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TOPIC: Are SC companies selling cellular junk?

Are SC companies selling cellular junk? 21 Oct 2013 06:36 #995

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The OSIR MSB deal led to a lot of discussion at the Cell Therapy Industry Group at Linkedn. The latest one- 75 posts!!!- was very interesting and centered around what type of product Grafix really is, but mainly discussed the issue of culturing in manufacturing conditions i.e. making 10.000 or even much more doses of product from one single healthy young donor. :cool:

I have never trusted that and kind of was inclined to believe Hedrick when he stated a while ago- autologous has the problem in variability of the patients cells, but allogeneic has the problem of POTENCY of the cells, which appears to be coming out in the luke warm clinical trials results so far.

Centeno wrote an article in his blog with HIS learnings from the discussions of which I add a few alinea´s here- my thinking is- at one tome MSB will become a great short and be careful with ATHX- do not load up too heavy or at least take note of this issue :winky:

Full article here : Selling Cellular Junk?????

Let’s return to our number 10,000. In fact, lets also add the number 100,000. These are the number of doses that most commercial cell therapy companies claim that they can grow from a single young donor. I knew this was an issue a few years back, because even on the best day, since these doses require 10-100 million cells each, we could only grow about 50 doses from a very young donor. Maybe, a real outstanding donor might grow 100 doses. However, how are these companies growing 10,000-100,000 doses? You guessed it, they’re growing the snot out of these cells. I learned this week, that most of these companies are routinely growing these cells to P6-P10! Yikes! This is the cell therapy equivalent of making someone slave in the mines for 22 hours a day! Almost all of the published research would point in the direction that by the time these cells exit the commercial culture process they are much less potent than they would have been if they had been grown to a more appropriate P2 or P3 stage. They are the cell therapy equivalent of using a copy machine to make a copy of a copy of a copy of a copy of a copy. The end result isn’t much like the original.

I’m sure many of these companies will argue that since they use young donors in the prime of their lives, this allows them to grow the heck out of these cells. While there may be a tiny kernel of truth in that argument, it really doesn’t hold water. In fact, a study from a large European University just showed much less clinical efficacy in treating transplant patients with young donor cells that were P3-P4 (grown much less than the commercial cells) versus P1-P2 cells. How big a difference? 75% of the patients who had the P1-P2 cells survived Graft vs. Host Disease (the severe rejection of an organ transplant) whereas only 21% of the patients who got P3-P4 cells lived! In context, these commercial cells are grown twice as long as the bad cells in this study. In addition, the medical literature is rife with studies that show that someone else’s cells are chewed up by the host’s immune system as they begin to differentiate into other cells-a hallmark of adult stem cells. So while you have the advantage of these off the shelf cells coming from a young donor, you have the disadvantage that they will get chewed up by the host patient’s immune system.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Are SC companies selling cellular junk? 23 Oct 2013 03:16 #1001

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Of course- not everybody agrees with Centeno on this issue and the general feeling is that everybody will have to wait until "the cell therapy fat lady starts to sing" :grin: :joy:

The (almost) last post in the thread I thought hit the nail pretty well:

Anytime more expensive solutions are pushed through the system when less expensive ones would have gotten the same result, that's very bad for medicine. We no longer live in a medical environment of unlimited budgets. On allo cells, if you mean that I said all are bad, I don't think that. To the extent that companies are sacrificing quality for the business plan, that is bad. Those companies are taking what should be a more powerful therapy (highly potent MSC lineage cells) and making them less potent and more susceptible to disruptive technologies from the bedside. Meaning if your cell could have been a 10/10 in short duration culture and you instead made it a 4/10 by growing the snot out of it-it's more likely to be supplanted in the marketplace by a bedside cell that's a 5/10.


I am convinced bedside will win and that the "efficacy scores" will be much clearer than 4/10 versus 5/10- but anyway- this potency issue with cultured cells will open folks eyes a bit sooner on the issue- Is my guess. :winky:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Are SC companies selling cellular junk? 23 Oct 2013 04:56 #1002

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and now - just in case, we are all not aware- that thing about the "fat lady" since I think this will be used more often going forward instead of our "time will tell"-

from Wikipedia:

It ain't over till (or until) the fat lady sings is a colloquialism. It means that one should not presume to know the outcome of an event which is still in progress. More specifically, the phrase is used when a situation is (or appears to be) nearing its conclusion. It cautions against assuming that the current state of an event is irreversible and clearly determines how or when the event will end. The phrase is most commonly used in association with organized competitions, particularly sports.
The phrase is generally understood to be referencing the stereotypically overweight sopranos of Grand Opera. The imagery of Richard Wagner's opera cycle Der Ring des Nibelungen and its last part, Götterdämmerung, is typically the one used in depictions accompanying reference to the phrase. The "fat lady" is the valkyrie Brünnhilde, who is traditionally presented as a very buxom lady with horned helmet, spear and round shield (although Brünnhilde in fact wears a winged helmet[citation needed]). Her aria lasts almost twenty minutes and leads directly to the end of the opera, though the character Hagen has one final line, "Zurück vom Ring!", to sing after Brünnhilde's death, and there is also a substantial orchestral finale.[1] As Götterdämmerung is about the end of the world (or at least the world of the Norse gods), in a very significant way "it is [all] over when the fat lady sings."

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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