October 30, 2024 • 26 mins
Unlock the future of orthopaedic surgery with our enlightening conversation featuring James L. Cook, DVM, PhD, OTSC, a pioneering expert in regenerative orthopaedics. Learn about the transformative potential of cutting-edge treatments, including the innovative combination of Hyaluronic Acid (HA) and Platelet-Rich Plasma (PRP) for joint health. Dr. Cook sheds light on the importance of evidence-based practices, regulatory challenges with mesenchymal stem cells, and the perils of unverified "stem cell" treatments. We emphasize the need for clear guidelines and insurance coverage to responsibly advance this promising field, ensuring patient safety and efficacy.
Discover the groundbreaking advancements in biologic joint regeneration, from the promising results of PRP and Bone Marrow Aspirate Concentrate (BMAC) to the future of biological grafts and tissue-engineered solutions. Dr. Cook discusses the necessity of standardization for consistent outcomes and highlights the crucial role of comprehensive care centers. We also delve into the financial considerations and insurance hurdles that patients face, stressing the importance of integrating these innovative treatments into mainstream orthopaedic care. Join us for an insightful exploration of how regenerative orthopaedics is poised to revolutionize patient care and the future of orthopaedic surgery.
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Episode Transcript
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Speaker 2 (00:21):
Welcome to the AOA Future in Orthopedic Surgery
podcast series.
This AOA podcast series willfocus on the future in
orthopedic surgery and theimpact on leaders in our
profession.
These podcasts will focus onthe vast spectrum of change that
will occur as the futurereveals itself.
We will consider changes asthey occur in the domains of
(00:42):
culture, employment, technology,scope of practice, compensation
and other areas.
My name is Doug Lundy, host forthis podcast series.
Joining us today is Dr JimmyCook.
Jimmy Cook is a board-certifiedveterinarian.
He also has his PhD and is thedirector of the Thompson
(01:03):
Laboratory for RegenerativeOrthopedics and the director of
operations and research at theMizzou Bio Center and the
William C and Catherine E AllenDistinguished Chair in
Orthopedic Surgery at theUniversity of Missouri.
As I said, he's board certifiedby the American College of
Veterinary Surgeons and theAmerican College of Veterinary,
sports Medicine andRehabilitation.
He trained at the University ofMinnesota and the University of
(01:26):
Missouri.
His research interests arefocused on in vitro and in vivo
models, tissue engineering,osteoarthritis, meniscal
replacement and regeneration,articular cartilage, as well as
other areas.
I had the pleasure of meetingDr Cook at the Southeastern
Orthopedic Symposium run by DrJim Standard, and I was
(01:48):
immediately blown away byJimmy's incredible knowledge of
regenerative orthopedics, of PRP, bmac, of all that stuff that's
out there and the true natureof it.
So, dr Cook, sir, welcome tothe podcast series.
Speaker 3 (02:03):
Thanks so much for having me, Jimmy.
Speaker 2 (02:05):
you are also one of the nicest folks I've ever run
into.
Thank, sir, welcome to thepodcast series.
Thanks so much for having me,Jimmy.
You are also one of the nicestfolks I've ever run into.
Thank you so much for all thework that you do for our
patients and all theunderstanding on this.
Can you just give the audiencejust a overview of what your
work is, what your background isand how you got into this?
Speaker 3 (02:19):
Well, you gave a great intro, thanks.
I mean, I kind of came from theveterinary world and then went
over to now.
What I say is work on thetwo-leggers full-time.
And so, as you mentioned, jimStandard, a great friend of both
of ours and my chair, and justa wonderful clinician, scientist
and human being, brought meover here as we were kind of
developing this area, to behonest with you.
(02:39):
So both in the osteochondraltransplant and meniscal
transplant area of regenerativeorthopedics, but also in the
orthobiologics, and so we reallywanted to bring those forward
in an evidence-based way.
Certainly, we wanted to look atdiscovery and groundbreaking
cutting edge, but do it in areally thoughtful and, again,
evidence-based way.
Speaker 2 (03:01):
So can you give us an overlay of what the current
state is in the United States?
For, however you would define,I'm not going to put any any
parentheses on it.
I'll let you figure out.
You define for us whatregenerative orthopedics is.
What does that mean in the USand what are the current players
in that?
Speaker 3 (03:18):
Actually I think you said it and we're still in the
defining stage, right.
So I would say it's thefrontier stage which is good and
bad.
I mean, it's fun to be on thefrontier and you know we can
explore new directions.
But there's limited guardrails,and I think you know,
especially when we talk aboutpatient safety in combination
with efficacy and I always sayit's what we're trying to figure
(03:41):
out is what we can do, what weshould do and what we shouldn't
do, and I think that's reallywhere we're at.
So again, I mean, the FDAguidelines for what we can use
as indications are even notsuper specific.
They're these general kind ofminimally manipulated, not
combined with other substances,homologous use, administered
(04:04):
during the same procedures,collection.
But that's a little tough too,and so again, I think it's
really our responsibility, youknow, to define that for
ourselves and base that on thepatient, base that on best
current evidence.
But then that's also going tohelp us in the long run, because
the other, I think, difficultthing about the frontier era of
this is it's hard to getinsurance coverage right and you
(04:28):
don't want to just cash pay,cash pay, cash pay.
Number one, if it's not worthit, cost effective, but number
two we're never going to getinsurance coverage if we don't
kind of demand that based on theevidence.
Speaker 2 (04:40):
So we're talking about stem cells here, right?
Speaker 3 (04:43):
Yeah, my favorite.
So honestly, for me that's onething.
If you use the terminologycorrectly.
That is actually clear.
So true stem cells cannot beused and without IRB approval
for a special indication inorthopedics today and a lot of
people, I think even orthopedicsurgeons are going to say like
(05:04):
what, everybody's using them,they're on all the billboards
and all the advertisements.
I see patients every week thatpaid X thousands of dollars for
stem cells.
