Osteocell Plus vs. Trinity Evolution

Can somebody please explain the difference?

 

You already know the answer to this question smart ass. Oh, let me guess.. your a surgeon on the Cafepharma board doing your due diligence in order to make a good prescribing decision for the best outcome for your patient? Ok..

 

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.

 

ok Medtronic boy!
You know a little too much about this product.. and at the same time dont know shit.
Go sell your litigtion juice on a sponge. Have fun on your depositions when the attorney asks you how you marketed your crap

 

Perhaps I am informed. Or perhaps I just drink the "koolaid." The point was for you to enlighten me not spit insults. Or is there nothing to say?

Is this forum for open discussion or just rhetoric and insults?

 

I'm curious about this too. How is it that Osiris can seemingly process a tissue and still not be required to do a regulatory submission? It doesn't seem like this is minimally manipulated- particularly if they are making claims of higher stem cell concentrations. Contrast this to a company like Harvest that is doing 510ks for centrifuges to prepare bone grafts.

It seems like all of these technologies should be in clinical trials- at least if they want to make claims about invoking the power of stem cells.

 

would somebody please just answer the flippin question above?

 

who said anything about increasing the "power" of the stem cells??

 

to : Concerned Scientist.

what is your opinion? what is best for the patient?

 

What I look for in a biologic product is what the FDA looks for with a pre-market approval: safety and efficacy.
Get some good safety data out there and prove the whole immunodepletion process. This part should be easy enough for these products.
The efficacy is the real killer. Get solid prospecitve, blinded, randomized clinical trials in spine out to the typical 24 month data point. Have a real clinical control studied in the study at the same time - no historical control.
Be truthful about exactly what it is: If there is DBM in it, then why does the package insert not state it (Osteocel Plus). If it has 250,000 stem cells/cc, then why does the package insert say native cell population (bone marrow has at the high end 1,500 stem cells/cc).

So far neither of these tissue products (the claim of DBM should push these products at least to a 510K if not really to a PMA process soon) meet my criteria of "would I put it in my own mother?"

At best it approaches a DBM like product, but there are several DBM products out there with better pre-clinical evidence than these two products, i.e. Osteotech Grafton, Medtronic Progenix, and perhaps Synthes DBX.

 

Mr. Concerned Scentist.....what is your purpose here? Who do you work for, and what is the reasoning behind your numerous posts objecting to the use of MSC's in skeletal surgery?

Oh, I get it.. your just like a watch dog looking out for the good people of this world.
Keep it up.

 

My purpose is honest dialogue and an attempt to understand better a product that hides behind a tissue registration and little evidence to support their claims. The patient loses in the end. And yes that is where my concern rests regardless.

No, you are wrong. I am not against the use of MSC's in surgery. I am very much in favor of it. IF it is proven out as beneficial to the patient. But so far (while you may claim that it is safe and does no harm), I would claim that a surgical failure does in fact do harm to that patient. Over reaching claims do nothing but confuse the market. The obvious 800 lb gorilla is BMP-2. It is not the end all answer to everything. But you got to hand it to them for how they did their study and continue to research regardless. They are just the big obvious example and other products and companies do this as well - not just for their own self interest but for the betterment of the patients. You are not selling used cars here, there are real people on those OR tables. If you cannot see that, then I hope the doctors you work with can see that in you and look elsewhere.

There are many advances coming with MSC's whether with basic research into various stem cell concepts, Mesoblast clinical trials with cultured stem cells, Osiris' original work with their cultured stem cell products. The Osteocel/Trinity products may grab hold of a similarity to Osiris' original work but they are not the same technology. I mean if MSC's were the only concern, then BMP-2 for all rights is a MSC product as well. It uses the body's own stem cells through attraction, reproduction, and change. DBMs have a small amount of BMPs and those interact with MSCs as well.

Of course, there are other bone grafting products out there as well from DBMs to ceramics etc. Many different indications and intended uses. If you are going to make statements like 250,000 MSC/cc after you came to market 4 years ago marketing the same product with the same outcome but you only had 1,000 MSC/cc. Then explain it. Explain how there would be enough MSCs naturally occurring even with concentrating them.

If you got no answer, then fair enough.

 

you state

"But you got to hand it to them for how they did their study and continue to research regardless. They are just the big obvious example and other products and companies do this as well - not just for their own self interest but for the betterment of the patients"

FOR THE BETTERMENT OF THE PATIENTS?

Oh really, where were they for the patient when every doc was sticking a large kit of BMP in a TLIF cage and did nothing about it when they know the TLIF study got halted due to eptopic bone growth?

Where were they for the patient when Boden was in front of a room of a thousand spine surgeons telling them how to dose it in the Posterior lateral gutters and how much to jam in a TLIF?

Where were they when they knew all of their reps where wearing out laser pointers in cases across the country pointing to the cervical spacer the tech needed to fill with BMP when they KNEW it was not indicated for this procedure!!!!????

I could go on forever on this one You lost allll credibility with your "betterment of the patient" statement. You either have your head in the sand or work for Medtronic.

 

BMP is but one example of a product with clinical studies for the "betterment of the patients"

The point is. Where are those same studies for Osteocel, etc.?

Much has been learned over the years since the first launch of BMP (both with BMP-2 and BMP-7) and it has all been addressed in package insert updates and letters to the doctors. You raise good points. However, the clinician drives and decides what is best for his patients, correct? They also do their own clinical research as well.

This discussion was merely using the big gorilla in the room as an example, I could have easily used Grafton as well.

This still has not answered the same point from the beginning: where is the clinical efficacy of Osteocel and what is the proof of how a 250,000 MSC/cc claim can be physically possible in a human donor regardless of concentration steps.

Going off on an example of a company who had to go through a decade of clinical and pre-clinical just to put the new product on the market is pointless. It just shows that you do not have an answer to the original question.

 

There has been a ton more research and papers done on Infuse. BMP products have been out longer than the newer MSC tissue products (Osteocel, trinity).

They are in the process of doing prospective studies looking at efficacy. I have had a chance to view many of the initial data compared to other grafting options..bmp, etc and the results are very exciting. Whether its 2 million per cc or a 10k, bottom line is if it is getting fusion results similar to BMP, than its an effective product. Definately more than regular allograft tissue alone, so the MSC's must be doing something.

 

The truth is that Osiris's Osteocel has done nothiing to their product but call it "PLUS" and state a new cell amount. Who is Osiris? Do they get their product from a Mortuary... Orthofix has signed a contract with MTF the biggest tissue bank in the country to produce their new Trinity Evolution.

 

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.

 

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!!!!!

 

Yeah they picked up a few things....proprietary technology and trade secrets! It wont be long before this will be in court.....trust me on that. Blackstone tried to acquire Osteocel however they didnt have enough money and tried to use their shitty stock to purchase. Osiris laughed in their faces.....great company right. its a reason why nuvasive is grown so fast.

And tell me how the product is inferior if even the trinity evolution product guide states that the product is the exact same as trinity. 250k msc per cc.

 

The comments before about working with a mortuary are made in reference to the very low standards set by the FDA for allograft and the only slightly higher standards set by the AATB. I don't think this was a specific reference to Osiris, but without published information about what types of screening they are doing to their tissue it leaves room for concern.