Inside Regenerative Spine Care: Evidence, Risks and Real Alternatives

Speaking of Women's Health Podcast Host Dr. Holly Thacker sits down with Dr. Alison Stout, an interventional PM&R and sports medicine specialist at Cleveland Clinic and president of the International Pain and Spine Intervention Society. They discuss regenerative spine care and what’s regulated, what’s risky, and what actually helps when chronic back or SI joint pain won’t let up.

Not everyone is a candidate for regenerative injections, particularly those without a clear anatomical target or with uncontrolled conditions like diabetes. They close the interview with credible resources, how to book with Dr. Stout's spine team, and a reminder that the most powerful “regenerative” therapy often starts with motion: build capacity, reduce load where it’s highest, and let biology work for you, not against you. 

If this conversation helps you rethink your next step, share it with someone in pain, subscribe for more evidence-first insights, and leave a review to help others find the show.

Transcript

Meet Dr. Alison Stout

Dr. \ 0:00

Welcome to the Speaking of Women's Health podcast. I'm your host, Dr. Holly Facker, and I am back in the Sunflower House for another new addition with a very special guest. And I want to welcome Dr. Alison Stout. And let me share a little bit about you. She's very fascinating. I didn't even know about her field, specifically what she's done until very recently. So I'm very excited to have her on this podcast. She is a physician and a colleague of mine at the Cleveland Clinic in Cleveland, where she practices design and musculoskeletal medicine. And she also engages in clinical research and teaching. She specializes in comprehensive non-operative design and musculoskeletal care, including fluorescopically and ultrasounded guided interventions. She earned her medical degree from Cartesville College of Osteopathic Medicine before completing a year in training at Johns Hopkins in Baltimore, Maryland. And then following her physical med and rehabilitation residency at the University of Washington, she completed a musculoskeletal medicine and interventional design fellowship in Bellevue, Washington. She is board certified in physical medicine and rehabilitation and sports medicine. Welcome to the Speaking of Women's Health podcast, Dr. Stout. Thank you so much. Tell us a little bit about yourself personally. That's all your uh impressive uh physician credentials. Any anything personally you'd like to tell us about yourself?

SPEAKER_01 1:51

Well, it's kind of a physician credential, I guess, in a way. It's um I'm newly the president of the International Pain and Spine Intervention Society as well. And uh that's exciting. That's a personal achievement of mine. I just I love it. It's it's a passion of finding evidence in in what we do.

What Regenerative Medicine Really Means

Dr. \ 2:10

Well, congratulations on that. So tell us what is regenerative medicine and and what are some important caveats?

FDA Crackdown And Supply Chain Risks

SPEAKER_01 2:19

Regenerative medicine, especially for spine and the musteoskeletal system, is is kind of a uh hot topic, right? People are really excited about it and it has been since for a couple decades now. Um, but the thought of you know taking damaged or aging tissue and uh and then renewing it, right? Like let's let's you know get those those joints feeling better, let's get those discs feeling better, get them looking better, all that. Um and and with that, you know, that excitement has come a lot of uh uh people capitalizing on it, right? So I think I mean uh the one thing I want people to understand is there's a lot out there that's not what it says it is, right? So so regenerative medicine is exciting and it and the research continues to be, you know, something to look forward to, and it's not where we need it to be for mainstream use. So all those ads out there, all the stuff out there, say on the street uh or at the office down the street or on you know every other corner in some cities, may or may not be providing something that's scientifically proven, right? So um there's kind of a hidden crisis in regenerative medicine. Um, there was an article actually published in pharmaceutical technology just two months ago, and it's uh uh about this FDA crackdown on enforcement of regulation on regenerative products. And one of the most alarming issues uncovered by the FDA was this growing corruption happening within the regenerative biologics supply chain. Like so the products coming into these clinics. Yeah. So they repeatedly revealed concerns with mislabeled or falsified tissue origins, improper or missing donor screening. Yikes. Yeah, illegal tissue processing. Yeah, yeah. Uh so for example, several products that were being marketed as quote, umbilical stem cells or Wharton's jelly contain zero live cells, poor quality tissue fragments, degraded proteins, no traceability at all what products they actually were. There were even cases where the tissue source listed on the vial didn't match at all what was discovered during inspection.