But those are and we have touse the air quotes here.
Those are stem cells inquotation and they're not really
that.
And the problem is I think weget confused of you know what
(05:24):
basic science or eventranslational science tells us
about true mesenchymal stemcells, which are very powerful
little cells and can kind of doall the things that we hope to.
But again, based on current FDAregulations, we can't use those
(05:44):
.
But again, based on current FDAregulations, we can't use those
.
It's actually illegal to usemesingual stem cells in clinics
today without some specific IRBapproval.
And so the stem cells thatpeople are using, again in the
air quotes, don't have thatrobust evidence and a lot of
times they don't work.
And I think you know not toscare anybody or be, you know,
too hyperbolic here, but youknow we've definitely seen some
(06:06):
safety issues with the stemcells in quotation.
So, yeah, we focus on all theother ones that are much more
clear, I think, in terms of alegal, appropriate pathway, with
some evidence-based indicationsin level one and two studies
that can safely help people ifused as we should, not as we
(06:28):
just can.
Speaker 2 (06:30):
Right, right.
And I love when folks come insaying, well, I had stem cells,
and I'm like, wow, in the US,and they go, yeah, I go, that's
against the law.
Actually, does the Food andDrug Administration know about
that?
And their eyes get as big assaucers and what they really
meant was, you know, was PRP, orsomething like that.
Speaking of which, as you seeit, what's the current stand for
(06:53):
PRP?
Speaker 3 (06:54):
if you want to throw BMEC in there as well, yeah, I
mean that's definitely whatwe're using mostly in this area
of regenerative medicine.
Orthobiologics is PRP.
I think it definitely hasrobust evidence, especially in
certain indications.
I mean, I think, for mild tomoderate osteoarthritis.
We can be very confident inleuko-reduced platelet-rich
(07:17):
plasma, autogenous platelet-richplasma, as you know, being 70
plus percent likely to have goodpain mitigation and functional
improvements in patients, atleast with knee osteoarthritis.
And I think we can we canexpand that to some of the other
joints.
You know get about a 75, 70,75% successful response rate if
(07:41):
you will, for about six to ninemonths, I think.
Safety equivalent to placebo,so it's very safe.
It's one thing I love about PRPsuper safe.
And then efficacy.
I think you know in level onestudies more robust efficacy
than hyaluronic acid alone, andso that's definitely what.
I, if somebody says what is theevidence, kind of like you just
(08:03):
asked me, that's what I wouldsay from there, I think the
other indications are increasing.
So we use it a lot PRP fortendon hamstring epicondylitis,
you know those other indicationswhere we can jumpstart the
healing process, try to speed upthe healing process.
(08:24):
But also, then, what's coolabout PRP, right, is it's this
biological soup, and that's whatI.
You know, one thing you'veheard me say before and I try to
always add in theseconversations, is we're never
smarter than God.
And so I think you know, tryingto give a super physiologic
dose of one thing like back toyou know BMP or even HA, you
(08:46):
know those are basically superphysiologic doses of one
component of an incrediblycomplex healing joint health
metabolism process.
So what's cool about PRP is it'sway more than that.
Right, it's a soup of kind ofphysiological during the healing
process 1500 different proteinsin every little platelet.
And what's cool for us asorthopedic surgeons is a lot of
(09:08):
them are geared towardmusculoskeletal health and
healing anti-inflammatory,anti-nosusceptive,
anti-degradative, you know.
And so just along with them,the growth factors and the
things that stimulate healing.
And so it's just cool, it'scool to think about and it's
cool to try and harness that forthe benefit of the patient.
Speaker 2 (09:27):
Very good, that's a great overview on PRP.
What else is out there besidesPRP that's in your mind is
currently cool, acceptable, safeand effective in 2024?
Speaker 3 (09:39):
introduced, except for a chronic degenerative
process.
Because I think you know, weall know, we hopefully remember
from our physiology classes thatyou have to have inflammation
to get something to heal and soit's just the right type of
(10:01):
inflammation at the right time.
And these degenerativeprocesses, chronic ones
inflammation process hasactually failed to jumpstart the
healing process and so we kindof restarted in those.
So again, usually like adegenerative Achilles, you know,
maybe where there's somecalcification around a tendon or
calcification within the muscle, we might switch to the leuko
(10:22):
rich, so white blood cell high,containing PRP, to again
stimulate that process and useall the other parts of PRP to
try to get that going.
For me it's easy to then kindof get the algorithm so
Lugaridus, prp for everythingexcept degenerative processes,
except when the indication hasthe word bone in it.
(10:43):
So if the indication has theword bone in it so tendon to
bone healing, non-unionfractures, stress fractures, for
us the osteochondral allografttransplantation where we're
trying to get osteointegration,as soon as you say bone is the
primary thing in the indication,then we switch to bone marrow
aspect concentrate, so BMAC.
So again, at least for us it'sa simple algorithm that we go
(11:06):
through that way and the coolthing about that is then you can
really use the indications forlabel which also then means
insurance coverage prettyeffectively in those ways.
The only other thing that we'redoing quite honestly in this
arena is we are sometimescombining HA with PRP in the
joint.
(11:26):
I would say there's burgeoningemerging evidence for that
coming on.
It does make sense to mescientifically because HA is one
lubricant, right, that has someother properties, but it's
really.
Ha is really mostly forcartilage on soft tissue
lubrication in the joint.
Superficial zone.
(11:48):
Protein or lubricant is for thecartilage on cartilage
lubrication and what's coolabout that is PRP has a bunch of
that in.
So if we take advantage of theHA, which PRP does not have,
combine it with all the greatparts, including superficial
zone protein, lubricin and PRP,then maybe we're even
accentuating the PRP to themaximal level Safe and effective
(12:11):
.
The biggest thing there, Ithink, is it's a bigger
injection and probably insuranceis only going to cover the HA.
So you're going to have to goback to the self-pay part for
PRP, even if they would havecovered it for something else.
