Ethical Guidelines for Orthobiologics

Neokine (www.neokine.com) is siding with science-based medicine. An Ethical approach is missing in many practices, claiming the correct use of biologics. We like and support the principles laid out by Dr Centeno of Regenexx stated below.

Background: As providers who use orthobiologics to treat our patients, we have observed unethical behavior and advertising that isn’t consistent with best physician practices. Hence, we wish to provide a set of ethical guidelines for orthobiologic use to which we can all strive to adhere. For the purpose of this document, orthobiologics are defined as substances that can facilitate the healing of bone, tendon, ligament, muscle, cartilage, or nerve. These include stem cells and other cells such as macrophages, leukocytes, pericytes, RBCs, etc, cytokines, platelet rich or poor plasma, serum, extracellular matrix, fat grafts, and other tissues.

1. If outcomes and risks are discussed, you should have at least case series outcome data on the specific procedure you are performing. If that’s not available, then you should discuss outcomes solely based on your experience.
2. If research is posted to your web-site, it needs to be research that represents the procedure you are using. For example, if the provider is using stromal vascular fraction from adipose tissue, posting research that used culture expanded mesenchymal stem cells is inappropriate.
3. You should practice within your specialty area. For example, providers that are commonly trained to see neuromusculoskeletal injury such as PMR, Orthopedics, Interventional Pain, Family Practice with a Sports Fellowship, or other disciplines where significant MSK training has been pursued should only treat patients with neuromusculoskeletal injuries. As an example, an orthopedic surgeon or PMR specialist treating patients with multiple sclerosis with an IV infusion of stem cells is inappropriate.
4. Claims made about the cellular or cytokine content of a product or procedure should be substantiated using reasonable science. For example, a physician should not rely on the testing from a manufacturer that purports to have an amniotic or cord “stem cell” product unless the data supplied can substantiate the claim. If the claim can’t be substantiated, then the act of that provider advertising to the public that he or she is performing a stem cell procedure constitutes consumer fraud.
5. The use of orthobiologics is a physician level procedure. The goal for regenerative medicine is the improvement of existing surgical or interventional subspecialties or the creation of new ones that require physician level thinking, knowledge, and experience. Hence it is not appropriate for a mid-level provider to be practicing regenerative medicine of the neuromusculoskeletal system using orthobiologics.
6. Your use of orthobiologics must comply with all applicable state and federal laws, regulations, and guidance documents.
7. Whenever possible, the use of investigational procedures, substances, or devices should be the subject of research or data collection and that information should be made available in a public forum.

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Written by

 Chris Centeno, M.D.
CEO at Regenexx

To take advantage of our special offer please contact Neokine at www.neokine.com or 855-9-NEOKINE (855-963-6546)

For more information about NeoKine and it's incredible pain management product EnPLAF, please visit our website www.neokine.com

Do you or a loved one suffer from some form of Arthritis?

Half of mature adults end up with the painful “wear and tear” condition called Osteoarthritis, and millions of more Americans suffer from Rheumatoid Arthritis, Fibromyalgia, Gout, and other less-common arthritic diseases.

Unfortunately, arthritis has no cure.

So doctors write millions of prescriptions for medications that treat the symptoms of the disease. Millions of more folks with arthritis buy pain-relieving drugs available without a prescription at their nearby pharmacy.

Yet, side effects from these drugs can actually be worse than the condition itself.

The myriad dangerous side effects from various over-the-counter and prescribed drugs used for arthritis include stomach ulcers, GI bleeding, cancer, diabetes, heart attacks, suicidal thoughts, and many others.

Most mainstream doctors don’t even know about safe, scientifically proven natural remedies for arthritis — which do exist. And because they aren’t highly publicized, many of these therapies are virtually unknown to the general public.

Neokine has developed and made clinically available safe and natural ways to beat arthritis pain and inflammation, combat joint damage, and help you live a more active, energetic life.

Because arthritis is so common, particularly in our aging population, Neokine wants to make this information available to as many sufferers as possible.

To take advantage of our special offer please contact Neokine at www.neokine.com or 855-9-NEOKINE (855-963-6546)

For more information about NeoKine and it's incredible pain management product EnPLAF, please visit our website www.neokine.com

Steroid Injection Risks: STOP INJECTING PATIENTS WITH STEROIDS!!!

I love blogging about my experiences in clinic, especially the ones that make my blood boil. One of those blood boiling issues is steroid injection risks. This past week, while seeing patients at our licensed, advanced stem-cell-culture site in Grand Cayman, I saw a guy whose hip MRI from December wasn’t that bad. In fact, it didn’t fit with his quickly declining function and elevating pain. A quick preprocedural X-ray confirmed what I had feared—two steroid shots he had in that hip a few months back had accelerated his arthritis like pouring gasoline on a bonfire. So this post is aimed squarely at the legions of physicians who continue to use steroids…

Steroid Injection Risks Are Nasty

Physicians around the country inject high-dose corticosteroids in joints like it’s holy water. The dose they use is based more on medical tradition than on science. You see, while the milligram dose range used sounds small (after all, it’s only a thousandth of a gram), to the body it’s massive. In fact, it’s a million times too much as the joint and cells of the body are used to seeing a billionth of grams (nanograms).

