<p>If so, how did it work out? </p>
<p>(My knees are fine. Asking for a friend).</p>
<p>Quackwatch would be a good first place to check, dstark.</p>
<p>Seriously? You think regenexx is a scam?</p>
<p>You’ve probably seen this, dstark, but just in case:
<a href=“Are a Third of Knee Replacements 'Inappropriate?'”>Are a Third of Knee Replacements 'Inappropriate?';
<a href=“http://onlinelibrary.wiley.com/doi/10.1002/art.38685/abstract”>http://onlinelibrary.wiley.com/doi/10.1002/art.38685/abstract</a></p>
<p>The study says that knee replacement is much overused. Unfortunately it doesn’t say what the people who shouldn’t have had the surgery should have done instead, at least in the abstract of the study. Dissenters to the conclusion say that the guidelines are too strict, and the controversial surgeries were justified.</p>
<p>It could be a scam, it may be not a scam… It is an “adult stem cell therapy”, and from what I could gather, the maker was engaged in a lengthy battle with the FDA:</p>
<p><a href=“D.C. Circuit Rules That FDA Can Regulate Autologous Stem Cells”>http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/02/dc-circuit-court-of-appeals-rules-that-fda-can-regulate-autologous-stem-cells.html</a></p>
<p>Being around biotech for a long time, I’ve seen a fair share of quackery being sold to investors as the next big miracle. The very fact that they decided to take on the FDA instead of complying says something fishy is going on. </p>
<p>As long as they don’t have valid independent studies showing efficacy, its as good of a deal as sheep placenta facials, imo.</p>
<p>
</p>
<p><a href=“http://www.quackwatch.org/02ConsumerProtection/FDAActions/regenexx/overview.html”>http://www.quackwatch.org/02ConsumerProtection/FDAActions/regenexx/overview.html</a></p>
<p>I tried synvisc & steroid, but the only thing that brought relief was a full replacement.</p>
<p>I thought of you when I read that study result, emeraldkity. You might have been one of the people the study says shouldn’t have had a knee replacement-- but what else were you supposed to do? </p>
<p>My elbow surgeon mentioned this to me. He said it is big with professional athletes. However, it is no approved by insurance so he will do a more invasive procedure. </p>
<p>CF…,</p>
<p>No. I haven’t looked into this.</p>
<p>I think I will stay out of this. :)</p>
<p>but what else were you supposed to do?</p>
<p>Precisely.
I could no longer go around the block * with a cane* at 55 yrs old.
I wasnt more than 10 lbs overweight, and while I know people my age and younger can mostly adjust to reduction in mobility, say if they are a paraplegic. Why do that if there are other options?
I was always fairly physical if not really athletic, and I felt my life was basically over.
Now i can walk several miles at a time and I just keep getting better.
To encourage people like me who are desperate, to try a treatment that isn’t really tested, and is undoubtably pretty expensive and not covered by insurance- that just isn’t very nice.</p>
<p>The FDA looked at their product (basically a cell culture) and said that it was “a drug” (biologics also fall in this category). The company, instead of going through the applicable clinical trials, etc., decided to fight back and argued that it was a surgical procedure that was outside of the FDA’s jurisdiction. The FDA won the latest round in this fight:</p>
<p><a href=“http://www.cadc.uscourts.gov/internet/opinions.nsf/947528CDDA0B9A5A85257C7500533DF4/$file/12-5254-1478137.pdf”>http://www.cadc.uscourts.gov/internet/opinions.nsf/947528CDDA0B9A5A85257C7500533DF4/$file/12-5254-1478137.pdf</a></p>
<p>It looks like that in order to comply with the FDA, the company moved their operations outside of the US and is now offering their procedure involving cell culture in the Cayman Islands. What is now offered in the US, at least according to what they say on the web, is the “light version” of the procedure that involves same day transplant (no culture):</p>
<p>“[Disclaimer: The Regenexx same day procedures (-SD, -AD, -SCP, -PL-Disc, etc…) are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered through RegenexxCayman, which is an independently owned and operated medical services provider operating exclusively in the Cayman Islands and is not part of or affiliated with the Centeno-Schultz Clinic or any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by RegenexxCayman is not approved by the U.S. FDA for use in the United States.]”</p>