So that's the only, I think,thing we have to navigate when
we're trying to combine those.
But in terms of safety andefficacy.
We've been really happy withthat one navigate when we're
trying to combine those.
But in terms of safety, andefficacy we've been really happy
(12:32):
with that one.
You know I'm definitely keepingan eye on things like Amnion,
but I just, you know, haven'tseen the evidence yet and I'm
just not sure that when youbreak it down to its components,
at least for in the joint andthe primary musculoskeletal
indications that we typicallytalk about or reach for, or
regenerative orthopedics orbiologics, I'm just not sure the
(12:53):
components are really gearedtoward that.
You know, it's definitely not asdiverse of a composition as PRP
and it's really, you know, moreof a, I guess, early process
developmental.
I mean, that's where it isright, it's in the, it's in
utero or in the placenta, and so, you know, I just think it's
kind of geared toward adifferent thing.
I mean, that's why I would say,is it?
(13:14):
You know it's kind of funny wetalk about this topic, because I
think, you know, reallyregeneration is pretty
impossible once you're an adult,you know.
So what we're trying to thinkabout is more effective repair,
better remodeling, better tissuehealth, and so, again, that's
(13:35):
where I think, coming back tothe things like BMAC and PRP,
where it's geared toward healingtissues that have been damaged,
rather than developmentalbiology, if you will, it just
makes more sense to me in a realworld orthopedic practice.
Speaker 2 (13:52):
So that's very interesting.
So you touched on the amniotics.
Others like adipose.
There's a lot of other playersin the mix.
Any thoughts on any of thatmore fringy kind of restorative
stuff that's out there now?
Speaker 3 (14:08):
I really think those are all and this is opinion but
it's based on lack of evidence,I would say so everything I've
tried to say up until this pointwas based on evidence, clear
evidence.
Now I'm saying opinion based onlack of evidence and that
always scares me because it'sbeing used so so much.
But I think you know adiposederived stem cells, again in
(14:29):
quotations.
Even bone marrow derived stemcells, again in quotations, even
bone marrow derived stem cells,again in quotations For the
indications that we're talkingabout.
I just have not seen theevidence and we totally avoid
them Because the other reason is, I mean, without that evidence
they're all way more expensiveand zero covered by insurance
for orthopedic indications, zerocovered by insurance for
(14:53):
orthopedic indications.
So here let's just compare itstraight up, right PRP, you know
, I mean probably the most I'veseen for a single injection
around the country is around$1,200.
Cash pay here it's honestly thePRP part is $250 for a single
injection.
So even if you have that rangeand then you compare that to
what even in town here inColumbia, missouri, or what I've
(15:13):
seen across the country, ismore like about 1800 to I've
seen for a single injectionadvertised $11,000 for adipose
or bone marrow drive, stem cellsand quotations.
And then about 50% of our PRPsare covered by insurance now for
knee osteoarthritis and 0%across the US are covered for
(15:37):
stem cells by insurance.
Stem cells and quotation byinsurance.
I mean it just seems prettyclear, right Like you just stack
up those comparators and yousay, why would I do that?
Especially when, then, theefficacy evidence is completely
in favor of PRP or BMAC.
Speaker 2 (15:55):
I've got friends who unfortunately have got pretty
significant metastatic cancerand the oncologist here in the
US have basically said you knowyou're now in palliative care
and they don't want to give upyet.
So they have taken their life'sresources and gone to certain
(16:16):
countries outside the U?
S and paid for incredibletreatments and I'll put air
quotes on those that to dateevery one of those friends of
mine have had no benefit totheir cancerous and have died
from it, unfortunately.
But I've also been aware ofpatients who have left the
country in search of restorativebiologics and stuff.
(16:38):
Any thoughts on where that'sthe status of that is out there
currently?
in terms of outside of theUnited States, outside of the
developed probably the developedworld, you know, developed
Europe and such and other placeswhere we should be a little
wary.
Speaker 3 (16:54):
Yeah, that's it.
I mean, be wary for sure.
You know, the reallyfrustrating part to me about
this whole thing is truemesenchymal stem cells can have
amazing effects honestly,probably truly regenerative
effects in some applications andindications, when used
(17:14):
correctly and safely, and allthat.
So I don't want to throw thoseout and I think again every time
I just probably a nauseam, justsay like we really got to be
careful of semantics because,everything that we're using in
the us and unfortunately a lotof those other ones are the who
knows what, the stem cells andquotations and and potentially
very dangerous if and when andin some indications, when we or
(17:38):
other places in the world canuse true mesenchymal stem cells
that are shown to be that andyou have to show that by a bunch
of different scientific teststo say they're true mesenchymal
stem cells in some indicationsyou I think that can work.
I'll be honest with you.
You know I'd be hypocritical ifI wasn't saying this because
fortunately we're just part of abig ARPA-H grant that is using
(17:59):
stem cells to tissue engineerwhole joint replacement.
It's a moonshot.
I don't know if we'll get there, but I mean it's possible.
And wouldn't that be amazing ifwe're able to do that and truly
regenerate a whole joint orparts of a joint, that could
really move the pendulum, movethe needle in terms, under the
careful microscope no punintended of regulatory bodies
(18:35):
that are going to say likesafety first, man, I mean, and
especially, if nothing else,safety for your checkbook, right
?
I mean we've had people come tous that have spent over
$100,000 on stem cell injectionsor other regenerative
treatments, including in othercountries like you've talked
about and again, not only nobenefit but some of them had,
(18:55):
you know, inflammatory arthritis, immune mediated problems from
that, septic joints.
So it's just, it's, it's, it'sagain, it's just got.
We got to be super careful withit.
And I think you know, I don'tknow of any place that I could
say safely, does true, inside ofthis country, outside of this
(19:16):
country, you know, does thatsafely at this time point where
I would say like, yeah, it'sworth a try If you're at that
point like I'm going to lose myleg, I'm going to lose my joint,
I'm going to, you know, die ofcancer.
