The osteoconductive substrate bone matrix is available in cancellous strips, dowels, cubes and particulate. Why adipose derived mesenchymal stem cells? If one believes what is reported, harvesting MSC from adipose is a much richer source per donor. This product can be utilized and applied in cages, fractures, non-unions, foot and ankle fusions. Is Allostem a legitimate threat to Osteocel and Trinity? Considering that Allostem has all the essential elements for natural bone regeneration does the industry have another player to contend with?
TSB wants to know what our readers think, and has anyone had any experience with this product?
what sort of clinical papers or data is out on this? And what is the pricing compared to trinity and osteocel. If papers exist and the pricing is good, sounds like it will compete nicely with the two products.
ReplyDeleteWho's distributing? We all know that tissue banks have a poor history of distribution
ReplyDeleteSo Allosource produces Osteocel for Nuvasive and has this on the side. Does Nuvasive sue them next?
ReplyDeleteTrinity has done a great job in my area by signing on docs to help them with internal studies and by doing so taking market share.
ReplyDeleteI have been hearing about some nonunions popping up. Mainly from competitors, anyone else hear this?
I do see the potiential in stem cell therapy, but until data is released, I will remain sceptical.
I hear Medtronic is working on a product called StemFuse. Mixing a DBM, Infuse, and Stem cells. Makes sense.
ReplyDeleteNobody has been able to explain yet how those magical cells should survive after implantation. If you know your biology, you know how long a cell can survive without blood supply, and how long it takes for new vessels to grow into a graft. The math is simple, except for maybe those cells close to the surface, most cells will die. And what do cells do that die? They release lytic enzymes that will help kill more cells. That explains why after all these years we still have not seen robust data of robust posterolateral blocks of bone, but only ACDF cases where almost anything goes. In the corridors of conferences one can pick up talk about fibrous tissue formation instead, which makes sense. It seems that for now these products are not much more than an expensive, but not more effective or safe, variation on allograft chips/DBM combinations.
ReplyDeleteIf Medtronic is developing such a product the brains in Memphis should be shot.
ReplyDeleteMedtronic WILL NOT be pushing any stem cell based products. Scientists there did investigate and found absolutely ZERO benefit and limited if any bone growth from Osteocel or Trinity in an in-house investigation. I feel for the monkeys in this experiment...I feel even worse for the doctors being sold a false bill of goods/sexy marketing material...and ever worse again for the non-suspecting humans that end up with that crap on board!!!
ReplyDeletePlease prove that Medtronic got their hands on Trinity Evolution or Osteocel Plus, and describe what "investigation" they did. I think by investigation, you mean "marketing." You're simply trying to hold the Medtronic name over the heads of the companies representing stem cell based allografts. So, "feel" for the patients that passed away from ectopic bone and retropharyngeal swelling post InFuse...
ReplyDeleteWith Allosource and MTF already in the market, Medtronic would not want to seek an inferior tissue banking partner, probably because they know they would be utilizing donors that have been refused by MTF.
We all know that Osteocel "plus" is simply the same as the first generation Trinity Matrix. Nuvasive's marketing team is good at chess, but check the patent numbers. It's the same as the old Trinity.
Allostem...those "seeded" adipose cells will be washing out upon irrigation. Not to mention, they're really pushing the limits of the "minimally manipulated tissue" aspect of allograft regulations by "seeding cells" to a matrix...
It's a fact that MTF has the largest donor recovery network in the country, along with the strictest donor selection criteria. That is why they are able to produce Trinity Evolution using donors that average thirty five years of age, none of which are over forty five. Why? At age forty five, humans undergo a cellular adipogenic switch, which predisposes MSC's to differentiate into adipose tissue, making it less likely that they will form new bone.
See the work of Dr. Arnold Caplan for more on the effects of aging on MSC's.
Cell viability post implantation...see the old baboon study performed with Trinity Matrix. believe that NuVasive now uses this for supporting Osteocel.
Watch for the data to come...Trinity Evolution will prove to be the superior tissue form. Except maybe for the fact that NuVasive does not have bone stims as an exclusion criteria for their studies. (Chess.) Trinity Evolution will have pure data, without the use of bone growth stimulators.
Thanks.
Thank you Keith..
ReplyDeleteCan you show me the way to the 'old baboon study'? Normal search strategies don't turn it up. They do turn up this:"Differential cell viability of chondrocytes and progenitor cells in tissue-engineered constructs following implantation into osteochondral defects", which makes for interesting reading. 'Watch for the data to come' (Chess, and BS). The data claimed was generated before 2006, and apparently still is not published. (Check, called the BS)
ReplyDeleteWho is Keith?
ReplyDeleteWhen I wrote, "watch for the data to come," I'm speaking of the current multi-center PMA studies being conducted by NuVa and Orthofix, so I don't understand your "chess and BS" comment.
Be more coherent in your replies.
The baboon study was conducted in 2005, yes, and it wasn't published. I didn't say it was my study, I said check it out...the labeled cells survived implantation and were viable at defect margins at 9, 16, and I believe 32 weeks.
What are PMA studies? Do you mean post-market? They certainly are not FDA sanctioned studies, as these products got on the market through the minimally manipulated tissue loophole, allowing them to be implanted with no evidence regarding safety and effectiveness whatsoever. There have been claims about ongoing studies by Osiris, Blackstone, Nuvasive and Orthofix for years, more than long enough to have some data presented somewhere by now. Instead, we experience the same deafening silence as with the long touted Actifuse vs. Infuse study. Except for those discussions far away from the podium, where surgeons admit to seeing a lot of fibrous tissue in larger stem cell grafts.
ReplyDeleteYou want me to be more coherent, I take you up on that invitation: My advice is that you should learn to read. In my earlier post I wrote "The math is simple, except for maybe those cells close to the surface, most cells will die." You write: "...the labeled cells survived implantation and were viable at defect margins." Obviously you find this confusing, so let me explain that we are describing the exact same phenomenon. The difference is you quote a baboon study nobody has seen, and I just used my common sense.
I trust you did look up the article on differential cell viability; it really is very informative.
To me the issue is not (necessarily) the age of the donor, but the time between death and harvesting of the blood. The other issue is the 5 year packaging with some of these products. These cells are not cryopreserved in a -80C freezer and most will be dead within months. To be cryopreserved, they need to be near -200C which cannot be achieved in a hospital setting. Another issue with Trinity and Osteocel is that they guarantee a certain count of cells, but not specifically stem cells, so you never know exacty which cells you get or if they are still alive. Bring the studies, its just snake oil until then.
ReplyDelete