Matthew G Garoufalis, DPM, CWS reviews the basic science behind umbilical cord products and describes a variety of clinical uses with case presentations in the foot and ankle.
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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Matthew Garoufalis, DPM, CWS
Associate Chief of Podiatry Service
Jesse Brown VA Medical Center
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TAPE STARTS – [00:00]
Male Speaker: I’m happy to welcome Matt Garoufalis back to the stage. He gave a couple of nice talks yesterday. He’s going to be talking on the use of umbilical cord products once again in surgical and wound applications. As we know, Matt is from the Jesse Brown VA in Chicago and the past president of the American Podiatric Medical Association. Let’s welcome Matt Garoufalis. Thanks for doing that Matt.
Matt Garoufalis: Okay, good morning everyone. Thank you for being here. Let me also remind you about the slide that was just up there, all the VA folks, come join us at the second part of lunch today. I’ll be doing an update with Dr. Shegeris [00:43] on the VA Parity Bill which might be of interest to you, where we are and what you need to do to help us. But anyways, we’re going to talk about the use of umbilical cord products for surgical and wound applications because while we’ve been talking for a long time, for a few years now on different amniotic membrane products, now we’ve kind of shifted gears a little bit and gone to umbilical cord products and have had some experience using many of these different products. And I want to share some of my experiences with you and some background on this type of product. So we know that these wounds are always challenging. And so, as a result, we’re always looking for new products, that’s why there’s so many different wound care products out there. We’re always looking for new products that will help give us an edge and help our patients to heal a bit faster, look better, and increase our healing rates and our patient satisfactions. Well, umbilical cord products have come to the forefront now as a way of helping us do this because they offer a little bit of a different solution. Using the properties of umbilical cord such as the Wharton’s jelly which is full of growth factors, stem cells and things like that, we’ve been able to change the way that some of these wounds heal. There’s also a rich source of hyaluronic acid in the umbilical cord, which is a little bit different than the amniotic membranes. So, as I said, Wharton’s jelly, a much thicker, much robust extracellular matrix with a lot of collagen and hyaluronic acid, this particular product that we’re talking about is a dehydrated umbilical cord. So there’s a certain processing that allows us to dehydrate this and package it for you so it’s an off-the-shelf preparation. So one of the nice thing, it still has all the properties that amniotic membranes have. But because it’s a thicker product with a lot more connective tissue, it has some slightly different applications. And so, we need to learn about that and use it where it’s appropriate and I’ll give you some examples of where that is. So there was some staining done just so we can better understand this and we’ve got a collagen, this is a stain of an umbilical cord product. The collagen is in green. They hyaluronic acid is in red. And the cell nuclei is in blue. So we then overlay them altogether so you can see the different properties and the different components of this product. And you can tell there’s a high density of both collagen and hyaluronic acid. If we were to stain amniotic membrane, we would not get the same concentration of hyaluronic acid and maybe a little bit concentration of collagen type 1. So this is a close up of that final slide, the overlay of using all the different staining techniques. So that’s a very brief introduction into the science. I mean, it’s still early in the morning. How much science do we want, right? So let’s talk about more clinical applications. Some of these are some of the cases that I showed yesterday but I want to explain them a little bit different from the point of view of using an umbilical cord product. Here’s a patient with a transmet amp that dehisced due to his exuberance in performing some of his daily activities. A little too exuberant status post TMA, I’m sure we’ve had a few patients like that that we’ve treated. And he dehisced. And this particular wound was, while it looks pretty superficial, when you put a probe into this wound, the probe tends to sink a little bit deeper and a little bit deeper and so I didn’t want to use a typical amniotic membrane on this because I felt that even though the void doesn’t look deep, it’s cover by some soft tissue. I wanted to pack it a little bit. And while there’s all sort of options that we have in terms of what we can use to pack, this type of wound, I figured, let’s try something, you know, a little bit different and unique. We’ll use umbilical cord on this because of its thicker properties and its hyaluronic acid. So the picture on the right…
…shows that we’re laying down the umbilical cord product over the wound. And what we did is we actually used a probe to press it deep into the wound so that it was actually not laying flat in the wound. It was actually laying vertically in the wound to fill up the void. This comes as a dry product and so you have to reconstitute at the saline. And when you do that it beefs up really well, so it becomes very thick and very pliable. And with this product, we were able to fill this deficit in just one week, which was pretty remarkable. And that tells me that we have something here that could be a filler for a void that works extremely well. So we were able to re-epithelialize this patient four weeks. And here’s a patient that, of course, he’s already had his TMA, already a bit compromised and we didn’t want to go to a second procedure, a more proximal procedure and we were able to close this very quickly without the patient undergoing anymore surgery or getting re-infected or osteomyelitis. This is another patient with a first web space infection that we all know this can be quite debilitating. And we wanted to act as quickly as possible in closing this wound because even though he had an IND, he was still pretty active and pretty ambulatory, as many of our patients are despite our wishes. And we decided to use an umbilical cord product to see if we can speed the healing and the filling of this wound. It looks relatively superficial, but as we all know some of these wounds can be pretty deceiving at a bit of undermining and we did use the umbilical cord product on this patient to fill the void and noticed dramatic closure rates as we were using this product. We were able to get this entire wound epithelized in 9 weeks. So I think because of the hyaluronic acid, we have a different healing rate on some of these wounds. So it makes it a little bit interesting to use. This is a picture of a patient