Dr. \ 4:37

Oh my goodness, that's horrible.

SPEAKER_01 4:39

Yeah, and so patients don't know, and even the clinics themselves that are purchasing these products don't necessarily fully understand that several of the quote unquote stem cell products sold even in the United States, regenerative market, aren't what they claim to be, right? Um, and so in this this expose article, they actually said, you know, anytime you go to see someone and or you walk in, you're telling your patients, you know, you know, hey, you can you can try these things, they might not harm, they might not harm you, but you should ask these three questions always. And that's one, what FDA registered lab manufactured this product? And if they can't answer it, do not proceed. Can you provide the donor eligibility form, certificate of analysis, and the lot number? And these all all these documents should match the bio of the product. And then the third question, finally, a clinic should be able to provide the lab's most recent FDA inspection report or what's called a 483 letter. And to me, these are non-negotiables, right? So if you are in the US and having you want something done regeneratively, by all means, please ask these three questions. Um, because at least then you won't get, you know, injured.

What To Ask Before Any “Stem Cell” Offer

Dr. \ 5:51

Yeah, boy, that's really a concern. I mean, I I my as my patients know, women come in to see me, I expect them to bring in just their regular prescriptions that I've prescribe to them or other physicians have, as well as their supplements. I'm always looking for a lot number expiration, because if something's not a food or a drug, it's not regulated by the FDA. So are these stem cells not regulated or they are regulated because they're biologics?

SPEAKER_01 6:15

Yeah, so a lot of them uh are if they're minimally manipulated, they are not regulated, right? So, so say you go into a regenerative medicine place, they could take your adipose tissue.

Dr. \ 6:29

Oh, they can take all mine. I'll volunteer.

SPEAKER_01 6:34

And they may try to call it a stem cell injection, but it's not really because they're not allowed to manipulate it to the point that it's a drug. So a lot of these, so uh uh you know, on the corner places like not Cleveland Clinic, there's a reason I tell people they want, oh what, well, can I do regenerative medicine? Like, if it was well proven and we had a product that really worked, we would have it here at the Cleveland Clinic. They would have it at Johns Hopkins, they would have it at Mayo Clinic, and we don't because there's not outside of a study right now as far as stem cells and kind of the biologics go, other than platelet-rich plasma, and we'll get to that. But other than platelet-rich plasma, there's really not a lot out there that's proven um and could, and you know, if you don't ask dude, you know, the about the the certification and all that, um, could be could be dangerous. Uh more likely than not, it's it's gonna be costly and not help you then rather than hurt you. Um but I I I do like to throw out this cautionary statement first because everybody gets super excited about regenerative traction. Yeah. Um, one of the biggest ones is, you know, the disc, right? Or disc wear out.

Dr. \ 7:55

Oh yes, they sure do.

Why Top Centers Limit Biologic Injections

SPEAKER_01 7:57

And there's there's nothing to fix it. There's no surgery that fixes disc to wear and tear, disc degeneration, you know, the typical aging process of the disc. There's no procedures we have, you know, from pain perspective. So it's kind of this holy grail of people trying to figure out what to do with the this disc. I mean, that's one of the main ones. Um, and you know, for for right now, there's several studies ongoing that are, you know, state uh phase three clinical trials and and uh Cleveland Clinic is part of one of those. Um, but outside of that, you know, for the spine, really, unless you're part of a study, there should be no stem cells being injected into your spine for sure.

unknown 8:40

Yeah.

Dr. \ 8:40

And I have heard of um and and know of some patients and people who have uh extra money to spend who leave the country for infusions and things that sound a little bit specious to me. Is that you what you think they're doing? They're leaving the country to get stem cells.

