<p>but an independent university research group published a paper showing that the procedure was safer than FDA approved Synvisc.
So the claim to fame is that it is less harmful than other ineffective procedures.
Oh. Yay.</p>
<p>The studies will need to be replicated by other investigators and conducted under placebo controlled, double blinded protocols. Only then can we have stronger evidence to support it. I hope it works.</p>
<p>Unspecified reasons for knee issues-? There can be many causes, some needing medical treatment and others needing an exercise plan. </p>
<p>Most likely a search bot directed “Dr. Chris” to this site to address criticism of the technique. What patient would call their doctor to suggest they comment on a procedure mentioned on a message board? Why wouldn’t the patient just provide an endorsement based on their experience? If a procedure is effective and saves money over existing procedures it will be adopted by the medical community and covered by insurance. </p>
<p>Well, a lot of alternative medicine does work, although some of it is undoubtedly scammy. But, it’s not as though traditional medicine is exactly always effective either. So yeah.</p>
<p>Ahem. Now, right now as I type this, these folks are selling their technique and their dubious vitamins. And right now, they say they are setting up randomized controlled trials to prove that their technique works. Isn’t it more normal to start selling the technique <em>after</em> you prove it works, not before?</p>
<p>" We also have four randomized controlled trials that we are self-funding that are recruiting now…"</p>
<p>Good to know. The complete results of these studies are not going to be known for at least 3 years:</p>
<p><a href=“Search of: Regenexx - List Results - ClinicalTrials.gov”>Search of: Regenexx - List Results - ClinicalTrials.gov;
<p>dstark, if your friend wants to enroll and meets the criteria, here ^^ is the info. :)</p>
<p>Meanwhile, there are plenty of companies that offer similar unapproved treatments, and pricing in Mexico or Russia maybe even better… 
/sarcasm off. ;)</p>
<p>I wonder how long DrChris will continue posting in violation of CC TOS. ;)</p>
<p>We let DrChris’s posts stand since they did answer the OP’s question. Yes, he probably found the question through a Google search, but there is not a rule against that. If he had posted “cold,” we would have dealt with him differently.</p>
<p>I am happy DrChris is posting. Good to read his side. </p>
<p>I am also kind of done in this thread. My knees are fine. :)</p>
<p>To clarify, if the OP hadn’t used the name of the product, and just asked, “Are there other alternatives to surgery for bad knees?” and DrChris had joined to respond, I would have taken action. It’s a fine line sometimes.</p>
<p>First response from a reputable source would be how the patient needs to closely consult with his MD.<br>
Lately, it’s always a big flag when you google and every site points back to the company, its clinic touting the procedure or other obviously pro-product info- not saying planted, but would question whether it is carefully “cultivated.” You find this with all sorts of barely supported products- eg, miracle diets, rejuvenation treatments, etc.</p>
<p>ML, good to hear that that the mods are keeping the eyes on the thread - appreciate all the work you guys do.</p>
<p>A few comments:</p>
<ol>
<li>The following orthopedic procedures have no randomized controlled trials to support they work: all meniscus surgery, all knee surgery, all shoulder surgery, all ankle surgery, all low back surgery, all neck surgery…and the list goes on. So why again would a new procedure need randomized controlled trials to show that it works? Despite that, unlike these surgical procedures, we have invested in RCTs as stated. We spent two years not charging any patient in an IRB approved study before we were convinced that the procedure was working.</li>
</ol>
<p>It’s important guys to learn what being a doctor means. Even when I have blinded RCTs to rely on, most have such narrow inclusion criteria that they don’t apply to the unique person sitting in front of me. In fact, drug studies are purposefully designed that way to “stack the deck” for a positive outcome. The studies that do exist are mere suggestions of what might work for Mr. Smith, but provide no real assurance that any particular procedure, drug, or therapy will work. Or as someone once said, “In theory there is no difference between theory and practice. In practice there is.” Meaning, when a real patient stares you in the face and says, “Doc, fix me”, studies help a bit, but in the end it’s experience that helps to fix that person.</p>
<ol>
<li><p>Not covered by insurance-that’s true, but what is covered has no high level evidence to show it works. For example, tear your meniscus? Recent RCTs have shown that the surgery is no better than placebo or physical therapy. </p></li>
<li><p>The comparison by the European group for safety was to hyaluronic acid (HA), which is FDA approved as “safe and effective” for early knee OA. We, like tens of thousands of physicians in the US, use HA everyday, it works well for most patients with early arthritis. </p></li>
<li><p>Yep, loads of traditional medicine is not effective. </p></li>
<li><p>While drugs require RCTs before they can be sold, such is not the case for surgical procedures. Please see the list of surgical procedures above that have no RCTs to support that they work, only the observation of physicians or case series/comparison trials. In fact, there’s a good reason for this dual pathway for new therapy discovery, if every medical advance required a 100 million worth of research, we wouldn’t have in-vitro fertilization, cardiac surgery, or pretty much any medical procedure associated with saving a life in the ER (most of which came out of the experience from front-line MASH surgeons in Korea). </p></li>
