Wednesday, December 8, 2010

Stem Cells, Stems Cells, Stem Cells.............. Monty Python and The Holy Grail

Recently there have been a rash of reports debating the efficacy of stem cells.  Even Robin Young  acknowledges having ownership in this technology, witnessed by the many articles that are dedicated to promoting stem cells on OTW.   It has been reported that stem cells are the ultimate therapeutic panacea for your biologic needs.  Some people are paying up to $7,500 to have their own stem cells harvested, and stored for future use, regardless, whether they really know anything about stem cells and how they can be used.  Of course, a nominal $70 per month storage fee is included.  There is no free lunch in America.  But as an industry insider, one has to wonder, is it too early to declare that some have found the fountain of youth?  Could this be a re-run of an old movie?  As usual, there are two sides to every debate.  Some scientists and physicians are taking a conservative approach, warning that there is a need for ongoing research to validating the efficacy of stems cells for various applications before we start singing hosanna's in praise of another technology.  TSB is not a skeptic.  I believe that software is the future of spine, yet, before hardware becomes passe, there is plenty of work to be done.  Please excuse my naivete, before we coronate stem cells ...........why the fuss?

By some estimates,  it is forecasted that the stem cell market has the potential to be a $250 million dollar market by the year 2015.  Hopefully, this forecast was not made by Tony Viscogliosi.  Like any new therapy, validating efficacy and outcomes will determine its success or failure, and we're not talking anecdotal evidence. The so-called experts claim that stem cells are an improvement over current biologics.  Yet, isn't the current technology that is being sold by NuVasive and Orthofix, old technology with a new marketing spin?  TSB believes that somewhere deep in the recess of those little stem cells, there may be answers to some of life's wonderful mysteries.  Spinal Cord injuries?  Brain Tumors?  Soft-Tissue Injuries?  Spine Surgery?  Trauma?   But before we continue the quest for the Holy Grail in spine, can some industry "experts" pull back on the onslaught of articles proclaiming that stem cells  regenerated another tail on the Kimodo Dragon, or that stem cells were found to have grown another head on an 8 year old boy in South Dakota.  That one was in the National Enquirer.  If we could dress up Robin Young in a togo, what a sight, and have him walk around NASS proclaiming, Stem Cells, Stem Cells, Stem Cells, he would be playing the role of Commodus in Gladiator at his coronation proclaiming to be the Emperor of Stem Cells.  The real pioneers are the people in the laboratories that persevere and  commit an endless amount of time and energy into finding how these little cells interact.

Alan Milinazzo was quoted in an article as saying; "The traditional rod and screw device implants are very invasive techniques, and if you can remove the need for hardware, that is a benefit, and biologics can play a big role in that."  No kidding Alan.  But I don't want to break your bubble, it's gonna take advancements in gene therapy before you start talking about removing the need for invasive surgery and the implantation of hardware.  What a pioneer.  The newest attempt is by Allosource. The company has launched its stem cell bone growth substitute derived from adipose tissue and cancellous bone that is processed and cryopreserved.   But here is a question for our readers, in times of economic distress, why are people donating tissue that others are making money off of?  Some claim that biologics is where the industry is heading.  That's quite the broad stroke of a brush.  What do some of these people think has been going on in the industry during the last ten years?  Of course there are wonderful opportunities to make money at the expense of others.

If adult MSC's are the future in biologics, then TSB has a simple question, why would someone want someone else's MSC?  If a surgeon could harvest a patients stem cells intra-operatively, and deliver them in real time, why isn't the industry looking for additional ways to contain cost, rather than driving up the cost of biologics.   At a time when the state of the U.S. healthcare market is in a total state of disarray, why are we looking to increase the cost of medicine?  Not to burst the bubble of any of the aforementioned visionaries, but hardware is not going away, anywhere soon.  As long as surgeons are performing invasive, or even minimally invasive surgery in hope of alleviating back pain, there will always be a need to provide structural support.  In closing, TSB must ask our readers, is this hype or is this the Holy Grail when it comes to spine?


  1. It's hype until a randomized, double blind controlled study is performed demonstrating safety and efficacy. Too many stories out there, soon to be way too many 'case studies' I'm sure and not enough real data. Cost is a significant issue with these products. Word in my firm is that Allosource hasn't co-marketed Allostem yet because of significant patent issues.