PRP: Where It Helps And Where It Doesn’t

SPEAKER_01 9:00

Well, they they the problem is again, this you don't know what you're getting, right? Because it's not regulated by any so you leave the country and there is no regulation, right? So you a lot of these companies have moved away that these countries that may not have your best interest and really just have the bottom, you know, the money interest, the capital, you know, uh gain interest in mind, they will take their their product and and do an offshore clinic. That the that being said, there's plenty of countries where they're doing things correctly. Um however, I I s I caution that they don't have the same oversight as the FDA, because the FDA only operates in the US. So so when you go offshore, then you then the the the issue is then you have no you they are not gonna have an FDA 483 form. They're not gonna have anything to prove where this tissue came from. Um and and how they man if let's say you have your own stem cells that they're they're trying to do, then um how they're manipulating those cells and in in what capacity is is a question. Most of what we're have been studied now for at least from stem cells for pain and spine and joints, um are cultured stem cells, right? So they grow them in a lab, it's very controlled. There are, you know, there are a couple places where um those could be injected that could cost you quite a bit of money, like I think um in the US. But most, I would say 99.9% of them, if you're having stem cells injected in the US, are gonna be need to be part of a study.

Dr. \ 10:46

A study, being part of a research study. Yeah.

SPEAKER_01 10:48

So they're just not available outside of that. I had a patient looking, he he wanted to try it, right? If he wanted to try it, he wanted to try it. And the only way he could have it injected was to be a part of the study, the one, the one that he wanted. Yeah.

Dr. \ 11:01

Yeah, we've had uh in season three, we had a rheumatologist talk about uh PRP injections and how they're not FDA approved, but there is certainly some evidence, and that's a way that people with musculoskeletal problems, a lot of athletes, um, people with injuries may pursue that. I know my sister just had it done. She's like an Olympic level rower and injured her shoulders. I'm like, well, don't you just cut back on this? You know, you're doing I don't know that your shoulders are made for it, you know. It's really, no, no, I have to keep going. I'm going all around the world to compete. And then yeah, so you know, she went and had PRP and was happy about it. So can you um Yeah do in your field, do you do PRP in the spine?

SPEAKER_01 11:51

It was done in shoulders and knees and hips and in my prior life I did before the Cleveland Clinic. We don't have that set up, but I know the ortho the orthopedic department does use PRP injections for joints. Uh, and we're working to get it set up to be able to do it for spine if if someone really wants to. The what the places where it's studied in the spine are the joints in the spine, so the sacchariliac joints and the facet joints. PRP and the discs haven't been shown to work. Um, there's and and evidence in the other parts is very, very limited. Um, but it's better than stem cells and it's cheaper, right? And so I do think that PRP is not it is actually somewhat reasonable. Its cost is lower, its risk is lower, its likelihood of having some positive effect is higher than with uh a quote unquote stem cell product.

Dr. \ 12:46

Um and so for our listeners, what we're talking about PRP is plasma-rich platelets. So blood is drawn from the patient herself or himself, then it's spun down, and then that same serum that has like growth factors and platelets is then put back into the body in a certain place to try to facilitate healing. Is that right?

SPEAKER_01 13:08

That's correct. And so it's used in joints and in tendons, like your sister had in her shoulder tendons.

Dr. \ 13:14

Um, tendons are so slow to heal. Although we did have a podcast on acupuncture, and I had acupuncture for a tennis elbow, and I was really happy with that.

SPEAKER_01 13:24

But oh, absolutely. Even dry needling. Yeah. So so the the the study that threw PRP, platelet-rich plasma, under the bus was actually that that interns said we're absolutely not covering this, was a study that compared just dry needling the Achilles to platelet-rich plasma and Achilles and showed they were equivalent.

Dr. \ 13:43

Wow.

SPEAKER_01 13:43

Right. So you're one of those cheaper.

Dr. \ 13:48

Although I don't understand why it's expensive if you're just drawing off the patient's blood. Is the machine to spin it down or or is just everything inflated costly?

