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2018 Orthobiologics Surgical Skills Online
6 - Panel Questions
6 - Panel Questions
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So, it's, we did a lot of time for questions. I think we really, Arne, we're done with the first session. Are we not? I don't have the agenda in front of me. We're done, right? So, why don't we do some question and answer and have the faculty come up. And then we're going to have a legitimate break, too, where you can curbside faculty. But I want to use this time, let's just say 10 minutes. I don't really, nobody has anywhere to be tonight, right? So, I don't really, I don't really care that we're a little behind. But we're having beer and pizza, shocker. We love beer, right? Okay. No one gets that, huh? Okay. God, you guys are such a slow crowd, man. Yeah. Don't you love beer, Tom? Okay. I don't like beer. I want my judge to drink beer. There you go. All right. So, if you don't mind, we're going to have some questions. If you could push, just because this is a huge room, push that little button right there. Look down on your desk. Yeah, if you don't mind speaking to the mic. Thanks. Hold the, I think you have to hold it down. Yeah, good. That's it. What's the status of this in Europe? Of what? All the biologics, are they ahead of us? Typically, they are on other drugs. Go ahead, Ken. Well, they did start the studies earlier. So, they've been doing this earlier. I will say, from a regulatory perspective, the EMEA is actually sort of looking now at what the FDA is doing. So, very commonly, like what happened with cell products in Europe, they're way out ahead at first. Then, their regulatory body says, oh, wait, maybe we should get involved. And then, things change. But you'll see there's a lot of good PRP and BMAC studies and Enstride. Enstride is one of the blood products that's spun down a second time that was done in Italy. And so, they've been doing studies a little bit longer than us. I will say, in Asia, they have, you know, we have no, to my knowledge, no culture studies ongoing. Adam's going to, Adam Anstis is here. He's going to talk a little bit about it. But we, in Asia, they have probably the largest number of studies looking at cultured MSCs from a variety of sources, including hematopoietic. We just don't have, I don't know, to my knowledge, I don't think any culture studies. We had the one OSIRIS study that you were involved with, Tom, right, with OA and meniscal tear. And since then, you know, the problem is the cost of entry is somewhere between $30 and $50 million, right? And even then, that's not assured reimbursement. So, the clinical trials have created a barrier, which is why we're talking about stuff that's sort of below the bar here that falls into what Ken talked about in the 361 pathway. Go ahead. To jump on that, you think we can do it in China, at least experiments in China. Well, the CFD, the Chinese FDA is very strict as well. And I think in Korea, it's a little looser culture for these cellular manipulations and cellular insertion. By the way, in South America, in Chile, and in Spain, there are a number of cultured studies going on and cultured sites where you can get cultured stem cells. But again, regulatory bodies are now retroactively going back to look at them. I mean, the majority of what we're going to talk about, you know, is things that are available today. But even U.S. or domestic companies are going offshore because of, you know, to skirt the regulatory issues. You can, in Chile, you can get an expanded adipose, it's actually expanded cord cell, stem cell product for $1,000 injection, $1,000. Other questions? Just push, if you don't mind, push down the button there and just hold it down. Thanks. Is there any good evidence ciphering between a single shot hyaluronic acid, like a monobist, versus a series of three? And the second part of that question was the spacing of one week apart or whatever, how often you do it apart? Where did that come from? Is there any good evidence to support? Yeah, so Ken, you're the HA expert, aren't you? I'll tell you a little story. So years ago, like 12, 14 years ago, it was a long time ago, right? It could have been 20 years. We had a cartilage course in Chicago. It was like the first live surgery course. And it turned out great. And we had it at Rush. And I invited Ken to give a talk on nonoperative treatment. And everyone says, what did I do wrong? Who did I piss off, you know? So ever since then, he's been asked on a regular basis to write chapters. I don't even think, do you do surgery actually? Yeah, so he always gets tagged with the nonoperative questions. So go ahead, Ken, I'll ask you. Well, I don't, first of all, I think it's a very good question. All the data I've seen, there's no difference between the three and the one. I mean, I've always done one because it seems to me, why do you want to have to take up three visits for your patients? But this is with HA I'm talking about. I think you're wrong, actually. There is data. There is. And you've got to go start breaking up high molecular