I woke up this morning to find a rather bizarre attack ad by a stock market writer. The first reason this is bizarre is that we’re not publicly traded nor do we ever hope to be. I guess you know you’re successfully rattling the cages of traditional orthopedic medicine when you get attacked for no good reason.
The attack ad entitled, “Pluristem’s PLX Cell Therapy For Muscle And Tendon Regeneration Will Revolutionize Sports Medicine” centered around a company called Pluristem, barely on my radar. In fact, if you search this blog you won’t find a single mention of the company. The attack may have been initiated by this blog, that exposes what I see as a mounting problem with publicly traded stem cell companies and the pressure they’re under to make their offerings look good on spreadsheets. The issue exposed is that the number of doses these companies claim that can be grown from a single donor strains credibility. I understand the reason they’re doing this, it’s simple business math. The regulatory costs of growing cells is huge, add in sky high manufacturing costs and you’re all of sudden in a world where a vial of stem cells costs $10-20K!, This is a price that’s absurd in today’s orthopedic market and one that means almost certain commercial death as no insurance company in their right mind would cover that cost. Hence a way to make it all look more palatable is to claim to be growing huge dose numbers so that the demoninator of the spreadsheet (the cost of goods) looks less than it actually will be. This is the dance of publicly traded companies and unlike Ray Dirks (a stock or option holder in Pluristem), I hold no stock or options in any stem cell companies focused on allogeneic stem cells to treat orthopedic diseases.
The other reason I may have warranted this strange attack ad actually goes back to a Linkedin message board many months ago where I dared to bring up the obvious. Someone pointed to a small phase 1-2 trial to treat gluteal tendinopathy after hip replacement surgery where Pluristem’s mesenchymal stem cells were used. This was a trial of treating a strained muscle injured during hip replacement. I brought up, that as any of the thousands of physicians routinely using PRP can tell you, this is a diagnosis that responds nicely to $200 of platelets. Hence, why would doctors need a 10-20K vial of stem cells to do this? In addition, why take the risk of using someone else’s cells in a bottle (Pluristem’s are derived from placentas)? As one example of the issues with off the shelf cells from a donor, the FDA recently placed another Pluristem trial on hold due to a severe allergic reaction.
So now let’s get into the meat of the attack I warranted because I dared to state the obvious:
1. “Enter the questionable treatments: Regenexx, is a privately-held company pandering to sports superstars with promises of stem cell therapy that can’t be substantiated.” Wow, are we “pandering” to sports superstars? We certainly have treated some high profile athletes, most of whom we can’t discuss. So far Regenexx has published in peer reviewed publications, more data on the injection of stem cells in orthopedic patients than any other author world-wide, so is that “pandering”?. We have 821 unique patients in peer reviewed publications for which improvement and complications data is reported with our published total being more than 1,200. We also have about another 500 on the way this next year with one study of 116 patients with shoulder rotator cuff tears just submitted for publication. We have also funded four “free of charge” randomized controlled trials (RCTs), including one on rotator cuff tears now being recruited. Our registry study on 116 patients showed great results, but I’ll wait until it gets peer reviewed to discuss it. Our RCT has treated about the same number of patients as the Pluristem phase 1-2 clinical trial, but unlike Pluristem, we don’t have a stock price to worry about, so you won’t see us putting out press releases about how the first 13 patients have fared.
Where does Pluristem fit in this metric of publishing in orthopedic stem cells? 20 patients in a press release. I couldn’t find any reference this morning in the US Library of Medicine for this recent Pluristem tendinopathy study, so it seems like the only information we have about it is from the company. Realize that this is a company that got in trouble recently for hyping the information of a girl who they claimed was saved with their cell therapy, pumping the stock, cashing in, and then not reporting that this poor young girl died anyway. Could that be “pandering”?
2. “Science takes a different view, citing FDA warnings that unapproved autologous stem cell treatment given to athletes could form tumors as the cells multiply and roam to other parts of the body. Animal studies show regenerated tissue from the body’s own source is not durable. Scar tissue could develop and cause tendons or ligaments to stick to skin, pulling an even bigger tear in an already serious wound.” While this little ditty doesn’t reference us, it infers some things that are pretty scientifically nutty. First, that autologous stem cells form tumors. We published a paper on this topic years ago, that was heralded by an independent group of scientists in Europe (who I have never met) as the highest quality paper of it’s kind. There were no tumors. We’re now readying an n=2,300 complications paper for submission that will show similar results. However, don’t take my word for it, just look at the largest paper published on autologus stem cells and tumors to date by orthopedic stem cell pioneer Phillipe Hernigou. This was a recent 12 year follow-up of almost 2,000 autologous stem cell treated patients where more than 7,000 MRIs and 52,000 x-rays showed no evidence of tumors (in fact the cancer rates were less in the treated group).
