Osteocell Plus vs. Trinity Evolution

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Anonymous said:
Who is Osiris?? They are only the inventors of this particular stem cell product. NuVasive now calls it Osteocel Plus. They have said they validate the new stem cell amount or throw the tissue away if does not meat the criteria. Orthofix only use to distribute the product. And Trinity evolution was just used for the first time in a patient in May I believe.

MTF has no experience on the unique and propietary way to harvest and maintain these MSC's in the tissue. So unless they completely ripped off Osiris's technique (which im sure will be followed by a lawsuit from Osiris and nuvasive) they have come up with some new and improved technique...which i highly doubt. A lawsuit will be coming along soon

Seriously, this is probably the dumbest fuckin statement on the entire thread.
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First, cell sorting is not novel or new. What was novel is the idea to sort out cells that do not have the potential to grow bone, combine it with a tissue structure, duck the fda and get it on the market. While brilliant, that is not something that you can patent. Any company can minimally manipulate (if it is that) tissue to remove unwanted cells, package it and sell it. The only thing that Osiris might have developed, and could protect, is a means to quickly identify unwanted cells. But, there are numerous ways to accomplish that objective without violating a patent.
 






I am outraged that there are not clinical trials to determine the safety and efficacy of many of these products, but especially trinity, osteocel plus, trinity evolution. As a patient advocate, patients should be well informed they are receiving human adult stem cells, not just "allograft". It is alarming that this product is being put in patients with so little due diligence or evaluation of evidence based literature to support its use. I am pleased to hear someone knowledgable challenge this.
 






I can understand your outrage regarding a product that has no clinical proving efficacy. However, those selling BMP's know the damaging effects of their product even though their clinical says otherwise. Trinity has an unfunded study in print that clearly shows its effectiveness in treating high risk patients that go on to fuse successfully with no complications. To say that Trinity has no "evidence based literature" is simply untrue. The science behind MSC's and stem cells in general, especially MuscleSP cells, is incredible and very well published. I agree that SURGEONS should be educating their patients on what they are about to implant, and that goes for ALL implants! For those of you who are uneducated regarding the use of MSC's for skeletal repair, I highly encourage you to read before you write. VIOXX was shown to be more effective than Celebrex in clinical trials too, but.....
 






Anonymous said:
I can understand your outrage regarding a product that has no clinical proving efficacy. However, those selling BMP's know the damaging effects of their product even though their clinical says otherwise. Trinity has an unfunded study in print that clearly shows its effectiveness in treating high risk patients that go on to fuse successfully with no complications. To say that Trinity has no "evidence based literature" is simply untrue. The science behind MSC's and stem cells in general, especially MuscleSP cells, is incredible and very well published. I agree that SURGEONS should be educating their patients on what they are about to implant, and that goes for ALL implants! For those of you who are uneducated regarding the use of MSC's for skeletal repair, I highly encourage you to read before you write. VIOXX was shown to be more effective than Celebrex in clinical trials too, but.....
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've represented BMP for many years, but I can't really say I've sold it. That is not to say that sales haven't grown, mostly through off-label applications, and yes I have profited from those sales. While the use of BMP has gotten out of hand over the past few years, and I have been uneasy to the point of confronting surgeons, I never knew, until this year the damage that BMP could produce when applied inappropriately. My past concerns have been cost and the unknown of safety and efficacy. These are the same concerns I have with bone growth products including stem cells, silicated kitty litter and stimulators. Until forced, no company is going to do the necessary science.

The solution is simple and it does not involve countless lawsuits or sending hard-working people to jail. First, all products, even tissue, should be required to be proven safe and effective. Companies can either pay the cost of such studies or through taking profits from non-labelled or off label and matching them with government spending to cover the cost of proving such.
 






Can you please provide the reference to the "unfunded study in print" on Trinity? It would be much helpful. Considering other recent articles that came up in JBJS.

