Over the last almost decade that we have been offering stem cell treatments, we have graded patients with regard to candidacy. These Good, Fair, or Poor candidate grades have literally dissuaded hundreds of patients who were considered less than stellar candidates from undergoing the procedure. Several years ago, after we had enough outcome data on the Regenexx-C cultured procedure, we lifted those grades as the statistical analysis didn’t show that more severe arthritis patients did any worse than patients with mild arthritis. However, we kept them in place for the Regenexx-SD procedure, as the literature on platelet rich plasma did show that PRP didn’t work nearly as well in moderate and severe arthritis as mild arthritis. In addition, the same holds true for knee micro fracture. Again, we turned away hundreds of patients because adopting a conservative candidacy system that fit with what we knew about regenerative treatments and arthritis was the right thing to do. In 2012, our first registry analysis of Regenexx-SD showed that these candidate grades roughly followed the outcome (patients then considered “Poor” candidates with severe arthritis generally had less robust outcomes than those who were “Good” candidates with mild arthritis). So we continued to try to convince many patients with more severe arthritis not to undergo the procedure. This past month we began updating the data analysis for 2013 of many more knee cases in our registry. Interestingly, as the numbers of patients being tracked increased, the association between severe arthritis and poor outcome didn’t hold up, meaning that the severe arthritis patients who chose to do the procedure anyway had about the same outcome as the mild arthritis patients. So after many years of turning away hundreds of patients, we now feel comfortable in the statement that the Regenexx-SD proprietary knee stem cell procedure and it’s three part treatment process works as well in severe arthritis patients as it does in mild patients.
First, it’s important to note that the fact that our stem cell procedure works in severe arthritis patients may not extend to other treatments being offered by others. For example, as I have said many times, fat stem cells are less potent in the treatment of orthopedic problems than bone marrow stem cells. In addition, the Regenexx-SD procedure is a very different bone marrow stem cell isolation process than commercial bedside machines on the market. Second, we have developed and continue to develop candidacy guidelines based on the unique factors that we are identifying in the registry that will only be known by Regenexx providers, some of which aren’t obvious.
The upshot? We did this the right way, unlike many others in this field offering stem cells for every known disease. Like I said in the last post, there’s the Regenexx procedure and then there’s stem cell guesswork. Again, click here or on the thumbnail above to see the full PDF report.
RegenexxCayman 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.
This past two weeks we’ve been shoring up our registry data collection on long-term patients treated with both the Regenexx-SD and -C knee stem cell procedures. Unlike the newbie clinics just starting to treat patients with stem cells, we have patients that are out 2 plus years up to 8 years out from treatment with our novel stem cell therapies. Tracking these patients this far out can become a logistical nightmare. While having a clinical research organization grade software platform and multiple staff devoted to contacting patients and even offering a free iPad each month to responders all help, patients get busy with their lives. As a result, we’ve called in the heavies to get those older patients to fill out those standardized questionnaires-the doctors. We now have the treating physicians contacting patients. I’ve sent many personal e-mails and made many calls-so I’d like to highlight two patients I communicated with this past week.
SP was last featured in a prior blog about 1.5 years ago for a knee trochlear groove cartilage hole that showed healing on his MRI taken after his Regenexx-SD knee stem cell treatment. So how is he doing at more than 3 1/2 years out from his stem cell treatment? Great, he reports continued 100% relief with no evidence of knee problems. He’s a very fit personal trainer, so he works this knee hard.
The second patient is one I haven’t blogged on yet-LM. LM is an active skier in his 60s who was seen by our clinic in 2011 and treated with the Regenexx_SD procedure. At that point, he had failed an arthroscopic knee debridement surgery and was having difficulty returning to activity. He had meniscus tearing and mild to moderate arthritis and no ACL is his knee (torn decades earlier). I spoke to him this past week and he relayed that his knee was now 90% better and continuing to improve due to his stem cell injection in summer of 2011. He now bikes 20-30 miles at a time.
The upshot? We’re now continuing to shore up data collection so that we can update all of our infographics and submit more research publications. This is an immense amount of work, but necessary if we want to eventually publish all of the data – the rock stars mixed in with the patients who didn’t benefit, so that the average person has some sense of the real odd’s of a successful treatment.