<p><a href=“Regenexx: Frequently Asked Questions and Answers”>Regenexx: Frequently Asked Questions and Answers;
<p>I would be very, very suspicious about injecting into my body cells grown in a non-GMP compliant lab, ie a lab that does not follow strict protocols and is not inspected by the FDA (and as we know, cultures can easily get contaminated, mislabeled, etc). </p>
<p>As far as professional athletes go, their endorsement of the procedure does not mean much - as history repeatedly shows, some of these guys would inject anything, including dubious stuff, into their bodies to try to enhance performance. </p>
<p>If your friend is up for a month-long vacation in the Cayman Islands and has the money to pay for and is willing to be injected with something of unknown nature, then good luck to him!</p>
<p>BB, :).</p>
<p>All, this is Dr. Centeno, developer of these procedures. I’d like to clear up some misconceptions here:</p>
<ol>
<li>Regenexx is not a scam. We have published research on what we do and continue to publish. We have a full time biostats person who does nothing but mine our treatment registry for outcomes and decision points about the procedures. For our peer reviewed research, see here: <a href=“Our Approach - Regenexx”>http://www.regenexx.com/about-regenexx/research-based-stem-cell-procedure/</a>. For our registry outcome information by joint, see here: <a href=“Patient Results - Regenexx”>http://www.regenexx.com/2013-regenexx-patient-outcome-data/</a></li>
<li>Our disagreement with FDA was over whether your stem cells, if cultured to get bigger numbers, were a drug or a medical procedure. Two former FDA directors (vonEschenbach and Gottlieb) agreed with our position as did Boston College and NYU legal scholars. The moment FDA took the official position that the cultured cells were a drug, we stopped that procedure (2010). That had no impact on our same day procedure, which we had always used and the which the FDA had no issue.</li>
<li>The lab that licensed the Regenexx cultured procedure in Grand Cayman uses the same safety guidelines as the ones used in the FDA Carticel procedure. In addition, not only did we publish two safety papers (listed in the link above), but an independent university research group published a paper showing that the procedure was safer than FDA approved SynVisc, see <a href=“Regenexx-C Safety Paper”>http://www.regenexx.com/2013/07/new-study-regenexx-c-safety-paper-is-the-best-of-the-best-in-published-stem-cell-papers-for-arthritis/</a></li>
</ol>
<p>In summary, I was asked to chime in on this discussion by a patient who felt there were some misconceptions about what we do to help patients with the Regenexx procedures. I’m happy to answer any other questions. </p>
<p>DrCenteno, I appreciate your post.</p>
<p>Where was the research published?</p>
<p>Bumping this up since valuable questions can be asked</p>
<p>I looked at all seven of the papers authored by Dr. Centeno. And the evidence that the treatment works is, shall we say, on the thin side. I’m not saying it doesn’t work. I’m saying that the evidence presented there is not enough to convince me that it does work: a non-blinded study with 24 patients who had the treatment, another non-blinded study where 6 patients had the treatment and were compared with 4 who did not. </p>
<p>And then I go to the Regenexx page to be greeted with, “Very humbly…The Regenexx-C Safety Paper is the Best of the Best!” This is not my idea of humility, nor is this hucksterism my idea of the correct way to offer a disputed treatment of non-proven effectiveness.</p>
<p>Moreover, it’s a mystery to me why this treatment has a drug-sounding name.</p>
<p>The links are above, there’s a list of publications. We also have four randomized controlled trials that we are self-funding that are recruiting now with an additional 5 registry based papers in the publication pipeline. </p>
<p>BTW, here’s a link about the guy that runs the quackwatch site: <a href=“http://www.quackpotwatch.org/quackpots/quackpots/barrett.htm”>http://www.quackpotwatch.org/quackpots/quackpots/barrett.htm</a>. </p>
<p>Not covered by insurance. I assume that applies to the $100/month special vitamins, too. Sadly, there is a segment of the population that eats up the whole “too new for insurance” line.</p>