status post-TMA that, of course, again, a little bit too active for his post-op structure, and re-ulcerated the most distal aspect of his TMA. We went and did a gastroc recession on this patient which is pretty well-known to our community as one of the options when we have a four-foot ulcer doing a gastroc reception or Achilles tendon lengthening, we’ll take some of that four-foot load off so that we can allow the wound to heal. But we weren’t satisfied with just that because this wound, again, was very deep and probe was very deep after a pretty debridement, we put the umbilical cord product on this and this patient went on to heal in 9 weeks. This was his 7-week picture and with pretty rapid closure and filling in of that wound. So we’ve used it, also, this is a very unique case and actually one of our first cases of using this product. This was a 71-year-old patient with type 2 diabetes, of course, all these wonderful comorbidities that we’re all used to seeing in our patients. But he had a venous leg ulcer that did not have a bottom to it or a floor of the ulcer. We could actually see his tendon moving back and forth through the ulcer. So it was relatively deep and that is a little bit dangerous for this type of patient. And so we wanted to create something that would give us a covering between the tendon and the rim of the ulcer that we were trying to close, various attempts at using many different products could not get this wound to close because the floor of the ulcer was actually the tendon sliding back and forth. And you would think that a mobilization would do the trick. This patient was immobilized firmly every week in a rigid structure and still we could not get this to close. So you can see the larger ulcer on the four-foot. And the floor of that is the tendon moving back and forth, extensor digitorum longus tendon. We then used this graph because it’s pretty thick and pushed it into the ulcer and created a floor of the ulcer over the tendon. So once we secured it in place with a couple of stitches, we then could move his ankle up and down. We didn’t see the tendon moving at all. We could tell it was moving underneath the graft but now we had a floor of the ulcer that we could begin heal. This worked really well and this is us placing it. And he began to get granulation tissue over the tendon. And at two weeks we had a granulation bed like we would expect to see in a venous leg ulcer, a normal venous leg ulcer.
We continued to put the graft in there underneath the skin edges and this patient went on to totally epithelize in 10 weeks. This patient is a BK on the other side for a similar finding several years ago. He had very deep venous stasis ulcers that communicated deeply and he lost his leg. We’re able to save his leg this time using this unique application of using umbilical cord because it’s much thicker and it’s the floor of an ulcer, and beginning to, and it was able to start healing. So after using this in wound-healing applications, you know, we get a little creative sometimes and we begin to say, “Well, gosh, it works good in wounds and it has this consistency, how about if we try it in surgical applications?” So we did. We used it in plantar fibromas because we need to replace the excised plantar fascia that we’ve just created a hole in the plantar fascia by excising this plantar fibroma. And it worked out pretty well because we now created a new flooring for regrowth of the tissues. And I probably would hazard to say that we’ve created a new plantar fascia. But I would say that we filled in the void very nicely because this patient healed obviously very nicely, minimal scar tissue formation. And upon palpation of the surgical site, it felt extremely firm and to me it felt as if there was – we never did a procedure there. So it worked out pretty well for this patient, totally pain free. Another place that we used this, of course, is in the tarsal tunnel when it’s the last place that we need scarring. And while we’ve had a lot of experience using amniotic membranes in the tarsal tunnel, I’ve been doing that for about three or four years now, how about if we use this thicker product to wrap around those vital structures in the tarsal canal. So we’re using the umbilical cord, provided there’s enough room at the time of our surgery because it is a thicker, a little bit beefier product and lay it in next to these structures. And we can even sew it in place although in the tarsal canal, I don’t want to sew it in place, I don’t want to put that deep suture in that area because that’s the last thing we need. But I just lay it and wrap it around those structures and then close as we normally do. But how about using it in other boney procedures? Well, the Valenti procedure is a place that we figured would be a great opportunity. It’s a procedure that has been losing favor for more advanced procedures such as joint fusions or joint replacements, but it’s a procedure that in theory works really well. In theory, you’re taking a join that is jamming because of osteophytic bone formation or for whatever reason and it doesn’t move anymore. The patient is in a lot of pain. Remodeling that joint allows normal range of motion. The problem is that once, as we all know, in surgery, once you open up a joint, a joint is never really the same again and what happens in Valenti is very often the number one complication of Valenti is fibrosis down the road. All that hard work you did in the operating room to clear all that boney jamming and those osteophytes is substituted by fibrosis and the patient doesn’t – no longer has a range of motion. So we looked at Valenti procedure again because we did a lot of work in this procedure in the late ‘80s and ‘90s and we said, “This should work. If we look at the properties of umbilical cord in tissues, why shouldn’t it work on bone?” We know that it reduces scar tissue and fibrosis, reduces inflammation, has a nice collagen scaffold, has those growth factors that we all know about, immune privilege, so the body is not going to spit it back out. And as we’ve seen in some of our other patients, seems to reduce pain. Well, it’s like made for this type of procedure. So we started using it. We decided even that we’re going to do a bit of a study. So we started putting some criteria together and looking forward to doing a case series, and this is kind of our thought process as we look for patients to do these procedures on and we’re going to follow them up for about a year to 18 months and see how they do and then present our findings later on either our early findings will be next year, probably in two years. But here’s a procedure, a patient that came to us who’s already had four procedures. And this is the presenting x-ray. He has already had an akin of course with a nice long screw in there; lots of osteophytic formation around the first MPJ and total fibrosis of that joint could not bend that joint very much at all. The center, the middle picture shows the findings once we open the skin.
