FDA: Your Body is a Drug and We want to Regulate It

February 2nd, 2012

fda body drugERRATUM: Many news sites and blogs have been misreporting that FDA wants to regulate our Regenexx-SD treatment, this is not the case. The issues over stem cells=drugs are with the Regenexx-C Treatment (now in the Cayman Islands)

As many of our followers know, we’ve been engaged in a David and Goliath struggle over a basic civil right-who gets to regulate your body. Most of us, when posed this question, would say that the answer is clear, our body is ours to regulate. However, not according to the FDA, which in court documents has now said that since it regulates chemical drugs, and since all living things produce chemicals, then all living things fall under FDA jurisdiction (there’s an excellent legal review of the background issues leading up to that point by KL Gates). This nutty statement by FDA came in recent court filings in response to a judge’s order slapped on the agency in our landmark case. The judge pointed out that congress only authorized FDA to consider chemicals which had “chemical action” as a drug. The judge also asked the obvious question, how do you get from chemicals=drugs to cells=drugs? She gave the FDA 30 days to respond and denied their motions. Well the response is epic in it’s hubris and concerning for every American who considers their body not to be an FDA regulated drug factory. In FDA’s response back to the judge, their own internal expert responded with, “When living cells interact with their environment to mediate repair of and/or regenerate damaged tissue, they do so by chemical action.” So here’s the agency’s logical fallacy:

-Congress said chemicals=drugs

-All cells produce chemicals

-Hence cells=drugs

??? If you think I’m kidding, check out these recent letters by the agency that fat processed at the bedside to obtain stem cells is a drug (here and here). This “interesting” assertion in our case is now making it’s way around the internet (see Gizmodo, SlashGear, Alliance for Natural Health, The Blaze, The Examiner, OzHouse, Attack Machine). My favorite comment on the topic is by a non-US citizen discussing the SlashGear story:

Hahaha, you Americans always provide us with the best jokes. Pizza is a vegetable and the human body is a drug, well played sir!

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1.5 Year Follow-up on Knee Stem Cell Procedure

February 1st, 2012

knee stem cell procedure

It’s always good to hear from Regenexx-C patients to see how they’re faring long-term. JB is a 52 year old male who had a 15-20 year history of right knee pain who we treated about a year and a half ago using his own stem cells. This knee had undergone several menisectomies through the years and by about 2007 he started to have problems with his active lifestyle (he loved bow hunting in the mountains). He then began cortisone shots with all of the associated risks. By 2009/2010 he was told he needed a knee replacement due to severe arthritis. At that point he was nearing a master’s level archery certification for bow hunting and he knew that he could never achieve that lifetime goal with a knee replacement. Another issue was that he couldn’t stand for more than 5 minutes without having to hobble someplace to sit down. When he was first evaluated, we thought he has a poor candidate for our stem cell procedure because of the severe medial knee arthritis and loss of much of his meniscus due to the surgeries. However, he still wanted to try the procedure, as he was adamant about needing to avoid a knee replacement. He was treated by our clinic through the injection of his own stem cells into the right knee in the early summer of 2010. One month later he could stand for long periods and over several months he got to the point where he felt good enough to begin exercising again and began losing weight. This year his untreated left knee is worse than his treated right knee. The right knee, other than soreness after intense activity, is functioning great. He reports more mobility and range of motion, which has allowed him to strengthen his quads. He can also now stand for extended periods of time without hobbling around like an old man. I spoke to him yesterday because he’s now back to get a second round of Regenexx-C treatments for the right knee, and wants stem cell treatments for the left side as well. The upshot? JB’s knee isn’t perfect, but he was able to achieve his archery certification without a knee replacement and hopefully we can keep him bow hunting for many years to come!

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Meniscus Tear treated with Stem Cells rather than Surgery

February 1st, 2012

meniscus tear stem cells

Before we opened our Regenexx-C clinic in the Caymans to continue our ground breaking work outside of the stifling climate for medical innovation in the U.S., some patients made the long trip to China where we licensed a site in an orthopedic hospital. I just received an e-mail from one of those patients that I thought was worth posting (from Oliver G):

“I was diagnosed with a degenerative tear of the posterior horn of the right medial meniscus in 2009. It was operated on twice, but both times, the surgeons were not able to find the tear that was showing up on the MRI. Thankfully, this meant that my meniscus was left intact for later stem cell treatment, and was not removed. According to many studies that I have seen, had they removed any significant part of the meniscus, this would have seriously increased my chances of getting arthritis further down the line.

I was also diagnosed with a small lesion on the medial femoral chondyle, and some debridement was done during the failed meniscus surgery.

I started receiving the Regenexx C treatment in June of 2011 for the hidden meniscus tear which appeared under the surface of the meniscus on the MRI – this is most likely why the surgeons had trouble finding it. The stem cells were placed on the bottom part of the meniscus, and the chondral lesion was also treated with stem cell injections. This was repeated three times.

