Brian Shiple, DO, a Sports and Spine Regenerative Specialist at the Center for Sports Medicine, talks about new therapies, called Discseel and SpineRenu, that improves symptoms of chronic back pain.
Interview conducted by Ivanhoe Broadcast News in January 2022.
For a lot of patients, does Discseel solve the problem, or does it extend that time before they need surgical measures?
DR SHIPLE: In some cases, it’s an excellent long-term management tool where we may have to do treatments down the road maybe, once a year, or once every two or three years. But the problem in the disc of our patients is that an injury occurs, and it can be degenerative, or an acute car accident, or fall at work, or something like that, and they tear their disc. That tear is called an annular tear and the annulus does not have a good blood supply and it has poor potential to heal on its own. So, patients have years of chronic pain, it’s difficult to prove, it’s not seen commonly with an MRI, and we have a high clinical suspicion that they have this. Once we get into treating it, we prove they have it with an injection of dye that we can see on an x-ray, and then, we know they have a tear. We don’t know if it’s symptomatic or not, but we have developed a program where we treat all the tears and we end up treating the symptomatic ones, as well as ones that may become symptomatic in the future. My patients will say that their years of a fragile back, they are careful, because their back may go out on them periodically, nut that all goes away. When they heal, their backs become sturdy and the comment I love to hear from my patients after years of chronic pain is, ‘I don’t think about my back anymore.’ That’s exciting and, am I curing their back condition? Not necessarily, but I’m healing that tear. We have evidence of that in our cases and in the literature.
Can you explain what Discseel is?
DR SHIPLE: Sure. When you look at our field of regenerative medicine and how doctors have been treating the spine with things like platelet-rich plasma or bone marrow concentrate, a physician that invented the Discseel procedure had the novel idea of using an off-the-shelf vial of a protein, called fibrinogen, that’s been used for 25 years in surgery to help seal things when the surgeons are cutting to the bowel or a heart valve. They use this, it becomes like a thick glue that they use to seal things instead of reinforcing sutures. He had the novel idea, and he really proved the concept of in an annular tear in many of our patients that are symptomatic, the tear is leaking. It’s leaking an inflammatory chemical out into the nerve area that causes our patients pain and if he could seal that tear and stop that leak, he could stop the patient’s nerve pain. What he found and proved in research was that not only was he sealing these tears, but they were healing. So, he started using it in clinical practices. He did a lot of research with it and he has proven that by sealing these tears, he’s getting these patients to heal their tears. That has been a game changer. Everything else in our regenerative medicine field does not address that annular tear in stopping that leak. He’s the first one that started doing that and it’s been a successful program. I actually trained with him and had it done to my discs and it helped me greatly.
Can you describe the steps that you would have to take? Is it a one-time time injection for patients? How does that work?
DR SHIPLE: That’s a great question. Most of the things that we do to the disc, it’s usually what I like to call a ‘one and done’. The needle is placed in the disc, first and then, dye is injected in to confirm there’s a tear. If there’s no tear, it doesn’t get treated. We pull the needle back to the edge of the disc, and the needle hole is sealed, and we get out. We don’t want to leave a needle hole into the disc. But if there is an annular tear there, then it gets treated. The treatment is just injecting this combination of a few different drugs, but the main one is this glue-like fibrinogen that’s turned into like hard Silly Putty once it’s activated. That sealant is very sturdy to the disc, so the patient can return activity very quickly. Not sports activity but return to life very quickly.
How long have you been using this? When was it FDA approved?
DR SHIPLE: It’s not FDA approved. There was some FDA involvement in research projects with the developer, Dr. Pauza, and unfortunately, the FDA asked Dr. Pauza to change the technique that he was used to and proved in research how it worked. It’s complicated, but he knew that if he changed the protocol to the way the FDA wanted him to, it would not hold up in the research. And it didn’t. So, he backed away from the FDA research and continued doing what he had proved in his research, and he’s been doing that ever since. Now, he’s training physicians, like me, around the country and they’re building a sizable network of capable practitioners that can offer this to their patients.
Is it considered experimental or how do would you describe it?
DR SHIPLE: It is. Yes, it’s not FDA approved. It’s still considered an experimental procedure, but it has strong data behind it showing that it works.
Can you talk to me a little bit about Neal’s case?
