Listen to the whole interview here or read the transcript below:
Peter: Spring’s here, and spring cleaning is underway. Case in point, I was doing some in the yard the other day moving around some 4x4s. For me, it’ll be a 2-or 3-day affair and that’ll be it. But I know there are a lot of people who are listening that deal with back issues, neck issues on a daily basis. And it becomes just overbearing for a lot of people as a result. You don’t know what to do, you don’t know where to turn, and surgery is not really the direction you want to go in. What do you do?
Dr. Jay Downing is here, First State Spine and Regenerative Medicine in Newark, and we’re going to talk about maybe something you should consider, at least.
Doctor, first of all, good morning and thanks for coming in.
Dr. Downing: Thanks for having me in, Peter.
We have talked before, I think, about the spine and the fact that we as humans kind of ask a lot of our spine. And it becomes an area where people end up with issues as a result.
That’s certainly true. 80% of all people over 50 see a doctor for back problems at some point in their life. It’s a very common problem. It’s actually normal to have back pain when you look at it, statistically.
Yeah, and with the neck thing – is that just a connection, a direct line? You know, if you have neck issues are they generally related to the back as well, or independent, or what?
The dynamics are a little different. Our heads are not as heavy as the upper half of our body, so the lower back – the lumbar spine – does a lot of the heavy lifting, and that’s the real wear-and-tear area. Our neck has more mobility and so we see a slightly different problem in the cervical region. All in all, as people are over 50, it’s the lumbar region that is the most problematic and causes the most healthcare issues.
Okay. So you’ve been in practice for a long while now. What makes it so tricky to deal with back issues. Is it the physical makeup of the spine and the discs and the muscles, and all? Or what is it that makes it such a challenge?
Well you know, fundamentally, our spine, anatomically and structurally, is very similar to the spine’s of animals that still travel on all 4’s. It’s just really true. And so you look at the way a tiger or lion runs, their back has to move a little back. Their lumbar spine – but it’s not bearing weight. Now that we stand on our hind legs, it’s just inevitable that the discs and joints that were, in no disrespect to our Creator, our back was not designed for standing on our hind legs. And now that we do that, and we’re living longer, you know, Cave Men didn’t live into their 70s. Now that we’re living longer and enjoying generally good health, people’s lumbar spines take a beating.
Yeah, there’s degenerating elements that come with the price of those longer lives. Well let’s talk about your journey, if you will, to where we are not with First State Spine and Regenerative Medicine. How did you get to this point?
Good question. I’m a native of Delaware. I got my Bachelor of Science from Haverford College Medical School at Tulane. I did my residency and fellowship down in New Orleans, practiced anesthesia – I’m board-certified in Anesthesiology – and subspecialty certified in Pain Medicine. And over the 30 years that I’ve been practicing, pain medicine has evolved. So initially, we had limited options, medications were one of them, and injections of corticosteroids and local anesthetics into the spine were very common procedures – generically referred to us an epidural steroid injection – are still a very common procedure. Over the last 10 years, regenerative medicine has started to come onto the scene. I would tell you that I’m a very cautious, skeptical person. I always dip my toe in before I jump in. And I was a little cynical about Regenerative Medicine at first.
As there has been more and more data developed, we decided at First State Spine to get involved in this area. We started slowly, we did a lot of research, and I’ve personally done a little under 100 patients for treatments in the lumbar spine. It’s been very gratifying. Our success rate went up: about ⅔ of our patients are ⅔ improved at the 6-month point. Which is obviously not perfect, but that’s good in back pain populations. Unfortunately, there’s no perfect answer for a person with back pain.
I see people obviously everyday come in with lumbar complaints. Many of them say “Doc, I’ll do whatever it takes, I’ll get surgery, I just need to get this fixed.” And part of what I have to do is educate people: wanting to get better doesn’t make you better and unfortunately taking a big step like surgery doesn’t necessarily make you better. On the other hand, if you have appendicitis, of course you have surgery. No doubt about it. If you have a skin cancer, of course you get surgery. But with a lumbar complaints, surgery is the last option. And clearly surgery has a role in treatment, but you need to follow a reasonable algorithm,: you start with ignoring for a while, which we all do. We all have denial. You try oral anti-inflammatories like Motrin, you try some physical therapy or chiropractic care. If that’s not working, then you might get advanced imaging such as an MRI, then you might see someone like me. But our first step would not be regenerative medicine. Our first step would likely be an epidural steroid injection, or one of these simpler techniques. This is assuming you’re not an extremist. And then when those steps aren’t working, and someone is at the point of considering reconstructive surgery, that’s where regenerative medicine becomes apparently a viable option.