Why undergo lateral release recovery at all? If I had to create a list of bad knee surgeries just based on the hundreds of patients I’ve seen with failed knee surgeries, lateral release for knee cap tracking problems would be near the top of that list. Based on that experience, it’s another knee surgery with a prolonged recovery and little scientific evidence to support that it’s effective. First to review, when the knee cap begins to track too far laterally in it’s groove (to the outside) and physical therapy fails, patients are often offered a lateral release surgery. The concept is simple: since the knee is pulling too far to the outside, the surgeon will cut the fascia on that side to try and reduce the pulling. Sometimes the medial side will be tightened as well. So what evidence is there that cutting this tissue and permanently altering the bio mechanics of the knee is a good idea? Turns out, not much, The existing scientific reviews show that the research is only level 3-4 (level 1 is the highest). This means that we have no solid evidence that lateral release works. Why do I see so many patients in the clinic that fail this surgery? As discussed in our practice’s e-book (Orthopedics 2.0), a healthy body is tuned to sub millimeter precision. Surgical healing occurs a few millimeters this way or that way. So the likelihood that cutting the outside knee cap fascia will result in perfect seating of the knee cap in it’s groove is small, as it’s more likely that the cut won’t loosen it enough or will leave the knee cap still too tight in the lateral direction. Even more importantly, the cause of the problem isn’t in the knee cap. The reason the knee cap doesn’t track well in it’s groove can be due to problems in the low back, hip, quadriceps, or foot/ankle. So not addressing these other issues causing knee cap pain and focusing on surgery for the knee cap when the cause isn’t there doesn’t make common sense.
Let me give you a cautionary tale from a patient I saw yesterday in clinic. He had a lateral release surgery several years ago for patellar tendon pain (the theory being that his knee cap wasn’t tracking right and this caused one side of the patellar tendon to be pulled on more than the other). At first he seemed to do well, then the problem came back so he doubled down for a second surgery, this time an arthroscopic debridement. He ended up with arthrofibrosis (joint scarring), so he “tripled down” and went for a third surgery to fix the damage the second had caused. The third surgery broke up the adhesions and scarring, but either the second or third surgery (or maybe even the first?) created a huge tumor like mass in his patellar tendon. So he had a fourth surgery to remove that mass. Now he still has the same pain he’s always had, but now what’s left of his lateral patellar tendon is a mess. He’s investigating whether stem cells will help fill the huge gaps now left in the tendon.
The upshot? I’ve seen very few patients through the years that have had good outcomes from and that were happy with their lateral release surgery. The reasons are pretty simple: surgical healing isn’t exact enough to create the kind of tiny adjustments that would make the surgery successful and the cause of knee cap problems is usually elsewhere. Take a few hours to read our e-book and find someone to take the time to figure out why your knee cap is messed up in the first place rather than trying to fix it with aggressive surgery.
How long does stem cell knee pain relief last for severe arthritis? We treat many medical providers with knee arthritis and other ailments. Why? First, medical providers like doctors, nurses, and physical therapists have (to quote the movie Jerry McGuire) “been to the puppet show and seen all the strings”. What I mean by this is that they have seen the big negative consequences that can come with invasive surgeries such as knee replacement, so when they might need one, they look for other options. This morning I’d like to highlight MF who is a 54 year old ER physician who had a 2 year history of knee pain with significant arthritis when he was first seen. Based on his recent communications, he had approx two years of about 75% relief with the Regenexx-SD stem cell procedure. Prior to the procedure, using the elliptical machine at the gym would cause his knee to become painful and swell. After the procedure he didn’t have much pain or swelling when he got off the machine. More recently he injured his knee again while doing heavy squats, so now he’s coming back for an update treatment. MF’s results highlight something we do see in some of our stem cell patients with more severe arthritis and who want to remain very active, update treatments are sometimes needed every few years to keep them moving at the levels they desire!
