Osteocel is a bone matrix, (a point of origin), that preserves stem cells found in bone marrow. These cells are harvested from a donor (within the first 72 hours), processed by demineralization and usually combined with a milled femoral head (remember the good old days when surgeons did that in the OR). The controversy surrounding both Trinity and Osteocel, is how many viable stem cells are delivered in each dose? Meaning how many have survived the harvesting process and the cleansing which in itself is an incredible purification process?
Trinity is marketed as an allograft product that has been processed (demineralized), from a deceased donor, resulting in a source of cells. It all starts to sound similar. Allogenic stem cells carry with them all the safety issues of any allograft product. The donors have to be adequately screened, cells must be tested for the presence of any virus or bacteria while the principal safety concern is the risk of tissue mismatch or infection in the recipient. Just like Osteocel, the controversy surrounding Trinity also centers around how many stem cells are viable or alive when delivered in each dose at the point of delivery. If Orthofix/Blackstone claims > 50,000 MSC/cc would that mean that there are 250,000 MSC in a 5cc dose? Are they all alive?????
Are physicians questioning any of these claims?
Marketing is a wonderful art. Unfortunately, when it comes down to these two products it's all show, all dough, and all anyone can say is STEM CELLS. Whenever I hear Osteocel Plus, I always wonder if that is the equivalent of pulling up to the Sunoco station and asking for the Ultra. Are you willing to pay more to get the same performance. The Spine Blogger wants to know what our readers think about these products!
Once upon a time, Osteocel and Trinity were the exact same product, co-marketed under different names by Osiris and Blackstone. Osiris sells Osteocel to Nuvasive, Nuvasive cuts Blackstone out, goes to Allosource for supplies and rebrands Osteocel to Osteocel Plus. So Blackstone goes to MTF, and voila, Trinity Evolution. Osiris experiences regrets, or no longer has an outlet for what it produces, and announces they will re-enter the fray with a new line called XC (as rugged as a Volvo?). Confused? That's probably because so far there is a lot of spin, and very little data. Back to the question, are there cells and are they alive? In all likelihood there are cells, quite a few are probably alive at time zero, but very few if any will survive for long following implantation as part of a larger graft. You know, cells also need food and air... So, after all this, what is left? Nobody knows for sure, but it could very well be a very expensive mix of allograft chips and DBM, loaded with a lot of lytic enzymes waiting to be released.
ReplyDeleteThere are currently 3 studies being conducted simultaneously with Trinity Evolution. Surgeons I've worked with are very happy with their results. Everyone I've introduced TE to has continued using it, and I've even converted a few osteocel accounts as a result of MTF's longstanding quality record and the value provided with TE as the second generation product. I agree with cells needing air and food, and the process MTF has noted for thawing TE provides exactly that. Bottom line - fusion is what spine fusion surgery is all about, and I've seen it occur without any complications when surgeons have used TE.
ReplyDeleteAnd TE has been available how long? Since May 09 in limited release, all of 3 months?? So what 'results' are they happy with???Please, we're trying to have a scientific discussion here, not a a sales pitch......
ReplyDeleteIf its a DBM, where is the 510k? If it is a DBM with stem cells, then its a new product, where is the PMA? What is the loop hole here? Is there any Data at all? Ive talked to both reps who can't explain the "proprietary process" of obatining these stem cells.
ReplyDeleteBetter question, what is the signal? What makes these cells turn?
here's the answer straight from the FAQ's: What is regulatory status of Trinity Evolution? TE is an allograft, registered by the FDA solely as human cellular tissue product (HCT/P) under 21 CFR Part 1271.
ReplyDeleteJosie, this is minimally manipulated donor tissue. Main controls are based on voluntary guidelines of tissue banks. Huge loop hole. There is not much propietary about harvesting bone marrow from a recently expired human being. The propietary claim is about how the cells that are immunogenic and which would cause rejection are selectively removed. Good story, publicly presented evidence so far very thin. Clinical results where it counts -that is lumbar, not just cervical- as discussed in the corridors at meetings: not so hot.
ReplyDeleteRECALL ALERT - Osteocel Plus Cellular Bone Matrix, 1cc Nuvasive. Recall # B-1694-09 AlloSource initiated recall by telephone on April 07, 2009. REASON - Osteocel Plus Ceullular Bone Matrix, recovered from a donor with a positive Hepatitis B core Antibody serology result, was distributed.
ReplyDeletehttp://www.fda.gov/Safety/Recalls/EnforcementReports/ucm187541.htm
How come no comment on all the new stem cell based products? Allosource that processes for Nuvasive launched Allostem which consists of fat derived MSCs bound to cancellous matrix. Certainly won't meet the 21CFR1271 requirement for an allograft being minamilly manipulated and for homologous use. Think Nuvasive will get ticked off as well?
ReplyDeleteHow can you possibly be so positive about the
ReplyDeleteSpine Technology Awards. The only person who benefited is Robin Young raking in the bucks. The judges didn't see the candidate entries until 30 min before the awards. Allowing PEEK as an entry? Come on, might as well enter the wheel.