Anonymous said:
I can understand your outrage regarding a product that has no clinical proving efficacy. However, those selling BMP's know the damaging effects of their product even though their clinical says otherwise. Trinity has an unfunded study in print that clearly shows its effectiveness in treating high risk patients that go on to fuse successfully with no complications. To say that Trinity has no "evidence based literature" is simply untrue. The science behind MSC's and stem cells in general, especially MuscleSP cells, is incredible and very well published. I agree that SURGEONS should be educating their patients on what they are about to implant, and that goes for ALL implants! For those of you who are uneducated regarding the use of MSC's for skeletal repair, I highly encourage you to read before you write. VIOXX was shown to be more effective than Celebrex in clinical trials too, but.....
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hahaha this is too funny watching this discourse concerning something that most of you know nothing about or the education to comprehend. The inquiry posed is legitimate. All the concerns are equally legitimate. I came upon this website trying to find unbiased information to suplement the diatribe provided by the sales reps. I have now made the conclussion that there is none!
 






I guess you have to have clever marketing to sell a $4k plus product that has no clinical data to back it's claims. I agree with the original poster...although it was slightly redundant after a while. Talk to some reps and ask them if they would have this stuff put inside them...Half of them don't even want the spinal hardware they sling implanted in themselves either. How do I know I'm not getting Joe Blow a 75 year old smoker implanted in me along with a plethora of other donors in the same batch. It is a cadaveric based product. If I am going to have surgery, I'd much rather use my own cells....at least I know where I've been! Lastly for the poster that mentioned the unfunded study and how the MSC's must be doing something because it's better than allograft...that's not saying much! Autograft is still the gold standard in most folks eyes and there are only 2 products on the market that have shown equivalence to autograft in prospective, peer-reviewed, Level 1, published clinical trials and I can assure you Osteocel and Trinity are not the 2.
 






I was offered a job selling Biologics for Nuvasive. Sounds like there is not a lot of profit in the Osteocell. Commission rates kinda suck. What do you think is a good rate for Osteocell for a seasoned rep with lots of Biologic business to bring?
Thanks for any help with this.
 


















Here's the recall details:

AlloSource—Osteocel Plus Cellular Bone Matrix: Donor
Tested Positive for Hepatitis B Core Antibody
Product Identifier:
1 cc Nuvasive Osteocel Plus Cellular Bone Matrix [Consumable]
Lot Nos.: 091327009, 091327103, 091327104, 091327105, 091327106, 091327107,
091327108, 091327110, 091327111, 091327112, 091327113, 091327114,
091327115, 091327116, 091327117, 091327118, 091327119, 091327120,
091327121, 091327122, 091327123, 091327124, 091327125, 091327126,
091327127, 091327128, 091327129, 091327130
Manufacturer: AlloSource [272068], 6278 S Troy Circle, Centennial, CO
80111-6422, United States
Problem: FDA states that the above bone matrix was recovered from a donor with a
positive hepatitis B core antibody serology result. FDA also states the manufacturer
initiated a recall by telephone call on April 7, 2009. FDA states that the recall is
complete. No further action is required of customers. The manufacturer has not
confirmed the information provided in the source material.
Regulatory Agency: Designation:
FDA Class II Recall No. B-1694-09, complete
 






I am no biologics wizard but recently spoke to a friend doing his PhD work (His 3rd PhD project) in Stem Cells. I asked him how well this new technology would do in the bone healing process. He began to laugh and said, "The companies are really marketing stem ceels for that?" He went on to tell me that in the knowledge of stem cells, we currently have little understanding. I asked him to explain what he meant. He said that we basically knocked on a door and when it opened we found the stem cell. He said now we have to go in to the house full of billions of stem cells, meet wach one of them, find out what they do and don't like, how they react to other factors whether currently known or still unknown and then try to figure out how to make them perform. In his eyes, he felt that it was similar to discovering the human dna strand. It took nearly 50 years to map and understand the human genome and we are still trying to figure out how to make it work in the human body. RHBMP2 is still only one factor and while it is a step in the right direction, I am confident that we will see other gene based therapies come to pass before we ever get a grip on Stem Cells. I dare anyone to engage a biologics rep in a serious conversation about how the Stem Cell (Osteocell, Trinity) works. Something tells me that if a PhD 3 lifleong researcher has no idea about how the Stem Cell is going to make an impact beyond marketing yet, then the Orthofix and Nuvasive reps are truly the best bullshitters in the game. I am not partial to one company or another, but RHBMP2 is the only product with true human retrospective, double blind, randomized, multi center studies. Something tells me that Orthofix and Nuvasive couldn't pass that mustard or they would have.
 