Japanese researchers presented a research study this week at the Orthopedic Research Society that showed periodic injections of stem cells delay cartilage degeneration in knee osteoarthritis. While this was an animal model, it fits with our 8 year experience of using stem cells in knee arthritis. We have always thought, especially in patients with more severe knee arthritis, that replacing the “stem cell reserve” in the knee was critical. In this theory of knee degenerative disease, the knee is no longer able to maintain itself due in part to fewer functional stem cells, thus the knee sprials out of control, creating a toxic stew of catabolic breakdown chemicals.
There were some other very good research studies at ORS this year. In another, researchers at Stanford found that “adipokines” (cell signaling chemicals that are more commonly found in obese patients) breakdown the meniscus more than knee cartilage. What’s interesting here is that in heavier patients, we often do see the meniscus fail first. This theory would argue that arthritis in heavier patients is not only mechanical (more weight equals more wear and tear on joints), but also chemical.
In yet another ORS paper, researchers found that short bursts of high intensity activity wear down joint replacement prostheses faster than sustained activity. The concerning part of this study was that fast walking predicted more device breakdown (as measured by a sensor on the patient). What’s the hallmark of the younger and more active patients now being targeted by joint replacement manufacturers? They frequently exercise in more intense bursts, walk faster, run, etc… So these findings are a bit concerning for younger patients with knee or hip replacements who want to remain active.
Can knee stem cell injections keep a professional mountaineer who needs a knee replacement stay in the field without major surgery? Jim Balog is the kind of unique and gifted person you can meet in the unique city of Boulder, Colorado. He’s a mountaineer who also happened to be a photographer who used those two skills to form the Extreme Ice Survey (EIS), a non-profit which works to record the changes to our warming world. If you come to our practice through Denver International, you’ll see Jim’s work up on the screens in the airport. EIS specializes in placing time lapse cameras in very extreme and hard to reach parts of the globe. I first took a look at Jim’s knee in the spring of 2009, more than 3 years ago. At that point he had just returned from Antarctica placing more cameras and his knee had swollen severely. He was planning a summer trip back to the arctic and was concerned that he wouldn’t make it. His MRI showed right sided medial compartment arthritis with partial to full thickness cartilage loss. At first we patched him together by getting rid of trigger points in his quadriceps and injecting hyaluronic acid. In November/December of 2009 and February of 2010 Jim returned for a series of Regenexx-C procedures. He’s since had a few SCP update injections in his patellar tendon that we’ve fit in here and there as Jim travels the world lecturing on EIS. Jim recently sent me the above trailer for a film about his work called “Chasing Ice”. In the end credits he gave me a very kind plug about how we used his own stem cells to allow him to keep climbing and stay in the field for his important work. Click on the image above to see more of this riveting work.
Can a knee stem cell treatment help knee arthritis in an older woman who also has back problems? LN is a 60 year old woman with a two year history of knee pain on the left and a 10 year history on the right. Because of this moderate to severe pain she avoided stairs, water aerobics, and spinning and had gained weight because of the inactivity. On the left she had arthroscopic surgery 8 years prior. SynVisc injections helped some while cortisone injections were no help. In fact, bilateral knee cortisone injections one year prior had significantly flared up both knees. Her knee MRI’s showed severe medial compartment arthritis with an extruded meniscus as well as problems in the ACL ligament. She also had a history of low back issues. She had Regenexx-AD stem cell procedures in Oct and Dec 2010 and after a partial response had Regenexx-C stem cell procedures in March, May, and Nov 2011. She’s now about 8 months out from her last knee injection. We also performed Regenexx-PL Disc procedures on her low back. This is what her husband reports to Dr. Hanson:
“I wanted to thank you for changing my wife’s life. I can’t believe how effective the Regenexx treatments have been on both of her knees and her back.Two years ago she was having great difficulty with pain in both knees and her back.Her quality of life has improved dramatically. The treatments she received in Colorado helped significantly with the Cayman Island treatment having a very dramatic positive impact. Prior to the treatments she avoided going up/down stairs and had difficulty exercising. Today she does spinning, elliptical and goes up and down stairs w/o a problem.
When I think of the alternative she was facing with knee replacements and the related risks and recuperation required, the results she experienced were like a miracle.
…Again, thanks for making L’s quality of life so much better.”
Again, we’re not able to help every patient. However, LN stuck it out and when the same day procedures weren’t enough to get her where she wanted to be, she moved on to the cultured procedure.