I still don't know of somewherewhere it's regulated enough but
cutting edge enough to say thatcompassionate humanitarian care
is worth it, if you will.
Speaker 2 (19:33):
Right, right, that'd be crazy if y'all could get
entire joint replacement justfrom not just from, but from
these restorative methods.
All right, which leads us tothe next part.
Where do you see this going?
And you could pick your futuretimeline, whatever you'd like it
to be 5, 10, whatever yearsahead.
Even further, what will thislook like in your and Jimmy
(19:53):
Cook's mind out there in thefuture, in terms of just the
direction you see, of how we'llend up?
Speaker 3 (20:01):
Yeah, I think I see two ways.
I mean one is, I think, justexpanding this current one,
because again, I do think wehave great arrows in the quiver.
I think PRP and BMAC are greatarrows in the quiver if you use
them well.
So I just like to get thosearrows clear and indication so
people are speaking the samelanguage, like when we say I
(20:22):
gave a PRp injection, what doesthat mean?
So we can compare apples toapples in different studies.
And then you know, also alongwith that is just get like
insurance companies.
It honestly kills me and Idon't.
I do get it because it's socomplicated, but at the same
time I don't because prp haslevel one evidence meta-analyses
that is better than ha, butinsurance companies will still
(20:45):
pay for HA, which is moreexpensive, and not PRP.
So I just say like, let's justget it pragmatic and practical
for the patient, like, and itstill benefits the insurance
companies, right.
So let's just get that wherewe're using the same thing,
we're talking about it in thesame way and we're getting it
paid for to help patients, whichwill move that part.
(21:06):
I think that will move thatarea vastly far forward, because
then we can do those studies,those registries that really say
like when does it work, whendoes it not work, what's can,
should and shouldn't in thisfrontier, and then we move off
the frontier.
We just know what we're doingfor patients.
The other part then is a thereally, you know, moonshot pie
in the sky, holy grail part,which is regenerating joints.
(21:29):
So I think, biological whetherthose are allografts, you know,
of different types, or trulytissue engineered regenerative
medicine I mean I think it'scool that ARPA has, you know,
put the money into saying likethis is crazy.
I'm like it's going to be thecoolest thing in the world if we
can do this, but let's give ita try, because we're going to
learn stuff and we're going tomove something forward.
(21:51):
You know, I mean you knowbetter than I do that metal and
plastic are awesome for theright patient.
I mean there's so, so, so manypeople that are happy with their
artificial joints and there'sso, so many people that aren't,
that want something different,right, and so I think if we can
just dial that in and havesomething that truly could be
(22:12):
regenerative or at least asjoint preserving, restorative as
possible to return function inthese young patients you know
that the average age forartificial joint replacement is
going down, which is a littlebit scary, and so trying to get
those two avenues going, I meanthat's my dream.
My dream would be that you knowbiologics are part of a
(22:36):
comprehensive care center inevery orthopedic institution and
everybody knows what can andcan't be done and what should
and shouldn't be done.
Speaker 2 (22:40):
In both of those realms- it's interesting because
part of what you're alsotalking about on the payer side
is there's a move, especiallyout of certain places like Texas
and Nashville, about moving offof procedural-based bundles and
onto diagnostic-based bundles.
So you could easily see in thefuture that this restorative
(23:02):
medicine would be part of a kneepain bundle where the
70-year-old with the destroyedknee goes on to total knee
arthroplasty and a 45-year-oldwith a big MFC injury could
enter the restorative side.
Speaker 3 (23:16):
Yes, yeah, I mean I would love that.
I mean that's exactly what Ienvision I think is the right
thing, right, I mean that's what?
And just those options thatpatients and you know healthcare
professionals understand whatthe options are and how they
would be cost and efficacy.
Effective, value-based, trulyvalue-based right Care moving
(23:36):
forward.
Speaker 2 (23:37):
Anything on meniscal transplants.
I know you work on that as well.
Anything, you see where that'sgoing.
Speaker 3 (23:42):
I mean, that's part of it for me.
I think we've really shiftedtoward viable, so fresh meniscus
transplants, and our earlyresults are showing that.
So again, the same kind ofthing like truly biologic, not
just a dead piece of tissue thatcan serve a biomechanical
function, which can be, good, ofcourse, but the truly
biological part.
You know I always say thatbiology and biomechanics are
(24:02):
inextricably linked inorthopedics and you really can't
have overall success withoutkind of combining those and
augmenting those together.
And so that's really what we'vetried to do, is take it to the
next level, truly make it abiological meniscus transplant
and a biological cartilagetransplant and hopefully let
those donor cells do their thingin the body and kind of keep it
(24:24):
longer term and more trulyfunctional in the joint.
Speaker 2 (24:29):
Any other futures and regenerative stuff that you're
thinking of?
Speaker 3 (24:33):
The only other thing I would say is I would like to
see like you were talking aboutis the truly cutting edge stuff,
but under a safety net.
So you know if we can, if wecan say this is high risk, but
you're fully informed, you knowit's maybe a humanitarian
situation, whether it's loss oflife or limb or loss of quality
of life Right, and say like,with all that fully informed,
(24:55):
under the guise of at leastsafety, you're taking more of a
risk on efficacy.
You know, let's, let's try thatin a center that's geared
toward this, that's going to dothe comprehensive patient care
that gives you the best chancefor that.
I would love to see that.
I mean it's difficult and risky.
You know both medical, legallyyou know, and just advocacy wise
.
But I think, if done right, youknow, like some of those, I
(25:18):
think about things like theCenter for the Intrepid Right.
You know that's trying crazystuff to save our amazing
veterans and service members'life and limb.
It would be cool to do that inthis area as well.