3. “Regenexx is an outspoken company promoting sports injury healing through alternative methods, including a popular procedure named PRP (platelet rich plasma) where a player’s blood is processed and re-injected hoping that concentrated platelets stimulate stem cells to help the body’s natural ability to repair itself. The downside is possible inflammation in the joint following reinjection of the platelets. Regenexx’s other offering involves extracting stem cells from bone marrow by poking a long needle into the ileac crest of the pelvis, culturing the cells for two weeks, and re-injecting them at the site of injury in an autologous procedure. This is not FDA approved and occurs only outside of the US, away from the FDA’s jurisdiction. My research did not turn up any testimony to Regenexx’s long-term durability of results.”
Wow! Regenexx invented PRP, a “controversial” treatment for tendons? PRP or platelet rich plasma, has been around since I was in high school in the 80s. There are now more than 10 FDA approved devices for inexpensively making PRP at the bedside, with many clinics (like us) deciding to make their own. On that front we believe we have a much better PRP mousetrap. There are likely 10-20,000 US physicians that commonly inject PRP into tendons that have nothing to do with Regenexx. Why? It works based on large randomized controlled trials. For example Mishra recently published a high quality trial of 230 patients showing good efficacy. Now this does beg an important question about Pluristem’s expensive off the shelf stem cell product for tendinopathy. If PRP has many trials showing it works and costs about 200 bucks to make, even if Pluristem can get their product cost down to a few thousand dollars (a very big if that depends on the crazy spreadsheet math discussed above), why would any insurer in their right mind pay several grand for a vial of stem cells when a cheap PRP treatment works just as well? Ah ha, now we have the real underlying reason for the attack ad. My guess is that I’m not the only person who has brought this to Pluristem’s attention. By the way, as of this morning, listed in the US National Library of Medicine, there are 146 papers with thousands of tendinopathy patients being successfully treated with PRP and no listed papers and one press release with only 20 patients being treated with Pluristem’s stem cells.
We don’t treat the majority of our patients with cultured stem cells, in fact the majority (about 9 in 10) get treated with same day stem cells using our Regenexx-SD+ procedure. Our long-term durability of results? See our paper referenced above which takes more than 800 stem patients out to 3 years and our recent on-line data which takes about a thousand out 4 years. Pluristem? No publications as discussed, 20 patients mentioned in a press release followed for 6 months.
This is a crazy way to be woken up while getting ready to write a blog post! Ray Dirks and Seeking Alpha have been called on the carpet before for pumping a stock by trashing other companies with blog posts that are riddled with factual errors. So this is not his first stock pumping, trash talking rodeo.
On the one hand, if Pluristem can produce a better stem cell mousetrap that can prove more efficacious than a simple and much less expensive PRP shot, God bless and God speed. There is no evidence of that at this point. As discussed, the company does have an issue. There is already a cheap and well studied therapy for tendinopathy that’s already widely available and rapidly becoming the medical standard of care called PRP. While Pluristem’s cells may do miraculous things in other market segments, in orthopedics, an insurance carrier just isn’t going to pony up big bucks for a vial of stem cells unless it’s dramatically better than PRP. Hence in the tendon space, this may be a product that arrives to market with no market.
The upshot? Ray, we’re not a competitor to Pluristem. That company is trying to produce an off the shelf product to sell to all doctors who would use it. We only accept 2-3% of doctors who ask to join our network. In fact, every FDA approved device manufacturer selling cheap and inexpensive machines and kits to make PRP are direct competitors to Pluristem. In addition, if Pluristem can get some data published that shows that it can outperform simple and cheap PRP on tendon healing consummate with it’s price, we’d be a big customer of what you’ree selling! So please keep it scientifically real and go after the guys who will really create problems for your company-the many PRP device manufacturers!
Since this post was written, this article has appeared on Pluristem about yet another pump and dump http://seekingalpha.com/article/2875876-pluristem-therapeutics-a-biotech-scam-promoted-by-a-bucket-shop?auth_param=vo1ir:1acvrgo:4349ee5c3cfc057a9f2467c5665d46d4&uprof=74&dr=1