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.