Human Trials Announced for Adult Stem Cell Spinal Fusion
Keep in mind that this is a company press release, but I think it is worth noting just the same:Mesoblast, an Australian adult stem cell company, has received FDA approval for conducting a "Phase 2" trial using adult stem cells to treat spinal disk disease. If it works, it would accomplish what today requires spinal fusion surgery. And these cells are not from the patient but "off the shelf" products which have been bioengineered ahead of time. Interesting.
Phase 2 trials are conducted to obtain some preliminary data on the effectiveness of a therapy in patients with the disease or condition being treated. This phase of testing also helps determine the common short-term side effects and risks associated with the therapy. Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people.
Keep in mind that if the treatment works, and if it is safe--which is still to be finally determined--it would still have to complete Phase 3 trials, meaning that it will be years yet before the therapy will be available clinically. But it does show that adult stem cell research is progressing nicely.
One final point: The pure commerciality of this press release stands out for me, illustrating an issue about which I have decidedly mixed thoughts. Biotech today reminds me of the old wildcat oil drilling companies of the early 20th Century. It is a big treasure hunt--with the potential for very positive societal results. A few companies will get very rich, while most will go belly up or be swallowed whole by their competition.
This is pure market capitalism and it gives me pause. On one hand, it is all about money, money, money. On the other hand, the drive to get rich urges researchers on to achievements that might not otherwise be obtained. But, it can also stifle beneficial products from coming to market through patent disputes, hostile takeovers, and all of the other accoutrements of 21st Century capitalism.
I am not sure what balance I think ought to be struck in such matters--and, of course, this concern extends beyond stem cell research. This much I do believe: If public money supports research, there should be some form of public payoff.
posted by Wesley J. Smith @ 9:51 AM
2 Comments
2 Comments:
Oh, so it's not "widely available" everywhere yet? I guess it must be no good, then.
Just kidding. But that's the ESCR lobby's criterion for adult stem cells, while their embryonic research, which has provided far LESS reason for enthusiasm, is received far less questioningly.
bmmg39: Right. SCIENCE published a bogus letter from William Neaves of the STowers Institute against David Prentice. Stowers accused Prentice of fooling people into believing that 72 adult stem cell treatments were in regular clinical use, which David never did. And he and his co-authors asserted that there were far fewer in regular practice with FDA approval, which they appear to believe is what is required before research can be talked about. And as you point out, they don't apply it to ESCR, which has zero FDA approved human trials yet! Nor does the media. And so the double standard continues on.
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