Sputter said:
I am no biologics wizard but recently spoke to a friend doing his PhD work (His 3rd PhD project) in Stem Cells. I asked him how well this new technology would do in the bone healing process. He began to laugh and said, "The companies are really marketing stem ceels for that?" He went on to tell me that in the knowledge of stem cells, we currently have little understanding. I asked him to explain what he meant. He said that we basically knocked on a door and when it opened we found the stem cell. He said now we have to go in to the house full of billions of stem cells, meet wach one of them, find out what they do and don't like, how they react to other factors whether currently known or still unknown and then try to figure out how to make them perform. In his eyes, he felt that it was similar to discovering the human dna strand. It took nearly 50 years to map and understand the human genome and we are still trying to figure out how to make it work in the human body. RHBMP2 is still only one factor and while it is a step in the right direction, I am confident that we will see other gene based therapies come to pass before we ever get a grip on Stem Cells. I dare anyone to engage a biologics rep in a serious conversation about how the Stem Cell (Osteocell, Trinity) works. Something tells me that if a PhD 3 lifleong researcher has no idea about how the Stem Cell is going to make an impact beyond marketing yet, then the Orthofix and Nuvasive reps are truly the best bullshitters in the game. I am not partial to one company or another, but RHBMP2 is the only product with true human retrospective, double blind, randomized, multi center studies. Something tells me that Orthofix and Nuvasive couldn't pass that mustard or they would have.
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When you get down to the bottom line, These products work and they're extremely safe (unlike RHBMP2). So doctors want them.

Do you know how InFuse works????? Neither do I, so Get over trying to figure it out. This technology is here to stay.
 






*** Prospective study participant for Trinity Evolution (et al). ***

I have a 3.5 year old injury C5-C7 herniations. I've gone to many doctors and read many blogs on spine technology. Sadly enough from where I sit ... the companies are selling, the reps are selling, and (God forbid) the surgeons are definitely selling too! And, if the FDA is anything like the Federal Reserve ... I might even wager that they're selling!!!

I know a rep for Stryker. Real conversations about his product to a friend seem counter productive to his mortgage payment. I think it's safe to say he wouldn't put a ceramic titanium disc in his mom. He did, however, discourage any rush to cut because he could only - truly endorse one Surgeon under the "if you must" clause. One surgeon out of literally dozens that he works with here in SoCal? SCARY! Sounds pretty inconsistent from the top down.

>>> If any of you neuro scientists/surgeons/students could answer the following it might help my quest: "Is my 3.5 year post herniation condition the ultimate plateau, or are there still possible beneficial results to look forward to should I proceed????" <<<

...... I ask because I am certainly not the man I used to be. Weird nerve cramps and spasms in left arm, fairly consistent numbness in fingers, fairly consistent migranes at the top of neck, possible hypermobility to left sided motions, loss of athletic prowess, and over all a bit gawd damn depressed after 3.5 years. Ugh.

(thanks).
 












Anonymous said:
I would like to get opinions based on something beside money
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It all comes down to relationships. Just ask the sales rep for osteocell in So Cal how her relationship with her boyfreind/surgeon built her sales. He called all the other surgeons for her and now indication or need isn't an issue. That's a an effective, but dirty, approach.
 


















Anonymous said:
Here's a novel idea..... How bout the fact that Blackstone/Orthofix absolutely built the stem cell market from the groud up in the past 3 years and might of picked up a few things along the way and might of helped MTF with the procurement process of the tissue. Why the hell to you think MTF partnered with Blackstone/Orthofix???

Nuvasive's days are numbered with an inferior product!!!!!
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I put by bet on Nuvasive. Better products mean more reps in the room, where the action actually happens...however, orthofix will still sell some stuff using their tried and true methods of paying docs and/or hiring large breasted bimbos.
 












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