PRP Variables That Change Results

SI Joint Pain: Options Beyond Steroids

SPEAKER_01 13:58

It's both. It's both, right? Yeah. It's the kit, it's the procedure suites, you know, if you have ultrasound guidance, it's not as expensive as as if you had fluoroscopic or x-ray guidance. Um, and in in platelet-rich plasma, there's still, you know, you look at the studies on it, and it's still so difficult to tell what is best practice. You know, so there was a review article that looked at, you know, what in PR for platelet-rich plasma injections of what and how often and all that. And there's still so much that needs to be researched that we don't know the answer to. So for just a couple examples, we don't know the exact number of platelets we need. Um, we we think the goal is around 1.5 million. And there's some studies that suggest too much more than that. It might have an inhibitory effect, it might not help you as much, right? So there's that we don't know. Um, and then in a single person, like my growth factors might not be as good as yours. And so if I have PRP, it might not work for me, right? Because my growth factors have some sort of congenital problem, some genetic issue already, right? That's why I had the tendinopathy in the first place, right? So there's that. Um and then there's there's questions of like there's two, there's two types, leukocyte rich versus leukocyte poor. And I think that's really important for people to understand because that is something we know between, say, the injecting the joint versus the tendon. When you inject the tendon, you want an inflammatory response. So you do the leukocyte rich. And then if you want it in a joint, you don't want to stimulate too much inflammation, and so you do leukocyte poor. And uh, even a lot of uh physicians aren't really aware of that, and they're you know, they're doing plate rich platelet-rich plasma injection with the same kit for everything, and it may not be healthy, right? Yeah, yeah. Um, other questions like uh what if you use local anesthetic? Well, local anesthetic has been shown to inhibit platelets, right? So there's data that says you shouldn't inject with a with a local anesthetic when you're doing this, um, because it could inhibit the actual platelet activation and and the growth factors. So there's still a lot of questions in that. There's still some evidence, and I I think um it's reasonable, it's not unreasonable. So let's say let's take an a real world example. Um, sacroiliac joint pain. We know we can inject that joint. We inject it with x-ray guidance for the most part, and we put anesthetic and steroid in it. Well, we know steroids have limitations, right? Yes. Yeah. So so you say you get an injection and you get relief and it lasts three, four months. You get another one, it only lasts two months. Well, we're not gonna keep doing this, right? The only other treatment that's currently paid for is SI joint fusion. Okay, so you're gonna go from a steroid injection to a fusion. To me, if I'm in that boat, you know, I might think about platelet-rich plasma. There's a little bit of evidence, maybe it works. It's gonna cost me money out of pocket, but then I can avoid a sacraliac joint fusion, which in women's health, I we we know that SI joint fusion hasn't been around that long. I honestly wonder what will happen to the, you know, especially women who have their SI joints fused, once they get a little bit osteopenic. Are they more at risk for a sacral insufficiency fracture? We don't know this, right? We don't know what'll happen to these people when these young women who are 30s and 40s who have an SI joint fusion on especially both sides, and then when they're osteopenic at 75 or 85, are you?

Dr. \ 17:42

Well, hopefully, if if they're listening to the speaking and women's health podcast and they've heard a lot of our podcasts on osteoporosis, they won't get to that point. But what an excellent point. And you've been listening to the Speaking of Women's Health Podcast. I'm your host, the executive director, Dr. Holly Tacker, and I'm speaking to a Cleveland Clinic colleague, Dr. Allison Stout, who is an interventional spine, physical medicine and rehabilitation physician. And we are talking about regenerative medicine for spine care. I had a colleague who almost had to retire early because of severe SI joint pain. And certainly the spine, it just seems like it maybe wasn't as well designed for us bipetal humans as it should have been because so many people have spine problems. In fact, one of my most listened to podcasts, and I am not a spine expert, but um my brother said, I'm having sciatica. Do a podcast on this topic. You know, I had a girlfriend who was like laid up and couldn't even walk and was in severe pain. And all these people were like, you've got to get some good information out about the spine. So I just kind of did the basics. Um, but tell us what are some of the treatments that you're using in your um interventional spine uh treatment practice?

SPEAKER_01 18:57

So we use a lot of diagnostic injections and then radio frequency ablations, so for joint pain in the spine.

Dr. \ 19:07

Uh so that is if you can locate where the pain's coming from where the pain's coming from, right? Does ablating those nerves like damage them so that then they don't function anymore? Does that cause muscle weakness or that's a really good question?

