I recently ran across a press release which identified a business relationship I found interesting. Apparently, the Canadian company Chemaphor, maker of the nutritional supplement Oximunol which I have discussed in the past, has entered into a licensing arrangement with Vet Stem, an American company marketing fat-derived stem cells in animals as a treatment for arthritis and other orthopedic problems as well as, potentially, just about any other disease under the sun. This will make it possible for the Vet Stem process to be marketed in Canada.
I haven’t addressed the Vet Stem marketing issue directly here, but I’ve been involved in some discussions on the subject elsewhere. As I pointed out in my recent post about stem cell therapy in general, the approach has significant biologic plausibility and some supportive in vitro and animal model evidence to suggest it may someday be a valuable clinical therapy. Unfortunately, the selling of it as a product for humans and, primarily via Vet Stem, for pets, is far out in front of the evidence that this hope will be borne out in the real world. For example, the only clinical research I have yet found concerning autologous fat-derived stem cell treatment for dogs is two papers, both funded by Vet Stem.
1. Black, L. L., Gaynor, J., Adams, C., Dhupa, S., Sams, A. E., Taylor, R., et al. (2008). Effect of intraarticular injection of autologous adipose-derived mesenchymal stem and regenerative cells on clinical signs of chronic osteoarthritis of the elbow joint in dogs. Veterinary Therapeutics : Research in Applied Veterinary Medicine, 9(3), 192-200.
2. Black, L. L., Gaynor, J., Gahring, D., Adams, C., Aron, D., Harman, S., et al. (2007). Effect of adipose-derived mesenchymal stem and regenerative cells on lameness in dogs with chronic osteoarthritis of the coxofemoral joints: A randomized, double-blinded, multicenter, controlled trial. Veterinary Therapeutics : Research in Applied Veterinary Medicine, 8(4), 272-284.
The first lacked a placebo or standard treatment control, blinding, and randomization, so it essentially amounted to an uncontrolled case series funded and evaluated by the company selling the therapy. Both investigator and owner subjective evaluations showed changes in some measures, up to about 30-40% improvement at the most. This cannot be distinguished from a non-specific experimental effect with this design.
The second was reported as a double-blinded, placebo controlled randomized study, though the details of these controls were not reported. There was a 14% dropout, which is not excessive though it is difficult to tell if it would have changed the statistical outcomes given that dropouts in studies tend to be treatment failures. Of 13 measures evaluated by investigators, there were statistically significant differences in 3 when the data for all investigators was pooled (none for investigators singly, obviously with smaller sample sizes). Of the subjective owner evaluations, 13 measures graded on a 5-point scale, 1.9 measures improved by >/= 2 points in the placebo group and 4.7 measures by >/= 2 points in the treatment group, but this was not statistically significant (and 5 of the 18 dogs that completed the study were not included in this evaluation for a variety of reasons).
Both of these studies do provide some support for the claim that fat-derived autologous stem cell injections may have clinical benefit for the conditions examined, but the evidence they provide is very weak due to limitations in the study size, design, and possible biases. My concern is that such weak evidence, even added to the suggestive pre-clinical information and to study results from other species, does not justify selling an invasive and expensive medical procedure to pet owners. At best, the therapy should be offered as an experimental intervention with strict informed consent guidelines and a system for evaluating outcomes that is as objective as possible and as independent as possible of the company hoping to profit from the therapy. The situation is similar for other species that Vet Stem offers to treat, though there is a bit more clinical evidence for horses.
Similarly, the Chemaphor product Oximunol is supported only by theory and in vitro studies with no published clinical trial evidence to suggest safety or efficacy in veterinary patients. Even under the lax standards of regulation applied to nutritional supplements, the company would likely not be allowed to make the medical claims for the product they make in marketing materials, but they specifically acknowledge pursuing the veterinary nutraceutical market partly because they face “lower regulatory hurdles” than the human market. In their current press release, the company states ” With the recent announcement of the Vet-Stem stem cell licensing arrangement, Chemaphor is evaluating the establishment of a sales team to promote the use of Oximunol(TM) Chewables as well as the Vet-Stem products for companion animals.”
The two companies clearly see a synergy between their products and corporate philosophies. Unfortunately, the common bond seems to be a desire to rapidly and effectively market medical therapies in advance of adequate safety and efficacy data. The regulatory structures applied to medical devices and drugs in the U.S. by the FDA are not capricious bureaucratic hurdles, they are the response to a series of medical tragedies in which the public was harmed by therapies that had not been adequately tested. The exemptions to this process offered by DSHEA, and by the pragmatic inability of the FDA to enforce existing rules in veterinary medicine, should be understood as weaknesses and a danger to the public, not opportunities. I have little doubt that the promoters of these therapies believe they are safe and beneficial, and the current state of the evidence does not by any means show they are wrong. But the history of medicine makes it clear that such faith often turns out to be misplaced, and that shortcutting the process of vetting new therapies does more harm than good. We can only hope that does not turn out to be the case with these products.