DR SHIPLE: Neal came to me 15 years ago as an Ironman triathlete. He was a young man, in his 30s, and he had a congenital condition where his bottom vertebra was slipped; we call it a listhesis, it’s one vertebra slipped forward on the other, and that creates instability at that disc level. That disc degenerated, herniated, was torn, and was unstable. I did stabilizing treatments with injections, using things like dextrose, prolotherapy and PRP to stabilize his ligaments, which helped his pain. He was able to train and compete, and before I treated him, he was having great difficulty training. So, I was able to get him back to training, but he always had some pain in his lower back. As we got to know each other and other injuries popped up, I started talking to him about the promise of the Discseel procedure, because I knew it was out there, but I wasn’t using it until more recently. I was skilled at putting needles in the disc, it’s just adding this medication was new to me. I told Neal that we could put that on the list, and within two weeks, he was training again. The developer of the procedure does not want his athletes training two weeks after the procedure, it’s more like six months after, just to be careful. But a lot of my athletes will take what I say with a grain of salt and do what they want to do. Neal was doing great. At the two-month mark, he was pain free and training hard. When I see him for another problem, I’ll casually ask him how his back’s doing and he’ll say, ‘I don’t even think about it anymore’.
How many patients have you treated with it?
DR SHIPLE: About 50.
Does insurance cover Discseel because it is experimental?
DR SHIPLE: No.
What is the out-of-pocket cost?
DR SHIPLE: So, as a licensed provider, we’re all licensed to charge the same amount. The licensed cost to do this procedure is $14,500 and then most practices do this under conscious sedation, and the conscious sedation is an extra fee of around $1,000. But for people who are in chronic pain, I think it’s a value. I’m involved in a practice in Delaware that treats a lot of spine injured patients in a worker’s comp panel.
I want to switch gears and talk about SpineRenu. Can you tell me a little bit about that?
DR SHIPLE: Back when I heard Dr. Pauza speak about the Discseel procedure and the novel concept of treating an annular tear, I was treating patients with PRP in their disc and getting some success. But there were cases that I couldn’t successfully help, so when I heard his concept and I knew that we were skilled at separating the different components of our patient’s blood that had some of these proteins that Dr. Pauza was using, I got the idea that we could combine these treatments and put the cellular part of the treatment into the nucleus and put the proteins that have the potential to help the annular tear heal in the annulus. So, I started combining these treatments and experimented with my patients in different sequences and amounts of these proteins in cells and we landed on a unique technique that seemed to work. When I was hired by the Worker’s Comp Spine Program down in Delaware, I taught five of their physicians how to do my protocol, and we have used it for over two years. About 100 patients are over a year out from our work and the doctors could not be happier with the results they’re getting, so, we termed the Spine ]Renu program. We started a company to train physicians in certain regenerative medicine protocols and one of them is the SpineRenu program.
Can you walk me through the process, step by step?
DR SHIPLE: Yes. We take blood out first and make it into PRP. Most of the time, when we make PRP, we throw away the plasma. In this case, the plasma has these proteins that we have worked with that we want to use in the annulus, so we save that and we concentrate it down to about 10 to one, and we extract a lot of the water out of these proteins so it ends up with a very thick, yellow looking fluid and we inject that into the annular tear. So, that’s very helpful with healing the tear. Then, the cellular component, that we know has a potential to help the disc recover and heal, we combine those two treatments in these patients. My philosophy on treating the spine is it’s not just the disc. We have ligaments back there. The ligaments can get stretched and torn and that can cause pain. We have little knuckle joints, that are called facet joints, they’re paired on right and left side of our spine at each disc level. Those can become arthritic, they can become unstable, and they can cause pain, so we treat those. We have muscles back there that can get torn, and they can atrophy and cause pain. The nerves themselves can become impinged and tight and we’ll inject those nerves directly, we call it the functional spinal unit. The whole functional spinal unit gets treated, not just the disc.
Just for clarification, are you also using the same material that you used in Spine Renu or just the protein that comes from the patient?
DR SHIPLE: There are four different products that we make from the patient’s blood and bone marrow. From the blood, we make PRP, and we make something called a platelet releasate. A platelet releasate is a noninflammatory, or anti-inflammatory, form of PRP that we inject on the nerves to help de-inflame them and help calm them down. Then, we also use the plasma to concentrate and help the annular tears heal. Then, the bone marrow is concentrated, and the cellular part of our bone marrow has all kinds of things in it, but what a lot of patients understand is it has some stem cells in it that we’re using to help stimulate a strong healing response in the patient’s disc.
Which patients are better suited for Discseel and which patients are not going to feel the effects of Discseel?