And it can step in and be an alternative to that. I mean – I don’t want to call it a drastic procedure – but it’s serious surgery you’re talking about. I can’t tell you, I know too many people frankly, and maybe this is just by consequence and circumstance, that ahve had back surgery, and ended up needed more of it, or it didn’t take, per se. And so it’s not guaranteed as you referenced.
Right, I’ve been in this community for 30 years. There’s a lot of excellent spine surgeons and they have a lot of excellent results. But in my practice, on a daily basis, a good half of the people I see have already had back surgery. So that’s sort of proof that it’s not curative. It’s part of the management, and some people do need to have surgery. They’re just unstable and they need surgery. But it’s not a cure-all, and that’s why all the good spine surgeons start with the same conservative steps I’ve just described. That’s just the way you practice medicine.
So let’s break down Regenerative Medicine. I’m sure people can get a handle on it if we kind of paint them a picture. What is the science and what is the application?
Fundamentally, “regenerative” is a good word. When you do an internet dive on this, the term “stem cells” often comes up in your research and advertisements you get in the mail. The point here is we are trying to encourage the normal cartilage growth that is deteriorating and are not doing well, and that’s leading to the degenerative disease. Think of it as an easier way to look at it, like a knee joint. Part of the reason people get a knee replacement is the cartilage has worn down, they’re bone-on-bone, and they’re miserable. So they literally cut the joint out and put a mechanical joint in. If you could catch this while the cartilage is just deteriorating but not yet gone and encourage some normal cartilage growth, you wouldn’t need to have a knee replacement. Now the back is a little more of a complicated structure. The discs are cartilaginous in general. There are joints in the back called facet joints, which are true synovial joints with the cartilage in them.
If you could encourage normal cartilage growth or slow down degeneration, you could postpone the inevitable aging process. So regenerative medicine is not miraculous. It does not turn back the clock. The real point is to encourage real cartilage growth and delay deterioration.
So what we’re doing here is using mesenchymal stem cells – the fundamental way we approach it for the lumbar spine is: we extract some of your own bone marrow, process it, or concentrate it. Bone marrow, when you think about it, are primitive cells that can go on to form all kinds of blood cells. But they can also apparently have growth factors – they can encourage other forms of growth. SO we purify bone marrow, mix it with some of your purified platelet-rich plasma, you’ve heard the term PRP, and inject that into the disc. And then that medical procedure takes about an hour to do. Then you go home the same day. That’s the essence of it. IT’s not that complicated, but what we’re trying to do is encourage normal, or regenerative growth. We’re not trying to grow a new disc, just improve the one that’s there.
And you correct me if I’m wrong. It sounds like it holds the promise of a more stable scenario back there then maybe some surgery would offer. You’re using stuff within your own body to potentially fix a problem.
Well, one of the problems with surgery – and the main surgery for a degenerative disc disease is a fusion, where they literally bolt the bones together, hope they grow together and make it solid like putting a mending plate in a car. I make the analogy like if you have rust in a car then you have to put a mending plate or something to support the frame. Your lumbar spine has to carry our weight. So that surgery often goes very well, tbut the problem is you’ve put more weight somewhere else. So if you weld the one length of the chain, the other links have to do more work.
Ah, yeah.
Then you have what is called adjacent segment degradation. The guy next store starts to get beat up. So with regenerative medicine, we aren’t fusing anything. We’re just trying to regrow, or rejuvenate the area that is diseased. So you maintain your normal flexibility and hopefully don’t develop the adjacent segment degradation that I’ve described.
Unfortunately with major lumbar reconstructive surgery, only about 60% of the patients are happy 3 or 4 years later. In other words, it’s not a failure, but they’re still having problems.
Yeah, yeah.
It’s not a perfect option. Thus far with regenerative medicine, these cases we’re doing initially, are people who were literally considering surgery. They’re people who have already gone there – on the cusp. They’ve already been 6 months since their injury -they’re literally considering surgery. And about 66% of those people are happy. So we consider that a good thing. It’s also much less invasive than surgery, and frankly, much less expensive than surgery.
You said they can go home the day of this?
Yes!
Amazing.
The actual outpatient procedure is done under intravenous sedation – you’re not under sedation, but you’re not sound asleep for the procedure. A little bit like a wisdom tooth extraction or something. It’s not fun but it’s not hurting. But yeah, you go home the same day. If you had an office space job, you could go back to it in a few days. If you were doing heavy work, you need 4-6 weeks for recovery. It all depends. On the other hand if you were doing an office space job and had lumbar fusion, you could still go back to work in a few weeks but for heavy duty work, you can’t go back for months. There’s always a healing process.
What do you tell people – “Hey, when will I feel better?” I know we’re walking kind of parallel to what [we just mentioned]. But when is it? Depending on the severity? The location of what we’re doing here or what?