Speaker 2 (25:30):
Wow, it's been once again an absolute pleasure to
discuss restorative regenerativebiologics and surgery with Dr
Jimmy Cook, who is the directorof the Thompson Laboratory for
Regenerative Orthopedics atMizzou, working alongside all
the great orthopedic surgeonsout there at Missouri and trying
to find the restorative waysand the best ways for us to use
(25:51):
these new and interestingbiologics coming down the pike
and, if you haven't heard italready, Jimmy knows more about
this stuff than anybody I know.
So, Dr Cook, thank you onceagain so much for being on the
AOA podcast.
Speaker 3 (26:03):
Thank you, it was really fun and I learned a lot
too, so thanks.
Speaker 2 (26:05):
Thanks, Jimmy, All right y'all and stay tuned for
more futures in orthopedicsurgery in the podcast series by
the AOA.
Thank you.
Welcome to the AOA Future in Orthopedic Surgery
podcast series.
This AOA podcast series willfocus on the future in
orthopedic surgery and theimpact on leaders in our
profession.
These podcasts will focus onthe vast spectrum of change that
will occur as the futurereveals itself.
We will consider changes asthey occur in the domains of
(00:42):
culture, employment, technology,scope of practice, compensation
and other areas.
My name is Doug Lundy, host forthis podcast series.
Joining us today is Dr JimmyCook.
Jimmy Cook is a board-certifiedveterinarian.
He also has his PhD and is thedirector of the Thompson
(01:03):
Laboratory for RegenerativeOrthopedics and the director of
operations and research at theMizzou Bio Center and the
William C and Catherine E AllenDistinguished Chair in
Orthopedic Surgery at theUniversity of Missouri.
As I said, he's board certifiedby the American College of
Veterinary Surgeons and theAmerican College of Veterinary,
sports Medicine andRehabilitation.
He trained at the University ofMinnesota and the University of
(01:26):
Missouri.
His research interests arefocused on in vitro and in vivo
models, tissue engineering,osteoarthritis, meniscal
replacement and regeneration,articular cartilage, as well as
other areas.
I had the pleasure of meetingDr Cook at the Southeastern
Orthopedic Symposium run by DrJim Standard, and I was
(01:48):
immediately blown away byJimmy's incredible knowledge of
regenerative orthopedics, of PRP, bmac, of all that stuff that's
out there and the true natureof it.
So, dr Cook, sir, welcome tothe podcast series.
Speaker 3 (02:03):
Thanks so much for having me, Jimmy.
Speaker 2 (02:05):
you are also one of the nicest folks I've ever run
into.
Thank, sir, welcome to thepodcast series.
Thanks so much for having me,Jimmy.
You are also one of the nicestfolks I've ever run into.
Thank you so much for all thework that you do for our
patients and all theunderstanding on this.
Can you just give the audiencejust a overview of what your
work is, what your background isand how you got into this?
Speaker 3 (02:19):
Well, you gave a great intro, thanks.
I mean, I kind of came from theveterinary world and then went
over to now.
What I say is work on thetwo-leggers full-time.
And so, as you mentioned, jimStandard, a great friend of both
of ours and my chair, and justa wonderful clinician, scientist
and human being, brought meover here as we were kind of
developing this area, to behonest with you.
(02:39):
So both in the osteochondraltransplant and meniscal
transplant area of regenerativeorthopedics, but also in the
orthobiologics, and so we reallywanted to bring those forward
in an evidence-based way.
Certainly, we wanted to look atdiscovery and groundbreaking
cutting edge, but do it in areally thoughtful and, again,
evidence-based way.
Speaker 2 (03:01):
So can you give us an overlay of what the current
state is in the United States?
For, however you would define,I'm not going to put any any
parentheses on it.
I'll let you figure out.
You define for us whatregenerative orthopedics is.
What does that mean in the USand what are the current players
in that?
Speaker 3 (03:18):
Actually I think you said it and we're still in the
defining stage, right.
So I would say it's thefrontier stage which is good and
bad.
I mean, it's fun to be on thefrontier and you know we can
explore new directions.
But there's limited guardrails,and I think you know,
especially when we talk aboutpatient safety in combination
with efficacy and I always sayit's what we're trying to figure
(03:41):
out is what we can do, what weshould do and what we shouldn't
do, and I think that's reallywhere we're at.
So again, I mean, the FDAguidelines for what we can use
as indications are even notsuper specific.
They're these general kind ofminimally manipulated, not
combined with other substances,homologous use, administered
(04:04):
during the same procedures,collection.
But that's a little tough too,and so again, I think it's
really our responsibility, youknow, to define that for
ourselves and base that on thepatient, base that on best
current evidence.
But then that's also going tohelp us in the long run, because
the other, I think, difficultthing about the frontier era of
this is it's hard to getinsurance coverage right and you
(04:28):
don't want to just cash pay,cash pay, cash pay.
Number one, if it's not worthit, cost effective, but number
two we're never going to getinsurance coverage if we don't
kind of demand that based on theevidence.
Speaker 2 (04:40):
So we're talking about stem cells here, right?
Speaker 3 (04:43):
Yeah, my favorite.
So honestly, for me that's onething.
If you use the terminologycorrectly.
That is actually clear.
So true stem cells cannot beused and without IRB approval
for a special indication inorthopedics today and a lot of
people, I think even orthopedicsurgeons are going to say like
(05:04):
what, everybody's using them,they're on all the billboards
and all the advertisements.
I see patients every week thatpaid X thousands of dollars for
stem cells.
But those are and we have touse the air quotes here.
Those are stem cells inquotation and they're not really
that.
And the problem is I think weget confused of you know what
(05:24):
basic science or eventranslational science tells us
about true mesenchymal stemcells, which are very powerful
little cells and can kind of doall the things that we hope to.
But again, based on current FDAregulations, we can't use those
(05:44):
.
But again, based on current FDAregulations, we can't use those
.
It's actually illegal to usemesingual stem cells in clinics
today without some specific IRBapproval.
And so the stem cells thatpeople are using, again in the
air quotes, don't have thatrobust evidence and a lot of
times they don't work.