Ablations For Spine Pain Explained

SPEAKER_01 19:22

So we for the facet joints, we ablate the nerves and they do have some innervation to the multifida muscles specifically, which low back stabilize the spine. Yeah. Right. And in the low back, if you only do a couple joints, not the whole spine, the what we found is that doesn't have any repercussions into function. Like so they did a study where they had radiofrequency ablations and uh they were successful. They they proved they ablated the nerves, they did EMG that showed they had denervation in their multifida, and they had an MRI, and the radiologist couldn't predict where the ablations were at based on the MRI, because when we're older and in pain, our multifidi atrophy anyway, most likely. So, yes, there is some of that. Um, these nerves grow back, however, right? So it's not a forever thing uh for the for the facet joints. A more recent ablative technique is called basavertebral nerve ablation, and so this is a newer concept that has come up in the last six years. So we talk about the disc, the disc, the disc, and what they found over the last six to ten years is that the end plates on either side of the disc have pain sensors and are often actually the cause of the pain. And our our Cleveland clinic uh person, Dr. Modic, his they're they're named after him, Modic changes of the end plates. Then you know, the the end plate degenerative changes are markers that someone might be a candidate for this. So if someone has just back pain without the sciatica, they shouldn't have sciatica with this, they might be a candidate to have a radio frequency ablation to treat their pain in their facet joints or around the disc in what we call the end plates. Um, and that the the basal vertebral nerve ablation is a little more intense. It's getting, you have to get into the vertebral body, um, which requires you know access through the pedicle, similar to like a kyphoplasty or something like that. Um, and and but most patients tolerate it really well. And about 75% of people get good relief of their back pain who have been well selected for this. And again, it's not 100%, right? So it it's good and it's a newer thing, but it's for a very specific subset of patients. Um and I would say in that, in those both those treatments, the regenerative piece is then you have to couple that with function exercise movement.

Dr. \ 21:58

Oh yes, always. have to do the physical therapy.

Basivertebral Nerve Ablation Candidates

SPEAKER_01 22:02

Well and and what I want to drive home is the regenerative capacity of your body is only unleashed when you are active, right? So let's take for example the disc. The disc you can promote regeneration with activity. You don't need a regenerative injection, right? And of course you can overdo it with activities and you can cause an injury or things like that. However, there's that that medium thing where if you're sedentary, you are not utilizing your own internal regenerative medicine. Right. So so I think any of these treatments that are for pain that we do injection wise, whether that's a steroid injection or say a radio frequency ablation or denervating something. The really the goal is then to couple that with improved movement for health reasons, for regenerative reasons, for every I mean for everything, right? But but what we don't want to get into is oh we just do this procedure and that's all there is. That's that's not how these things work. They work um together.

Dr. \ 23:19

So it really has to be a comprehensive program with probably physical therapists, the primary care physician involved, good nutrition, good sleep hygiene, all of that. All of that.

SPEAKER_01 23:32

Bone health, right?

Dr. \ 23:33

All that right I'll I'll see people I'll see patients who have some sort of um invasive spinal procedure or hardway hardware placed or kyphoplasty and I'm an osteoporosis expert. And then they'll have a fracture above or below the area that's under stress and their bones are still very unhealthy. Right. And so even if you mechanically fix you know like one part of your house if the rest of it's falling apart and is a mess, the structure is it's going to be a big problem.

Movement As The Real Regenerator

SPEAKER_01 24:05

It's a huge problem. And I think uh on that same line of interventions, we've come to find out that the steroids we inject are absorbed into your bloodstream, right? So there's systemic absorption of these steroids with the same bone density effects as if you took them by mouth. Now we don't know the exact number but I'm part of a multi-society work group that has a consensus guideline that's uh being published that talks about it's already been done about the joints and and in that is a little bit about this the data on epidural steroids. But basically women with osteopenia or osteoporosis and men in that same age group. So basically women at 60 and men at 70 really shouldn't have more than around 150 milligrams of injected steroids in a year. And for most people that's not a problem. I think it's more the awareness right that you can't have a steroid injection in your shoulder because you want to row and then have your back done and then your hip and then you have all three repeated three times in a year. That's too much you know it's it's being reasonable about these things and part of and and making it part of a a bigger picture for your overall health I think is is again we're circling back to that but it it all everything we do has a side effect. Right. Yeah.

