Based on the many questions that TSB receives on a weekly basis via e-mail, those of us that contribute to our blog site have decided that we will submit some of your questions to solicit your response on the current state of the art.
Today's questions:
Will Biologics ever eliminate the need for hardware?
Are Stem Cells an answer, or another step in the evolution of biologics?
And as a follow up, who has some of the best biologic platforms, and why?
As usual, thanks for your input, your voice needs to be heard.
Biologics in a basic form will not eliminate hardware because you always need to stabilize the effected area.
ReplyDeleteLocal harvest of stem cells is the most effective way but if a person has osteo issues they may need to look elsewhere.
Integra Lifesciences has an interesting offering because they seem to be pushing the envelope between their dbm and synthetic products. In the dbm arena, they seem to have the only 3rd generation product and in the synthetic world their collagen /tcp products have a great amount of usage although Orthovita has a greater market share today for just the category.
I truly feel that stem cells are a beginning of something...but what is that something! You need to be able to manipulate and control the condition of the cell as well as it's differentiating factors. How many reps out there really know how the cell becomes differentiated?? The words " stem cell" are being throw around the OR like crazy even from the most newbie rep. Most of the these products claim to have a huge amount of "native" cells in the product...what are "native" cells? RBC, WBC stem, adipose, what? The body just doesn't contain the amount of stems cell numbers some of the reps are speaking about...unless you use cross donors....which we all know where that goes! It is a promising technology but is being misinterpreted by the many who don't know what they are talking about....right now it is just a DBM with someone else's cells..can you say Hep B, Hep C etc. Nuvasive has already had a recall on osteocell b/c of Hep B!
ReplyDeleteSorry Annoymous Jan 18th. You are only partially correct. The stem cell based tissue products that are currently on the market contain only adult stem cells - that is the other cells that could cause an immune reaction have been removed. With respect to numbers of stem cells, yes it is possible to harvest over 50,000 live stem cells/cc from a cadaveric pelvis, and keep them alive until needed.
DeleteAlphatec's Puregen Stim Cell product claims it is immune privileged, so you would not have an immune response. Sounds promising, just too early to tell if the results are there for benefits in fusion/fusion rates.
ReplyDeleterhBMP-2 is still the only Biologic with Level 1 data to support its use as an autograft replacement. None of the other bone grafting products come close.
ReplyDeleteWhat does immune privileged mean? Sounds like another made up term by the companies marketing team! Any time an antigen enters the body there is an immune response....the cascade of bone healing is an immune response...
ReplyDeleteIncorrect my uneducated friend. Immune priveleged is not a marketing term it is a term taken from cellular science. Read a book or two.
Deletenutech is the shiznit.
ReplyDeletewhy da hell do i have ta click "post comment" like 3 -4 times before it axually publishes?
Nutech and BioDfactor are immune privileged!
ReplyDeleteAmniotic tissue is the next wave. Just ask your biologics director at your "legacy" companies.
"if you don't know, now you know TSB"
2 pac
8:50 - because you are clearly a moron, or trying to look like one.
ReplyDelete8:47
ReplyDeleteHow about the immune privilege means that they suppress a negative immune response, but rather evoke a positive response like the cascade of bone healing/formation.
There is a major regulatory gap here... Because stem cells only have to meet the 21CFR1271 guideline for minimally manipulated tissue for homologous use, there are no efficacy requirements or PMA requirements. In other words, all companies have to do is process the tissue in lines with the FDA requirements for processing, not necessarily prove the product does what it says it does...
ReplyDeleteTake from it what you will, but understand these products are not beholden to the typical evidence based medicine that virtually every other product in the bag is.
Biologics won't replace the role hardware plays, but over time they will replace the patients hardware treats. With improvements in diagnostics (god knows we need them) and the very low morbidity treatments like stem cells and gene therapy afford, in years to come they will be able to address many of the spinal pathologies earlier than we do currently.
ReplyDelete8:47 - immune privileged is not a marketing term. it's a well recognized condition that exists in various parts of the human body, such as the eye. in these areas the immune response to antigens is muted or absent.
ReplyDeleteto the questions posed, yes and YES. there is no question hardware will be obiated in the presence of appropriate and correctly deployed stem cells of some nature. needless to say, the state of MSCs is rudimentary. this question is akin to asking a trauma surgeon whether an IM rod will ever be replaced by a biologic. the answer is obvious but for some reason in spine we have a hard time translating that thought process.
when a biologic solution for restoring/maintaining spinal motion is discovered, the issue of fusion is moot. hands down, no combination of biologically inactive metal/plastic/whatever will ever provide a sustainable solution for restoring spinal motion.