And I think you know not toscare anybody or be, you know,
too hyperbolic here, but youknow we've definitely seen some
(06:06):
safety issues with the stemcells in quotation.
So, yeah, we focus on all theother ones that are much more
clear, I think, in terms of alegal, appropriate pathway, with
some evidence-based indicationsin level one and two studies
that can safely help people ifused as we should, not as we
(06:28):
just can.
Speaker 2 (06:30):
Right, right.
And I love when folks come insaying, well, I had stem cells,
and I'm like, wow, in the US,and they go, yeah, I go, that's
against the law.
Actually, does the Food andDrug Administration know about
that?
And their eyes get as big assaucers and what they really
meant was, you know, was PRP, orsomething like that.
Speaking of which, as you seeit, what's the current stand for
(06:53):
PRP?
Speaker 3 (06:54):
if you want to throw BMEC in there as well, yeah, I
mean that's definitely whatwe're using mostly in this area
of regenerative medicine.
Orthobiologics is PRP.
I think it definitely hasrobust evidence, especially in
certain indications.
I mean, I think, for mild tomoderate osteoarthritis.
We can be very confident inleuko-reduced platelet-rich
(07:17):
plasma, autogenous platelet-richplasma, as you know, being 70
plus percent likely to have goodpain mitigation and functional
improvements in patients, atleast with knee osteoarthritis.
And I think we can we canexpand that to some of the other
joints.
You know get about a 75, 70,75% successful response rate if
(07:41):
you will, for about six to ninemonths, I think.
Safety equivalent to placebo,so it's very safe.
It's one thing I love about PRPsuper safe.
And then efficacy.
I think you know in level onestudies more robust efficacy
than hyaluronic acid alone, andso that's definitely what.
I, if somebody says what is theevidence, kind of like you just
(08:03):
asked me, that's what I wouldsay from there, I think the
other indications are increasing.
So we use it a lot PRP fortendon hamstring epicondylitis,
you know those other indicationswhere we can jumpstart the
healing process, try to speed upthe healing process.
(08:24):
But also, then, what's coolabout PRP, right, is it's this
biological soup, and that's whatI.
You know, one thing you'veheard me say before and I try to
always add in theseconversations, is we're never
smarter than God.
And so I think you know, tryingto give a super physiologic
dose of one thing like back toyou know BMP or even HA, you
(08:46):
know those are basically superphysiologic doses of one
component of an incrediblycomplex healing joint health
metabolism process.
So what's cool about PRP is it'sway more than that.
Right, it's a soup of kind ofphysiological during the healing
process 1500 different proteinsin every little platelet.
And what's cool for us asorthopedic surgeons is a lot of
(09:08):
them are geared towardmusculoskeletal health and
healing anti-inflammatory,anti-nosusceptive,
anti-degradative, you know.
And so just along with them,the growth factors and the
things that stimulate healing.
And so it's just cool, it'scool to think about and it's
cool to try and harness that forthe benefit of the patient.
Speaker 2 (09:27):
Very good, that's a great overview on PRP.
What else is out there besidesPRP that's in your mind is
currently cool, acceptable, safeand effective in 2024?
Speaker 3 (09:39):
introduced, except for a chronic degenerative
process.
Because I think you know, weall know, we hopefully remember
from our physiology classes thatyou have to have inflammation
to get something to heal and soit's just the right type of
(10:01):
inflammation at the right time.
And these degenerativeprocesses, chronic ones
inflammation process hasactually failed to jumpstart the
healing process and so we kindof restarted in those.
So again, usually like adegenerative Achilles, you know,
maybe where there's somecalcification around a tendon or
calcification within the muscle, we might switch to the leuko
(10:22):
rich, so white blood cell high,containing PRP, to again
stimulate that process and useall the other parts of PRP to
try to get that going.
For me it's easy to then kindof get the algorithm so
Lugaridus, prp for everythingexcept degenerative processes,
except when the indication hasthe word bone in it.
(10:43):
So if the indication has theword bone in it so tendon to
bone healing, non-unionfractures, stress fractures, for
us the osteochondral allografttransplantation where we're
trying to get osteointegration,as soon as you say bone is the
primary thing in the indication,then we switch to bone marrow
aspect concentrate, so BMAC.
So again, at least for us it'sa simple algorithm that we go
(11:06):
through that way and the coolthing about that is then you can
really use the indications forlabel which also then means
insurance coverage prettyeffectively in those ways.
The only other thing that we'redoing quite honestly in this
arena is we are sometimescombining HA with PRP in the
joint.
(11:26):
I would say there's burgeoningemerging evidence for that
coming on.
It does make sense to mescientifically because HA is one
lubricant, right, that has someother properties, but it's
really.
Ha is really mostly forcartilage on soft tissue
lubrication in the joint.
Superficial zone.
(11:48):
Protein or lubricant is for thecartilage on cartilage
lubrication and what's coolabout that is PRP has a bunch of
that in.
So if we take advantage of theHA, which PRP does not have,
combine it with all the greatparts, including superficial
zone protein, lubricin and PRP,then maybe we're even
accentuating the PRP to themaximal level Safe and effective
(12:11):
.
The biggest thing there, Ithink, is it's a bigger
injection and probably insuranceis only going to cover the HA.
So you're going to have to goback to the self-pay part for
PRP, even if they would havecovered it for something else.
So that's the only, I think,thing we have to navigate when
we're trying to combine those.
But in terms of safety andefficacy.
We've been really happy withthat one navigate when we're
trying to combine those.
But in terms of safety, andefficacy we've been really happy
(12:32):
with that one.
You know I'm definitely keepingan eye on things like Amnion,
but I just, you know, haven'tseen the evidence yet and I'm
just not sure that when youbreak it down to its components,
at least for in the joint andthe primary musculoskeletal
indications that we typicallytalk about or reach for, or
regenerative orthopedics orbiologics, I'm just not sure the
(12:53):
components are really gearedtoward that.
