I’m hopeful for is that in five years, we’ll have a better idea of which patients fit where, and in 10 years we’ll be able to say, maybe we need to start sooner.
Dr. Joseph Segeleon: Okay. All right. And finally can anybody refer patients to you and can patients self-refer to you?
Dr. Donella Herman: Absolutely. So if patients have interest in orthobiologics, they can certainly make an appointment. With our clinic, they generally try to funnel them to me so we can, we can have that individualized conversation, but sometimes they come from other people within our clinic, if they have interest in and mention it to another provider, if you’re a provider outside of our clinic, we actually have an orthobiologics referral within the epic system. So if you just type in orthobiologics that referral will pop up, you, you associate the diagnosis and it will get them directly to my clinic for the conversation.
Dr. Joseph Segeleon: Okay. Well, great. Well, I know the time seemed to go quickly. This seems like a topic that we could wait into for hours, but I hope this was a good overview. Is there anything that I left out that you’d like to comment upon?
Dr. Donella Herman: You know, it’s an exciting time for orthobiologics. I’m really proud to be a part of it at Sanford because I do feel like we’re doing it right. And that’s kind of always been our, our mantra within the orthobiologics group is that if we’re going to do this, let’s make sure we’re doing it right. And I think that we have a really unique opportunity to not only provide the best care for our patient population, but also to develop information that can be used across the United States and the world in terms of how orthobiologics could be used and should be used moving forward.
Dr. Joseph Segeleon: Well, I appreciate your scientific integrity and I certainly appreciate all that you do clinically. I really appreciate educating Courtney and I on this topic because I learned a lot. So I’ll turn it back to Courtney.
Host: I learned a lot too, Dr. Segeleon. Thank you as always for being here, again, to help guide the conversation as we speak to our clinician experts in this space. Dr. Herman, wonderful to meet you and learn more about your practice and the healing that you provide for patients with pain. Thank you again for being here.
Dr. Donella Herman: Absolutely. It was my pleasure.
Host: Our Called to Care podcast series by providers for providers continues right here with our Sanford Health experts. I’m Courtney Collen. Thank you so much for being here. We’ll see you soon.
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