based on rotator cuff here. So I just push something and something happens. There, please. So, support for our laboratory research program. I'm going to mention a Smith and Nephew implant here. I have no relationship with Smith and Nephew here. So I thought I'd show a case and kind of a bit of discussion on the rationale and Gus set this up nicely. So standard rotator cuff tear, supraspinatus tendon tear, standard arthroscopic double row, trans-oscillator equivalent technique repair. Pretty straightforward, nothing special here. These moderate to larger tears, I will use biologic augmentation. Here I'll show you the use of bone marasculate concentrate. So standard anterior iliac crest aspiration. Usually harvest at least 60 cc's and concentrate down to seven cc's. Try to save an aliquot sometimes to store in our laboratories, submit to you that we should do that more so we can ultimately look at composition, biologic activity of what we're actually putting into our patient. I will then inject this at the tendon bone interface. I will show you injecting this in combination with thrombin and a calcium chloride may help to clot the material. The issue came up about localizing factors. So this is one way you may do to try to keep these materials at the repair site. So here I use this porous type one collagen scaffold material so I went ahead and finished our standard repair and then used this patch material. Most of you are probably familiar with this. This is a bovine collagen derived, highly porous collagen that serves as a scaffold to support tissue formation to fix with these small resorbable PLA staples. So we'll finish this and I'll go ahead and once the patch is on, remove the scope, drain the fluid, close the portals, put a needle in at the site, and then inject your bone marrow aspirate concentrate. It's like Gus's picture all of a sudden, all turns red. And the picture on the right shows you how we've done this. Inject the bone marrow aspirate with thrombin and calcium chloride. There's fibrinogen naturally in your plasma. That's in the blood. And you combine that with thrombin and calcium chloride, you can clot the material and it clots pretty quickly. So it can stay at that site, hopefully. Let me move on here. The question that's come up, could we aspirate from the parostate humerus instead of the iliac crest? Gus did some work in this area years ago. So it'd be easy to do. You could use your, here's your aspiration control card. You can then use that hole for your suture anchors. Took a picture, a radiograph showing your aspiration needle there. So we went ahead and did this with Camila Carvalho in our laboratory. We aspirated from the parostate humerus and iliac crest in the same patient and looked at the cells. This is showing, plating these cells or to count colony forming units. And we see higher yield from the iliac crest. And we went ahead and used flow cytometry with standard cell surface markers to measure MSCs. And we see, again, higher yield from the iliac crest. So it seems like you'll have a better cell yield from your axial skeleton, your crest, or vertebral bodies, that's been shown, than your appendicular skeleton. So likewise, if I'm doing it around the knee, I'm gonna aspirate from the crest, not the distal femur. So better take it from the iliac crest here. Post-operatively, pretty standard post-op course. And using biologics doesn't change what I do. I still do try to minimize NSAIDs. There's data on both sides here. COX-2 inhibition does have a role in bone formation, some of the healing. In addition to the bursts of gusts, some comes from the bone side. So the animal models demonstrate that. So I try to think about osteo-inductivity. And to that point, you might consider calcium and vitamin D. They're easy to do. You know, there might be some role for parathyroid hormone. I've used it rarely, just because you can't get it approved by insurance. By the time you get the approval, the patient's like six months post-op. So that's something we should think about. And there's some animal data and some early clinical data to support this. Maybe we should use a PRP injection at various post-op time points. I've not done that. There's much more we need to know about the biology, but just kind of some food for thought about how we may augment the biology post-op. All these things we do intraoperatively. What's a changing biologic milieu? At one week, at two weeks, at six weeks? And maybe we should think about things we can do down the line. So I'll show you briefly to follow up here, end up here, two clinical trials. First, some data here to support this on cell therapy augmentation. So like a lot of things we do, data's mixed. Go back nine years. Philippe Pruninger, one of the first to report on using bone marrow aspirate concentrates in cuff repair. 90 patients, half of them received a concentrated bone marrow aspirate. In a 10-year follow-up, about 87% of those with repairs with cells were intact, whereas just about half in the control group. And in fact, the long-term cuff integrity was better in those who received cells. A group from Seoul, South Korea, used adipose-derived cells in 70 patients. Again, half of these patients received cells. And again, the retair rate, structural healing on an imaging study was about half in those who received cells. And recently, Brian put together a nice study from the group at Rush on 91 patients, concentrated bone marrow aspirate, similarly. And about half, the retail rate was lower. So the structural healing was better in those patients who received cells. They reported no real differences in your patient-borne outcome measures and no difference in overall failure rates. But there's certainly some data here to suggest that some improvement in structural healing using cells from bone marrow as well as potentially from bone marrow aspirate. Lastly, we have two ongoing trials at HSS. So what I just showed you is things that you and I can do in the OR today. Here's some emerging options, perhaps. We have two clinical trials. One is completed, one is ongoing. The other one is using stromal vascular fraction cells. This is a randomized trial under an IDE, Invasive Genital Device Exemption, so we can use enzymes to digest the adipose tissue. Standard cuff repair, we're doing a lipo aspiration in the operating room here. Use abdominal aspiration, try to get at least 90 cc's of adipose tissue. And then, this is what this looks like. And this is prepared with a particular commercial system. This company has no relationship with us. This is all funded by the OREF, so this is an ongoing study to look at stromal vascular fraction. We just completed another trial. This is a phase one investigator-initiated trial using gene-modified human umbilical vein cells. This is under an IND, Invasive Genital New Drug application. These cells are derived from human umbilical vein. They're CD31 positive cells. They're transduced with a particular gene, this E4-ORF, that essentially confers the cells an anti-inflammatory and sort of pro-regenerative capacity. It kind of turns on the metabolic activity of the cells. These cells, they have transient in vivo expression. And so, we're looking at these with imaging studies of all standard patient-reported outcome measures. So, we put 7.5 million cells at the tendon attachment and 7.5 million cells in the muscle. And this just shows the injection here. It's cells in one on the far left there, cells in one syringe, and then a carrier vehicle that declots it on the other. And then, we put the needle in the repair site, both in the tendon and muscle, and inject. So, 20 patients, phase one studies, safety. Those are all completed, and that data's been reported. I'll stop there. Thank you. Thank you, Scott.

biologic augmentation

rotator cuff repairs

bone marrow aspirate concentrate

porous collagen scaffold

clinical trials