You know, it's definitely not asdiverse of a composition as PRP
and it's really, you know, moreof a, I guess, early process
developmental.
I mean, that's where it isright, it's in the, it's in
utero or in the placenta, and so, you know, I just think it's
kind of geared toward adifferent thing.
I mean, that's why I would say,is it?
(13:14):
You know it's kind of funny wetalk about this topic, because I
think, you know, reallyregeneration is pretty
impossible once you're an adult,you know.
So what we're trying to thinkabout is more effective repair,
better remodeling, better tissuehealth, and so, again, that's
(13:35):
where I think, coming back tothe things like BMAC and PRP,
where it's geared toward healingtissues that have been damaged,
rather than developmentalbiology, if you will, it just
makes more sense to me in a realworld orthopedic practice.
Speaker 2 (13:52):
So that's very interesting.
So you touched on the amniotics.
Others like adipose.
There's a lot of other playersin the mix.
Any thoughts on any of thatmore fringy kind of restorative
stuff that's out there now?
Speaker 3 (14:08):
I really think those are all and this is opinion but
it's based on lack of evidence,I would say so everything I've
tried to say up until this pointwas based on evidence, clear
evidence.
Now I'm saying opinion based onlack of evidence and that
always scares me because it'sbeing used so so much.
But I think you know adiposederived stem cells, again in
(14:29):
quotations.
Even bone marrow derived stemcells, again in quotations, even
bone marrow derived stem cells,again in quotations For the
indications that we're talkingabout.
I just have not seen theevidence and we totally avoid
them Because the other reason is, I mean, without that evidence
they're all way more expensiveand zero covered by insurance
for orthopedic indications, zerocovered by insurance for
(14:53):
orthopedic indications.
So here let's just compare itstraight up, right PRP, you know
, I mean probably the most I'veseen for a single injection
around the country is around$1,200.
Cash pay here it's honestly thePRP part is $250 for a single
injection.
So even if you have that rangeand then you compare that to
what even in town here inColumbia, missouri, or what I've
(15:13):
seen across the country, ismore like about 1800 to I've
seen for a single injectionadvertised $11,000 for adipose
or bone marrow drive, stem cellsand quotations.
And then about 50% of our PRPsare covered by insurance now for
knee osteoarthritis and 0%across the US are covered for
(15:37):
stem cells by insurance.
Stem cells and quotation byinsurance.
I mean it just seems prettyclear, right Like you just stack
up those comparators and yousay, why would I do that?
Especially when, then, theefficacy evidence is completely
in favor of PRP or BMAC.
Speaker 2 (15:55):
I've got friends who unfortunately have got pretty
significant metastatic cancerand the oncologist here in the
US have basically said you knowyou're now in palliative care
and they don't want to give upyet.
So they have taken their life'sresources and gone to certain
(16:16):
countries outside the U?
S and paid for incredibletreatments and I'll put air
quotes on those that to dateevery one of those friends of
mine have had no benefit totheir cancerous and have died
from it, unfortunately.
But I've also been aware ofpatients who have left the
country in search of restorativebiologics and stuff.
(16:38):
Any thoughts on where that'sthe status of that is out there
currently?
in terms of outside of theUnited States, outside of the
developed probably the developedworld, you know, developed
Europe and such and other placeswhere we should be a little
wary.
Speaker 3 (16:54):
Yeah, that's it.
I mean, be wary for sure.
You know, the reallyfrustrating part to me about
this whole thing is truemesenchymal stem cells can have
amazing effects honestly,probably truly regenerative
effects in some applications andindications, when used
(17:14):
correctly and safely, and allthat.
So I don't want to throw thoseout and I think again every time
I just probably a nauseam, justsay like we really got to be
careful of semantics because,everything that we're using in
the us and unfortunately a lotof those other ones are the who
knows what, the stem cells andquotations and and potentially
very dangerous if and when andin some indications, when we or
(17:38):
other places in the world canuse true mesenchymal stem cells
that are shown to be that andyou have to show that by a bunch
of different scientific teststo say they're true mesenchymal
stem cells in some indicationsyou I think that can work.
I'll be honest with you.
You know I'd be hypocritical ifI wasn't saying this because
fortunately we're just part of abig ARPA-H grant that is using
(17:59):
stem cells to tissue engineerwhole joint replacement.
It's a moonshot.
I don't know if we'll get there, but I mean it's possible.
And wouldn't that be amazing ifwe're able to do that and truly
regenerate a whole joint orparts of a joint, that could
really move the pendulum, movethe needle in terms, under the
careful microscope no punintended of regulatory bodies
(18:35):
that are going to say likesafety first, man, I mean, and
especially, if nothing else,safety for your checkbook, right
?
I mean we've had people come tous that have spent over
$100,000 on stem cell injectionsor other regenerative
treatments, including in othercountries like you've talked
about and again, not only nobenefit but some of them had,
(18:55):
you know, inflammatory arthritis, immune mediated problems from
that, septic joints.
So it's just, it's, it's, it'sagain, it's just got.
We got to be super careful withit.
And I think you know, I don'tknow of any place that I could
say safely, does true, inside ofthis country, outside of this
(19:16):
country, you know, does thatsafely at this time point where
I would say like, yeah, it'sworth a try If you're at that
point like I'm going to lose myleg, I'm going to lose my joint,
I'm going to, you know, die ofcancer.
I still don't know of somewherewhere it's regulated enough but
cutting edge enough to say thatcompassionate humanitarian care
is worth it, if you will.
Speaker 2 (19:33):
Right, right, that'd be crazy if y'all could get
entire joint replacement justfrom not just from, but from
these restorative methods.
All right, which leads us tothe next part.
Where do you see this going?
And you could pick your futuretimeline, whatever you'd like it
to be 5, 10, whatever yearsahead.
Even further, what will thislook like in your and Jimmy
(19:53):
Cook's mind out there in thefuture, in terms of just the
direction you see, of how we'llend up?