Seven months later, it would be safe to say that my condition has improved considerably. Although I haven’t done an MRI to see the state of the meniscus tear, my knee seems to have complete stability now, unlike before. That familiar pain in the back of the knee is no longer there. As for the chondral lesion, that too is much better, although I feel that if I were to have just one or two more treatments, that things would be just right. In short, I am truly amazed that such a non-invasive treatment can work out so well, and I thank all of the doctors and staff members who played such a central role in the healing of my ailments.

Lastly, I would like to thank Dr. Centeno for all the attention he gave me along the way, and also, for all his efforts and sacrifices involved in developing stem cell treatment. I would also like to thank the Neobiotech team, as they did everything they could to accommodate me while I was staying in China. They were gracious hosts, and I hope to be able to go back and visit them again sometime in the future.”

 

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Stem Cells and Cancer?

January 31st, 2012

Every few months this topic rears it’s ugly head in the media. Regrettably, the media commentators used for this issue usually have no special knowledge or expertise in stem cell biology. Since embryonic stem cells (ESCs) can form tumors and reprogrammed skin cells turned into stem cells (IPSCs) are genetically unstable, the commentator usually confuses these issues with adult stem cells (ASCs). These stem cell types are as different as apples and oranges. In particular, the type of stem cells we use (ASCs) are designed to repair tissue in the body, which is their natural function. To the contrary, ESCs are designed to make a person, so it’s not surprising they can form tumors with many different tissue types (Teratomas). In addition, artificially inserting new genes into normal skin cells to create a pharmaceutical product (an artificial stem cell or IPSC) is a really bad idea.

The kind of ASCs which we often use to treat orthopedic injuries are called mesenchymal stem cells (MSCs) and this type has an extra safety feature-they are contact inhibited. This means that once they cover an area and the individual cells touch each other, they automatically stop growing. Pundits argue that the culturing of MSCs can cause cancer! However, again, this is yet another confused issue with a kernel of truth, but not much more. If you grow MSCs for a more than two weeks in culture, they will simply stop growing on their own. For example, in the average middle aged person, somewhere around culture day 15-21 they will simply “peter out”. This is because MSCs quickly go into “replicative senescence” after a certain number of cell divisions. After this point, if you then add “tumor conditioning media” (a chemical “witches brew” of chemicals to force normal cells to grow tumors) and keep pushing the cells well past the point where most naturally die off and a only a few abnormal cells are left, over several months you will coax abnormal cells to grow. If you then take these cells and implant them in rats bred not to have an immune system (the body system which would naturally destroy these abnormal cells), you can create a tumor. Obviously no sane person culturing MSCs would ever push them to this point nor add chemicals that grow cancer cells and then reimplant these cells into patients without an immune system, but this phenomenon is often quoted as proof that ASCs cause cancer. This is like saying that if you drive your family car at 200 mph you could die or if you jump from the tenth story of a building it can be fatal. Our process of culturing cells (Regenexx-C) only grows stem cells for on average 11-17 days and also adds the extra safety step of determining karyotype by an outside lab before we will re-inject the cells. This extra safety protocol looks for cells that are abnormal. In addition, our entire procedure uses the patient’s own growth factors from blood platelets (platelet lysate) to grow the cells rather than adding in foreign substances like fetal calf blood and recombinant growth stimulants. In fact this platelet lysate culture technique has been studied by others and found not to produce any cells capable of creating tumors. In addition, we have studied our specific technique extensively across two published studies where hundreds of research grade MRIs of the areas stem cells were placed demonstrated no safety issues (Centeno et al stem cell safety study 1 and safety study 2). In fact, the safety profile of Regenexx-C was much better than the traditional joint surgeries it helped many patients avoid. The upshot? Small kernels of truth are often blown into nonsensical arguments by those who haven’t done their homework-this is true in politics and also true in stem cells!

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Helping a College Track Athlete’s Ankle with Stem Cells

January 30th, 2012

ankle stem cell treatment

Can stem cells help a college athlete with ankle problems? KW is 21 y/o university field and track athlete who was unable to compete due to ankle pain. She had a longstanding history of ankle sprains and had undergone high dose aspirin therapy as child due to a diagnosis of juvenile arthritis. When she was first evaluated by our clinic, her pain was a constant 5/10 in severity and located deep in the joint. Running and bending of the ankle all caused pain-which is a big problem if you’re a college track athlete. She had tried NSAID drugs (with their dangerous side effects), oral steroids (also with big side effects), and steroid and Synvisc shots into the joint (regrettably these joint injections were performed blind without any imaging guidance, so we don’t know if they actually got into the joint). Since she was getting nowhere with traditional non-surgical ankle treatment, she decided to try using her own stem cells. When we reviewed her ankle MRI, it showed degenerative changes in the main ankle joint, swelling, and sprains of two of the three main outside ankle ligaments. Our first priority was to stabilize her unstable ankle (for more info on this treatment approach, see our e-book-Orthopedics 2.0). As a result she underwent specialized injections to stabilize and strengthen the loose ankle ligaments (Regenexx-SCP into these ligaments). This was followed by a Regenexx SD stem cell injection to treat cartilage loss.

6 months after starting stem cell therapy for the ankle, Dr. Schultz received this e-mail which she has allowed us to share.

