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<p>[QUOTE="Concerned Scientist, post: 2974740"]OK... I am really interested in this Osteocel Plus product. </p><p>1) what is the main difference from Osteocel. Is it just that you now have 250k MSC/cc up from 50k MSC/cc which is up from the prior claim of 10k MSC/cc and the original 1K MSC/cc? </p><p>2) Is it that for the first time the product is referred to as a DBM? The original tissue registration for Osteocel/Trinity mentions nothing of demineralized bone let alone cortical bone. The new Osteocel Plus package insert still fails to mention demineralized bone or even the term cortical bone. Why so deceptive? Is it because DBM products require 510K clearance now? And neither Nuvasive/Blackstone/Osiris has this clearance. I mean Accell tried to skirt the 510K clearance for awhile before finally playing the game only to find out that their "new" DBM was really just Dynagraft with a new name. </p><p><br /></p><p>This is smoke and mirrors. If in fact you got a DBM product and you add some "cells" to it. (By the way the package inserts only go so far as the "native cell population." Not once do they mention Mesenchymal stem cells. Even the original Osteocel brochure only mentioned the word stem cells in the logo of Osiris Therapeutics: A stem cell company.) We all know what a native amount of stem cells is in the human bone marrow 1-1.5k/cc at best. How do you get 50k-250k? Oh yeah, the concentration step in the manufacturing process. Wait isn't this minimally manipulated tissue? The bigger this gets the more attention it gets. A DBM product (if this is what it is) with artificially high stem cells for the native bone is a NEW product. We can skip the 510K clearance of pre-1976 like product and go straight to the PMA process. See you in a few years after you finally do some clinical research on using your actual product (not culture expanded stem cells) versus an actual control (a novel concept). </p><p><br /></p><p>Let's assume that it isn't a DBM (which still only offers those exposed BMPs to a minimal amount, like nanograms/cc) and that you still skirt the system be pooling your stem cells in the human donor and concentrating them. How many MSC are in the human body on average if you harvested every last piece of cancellous bone from the body? Recall that Osteocel Plus has 250k MSC/cc. Well a little math using 580cc of cancellous bone (the average amount in a human body and that assumes everything instead of just the pelvis, long bones, and vertebrae) and a high native amount of 1,000-1,500 MSC/cc (see Muschler et al and the original Trinity/Osteocel monograph - oh and by the way we are talking stem cells per 1 cc of cancellous bone not bone marrow aspirate numbers, which still only get to 2,300/cc because they draw bone marrow from more than just the immediate 1cc of bone graft), you only have 580K to 870K MSC per donor. So at 250K/cc you can get a maximum of 2.3-3.5cc of bone graft per donor. And since no donors are mixed. How could you ever have a 5, 10, or 15cc graft product size? Again there may be 250k/cc but they cannot all be MSC. If they are then you are culture exanding, and that definitely would be out of bounds, hence Osiris considering a Osteocel-XC product. </p><p><br /></p><p>Again smoke and mirrors. If Nuvasive/Osiris/Blackstone is going to make claims like 250k MSC/cc or that it is a DBM, then back it up. I wonder why you find no data on the Nuvasive webpage. What are they hiding? What has Osiris been hiding all these years? Get some real clinical studies and publish them in real journals. I will happily shut up if you can actually back up what your product is and end this marketing confusion nonsense that does nothing but hurt the patients the doctors care for in a lame attempt to get some sales revenue.[/QUOTE]</p><p><br /></p>
[QUOTE="Concerned Scientist, post: 2974740"]OK... I am really interested in this Osteocel Plus product. 1) what is the main difference from Osteocel. Is it just that you now have 250k MSC/cc up from 50k MSC/cc which is up from the prior claim of 10k MSC/cc and the original 1K MSC/cc? 2) Is it that for the first time the product is referred to as a DBM? The original tissue registration for Osteocel/Trinity mentions nothing of demineralized bone let alone cortical bone. The new Osteocel Plus package insert still fails to mention demineralized bone or even the term cortical bone. Why so deceptive? Is it because DBM products require 510K clearance now? And neither Nuvasive/Blackstone/Osiris has this clearance. I mean Accell tried to skirt the 510K clearance for awhile before finally playing the game only to find out that their "new" DBM was really just Dynagraft with a new name. This is smoke and mirrors. If in fact you got a DBM product and you add some "cells" to it. (By the way the package inserts only go so far as the "native cell population." Not once do they mention Mesenchymal stem cells. Even the original Osteocel brochure only mentioned the word stem cells in the logo of Osiris Therapeutics: A stem cell company.) We all know what a native amount of stem cells is in the human bone marrow 1-1.5k/cc at best. How do you get 50k-250k? Oh yeah, the concentration step in the manufacturing process. Wait isn't this minimally manipulated tissue? The bigger this gets the more attention it gets. A DBM product (if this is what it is) with artificially high stem cells for the native bone is a NEW product. We can skip the 510K clearance of pre-1976 like product and go straight to the PMA process. See you in a few years after you finally do some clinical research on using your actual product (not culture expanded stem cells) versus an actual control (a novel concept). Let's assume that it isn't a DBM (which still only offers those exposed BMPs to a minimal amount, like nanograms/cc) and that you still skirt the system be pooling your stem cells in the human donor and concentrating them. How many MSC are in the human body on average if you harvested every last piece of cancellous bone from the body? Recall that Osteocel Plus has 250k MSC/cc. Well a little math using 580cc of cancellous bone (the average amount in a human body and that assumes everything instead of just the pelvis, long bones, and vertebrae) and a high native amount of 1,000-1,500 MSC/cc (see Muschler et al and the original Trinity/Osteocel monograph - oh and by the way we are talking stem cells per 1 cc of cancellous bone not bone marrow aspirate numbers, which still only get to 2,300/cc because they draw bone marrow from more than just the immediate 1cc of bone graft), you only have 580K to 870K MSC per donor. So at 250K/cc you can get a maximum of 2.3-3.5cc of bone graft per donor. And since no donors are mixed. How could you ever have a 5, 10, or 15cc graft product size? Again there may be 250k/cc but they cannot all be MSC. If they are then you are culture exanding, and that definitely would be out of bounds, hence Osiris considering a Osteocel-XC product. Again smoke and mirrors. If Nuvasive/Osiris/Blackstone is going to make claims like 250k MSC/cc or that it is a DBM, then back it up. I wonder why you find no data on the Nuvasive webpage. What are they hiding? What has Osiris been hiding all these years? Get some real clinical studies and publish them in real journals. I will happily shut up if you can actually back up what your product is and end this marketing confusion nonsense that does nothing but hurt the patients the doctors care for in a lame attempt to get some sales revenue.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
Osteocell Plus vs. Trinity Evolution
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
Osteocell Plus vs. Trinity Evolution
>