  2. TSB what are your thoughts on Alphatec's new stem cell, Puregen? From what I can tell the advantage to this stem cell is that it is a Live adult stem cell that is taken from live donors, not cadavers. Obviously they have limited studies available, but the product sounds pretty intriguing. One study shows 20% greater Osteocalcin production than MSC's after just 7 days. Just curious what your thoughts are?

  3. MSC's have been around for years and still no convincing data. As far as the Puregen hype,adult stem cells have fewer active cells. Amniotic stem cells have been used for years and could be the ticket. Jury's out, love to see the papers if any of these companies ever get the studies right.

  4. Aside from the fact that there is no real Level i clinical data on stem cells, and that there are inconsistent processing and cleaning methods with quite frankly a very low bar of quality, my problem with stem cells is that one day we will all wake-up and the stem cell industry will become regulated like BMPs. Its not there yet, but "minimal manipulation" can only go so far as it relates to allografts and adult donors. All it takes is another CryoLife fiasco with stem cells and quickly the regulatory loop holes that everyone is operating under will vanish. When that happens, dozens of the more than 100 stem cell companies will be out of business because the cost barriers and the regulatory barriers will be too high. Good luck trying to pick out which ones are making the right moves now for where this industry will be in 5 years.

  5. 100% hype,, PERIOD. OsteoCell, OsteoCell Plus, etc are no better than anything else that's currently on the market. All the companies that are selling these products have tried to do is capitalize on the complications seen w/ InFuse, while selling nothing more than a "spruced up" DBM concoction. While they tout how well they work in the c-spine (knowing that InFuse has seen major issues there), one must ask,, What doesn't work in the neck?
    Bottom line is that while stem cells may have a place in spine moving forward, touting them currently as the "holy grail" for fusion is nothing short of fraudalant.
    As for Robin Young and the way that he covers,, ummm "promotes" the industry,, well, I think TSB pretty much summed it up above.

  6. So far, it's mostly hype and very little substance. Note that all studies that measure alkaline phosphatase, osteocalcin and the like are IN-VITRO petri dish studies, where the living conditions of the cells are optimized and controlled. Very few data exist from IN-VIVO studies, and in these the animal model used, anatomical location of cell placement, quantity of cells used etcetera have very little to do with the conditions the cells will encounter when used in humans. That's why there are NO HUMAN data. A lot of work is still needed in the laboratory and animals before the promise of stem cells will be fulfilled in humans, and one day it will. Until then, spend your money wisely...

  7. Dressing up Robin Young in a cheerleader outfit seems more appropriate, however, for obvious reasons a toga is to be preferred...

  8. There is no substance to any of the posts that OTW publishes regarding stem cells. Are scientists and physicians studying and evaluating stem cells? yes. Are any of the products commercially available today, real innovation? no. At least not in spine. Why is it that the trauma and general ortho docs are less interested in using stem cells? Could it be that they are not as kooky as spine surgeons? Probably. Also they have been dealing with cost issues much longer than crazy spine doctors. JMHO.

  9. Studies have proven that a younger individual has more MSC's available for harvest than say that of a 60 year old patient. MSC's have the ability to differentiate into various tissue forms (muscle, ligaments, BONE). MSC's also have the ability to multiply.

    DBM's - they are osteoconductive with a little signaling power. What are they signaling??? MSC's and OPC's.

    BMP's - they lack the scaffolding requirement as well as the cellular requirement, but they do an excellent job of signaling the patients own biology to send MSC's and OPC's to the site to build bone. The issue is not only cost and reimbursement, but more importantly controlling where bone forms. Remember it's a sponge, and anytime you squeeze a sponge the liquid contained (BMP) will leak.

    Autograft was considered the gold standard for one reason - the harvested graft possessed all three properties needed for bone growth. The issue is the extra time needed to harvest and shape the graft. What is the cost of 1 min of OR time? Another issue is the cellular health of the patient. Age....smoker....diabetic...etc

    As a surgeon, it only makes sense for me to implant the cells needed directly at the fusion site instead of implanting a biologic to signal the same type of cells that may or may not be healthy.