weight, low molecular weight. That's right. And if you go, there are. Efficacy, I don't think it makes sense. Well, companies will have, even in their own product line, there are a few studies, mostly rheumatology literature that have shown, they will show differential efficacy. And I don't think MonoVisc, I don't think that product has ever been done, Gloria. They never did it with them, right, showing there was a difference. MonoVisc versus SynVisc, right? The ones that we can name from arbitrarily technical laws. That's right. I thought it was an arbitrary number. But it has been looked at. There's, at least I've seen data. They come, I've had two or three peer-reviewed papers that are level one trials looking at differences. I know, Arnie, you're chomping at the bit. Go ahead. Push the green. Push the button until you see green. Hello. I need a doctor. There is a retrospective study, hugely interesting, three shots, one week apart, and compared directly with a saline placebo. Right. First shot, and they've looked at this sequentially. First shot, you get four to six weeks of pain relief. One-third of the patients are responders. And there's the group that actually have been followed. Second shot, placebo, saline, four to six weeks of pain relief. The HA second shot, you can get up eight to 12 months. Third shot, saline, four to six weeks of pain relief. And the third shot, you can get up to 18 to 24 months of pain relief. One-third of the patients are responders. One-third of the patients are for sure non-responders. And the middle third, it's hard, the actual clinical assessment has not been done rigorously. So the take-home lesson is give them saline. If they, no, I'm serious. Yeah. Give them saline because saline gives you a washout, a huge washout. And if the patient responds, they can be a, there's a Kaplan hypothesis, they can be a candidate for HA treatment. But three shots gives you the maximum pain relief if there are responders. But, and you guys know in your offices, you get non-responders and you get responders. Yeah, we, last year we published yet another book report or a systematic review, but it was looking only at level one studies, double blind, saline as a comparator, 45% saline injections met the MCID. I mean, so yeah, that's the biggest challenge all of these drugs have is saline is not so bad. So what we really need to do is look at air, quite frankly. Yeah, air injection. The bottom line is the literature shows time and again, more injections, better response. Say that again. More injections, better response. Yeah, so you're saying there is, I know I've seen a few studies that have looked at one versus three, they've been very company specific, same company, different product one or three. Rachel, are you aware of anything? I haven't seen that data, but I was going to just add from a practical standpoint, while it is difficult to have the patients in every week for three weeks, having one adverse reaction to a big load of HA in the knee, which I've seen a couple times can be very... Have you seen it with high molecular weight? I haven't seen it in the last year, I would say, but I saw it back in training just a couple times. And I'm not, I actually don't remember which product we were using. But actually, I think I do remember which one, but that's a challenge because you get a red hot swollen knee after an injection, and then you have to fight that battle of do I have an infection? Do I not have an infection? It's just an inflammatory reaction. So, for me, I prefer to do the three, regardless of efficacy, if there is no published literature yet, which I think, as you're saying, there might be some, with three injections, even though it's an injection each week and it takes an office visit, I'd rather have that right now than doing the one injection and potentially risking that adverse reaction. Any other questions? Raise your hand. Oh, good. Okay. Go ahead and start there and we'll work our way around. Just push like the edge of it and hold it down. There you go. Got it. How about if you have the bilateral person? Because I think it's torture to give six injections. Don't change that at all and go to the one. So, what does a panel do? What do you guys do? One, I think that's what we want to know. What do you do? One versus three, and if you do change it up, what makes you change up? Just give, you know, quick answers there. What do you do? For HA, I do one. Okay. Tom? Synvisc one. I do three and I don't change it if it's bilateral unless the patient has a preference. We do three. And I have a PA do it because I have no patients, to be quite frank. Right here. I had a question for Ken about the same surgical exception. Is that under anesthesia, under OR, under office? What's the better definition? What does that mean? That's a good point. It says if you're at any establishment that takes something from a person and puts it back in at the same setting, it does not mean you have to have anesthesia. So, office would be the same. I'm going to do a tutorial. See right here? It is hard. It's not intuitive. Push the edge when you guys talk, right? Just