DR SHIPLE: That’s a great question. We don’t have head-to-head studies yet to say whether to do Discseel for this patient or SpineRenu. There are really two options I talk about with my patients, and we decide together what’s best for them. For the SpineRenu program, there’s a prep that we ask our patients to prepare for with the bone marrow aspiration, and it requires a strict diet, some supplements, and they have to refrain from alcohol. So, around the holidays, that is hard to do for some of our patients and they might decide to go with the Discseel, where they don’t have to be so restrictive. If a patient has prominent symptoms coming from some of these other structures, like instability or facet joint pain, I might sway them towards the SpineRenu, and treat more of the functional spinal unit as opposed to just the Discseel, where it’s just an annualar tear problem.
Is the SpineRenu fast-acting, too, or does that take some time for patients?
DR SHIPLE: We ask our patients to give it three months, but very surprisingly, patients get quick pain relief. I just treated a former Navy SEAL, and he had many injuries from his years as a soldier, and now, is out in the private world and has a business. He had great pain in his back for many years. He had a lot of symptoms in his legs, and he was keeping in contact with me after I treated him. Every week, it seemed like symptoms were getting better, and they were disappearing. Within two weeks, he was getting great pain relief and within four weeks, he was pain free. Not everybody gets that. Some people need a little bit longer than three months to realize the treatment effect and get good pain relief. But it seems like the Discseel takes a little longer to get to that clinical effect side compared to the Spine Renu, but they both work. In our data at the spine program down in Delaware, we’re getting statistical results that nowhere near as many patients have been treated with my program compared to the Discseel that’s been in existence for about 10 years now, but our data is showing comparable data to the Discseel, about 75% of patients are getting better.
Is SpineRenu covered by insurance?
DR SHIPLE: It is not, but in the Worker’s Model, they’re changing the worker’s comp laws down in Delaware to get this covered. I think that’s how a lot of our regenerative medicine successful procedures are going to get accepted by medicine and by the standard insurance companies, is it’s going to go through the state workers’ comp programs first because they have a lot at stake. These are expensive patients to take care of, the procedures are expensive, and if it doesn’t work, those patients can’t get back to their prior life’s work and they become stuck on Social Security and they can’t work and become nonproductive.
Are there any risks to this procedure?
DR SHIPLE: There are. In both procedures, whenever we use a needle in the human body, we have a risk of pain, bleeding and infection. When I’m putting a needle into the disc, causing an infection in a disc is a big deal. We try very hard and use very careful technique to reduce the risk of infection, and we have not had one. Even in our practice, in 31 years of doing injections in my patients, we’ve only had one infection.
Can you speak about Jeff’s case?
DR SHIPLE: Sure. So, Jeff came to me with what we call a failed back syndrome. He had his surgery years ago before I met him at the second to the last disc in his lower back. The surgery was a success, but it continued to cause pain. When a patient continues to have pain after a perfect surgery, the surgeons call it a failed back and they send him the physical therapy, they put him on pain medicine, and I feel so bad for them. So, when I was training with Dr. Pauza, and he was treating patients that had already had surgery and it failed, he proved to me that some of these patients’ disks are still leaking even after the surgery, and he’ll seal them. So, we ended up treating his disc with my Spine Renu program, with bone marrow, PRP and the concentrated plasma, and it worked. It helped his chronic pain get a lot better. But back then, I was only treating the obvious symptomatic disc. I wasn’t doing what I would call, now, a more comprehensive evaluation and paying attention to the other discs that could be causing pain in the patient. So, we got him better, but he didn’t have a sturdy back. He was still fragile, he still would have bad days or bad months, and we still had to do some procedures. Then, when he came back in this last year, I decided to do the full Spine Renu program on him, and he was game for it, and we ended up treating three discs. We treated the disc above the one that had surgery, it was leaking all over the place. It was so bad, and you couldn’t see it on MRI. You could not see anywhere near the degree of degeneration and annular tears that were found when we put dye in. So, we treated that, and within weeks he was doing much better. Now, when I asked him, how his back was or if his back bothers him, I loved hearing this. He said, ‘Doc, I don’t even think about my back anymore’.
Did you also have to treat the knuckles and the facet joints?
DR SHIPLE: Yes. With the SpineRenu program, we ended up treating three discs. Each disc level has two facets, so we treated each facet on both sides, so six facets got treated, and then I did some ligament work, and we did some epidural work.
Is this all done through a needle?
DR SHIPLE: Yes. It’s all done through a minimally invasive needle work and using x-ray guidance.
Is it correct to say that you developed the protocol or what is the best way to describe your involvement in?
DR SHIPLE: I didn’t invent the injection techniques. My protocol is the cocktails in the syringes delivered sequentially into the disc and into the functional spinal unit structures with the different combinations of PRP and bone marrow and platelet releasate, etc.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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Brian Shiple
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