And that there’s no joint space present at all. It was totally fibrosed. So we were able to go ahead and restructure the joint. We see the head of the first metatarsal after we’ve done our angled cut on that mote and we see the base of the proximal phalanx after we’ve done our second angled cut on that bone and created a new joint space. So we’ve then taken the umbilical cord and, as I said, it’s a dry product. So we moisten it slightly, so it’s maybe a bit damped. And it really increases the handling properties. And because it’s very, very tough and very rigid, but very structured, we’re able to sew through it. So what we did is we sewed it to the base of the joint and then sewed it to the top of the joint. So we actually cover all the boney surfaces. And we have the x-ray there of our boney reconstruction, our boney procedure showing we did remove the screw and we did do the boney evacuation of the joint or the fibrotic evacuation of the joint and the patient had pretty good motion after that. This patient went on to an uneventful recovery. He had the range of motion that we found in the table is what the range of motion he had three months afterwards, and again, at six months after the procedure. So he did quite nicely with this procedure. We’ve begun now, as I said, to look for patients that we can do this procedure on and lay this over the first metatarsal and into the base of the proximal phalanx. Here’s another patient that we’ve seen a lot of osteophytic formation around the first metatarsal head and then we do some boney remodeling using the angled cuts that were instructed to use in the Valenti procedure and we lay the umbilical cord product over the first metatarsal and sew it into the joint. The most important part we have found in our thinking is covering that first metatarsal, protecting that, so we reduce osteophytic formation at that level. So we’ve done quite a few patients. Here’s another patient with a whole bunch of comorbidities again. And he, outwardly, when we look at the patient grossly, you can tell he has a large skin change because of the osteophyte on the dorsum of his first metatarsal. So you can tell just before you even touch the patient that there’s something going on there that we need to address. And indeed upon opening up the first spray, we see a large osteophyte over the first metatarsal and that joint is not going anywhere. We go ahead and clean that out and make our boney cuts and we sew the graft in place, laying it into the joint space over the first metatarsal head and this patient has great range of motion at this point. So as I mentioned, we’re in the early stages of this study. We’re, at this point, we have a handful of patients. We don’t have any complications. We’ve noticed that pain management is a snap. They need very little pain medications afterwards. We start range of motion no later than two weeks after surgery. Some patients are eager to begin range of motion a bit sooner and they start that on their own. So we’re at nine months right now and we’re looking pretty good. So I look forward to coming back and updating everybody here on the progress of what we’re doing. But it looks like we have a viable treatment option here for many of these patients, especially in a younger population where fusion or joint replacement is not really the best choice, this allows them the possibility of having something done, increasing their quality of life and we’re using a product now that has some diverse applications. And I’m sure that as we go forward, you’re going to be hearing a bit more on some of the different applications of umbilical cord products because it offers us some different changes and opportunities. So with that, I’m done a bit early, so if there’s any questions, I’ll be more than happy to answer some questions. Yes?
Matt Garoufalis: Well, the cells are – they’re dead. They do contain all the growth factors and hyaluronic acid but they are indeed – because they’re dehydrated and they’re not living structures. So they do have the growth factors. They do have the proteins that allow them to proceed with healing. So a little bit different. Any other questions?
Audience: Where did you get your umbilical cord products? Are they the commercially available?
Matt Garoufalis: Yes, they’re commercially available.
Matt Garoufalis: There’s a whole room full of people out here that will be more than happy to make them available to you. Okay. Oh, Gary, okay.
Gary: So, Matt, great presentation. And has this, the application in using this been taken on by some of our sports medicine people? Because I could see application in other areas – shoulders, knees, recon?
Matt Garoufalis: Yeah, you’re right. It certainly has. There’s a lot of sports medicine folks that are looking at this and beginning to use it as an implant in joint reconstruction and things like that. So the applications are amazing and varied. So, yeah, the sports medicine community is jumping on board with this very quickly. All right. Thank you.
TAPE ENDS - [20:41]