    I've chosen the MTF product for three reasons:

    1. Cell Health - MTF has documented that the average age of their donors for this specific product is in the mid 30's. My Osteocel Plus rep does not have this documentation.

    2. Storage Requirements/Shelf Life - MTF control freezes their product to -180 degrees. Cell metabolism stops at -130. MTF validates each lot (donor) post cryopreservation for 70% cell viability. MTF's shelf life was once 3 months and is now 6 months. The literature on Osteocel Plus states that they store their product at -80 degrees and they have a 5 year shelf life. So you need to ask yourself, with cell metabolism still active at -80 degrees, how many cells are actually still alive at 3 months, 6 months, a year, two years, etc???

    3. MTF - I don't think many of you will argue that MTF is a very well respected tissue bank. I recently learned that they only accept 3% of their donors. Many of their rejected donors go to the various other tissue banks. What that tells me is if I were to use a tissue from another bank, then it was a donor that MTF rejected for one reason or another. Quite frankly, if I were on my table, I wouldn't want a piece of bone or any other form of biologic implanted from a rejected donor - period.

    I know there are a lot of good products out there. We've all heard that a plate is a plate and a screw is a screw. That true in many cases. With that said, what is changing and will continue to change is the biologic's used in operating procedures. I will continue to support MTF and their stem cell allograft until someone presents a better alternative. The science makes sense and I'm seeing the results within my practice, and that my friends is all that matters.

  10. Using stem cells in spine treatment for back pain is like giving your 16-yr old a ferrari to learn to drive. There should be more reasonable choices along the spectrum and the economic cost to achieve one's goal should be commensurate to the anticipated return. In other words, who's going to pay for it?

    To your point, stem cells may be the panacea for spine but in an embryonic state so how could one justify the R&D to determine whether stem cells will benefit spine when the standard of care has been so costly to the system, though the clinicial evidence to support the standare of care has been somewhat controversial. Has innovative exploration along the spine "spectrum of care" been so exhaustive that there's not a whole lot between fusion hardware and stem cells?

  11. What's the half life of a stem cell away from its host?

  12. 11:30 - why does it matter?

  13. From CFR 1271.10(a) Human cells, tissues, and cellular and tissue-based products:

    Subpart A--General Provisions Sec. 1271.10

    (a) An HCT/P is regulated solely under section 361 oof the PHS Act and the regulations in this part if it meets all of the following criteria:
    1) The HCT/P is minimally manipulated;
    2) The HCT/P is intended for holologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
    3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, perserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, perserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

    4) Either:
    (i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
    (ii) the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
    (a) is for autologous use.
    (b) is for allogeneic use in a first-degree or second-degree blood relative; or
    (c) is for reproductive use.


    Now for everybody to please interpret and opine - Which of the currently marketed "stem cell" "products" actually comply with section 361 as described above and therefore shouldn't be subject to full FDA review as a biologic?

  14. "If adult MSC's are the future in biologics, then TSB has a simple question, why would someone want someone else's MSC? If a surgeon could harvest a patients stem cells intra-operatively, and deliver them in real time, why isn't the industry looking for additional ways to contain cost, rather than driving up the cost of biologics. "

    Best point of the entire post. The products and devices DO exist to harvest the patient's own stem cells, but they are not used...


    $$$$$$$ and good marketing on the behalf of the biologic snake oil salesme.. *ahem* people. A 5CC dose is typically around $2,000 - and that EXCLUDES the carrier; it's no more than $1000 to harvest the patient's own cells. A one lvl PLIF could run upwards of $3500... at that point Hospitals are better off using Infuse and getting paid more.

  15. Well 11:34 if the half life is anything like that of say a red blood cell which has expired in around 100 to 120 days in the body. Then these companies are not going to have much time to collect process and deliver a viable cell are they

  16. The half life depends on many factors. Guess what the most critical factor of cell viability is? It is so obvious I won't even give it away here, except that without that factor stem cells will survive a few days at the most.

  17. Allograft: Take cadaver bone, wash it really well and sell it cheap.

    DBM: Take cadaver bone, wash it, digest it in acid, mix it with some sort of biocompatible polymer, and sell it for more.