the edge of it. It's not intuitive. You can just say push right there. Yeah. Or just push harder if it doesn't work, right? Push three times instead of one, maybe. Please. Are there issues with utilizing lipoaspirate given the mechanical manipulation required? So, you mean from an irregulatory point of view? So, here's my understanding. So, currently, when they first got their approval, they received a physical letter saying that it could be used in conjunction with arthroscopy. They're not saying they're isolating any cellular element that is mechanical disruption. And because the knee joint has fat, if you will, you could argue that since you're not depending on the cellular elements, which is what Ken was saying before, that it's still considered potentially homologous use. They just can't talk about its activity leading to the efficacy coming from the cellular side. And that's how they've been skirting the issue. And that's where the FDA is right now on adipose, as I understand it. So, I think that the, I wasn't going to, and I don't think we should at this point give specific answers as to what the FDA thinks about any one product. But they haven't, if you look at the doctrine, which I know you probably review, what do they say to that point? No, I'm saying exactly what you said is correct. And if you see it says that you can cleanse, you can shape, you can mill, you can rinse, that's really what you're doing in that process. So, I mean, I think there's a reason why you might think it might not. But I can't definitively give you what they're going to say at the end. Okay. Anyone want to comment further on that? We've had, this has been a subject of debate. Jason, we've been there before. Are you talking specifically, yeah, are you okay with that answer? You and I differed before, I think. So, I want to just see, push the edge. So, this, there you go. But mine doesn't work. Very good. Yeah. Well, the only, the confusing thing is the whole advent of the guidance documents and the actual regulatory, basically language and law. So, then what we're saying is, is that the new guidance documents say that in the future, that wouldn't fit the criteria, the current way of processing adipose. But in the current regulatory environment that is held to the regulation, you can mill it, as Ken said, so that fits the criteria for doing that. And especially, of course, if you do it during the same procedure or surgical side of things. So, this is the pivotal time for us to really help the FDA understand the difference between what they're trying to change on the guidance documents and what they already have in law. That's why this is confusing, right? Because you, I don't know, I probably made it more confusing by saying that. But stay tuned in the future. As of now, it's okay. But if the future guidance documents become doctrine and are enforceable, then the whole preparatory part of adipose tissue will become the question of whether or not that's going to be regulated. Okay. Thanks. Next question. Thank you very much. Yeah. We're using a broad spectrum of what patient you're injecting with OA, but do you, clinically, if you have more bone to bone, so you're thinking more bone pain than inflammatory pain, they come in with a knee that's cold versus hot, when do you choose to use OA, to use those shots in someone when, you know, clinically, it's not going to work, especially if their axis is terrible? I think that's a great question. And that's, you know, all patients do not arrive equally. And I think that's the best way to describe, as you just said it. So, there are patients who are sort of biologic patients. They have wet knees. They're synovitic. They have achy pain. They have night pain. They hurt without load. That's a way different patient than I only hurt when I load my joint. It doesn't swell, you know, that kind of thing. So, I, my personal belief is load arthritic, arthritic patients who are super sensitized to load are not generally as responsive to the, to the former. So, that, and we, and the thing is that's, that nuance is really important because that's not vetted in studies and so forth in terms of how they present. It's all about pain and, you know, ingo, ingo, some type of ingo functional or pain score. And it doesn't separate out those patients. Just briefly, can you guys tell me, do you have a sense of who's going to be responding or who's not based upon dividing patients into those two categories? Do you think that's a, a, a clear distinction, something at least worth talking about? I would agree with what you just said. I think that's a great way to divide it. And I think it's helpful, it's a helpful framework. And also, you just got to look at the patient with their alignment, with their meniscus status, with all of that. Because there may be other interventions that can be helpful other than the injections if they're perceived to not be a responder. Yeah, I think the, the painful phenotype is yet to be defined. So, you could have bone on bone and have pain, you may respond. But it doesn't make sense to me with the expense of these injections