Dr. \ 25:29

And are there instances when a patient should not receive some sort of regenerative medical therapy I I think there are instances where people shouldn't have regenerative medicine therapy.

Steroid Dose Limits And Bone Health

SPEAKER_01 25:44

I mean one if you don't have a good target that that would be probably number one. So um I had a patient who wanted uh their neck injected for neck pain and their their pain was everywhere and they they had hypermobility syndrome of some sort um and I I I I spent a lot of time with them uh uh explaining that you can't one you you have to have a very specific target when you're talking about regenerative injections and two you know the when you have uh like a hypermobility syndrome there's unlikely to be a single target uh and we don't know with you know congenital genetic problems with collagen will regenerative injections even help at all yeah yeah so so I would say that would be number one but that also goes for say uncontrolled systemic illness say diabetes would be number one right because your body can't can't function well so if you have uncontrolled blood sugars that's also a situation where you don't know what's going to happen to those cells it could be good it could be not so good right so um and then yeah I I I and I I think it's also having the right target having you've done all the the stuff to have the good the good outcome right you're exercising your you've got a treatment plan in in place and um you know you can't be on anti-inflammatory medications when you have regenerative injections right you can't be on NSATs. Yes like you have aspirin and motrin or toxicline yeah it's gonna inhibit the response right you can't have a recent steroid injection right so all the everything has to be lined up uh so you really need you need someone working on the whole you not just oh let's put this needle in this spot that hurts right so there has to be a bigger treatment plan.

Who Should Not Get Regenerative Injections

Dr. \ 27:45

So are there any online resources that you can because we have listeners in a hundred different countries you know where there are people um that are trained in spine intervention and helpful tips or further education about stem cells about PRP about you know blocks in the spine or those kind of therapies.

SPEAKER_01 28:10

That is a really good question. I know of no such resource online for regenerative medicine.

Trusted Resources And How To Book

Dr. \ 28:17

You know a lot of without there is is uh uh has conflicts because it's company right so they're selling selling yeah they're selling any any like social media um or online resources like that the clinic spine center has or um do you do any social media or any um like public horrible education yeah okay is there any um any listeners that are that are in the Ohio area or want to come to the Ohio area how they can make an appointment with you or do they need to see other physicians to be specifically referred to you? Oh no they I'm I'm happy to to see people um they can schedule with me or uh one of my spine colleagues um I can give that number it is 216 636 5860 so we'll put that in the we'll put that in the show notes um or any any links to this uh society that you're a president of do they have any patient resources or just all professional physician that one's uh professional the other uh organization that I'm involved with that does have patient facing uh resources is North American Spine Society and so they have spine yeah yeah so NAS North American Spine Society has patient facing and then Ipsys or International Pain and Spine Intervention Society has more uh physician focused uh and that's more a lot of what that organization does is is the evidence uh and it does have things about regenerative medicine they're not big on it right because it doesn't have a lot of data and and that that organization is very heavy on practicing science based evidence-based medicine uh with high high standards for say correct injection practices and things like that yeah and any comments we have a lot of physicians and clinicians who listen to our podcast as well for anyone who might be interested in entering this field I would uh assume it's pretty much hot pretty high in demand yes uh so one the the field of of regenerative medicine means that you have a basis in all you know the art of knowing when it's appropriate right that's like everything it's like yeah you can do the injections you could do regenerative medicine and you need to have the basis of of what what the other options are what the medicine is behind it.

SPEAKER_01 30:49

So uh you know I recommend that people do fellowship in pain andor in spine and musculoskeletal uh there's uh ACGME options off obviously for fellowship training there's non-ACGME for people in other countries uh there are training programs for interventional there there are several uh because in I know in uh like europe they there's no intervention spine musculoskeletal interventional fellowship program so there but there's programs for training in in several countries uh and I could list some of those resources I don't have them offhand but I can we can we can get them in the show notes okay well thank you so much Dr.

Dr. \ 31:31

Stout for joining us today and thanks to our listeners for tuning in if you haven't already please share this podcast with your friends and your family and if you enjoyed this episode give us a five star rating um or write a review and we'll be back next week for another episode. Until then remember be strong be healthy and be in charge