9:20 - you're correct about the regulatory hurdles (of lack), but in the future the FDA won't be the gatekeepers to clinical use, at least not in any effective sense. it'll be CMS/payors demanding high level evidence of favorable cost-utility. Pharma Co. can amply all the cell lines it wants but if the patient's expected QALY doesn't increase post-op, no surgeon is going to take that $X hit to their bundled payment.
ReplyDelete8:52, that quote is by Biggie Smalls. If I ever wrongly attributed a quote from Biggie to Tu Pac, I would quit the internet forever.
ReplyDeleteHoly sh*t, my eyes still burn from reading that.
Osteotech is the only company out there with clinical data to prove it's claims. Integra, Apatech, and Stem cells have bullshit claims based on Zero Clinical Data. Apatech also uses stocking distributors without any quality control....Talk about unethical practices! Buyer Beware!
ReplyDeleteNuCel and BioDfactor are definitely SH#T. No cell characterization at all. Absolute rank ametoors.
ReplyDelete10:10
ReplyDeleteCouldn't have said it better myself!
ewww, apatech!! is that really true??
ReplyDeletei can't wait to tell all my potential customers that! that's dispicable. infidels!!!!!
i know out here in the south, that nucel and biod have been gaining ground over trinity and osteocell plus.
cells from living folks under age of 40 or use dead trinity osteocell bone with minimal stem cells. it actually sounds like an "easy" sell.
no pun intended.
hocus pocus
no other topic seems to produce individuals that have figured it all out. What makes people think they are some sort of cell biologist. The fact is even the cell biologist have a tough time figuring this stuff out and what will actually work when implant into another host. Hopefully someday someone will do a study with Autograft, BMP2, Apatech, Osteocel and Puragen within the same controlled study. Maybe then we can just let the science do the talking rather than biased opinion. It makes us look bad when we are willing to swear our product rocks compared to the others.
ReplyDeleteIt's only fitting that there is as much confusion over "biologics" for spinal fusion as there is for spinal fusion in general.
ReplyDeleteEventually, probably not in our lifetime, biological options will replace traditional spinal procedures. Unfortunately, if we don't collect real safety and efficacy data we wont know who/when to use them nor will we be allowed to use them.
ReplyDeleteWithout this data, we will have an amplified take on our current situation - numerous choices with no true means of differentiating products other than catchy branding and biased studies. We'll continue to develop new, innovative, minimally invasive techniques with no real improvement in patient outcomes.
Agreed that this is the most confused segment of our industry. Claims are rampant, particularly for minimally manipulated tissue. I once saw a Vitoss rep (early on) tell a doctor that it was the same thing as Infuse! I would be willing to bet that none of the synthetics would outperform ground cancellous bone (another minimally manipulated tissue) in a properly controlled independent study. We all know that BMP will grow bone, but those of us that have been around a while know that it is not without risks including cystic formation, ectopic bone growth (many that require revision to decompress the nerves), tissue swelling and others.
ReplyDeleteStem cells make sense intuitively because they will be used how the body needs them because the body will send the appropriate signals to differentiate them into whatever tissue it happens to need. In a spinal fusion model, they might turn into osteoblasts, scar tissue, muscle, skin or whatever else is needed in the area. Perhaps the best use of stem cells would be to stimulate their differentiation with a single drop of BMP to get them all started on the process to grow bone just prior to implantation.
Regarding the stem cell products out there, I can't imagine a surgeon believing that a cell harvested from a cadaver and kept in a freezer up to 5 years would have a single viable cell. Your body give a signal when you die that triggers all of the cells to die (apoptosis). Plus the fact that the average tissue donor is very old and the older you are, the fewer stem cells you have. These cells need to come from healthy live donors in a controlled setting and truly cryopreserved (-200C) to keep them viable. Once they ship out they will have a very limited shelf life at -80C. The 5 year shelf life on some of these products only refers to the sterility validation of the packaging, not the viability of the cells.
Hardware will always be around because even if someone discovers a pill that will stop or reverse degeneration, people will always ignore their health and let it get out of hand beyond what any biologic therapy can restore.
I think we are in for a wild ride on biologics, and it will be even wilder unless someone does some really good studies as mentioned by another poster. For now, "buddy putty" rules and the science be damned. The docs care more about handling than effectiveness. The only reason biologics have grown is because so many people are selling it now, not because it works.
Integra really? Really?
ReplyDeleteTHeir DBM is def at the bottom of the line. Look at the composition of the product.