to do it on a bone on bone situation. I think it's ideally best from mild to moderate. And unfortunately, the literature doesn't really hone in on that enough. I would only add that I think you shouldn't forget everything else you know about mechanics and alignment and strength. And so, we don't, at least I don't just give these shots, these patients who, if they, if they are varus and they have KL3, say not four, but three, you know, I will combine the shots with an unloader brace. I don't forget that, that shifting load by 15% can make a difference. Because I agree, if it's pure load pain, the, and it's not a wet joint, you may not get a same response. I think you've got to remember all of that. And I think strength matters too. So, you've got a couple core, core to floor strengthening for these patients along if you want really good results. I don't think shots alone are going to be the only answer. Let's take two more if you don't mind and then we're going to move on, okay? Yeah, let's go that side and then we'll come back, please. Yeah, so some really great questions about the trees. I have a question about the forest. So, Thomas, in your talk, so profound, I wrote it down, you said you cannot inject stem cells in the United States. That's correct. So, fair enough. So, I think. Without an IND, go ahead. So, I think what Brian said earlier is true too. Hey, if the patients are steering the bus, they don't know the term orthobiologics. Some of them have heard of PRP. Some of them have heard other terms. They walk in the door and ask for stem cells. They walk in the door and ask for stem cells. You said you cannot inject stem cells in the United States. So, I guess from the panel, hey, is that true? And if it is. So, there's a nuance he was alluding to. So, Arnie, do you want to elaborate on what, I mean, I know what you're trying to say and I was, Tom and I were, who was I whispering to? Tom and I were whispering when you said that. So, it's a bit of a nuance. So, do you want to just, is it okay if I haven't clarified? Yeah. So, my name's Arnold Kaplan. I invented the term mesenchymal stem cell. And I'm going to beg Rachel to stop using the term stem cell because what your patient has in their head is you're going to inject something into the knee. The cells are going to lay on their dead cartilage and make new cartilage. And that's a stem cell. And there are, as Tom said, there is not one stem cell that can make cartilage that's currently sold in the United States. And that's a very important sentence for everybody in the room to understand. So, I agree. So, go ahead. So, I think the key is that, as Brian said, these are difficult patients. They're coming in, I mean, in the middle of your day and they begin with that question. And I really believe that what we need to do is educate the patient, which means it takes time to have the conversation you're having. So, if you define a stem cell as something that goes in a lab, proves that it can become a stem into multiple lineages, we don't do that in the U.S. But you're right, that's what they're asking for. So, I start to say, well, these are MSCs. We don't use the word stem. Arnie thinks it means this. We're signaling. We're trying to help your own body's MSCs come into the site. But it takes time. There's not an easy answer. Let's take the last one here and then we're going to go on to the second half. If you do an in-office procedure whereby you're injecting both platelet-rich plasma and HA, can you bill the insurance company for the injection code, the HA, but still have the patient do a self-pay for the PRP? Yes. That's my understanding. And that's from Marge Mele. Yeah, well, you sign the waiver just because of a compliance. That's a separate issue. But if you're just doing PRP, you're not supposed to bill an injection code. So, but if you do the HA, we code that separately and together and document it separately. And then we use the tracking code for PRP separate. And we don't, and yeah, so we dissociate it. All right. I think we're going to move on. That's great. Thank you, everyone. Okay.
Video Summary
In the video, the speaker and panelists discuss various topics related to injections for knee pain. They mention the use of hyaluronic acid (HA) injections and the debate over whether to administer one shot or a series of three shots. The panelists share different opinions, with some recommending one shot and others preferring three shots for maximum pain relief. They also discuss the distinction between patients who have inflammatory pain versus load pain, and how this may influence treatment options. The panelists mention the use of stem cells and adipose tissue injections, clarifying that while patients often ask for stem cell injections, there are currently no stem cell products available for use in the United States. The panelists also address billing procedures for injections, suggesting that insurance can be billed for HA injections while PRP injections may require self-pay.
Keywords
injections
knee pain
hyaluronic acid
one shot
three shots
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