    "Stem Cell Product": Take cadaver bone, sort-of wash it so you don't clean out all of the cells, freeze part of it, and sell it for almost as much as InFuse.


  18. great campfire tales from the army of stem cell "biologic experts" and hype machines such as Robin Young ... but all of the companies have the same problem.

    no data ... no data ... no data ... no data

    next topic please.

  19. the sin is that osteocell and trinity are cadaveric bone with very little if any stem cells, THAT IS DISGUSTING. HOW DID THEY MARKET THIS !!!!
    there are other technologies utilizing young ALIVE people cells with immediate processing (1 day) ..... but these companies are too small and cant fight the giants... never ever think mdt or nuva or any other big time company wants your awesome technology to succeed... in their marketing material they state that they get their bone from 60 yr old dead people... hello!!!!!! you dont have any stem cells worth using after you are 35 years old..... how do dr's not know this?!!? how does the fds not know this!!!!!!!! how the hell is this going on!!!!!!! it's like fools gold. i feel bad for the small companies right now

  20. This is all hilarious to me. I'm guessing none of you are selling this (but wish you were!) We've been using it in the neck and the lumbar for over a year now and guess what......... haven't had a non-union yet!! Sounds like a lot of jealousy that your companies don't have a stem cell product like we do!!! It's totally safe and it totally works. Get over it.

  21. i love the dr. who uses trinity, then sprays the patients own stems cells onto some vitoss, and mixes it all together. its amazing the hospital puts up with this voodoo.

    you know who you are, and should be ashamed of yourself.

  22. I can't wait to see the fusion data myself. Those of you writing that the currently available stem-cell based allografts are "spruced up DBM's" that need "carriers added" etc are going to have a hell of a time competing with the rest of us. I guess that's part of the reason we've grown our business so rapidly?

    To TSB's point regarding the harvesting of autologous cells- I agree. That's great and appropriate for younger (say, under 45) essentially healthy patients, but there's a ton of research published by those dedicated lab scientists that conclusively shows the quantity, quality, and mobilization capacity of MSC's and OPC's are drastically reduced with age. Surgeons already know this. Generally speaking, it's why younger people heal faster. After age 45, humans undergo a cellular adipogenic switch, which predisposes MSC's to differentiate into adipose tissue instead of bone. For those older, less healthy patients, it's a bonus if you can implant viable cells from young, healthy donors, directly where fusion is desired.
    The science already exists, but yes, human data is needed and on the way. It's been my experience that the surgeons involved in these studies have seen the results firsthand, and are pleased so far.

    These technologies are more expensive than DBM because it's far more sophisticated technology (two of them are anyway.) It's actually only about half the cost of Infuse, but it's safe. So yes, 1:00pm. BRILLIANT!

  23. Scientific data on the way, huh? You mean class 1? Or something else entirely like your product.

  24. The joke is that the institutions buy this stuff as the poor man's bmp. Company's and 3:37 sell this stuff as being as good as infuse without any real data. But it's cheaper, so they get away with it. The truth is, this is no better than a dbm, and when hospital's figure out they have been paying hyper inflated prices for something with equivalence to dbm. Then the market will be tainted for the real stem cell products.

  25. Stem Cell Therapy 800-842 1629. Limited supply now free. Dr Feder M.D.endorses it.

  26. Booooorrrrriiinnnnggg!

  27. Here's a little more dirt on Robin Young:

    He supposedly swindled a group of investors and surgeons into investing in his useless data mining company, Pearl Diver. He did so by claiming that the investment was explicitly for amniotic stem cell therapy that Pearl Diver had distribution rights to. Without anyone's knowledge or consent, he sold it off the technology to other implant and biologics companies for millions of dollars into his own pockets.

    This type of deceptive investment scheme is reminiscent of what the now incarcerated Bernie Madhoff pulled on his so called friends. The word on the street is that the investors are considering a lawsuit against Robin et al, or at the very least, exposing his spinal 'ponzi scheme' publicly. This type of securities/investment advisor fraud is stuff you read about in the Wall Street Journal, not on Orthopedics This Week, and should be rightly exposed.