“Besides that minor flare, I have had really promising results.  I understand that my body has set limitations, and I may never be permitted to run 60 miles or more a week like before, but I am just grateful that I am back on the track completing workouts with my team.  I run every other day (which are “work-out” days consisting of heavy pounding on a hard track surface) and cross train on days in between.  I have also began doing olympic (short reps, but heavy and explosive) weight training without any irritation.  I started doing ladder speed drills and hurdles drills this week, and have noticed no pain.”

We are encouraged by KW’s results and hope to continue to help her get back to the sport she loves!

 

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Cycling, Stem Cells, and Bone Mass?

January 27th, 2012

bone loss cycling

When I first saw this study in 2009, that seemed to indicate that competitive cyclists had poor bone density, I wasn’t sure what to make of it. The study showed that 25% of competitive cyclists were classified as “osteopenic” (weak bones). Well, after two more years of performing bone marrow aspiration procedures with knowledge of the study, I would have to say the study is accurate. Every middle aged male I’ve had on the table whose stem cell harvest was just too easy, when asked about primary source of exercise, states that it’s cycling. A bone marrow aspiration (harvest) for a stem cell procedure is the ultimate bone density test. In the procedure (which is very different than a bone marrow biopsy) a needle is worked through the bone at the back of the hip and what looks like a thick blood sample (where the stem cells live) is pulled out into a syringe. As a result, the doctor has an immediate sense of bone density, as in the usual healthy male the needle will require some pressure (bone isn’t like cement, but hard plastic). Why would cyclists have lower bone density? It’s likely because of the “use it or loose it” stem cell principle. We have stem cells throughout our bodies and also in our bones. When the bones are challenged by weight bearing exercise like walking, jogging, and weight lifting, the adult stem cells spring into action to shore up the bones under stress. However, if your primary source of exercise involves pressure and stress only on the legs and nowhere else, your leg bones will be strong with active stem cells making more bone, but the other areas where we measure for osteoporosis (like the spine) will be weak. In essence, you’re only activating stem cells in certain bones. The upshot? If you love cycling like many of our compatriots do here in Boulder, Colorado, mix in some weights!

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Advanced Cell Biology Lab Completed

January 26th, 2012

Many years ago, we began cell therapy with an on-site lab in our clinic. This was a small facility which quickly outgrew our office space at the time. As a result, we built a bigger/better lab down the street from our office (no space was available in our clinic building). This worked well until we moved the office. We have now replaced our lab a third time with an advanced clean room facility in the first floor of our new clinical building. Each time we have rebuilt the lab, we’ve learned how to make it bigger and better. Since a picture is worth a thousand words, I’ve included a video of our lab below. For comparison, I’ve included an example of a bedside machine used by most clinics offering stem cells in the U.S. (which would sit someplace close to a treatment room).

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The Regenexx Procedure Featured on “The Doctors” Today

January 25th, 2012

doctors stem cell

Our clinic and the Regenexx procedure for orthopedic stem cell injections will be featured on the nationally syndicated TV show “The Doctors” this afternoon. Dr. Centeno and Hanson will be in the lab and clinic and Dr. Hanson went to LA to tape the show with a studio audience. One of our patients, Barbee James was featured. To find out where this is being aired in your area, click here.

hanson stem cell

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The Regenexx procedure to be featured on “The Doctors” TV Show Tomorrow

January 24th, 2012

knee stem cell doctors show

We’re proud to announce our appearance on “The Doctors” TV show this Wednesday morning  and afternoon (1/25/12-promo link here).  The show will feature Dr. Centeno and Hanson in the clinic and lab as well as Dr. Hanson (Dr. Centeno was in China for the studio taping) in their LA studio with patient Barbee James. Barbee had breaks in the cartilage and received the Regenexx-C knee stem cell procedure in 2008 (MRI’s below). That stem cell treated knee is still doing well, but her other surgically treated knee is now requiring stem cell treatment after a failed micro fracture and continued problems since traditional surgery.

knee stem cell injection

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Exercise Increases the Stem Cells in your Muscles

January 23rd, 2012

muscle stem cells.jpg

Stem cells live all over our bodies and this topic is covered in our book, Orthopedics 2.0. Now a research team from the University of Chicago has found that a single round of exercise leads to more muscle stem cells in mice. This fits with research I’ve blogged on before showing that elderly weight lifters have muscles that look more genetically similar to their younger counterparts and that the stem cells in their muscle tissue can still make more stem cells (proliferation). In the new study the researchers found that stem cells in muscle (muscle mesenchymal stem cells) secreted factors that helped grow new muscle cells. The cells increase in number and secrete these factors in response to muscle strain. Their increase in number in the first 3 hours after exercise is not because the stem cells grow more of themselves, but more likely because pericyte cells migrate into muscle and become more muscle stem cell like. Pericytes are stem cell like cells that live around nerves and arteries lying in wait for trauma. When trauma is detected, they migrate out and can turn into certain types of mesenchymal stem cells to oversee repair. The upshot? This is one of several papers showing that exercise and weight lifting make muscles bigger and healthier through stem cells. So to put it terms of a 1990′s Nike commercial, “Just do it…”

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