What about incentivizing behavior to prevent problems from occurring in the first place? We Americans (patients, physicians, and industry) are so focused on treatment of problems after they become critical that we have lost sight of the real issue ........ Or, do we all have to buy into a fatalist mentality and believe that we just can't help ourselves as a species so we should just go for the #3 meal and biggie size it.
ReplyDeleteClinical data on osteotech...fine, who needs anything more, nothing too special about any DBM product out there. Apatech can also claim to have clinical data but it is based on studies done with bTCP and Novabone. Great marketing on their part. What's the beef with integra dbms 2:51? I think Progenix has had a few bad results though. Bottom line, docs want something to hold the allo bone and auto bone in place. Yes, BMP will grow what you want, Orthovita has no foot to stand on making those claims, just a designer bTCP. Hey, anybody actually know any facts about Puregen besides coming from living donors? As for BioD, etc, who knows, they've used amniotic tissue for years with good results. I'd like to hear from those who know, not somebody named professor dip-shit, please.
ReplyDeleteLifeNet is making some headway in the Southeast. They ran Allo-Source out of a few hospitals in the Charlotte area...their chips are currently stocked in 3-4 teaching hospitals in Raleigh-Durham area. Not sure what else they have?
ReplyDeleteI think its tough for a certain biologic to have staying power...other than BMP. And we thought having loyalty to a certain metal company was tough?
Perception is reality, but it seems like every week I see a new, drop dead gorgeous female biologic rep, who shows up trying to sell chips/putty etc...which isn't hard to do when you have unhappy neuro/ortho docs who are tired of seeing ugly metal male reps like myself for the past 9 years.
Check back in 6 months if my patient fused...that's if you're still around
Weak blog topic as it's redundant from just a few months ago:
ReplyDeletehttp://spineblogger.blogspot.com/2010/12/stem-cells-stems-cells-stem-cells-monty.html
How about something new to discuss instead of stem cells & continously picking on Globus?
2:51 here. Did you do your research on Integra DBM?
ReplyDeleteWhats the in it? Don't let the marketing pieces fool you. Do some digging, like any good rep should.
For any actually interested, the AAOS reviewed all of the published data on bone graft substitutes and published/presented their findings in March in New Orleans.
ReplyDeleteAccording to their review four products have level I clinical data: InFuse, Vitoss, OP-1, and Grafton.
Nothing beats InFuse. I know all about costs, but when used in appropriate dosage, the stuff fuses bone like gangbusters
ReplyDeleteIve actually seen some pretty impressive 6 month follow up films with Actifuse as well. I like the indication for PLF. Everyone else is just mish moshed with TCP, DMB, etc
The PLF indication was a fluke, story has it by the Apatech people on the inside that the FDA reviewer was leaving for another position and had to clear his desk of prior reviews, put his stamp on it without fully understanding. Go to the 510 K, get his name and see if he's still in that position. Nuff said. Besides, that impressive "fusion" on the 6 month follow up is HA, kind of hard to determine that from actual growth since it doesn't absorb for years.
ReplyDeleteCAN WE PLEASE HAVE AN ARTICLE ABOUT THE PENDING DISC REGENERATION TECHNOLOGIES ??
ReplyDeleteEVERY BIG COMPANY IS POURING TONS OF MONEY INTO THIS.
JNJ'S DIVISION OF REGERATIVE THERAPEUTICS WILL HAVE THIS OUT BY END OF NEXT YEAR.
I HOPE THIS SAVES OUR INDUSTRY.
Yes, there will be a disk regeneration product approved this year.
ReplyDeletePlease pass it down, that must be some pretty good shit you're smoking...
8:39,
ReplyDeleteIf you are referring to CAIS, JNJ isn't planning to submit that for approval until 2012. It's in Phase III right now, but just started enrolling late last year.
If you are talking about the product Intradiscal rhGDF-5 (worked on in collaboration with the same company, Advanced Technologies and Regenerative Medicine), it's still in Phase II. Which means it won't be around this year (or next, for that matter)...
Is there another disc regneration product in the works? Spinal Restoration (fibrin)? ISTO (chondrocytes)? Others?
9:30 Does Globus have any biologics? Maybe we could trash them both at the same time!
ReplyDeleteGlobus can telepathically fuse bone! No biologics needed!
ReplyDeletei stood in the OR all and now my back hurts.
ReplyDeleteI need an xlif cage with one stem cell in it. not two, just one.
5:29 what you speak of is an xtra xtra small stem cell kit and its only approved for OMF in gerbils so I cannot discuss here.
ReplyDeleteYes, Globus does have biologics, and they suck.
ReplyDeleteAs for this blog & the biologics topic in general, the field of biologics is all "hocus pocus" & B.S.