Speaker 3 (20:01):
Yeah, I think I see two ways.
I mean one is, I think, justexpanding this current one,
because again, I do think wehave great arrows in the quiver.
I think PRP and BMAC are greatarrows in the quiver if you use
them well.
So I just like to get thosearrows clear and indication so
people are speaking the samelanguage, like when we say I
(20:22):
gave a PRp injection, what doesthat mean?
So we can compare apples toapples in different studies.
And then you know, also alongwith that is just get like
insurance companies.
It honestly kills me and Idon't.
I do get it because it's socomplicated, but at the same
time I don't because prp haslevel one evidence meta-analyses
that is better than ha, butinsurance companies will still
(20:45):
pay for HA, which is moreexpensive, and not PRP.
So I just say like, let's justget it pragmatic and practical
for the patient, like, and itstill benefits the insurance
companies, right.
So let's just get that wherewe're using the same thing,
we're talking about it in thesame way and we're getting it
paid for to help patients, whichwill move that part.
(21:06):
I think that will move thatarea vastly far forward, because
then we can do those studies,those registries that really say
like when does it work, whendoes it not work, what's can,
should and shouldn't in thisfrontier, and then we move off
the frontier.
We just know what we're doingfor patients.
The other part then is a thereally, you know, moonshot pie
in the sky, holy grail part,which is regenerating joints.
(21:29):
So I think, biological whetherthose are allografts, you know,
of different types, or trulytissue engineered regenerative
medicine I mean I think it'scool that ARPA has, you know,
put the money into saying likethis is crazy.
I'm like it's going to be thecoolest thing in the world if we
can do this, but let's give ita try, because we're going to
learn stuff and we're going tomove something forward.
(21:51):
You know, I mean you knowbetter than I do that metal and
plastic are awesome for theright patient.
I mean there's so, so, so manypeople that are happy with their
artificial joints and there'sso, so many people that aren't,
that want something different,right, and so I think if we can
just dial that in and havesomething that truly could be
(22:12):
regenerative or at least asjoint preserving, restorative as
possible to return function inthese young patients you know
that the average age forartificial joint replacement is
going down, which is a littlebit scary, and so trying to get
those two avenues going, I meanthat's my dream.
My dream would be that you knowbiologics are part of a
(22:36):
comprehensive care center inevery orthopedic institution and
everybody knows what can andcan't be done and what should
and shouldn't be done.
Speaker 2 (22:40):
In both of those realms- it's interesting because
part of what you're alsotalking about on the payer side
is there's a move, especiallyout of certain places like Texas
and Nashville, about moving offof procedural-based bundles and
onto diagnostic-based bundles.
So you could easily see in thefuture that this restorative
(23:02):
medicine would be part of a kneepain bundle where the
70-year-old with the destroyedknee goes on to total knee
arthroplasty and a 45-year-oldwith a big MFC injury could
enter the restorative side.
Speaker 3 (23:16):
Yes, yeah, I mean I would love that.
I mean that's exactly what Ienvision I think is the right
thing, right, I mean that's what?
And just those options thatpatients and you know healthcare
professionals understand whatthe options are and how they
would be cost and efficacy.
Effective, value-based, trulyvalue-based right Care moving
(23:36):
forward.
Speaker 2 (23:37):
Anything on meniscal transplants.
I know you work on that as well.
Anything, you see where that'sgoing.
Speaker 3 (23:42):
I mean, that's part of it for me.
I think we've really shiftedtoward viable, so fresh meniscus
transplants, and our earlyresults are showing that.
So again, the same kind ofthing like truly biologic, not
just a dead piece of tissue thatcan serve a biomechanical
function, which can be, good, ofcourse, but the truly
biological part.
You know I always say thatbiology and biomechanics are
(24:02):
inextricably linked inorthopedics and you really can't
have overall success withoutkind of combining those and
augmenting those together.
And so that's really what we'vetried to do, is take it to the
next level, truly make it abiological meniscus transplant
and a biological cartilagetransplant and hopefully let
those donor cells do their thingin the body and kind of keep it
(24:24):
longer term and more trulyfunctional in the joint.
Speaker 2 (24:29):
Any other futures and regenerative stuff that you're
thinking of?
Speaker 3 (24:33):
The only other thing I would say is I would like to
see like you were talking aboutis the truly cutting edge stuff,
but under a safety net.
So you know if we can, if wecan say this is high risk, but
you're fully informed, you knowit's maybe a humanitarian
situation, whether it's loss oflife or limb or loss of quality
of life Right, and say like,with all that fully informed,
(24:55):
under the guise of at leastsafety, you're taking more of a
risk on efficacy.
You know, let's, let's try thatin a center that's geared
toward this, that's going to dothe comprehensive patient care
that gives you the best chancefor that.
I would love to see that.
I mean it's difficult and risky.
You know both medical, legallyyou know, and just advocacy wise
.
But I think, if done right, youknow, like some of those, I
(25:18):
think about things like theCenter for the Intrepid Right.
You know that's trying crazystuff to save our amazing
veterans and service members'life and limb.
It would be cool to do that inthis area as well.
Speaker 2 (25:30):
Wow, it's been once again an absolute pleasure to
discuss restorative regenerativebiologics and surgery with Dr
Jimmy Cook, who is the directorof the Thompson Laboratory for
Regenerative Orthopedics atMizzou, working alongside all
the great orthopedic surgeonsout there at Missouri and trying
to find the restorative waysand the best ways for us to use
(25:51):
these new and interestingbiologics coming down the pike
and, if you haven't heard italready, Jimmy knows more about
this stuff than anybody I know.
So, Dr Cook, thank you onceagain so much for being on the
AOA podcast.
Speaker 3 (26:03):
Thank you, it was really fun and I learned a lot
too, so thanks.
Speaker 2 (26:05):
Thanks, Jimmy, All right y'all and stay tuned for
more futures in orthopedicsurgery in the podcast series by
the AOA.
Thank you.
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