It would depend on the severity. As I said, we follow people up after the procedure, 1 month, 2 months, 6 months out because what we’re trying to do at this point is develop data so we can justify what we’re doing. And that’s really important. So we’re seeing improved pain scores within months.
That’s amazing.
Or, improvement in the patient.
Dr. Jay Downing is here. He is with First State Spine and Regenerative Medicine in Newark. We’re talking about what is, I would have to say, considering we’re putting together patient numbers, a growing alternative, if you have serious back issues, to going down the surgery path through regenerative medicine. So we still have a few minutes left, but I want to make sure we get in kind of this profile of “Who are the people that could benefit from coming to see you” What is the nature, perhaps, of the back injuries you most likely see, and who stands to benefit the most?
Regenerative medicine for the lumbar spine as I’ve described it is for low back pain. It’s not specifically a treatment for sciatica or that electrical feeling down the leg, which is typically from a disc that has bulged that is banging into a nerve. Which needs surgical correction.
For people who have mainly sciatica, surgery is 90-95% successful. But it’s for people who have axial low back pain – literally in the back and buttox. The patients who are candidates for this are people who have already tried and not done well with conservative measures.
So the algorithmic approach is activity modification, not bedrest, but not doing jumping jacks either. Activity modification, oral anti inflammatories, imaging, a trial of the conservative steps, which should be an epidural steroid injection type approach, perhaps injection of the joint, and at this point you’re probably about 6 months into your symptoms. And then if you’re not better at that point, you’re starting to consider surgical options. At that point, some people undergo a study called a discogram, where we actually pressurize the disc to see if the disc is the painful part of the anatomy. So these are people who are literally standing at the crossroad of needing surgery or just deciding to put up with significant pain. This is not pain on the scale of 1-10 scale that’s a 6 or greater. Pain that is affecting your daily living, impairing your sleep, your social life, yoru work life, you’re missing work. You don’t get this done because your back bothers you. You get this done because your back is impairing your life.
Well put. You mentioned conservative approach. The FDA – where do they stand on the kind of things that we’re doing when we talk about regenerative medicine?
That’s an interesting question. It is an area where patients need to be cautious about. Some of the treatments that are being promoted involve tissue that’s not from the patient – in other words – amniotic fluid or umbilical cord blood from an unknown donor. ANd then you do have some small risk of contamination or infectoin. With the system and approach we are using, and as I said, I’m a very cautious person, nothing is coming in from the outside. It’s yoru own blood that we spin down to create platelet-rich plasma, it’s your own bone marrow that we’re concentrating at the center. Nothing comes out, nothing comes in, it’s all just you. ANd so that way we eliminate the chance of contamination.
Also this is an area where the FDA is concerned about. There are people marketing umbilical fluid products and amniotic fluid products and there’s a small risk of contamination and the FDA cares about that. What we’re doing is just the patient’s own –
It’s self-contained.
Self-contained.
Very interesting. We’ve talked about regenerative medicine, what it is, how it is delivered, who would benefit, we need to tell them where you are. Where are you located?
We’re in Newark, Delaware. These procedures are done at First State Spine and I’m Doctor James Downing. If you’re interested, the website is https://firststatespine.com and I am still the only Dr. James Downing in Delaware that I know of, so if you search me you’d find the right one.
That’s a good thing. Moving forward, are you seeing more people coming in looking for some advice and potential options? It would seem like, with the nature of back surgery, it would be a worthwhile effort for the kind of people you mentioned to check this out.
It is an appealing option, Peter, and one of the things that is frustrating to me about this procedure – the Regenerative Medicine treatment – is not covered by traditional insurance at this point. That’s a frustration to me and that’s a frustration to patients. I talk to people about this, my nephew is a medical director for Blue Cross down in Virginia. He’s a caring physician. Insurance companies are not bad people. They’re not going to start covering this procedure until they are convinced it promotes health. And that’s why what we’re doing is keeping a careful registry of all the patients we’re doing. We have about 150 cases so far. When we have 1000, I think insurers will say “hey, that’s working as well as surgery” and that’s a win. But insurance companies, I think, and I strongly suspect, will start covering this when they realize [because ] they care about patients and when patients are doing well without complications, they will allow that as an option.
And so, if you’re listening to us now, like I said at the top of this, if back issues have become debilitating, overbearing, affecting quality of life, what’s it worth? That’s what it comes down to . Day to day if you’re losing out on spending time with family and friends, or not being able to complete work because your back issues are too much, by all means, check out what Dr. Downing has to offer. First State Spine and Regenerative Medicine in Newark. Also, the phone number is (302) 894-1900.