Just ask Drs. Polly & Kuklo.
What is the overall opinion of Scott Boden. He was once the grand wizard of all thing biologic, but I think he has spoken for at least 3 or more companies saying each one was the greatest. In my mind, his credibility went through the floor when he started doing paid speaking engagements for anybody that would pay him. His name is not as commonplace now, I assume, for that very reason. What credible docs are leading this arena?
ReplyDeleteI’d like to discuss Scott Boden and biologics. But first, I want to share some naïve ideas.
ReplyDeleteI’ve read a number of TSB strings now and this is my first response/submission. I like TSB and am glad I found it recently. I think there are a lot of informed folks on this site and I’ve come across some good, thoughtful opinions. Also, it’s one of the only sites where I can actually read and understand the language; spelling and grammatically correct English are archaic now, it seems.
Here it is though. I suggest that it would be better for the spine community at large (TSB blogsters included), if this TSB site was not used to drop unsubstantiated information, castigate surgeons or salespeople, and/or spread random, ugly opinions on some of these spine folks and companies, specifically by name. Certainly the whole idea of TSB is to share insights on people, companies, products, trends in Spine, the future of Biologics…but in a respectful manner? I just wonder about motivations when things get nasty and there are multiple blogs criticizing a specific company, person, or product. For example, I got the sense from the recent TSB string that Nuvasive was intentionally misleading and unethical in the promotion and use by reps in the OR of Neurovision. Was this a legitimate critique? Or did all of the blogs come from the same anonymous person, e.g. someone who’s competing/losing, or has some beef, with Nuvasive? It’s possible that Nuvasive would risk its whole existence on the potential liability of “reps touching patients” but I have to doubt that seriously. I don’t know enough about Nuvasive to have an opinion one way or the other, but after reading all of that string, I was thinking “Maybe I should steer clear of that company”. Then I realized how I had been led to a conclusion that could be totally unfair. I am just making a point – NOT interested in stirring up that same pot please. OK – I am getting off the soapbox – but I say this because I think it is important to not impugn someone’s character in a public forum like this.
About Scott Boden and leaders in biologics…I know a number of spine surgeons who are also good scientists and are well known in the biologics realm. Maybe in another post I will share my thoughts on the leaders in the biologics field. Yes Dr. Boden worked for a number of companies but he didn’t always say the nicest things about them all. I thought he was a straight shooter, critical thinker, a good scientist. He contributed a huge amount to biologics in spine fusion, and not just BMP-2. Of course he was instrumental in getting INFUSE through preclinical animal studies. He has been a little scarce over the last 3-4 years. My personal opinion is that Dr. Boden dropped out of the corporate funded biologics research world because it looked like the DOJ was going to be gunning for spine surgeons after they were done with the big ortho companies. I have no personal data or any 2nd hand information that Dr. Boden ever did anything illicit or non-compliant – please don’t read into this; I’m not making a connection. I just think he knew he might be a likely surgeon target of DOJ, being so high profile, and did not want to get dragged through the muck.
ReplyDeleteTom Einhorn, MD - BU Med Ctr -Boston- has extensive research in biologics. He is a trauma surgeon though, so our exposure is only at AAOS. very highly respected surgeon.
ReplyDeleteThe cell technology will certainly not come from any clinician. There is a whole new breed of scientist and emerging biologic companies who will take it from the bench to tech transfer.
ReplyDelete8:52
ReplyDeleteAgreed. I have found it somewhat disconcerting how little orthopedic surgeons know about bone healing. Of course, if you only talked to one, you would think that he knew it all (like he thinks), but their opinions are as varied as the reps for different companies. As someone already mentioned, it seems to be more about the handling than the material or the science behind it.
Really very nice blog and great discussion here..Thanks!
ReplyDeleteSurvey Questions
7:19,
ReplyDeleteYeah, that whole "science" thing that underlies biologics is just a bunch of hooey. Let's just fix the patients with a hammer and some nails...
Note the sarcasm here...
Agree with 8:52 and 7:41--it's amazing how little some people in this field understand about bone healing...
BioDlogics is pure shit ...technology is behind the times,no cell count,handling characteristics are a joke,Investors wont even use product.
ReplyDeletePresident is a crook who just gets investors money and doesn't pay them back.They will not be around very much longer.
I totally agree I know the people behind the products...the surgeons who put up the money are respectable other than that they are a bunch of crooks who wanted to sell and make millions...TOO LATE NOW !
ReplyDeleteBIO DISHONEST....HAAAAAAAAAAAAAAA
ReplyDelete