    This guy clearly runs an on-line journal covering the orthopedic and spine sectors to push his own products and agendas. Just look at the OTW Spine Awards at NASS -- what a joke. He has lost his credibility in our industry and simply can not be trusted any longer.

  28. 5:21 Robin's Pearl Diver company is co-located with the VBros MCRA company in Wash, DC. Thats a marriage.

  29. The question is does anyone have the gonads to finally bring this entire charade to an end? Stem Cells, Stem Cells, Stem Cells. What a crock of Robin Young propaganda.

  30. To 3.37. "We've been using it for over a year and have not seen a non-union." That creates the impression you're a surgeon, but I have my doubts. If so, let me give you a little basic lessons so you can treat your patients the way they should be treated. First, in ACDFs almost any graft material works, so using cells at 500 dollars a cc is criminal overkill, should they work in the first place. Second, if you have been using it for a little over a year, how many patients with lumbar procedures actually have 12 months follow-up? Five, 10, 15, 20? If more than 20, you probably operate on any passer-by. Were they interbodies? If you keep abreast of the literature, and know how to sieve out the few articles that have not been blatantly paid for, you should know that interbody fusions in healthy and younger patients also don't need Infuse or cells to get 96 to 98% fusion rates. That is, if you know how to actually prepare the endplates properly, which is not a given. If they were posterolateral fusions, you may have seen a little thin sheet of bone forming on the outside of these precious cells, and of course that is the radiological sign you swear by. Closer inspection, which you will get the opportunity for when they come back with new pain because they did not need this procedure in the first place, will show you that beyond that little sheet of mechanically insignificant bone the rest of the cells have turned into functionless unorganized fibrous 'tissue'. You say "its totally safe and it totally works. Get over it" I know you will 'get over it' when the truth comes out, your money is already in the bank. I hope your patients do too.

  31. Well your friends with their fancy persuasions
    Don't admit that its part of a scheme
    But I can't help but have my suspicions
    'Cause I ain't quite as dumb as I seem

    How long has this been goin' on

  32. To 3:37.

    "We've been using it in the neck and the lumbar for over a year now and guess what......... haven't had a non-union yet!! "

    This screams for a rebuttal, without the need for guessing. You imply you're a surgeon, and although that is doubtful given the rara nature of your post, let's assume that's true.

    #1: In ACDFs almost every graft material works. Adding these cells at 500 dollar a cc could be considered criminal overkill.

    #2: In lumbar fusion results are judged at 12 or 24 months. How many of your lumbar patients are at 12 months? If there are more than 20 it means you operate an awful lot of patients, but hat still is a low number to judge a product on.

    #3: If the lumbar patients were interbody procedures, you could have learned from the few articles out there that are not completely commercially driven that in the bulk of patients, who are in their mid 40s and otherwise healthy, autograft and other (cheaper) grafts result in 95 to 98% fusion rates. That is, if you do a proper endplate preparation, which admittedly not everybody seems capable of.

    #4: If the cells were used for posterolateral fusions, there may appear a thin sheet of mechanically insignificant bone on the outside of the graft, which probably gives you the radiological sign of fusion you're looking for. Upon closer inspection, which you or one of your competitors will get the opportunity for when the patient comes back with new complaints, you will find that beyond this sheet the rest of the cells have turned into non-functional, unorganized fibrous 'tissue'.

    "It's totally safe and it totally works. Get over it." Given the superficial nature of your post, it's safe to assume that when the truth comes out, you will get over it. Hopefully your patients do as well.

  33. Someone likes Donny Osmond!

  34. I believe that an old English band named Ace actually sang those lyrics, as for Donny Osmond .... And they call it puppy love.......I'm sure you can fill in the rest

  35. Caution - may induce sleepiness and a strong desire to sing love songs with your sister -

  36. I've spoken with many Surgeons who are currently using or have used Osteocel and Trinity. From what I see, if they have financial ties to Nuvasive, they will use the product. If they don't, they use it for a month, track their results, see nothing extraordinary and stop using it. Even the Surgeons with financial ties seem to be mixing with a scaffold. I have yet to hear that Osteocel is working any better than a ceramic, much less autograft or infuse. Marketing, pure and simple.