What happens when you dramatically overdose tissues used to seeing nanograms of steroid with milligrams? Bad stuff!

Why, Then, Are We Still Injecting Patients with High-Dose Steroids?

Steroids are an inconvenient truth. They can make a patient feel better for a while, but they also likely cause more long-term harm than good. So why do we use them? First, many physicians don’t have anything better to offer. Let’s be honest here. In a world where regenerative medicine solutions are exploding, that’s just a simple lack of imagination and knowledge on the part of the physician. Second, they’re covered by insurance, and many physicians have a hard time thinking outside of the insurance box, even if what’s in that box is not in the best interest of the patient.

How We Can Keep Our Insurance Overlords Happy and Help the Patient

When we first began using stem cells in 2005, the research was clear that nanogram-dose (ultra-low-dose) steroids was what the body was meant to experience. Meaning when you look at in vitro studies where cells are exposed to corticosteroids, the appropriate dose range to get an effect is in the tens- to hundreds-of-nanogram range. This is more than enough to activate receptors. In fact, steroids in this dose range can do some cool things, but steroids in the much higher milligram-dose range (one million times more) kill cells. Hence, the solution would seem to be simple: given the steroid injection risks, if you have to use steroids, why not just use them in the appropriate dose range for the body?

We’ve been using nanogram steroids for a decade now, and I can tell you that they work very similarly to their bigger milligram-dose cousin. You observe the same suppression of inflammation, and you’re not killing cells. In fact the only time I’ve seen them not work is in a patient with severe inflammation due to a systemic disease or in a patient whose body has gotten used to the sledgehammer effects of high-dose steroids.

The upshot? Ladies and gentleman, madams and monsieurs…it’s time to ditch the high-dose steroids! Just use the low dose version to protect your patients!

Source

http://www.regenexx.com/steroid-injection-risks

www.NeoKine.com

Are we living in the age of Modern Medical Miracles?

If giving birth wasn’t the most extraordinary “medical miracle” we have ever seen, bringing twins, triplets or quadruplets into the world, most certainly is. But birthing obviously isn’t a modern phenomenon. Our ancient ancestors relied on instinct and earliest techniques to give life to the next generation. The modern part of childbirth centers around calculation, prediction, and consistency. Ultra-sounds deliver proof of well-being of the offspring in the mother’s womb itself, prompting interventions to ensure birth of a healthy baby.

Over the course of recorded medicine, there have been countless medical breakthroughs, and probably as many forgeries, phonies, and frauds as there have been genuine advances. Identifying and describing the DNA double helix and unlocking the genetic code, the discovery of penicillin, the Polio vaccine, the X-Ray, the MRI, statin drugs, organ transplants, antibiotics, cloning, even the home pregnancy test are just a few game-changing medical breakthroughs. And most have occurred within the past century!!!

The list of recorded medical frauds goes back to “snake oil salesmen” traveling the country putting on medical miracle shows in small towns, selling their largely useless wares, and then disappearing off into the night. There have also been countless medical devices guaranteed to make their users taller, smarter, thinner or more romantic. Today, just turn on your television or surf the web for a bit and you will witness scores of “miracle” fixes. The “recently discovered” miraculous healing powers of nuts and berries, powders that will build muscle, diabetic wonder drugs that allow diabetes sufferers to eat anything, anytime and never worry about watching what they eat again. If it seems too easy, it probably is for a reason. It doesn’t work.

A real modern miracle is never one that has been “instantly” discovered. A true breakthrough is always the result of years of study, countless tests, successes, failures, repetition and challenges even before it is introduced as a diagnostic or therapeutic intervention. By the time a real medical advancement is brought to the public’s attention, there have been virtually countless tests and studies done and repeated. True scientists want to have their “breakthrough” verified to the core before it goes from bench to bedside.

Enriched Platelet Factors (EnPLAFTM) is a novel concept in which the growth and healing factors found in one’s own blood can be isolated, harvested and re-injected back into one’s own body to enhance healing, regeneration and provide pain relief without chemicals, drugs or genetic enhancements of any kind. EnPLAFTM based therapies provide convenient, safe, cost-effective and highly efficacious therapy options for patients in several therapeutic areas including orthopedics and pain, podiatry and wound healing, aesthetics, sexual health, and dentistry.

Platelet Rich Plasma (PRP) has been used in several therapeutic areas described above. But PRP has several drawbacks which limits its utility. Although EnPLAFTM is a newer technology, it is tested and proven to be better than PRP in several ways. It clearly addresses the limitations that PRP presents. EnPLAF™ based therapies use ‘the power of yourself’ to provide a viable non-invasive, non-surgical alternative to suffering patients. Check out the NeoKine website (www.neokine.com) for more information about how EnPLAF™ works, how it can benefit you, and how to connect with a clinic that offers this truly breakthrough treatment.

For more information about NeoKine and it's incredible pain management product EnPLAF, please visit our website www.neokine.com