<li><p>Our patients are pretty loyal, do a search of discussion boards, you’ll see them popping up all over the place. </p></li>
</ol>
<h1>1 - why did you decide to proceed with trials for what clearly did not need them instead of moving forward with the culture-based procedure? Seems wasteful to me. My guess is to build up the competitive advantage to differentiate your product from many similar procedures being offered all over the country and abroad.</h1>
<h1>2 - agree, insurance companies have their own reason for covering procedures, one of them, though, experimental and unproven nature of the procedure. Is this the reason for the co onvesting per #1?</h1>
<h1>3 - one drug, one study, one group of patients.</h1>
<h1>4 - true. But what is the point of making the statement?</h1>
<h1>5 - the procedure that was moved outside of the US was determined to involve drug manufacturing (unless an appeal overturns this). So why would not you invest in clinical trials if you are convinced that the outcome would be positive?</h1>
<h1>6 - just saying that this is not a valid argument. There plenty of loyal followers of dubious stuff.</h1>
<ol>
<li>The procedure at that time, was very new-it seemed prudent. It also cost our small medical practice hundreds of thousands of dollars-which may not sound like much to Pfizer, but for us it was a huge expense. </li>
<li>We don’t do research to get insurance coverage, but if there’s enough research, that can follow. However, as an example, the FDA approved cartilage culture procedure “Carticel” has less research than we have, but because of it’s high cost, has lousy insurance coverage. Even if they had drug like studies, they would still have poor coverage due to cost.</li>
<li>?? There are many studies on HA for early knee OA.</li>
<li>Responding to an above post.</li>
<li>That “investment” is currently about 100M. The knee procedure has no patent, hence investing 100M is not practical nor would any sane VC put up that money without a patent. For the procedure that does have a patent pending because it involves lots of novel things, it was licensed to a company that is pursuing clinical trials and FDA approval. </li>
<li>This is not an argument, but a statement. </li>
</ol>
<p>So the argument goes like this, then?</p>
<hr>
<ol>
<li><p>We don’t have any randomized controlled trials to prove that our treatment works.</p></li>
<li><p>Some traditional, accepted treatments, like knee surgery, also don’t have randomized controlled trials to show they work.</p></li>
<li><p>When randomized controlled trials of traditional, accepted treatments (like knee surgery) are done, sometimes scientists discover the treatments are not effective.</p></li>
</ol>
<p>THEREFORE, you should get our untested treatment!</p>
<hr>
<p>I notice that this same argument is equally convincing for every single treatment ever promoted, including the scammiest medicine-show quackery. So I can’t say that I find the logic convincing.</p>
<p>But do keep posting, Dr. Chris. The thread is endlessly entertaining. I can’t wait to show it to my husband and son, connoisseurs of dubious claims. </p>
<p>Having had knee problems since 2006, I reached the end of my rope in early June and saw an orthopedic doctor who is considered to be one of the best knee doctors in the country. I felt he would be the one to lead me in the right direction. He went over my x-rays with me and declared that I am bone-on-bone in both knees. After discussing my previous treatments (Orthovisc, Supartz, Euflexxa, PT, surgery), I asked him about the possibility of stem cell injections for my knees. He told me that he does not see that as a viable option for me. He is the head team physician for our local NFL team and said they are using stem cell therapy in some of the players and, that for every player who has success with the treatment, there is a player who does not. He said he believed my knees were “shot” and sent me for MRIs. He called me a couple of days later and said, in his opinion, I had exhausted all other options and referred me to a joint replacement surgeon. I’m getting new knees in November. </p>
<p>A couple of years ago, I had also asked another doctor about stem cell therapy and he said insurance companies don’t pay for it and it would likely be about $8,000. I don’t know if that is the same today.</p>
<p>Hope your surgery goes well, SplashMom.</p>
<p>No Cardinal, the argument goes like this: </p>
<p>If you want to make sure that every surgical procedure you have is supported by randomized controlled trials, this won’t happen in your lifetime nor mine. Hence you have nothing (using your logic) to base you medical decisions on, since about 70% of medicine doesn’t have that evidence base. So if you get sick (everybody eventually does), you will have to do what we all do, base your medical decisions on the best available evidence and listen to your doctor or find a new one.</p>
<p>Our treatment is far from untested, we’re tracking about 3,000 patients in our registry. As I’ve said, there’s a big difference between actually having experience and just living in the comforting world of theory. </p>
<p>Take for example Splash, I also hope the surgery goes well. However, we also have no RCTs supporting that knee replacement is effective. Is your advice to her not to undergo the surgery of this “untested” procedure " (untested because we have no level 1 evidence). The procedure has loads of registry data, but not a single RCT, certainly not a double blinded one. Yet there are many happy knee replacement patients and many surgeons who will tell it works well. </p>
<p>Guys and gals, I appreciate your time, I have to go see patients with real problems and give them advice about what might be best to help them. Some of the studies of the types we discussed could help guide a few decisions today, but in reality most won’t help very much. </p>