Mar 17, 2016
In a commercial advertisement appearing on page 3 of the Monday, March 14, 2016 Chicago Tribune, a claim by the Osteo Relief Institute bases, in part, the validity of a “cutting-edge” treatment-Viscosupplementation intervention-on an article published in the Journal of Managed Care Pharmacy. Having published over 100 scientific papers in peer reviewed journals and never having heard of the Journal of Managed Care Pharmacy; I looked up the Journal to learn it is an advertising vehicle for the pharmaceutical industry.
From the American Academy of Orthopedic Surgeons: “AAOS Evidence-Based Clinical Practice Guidelines are based on a systematic literature review of published studies. Multidisciplinary guideline development groups construct Evidence-Based Clinical recommendations.” “Although some patients report relief of arthritis symptoms with viscosupplementation, the procedure has never been shown to reverse the arthritic process or re-grow cartilage”. The AAOS no longer supports the use of Viscosupplementation in the treatment of arthritis.
What we do with your stem cells at Regenexx is not only address symptoms of arthritis; based on our clinical trials, data base, and scientific publication documentation, is to improve function while addressing the progression of arthritis at a molecular and bio-immune level. Stem cells, in addition to the cytokines and growth factors in Bone Marrow Concentrate, have the potential to regenerate cartilage. Because of the lack of proven success over 20 years as determined by meta-analysis of the scientific literature concerning viscosupplemenation, the Regenexx network is moving away from offering Hyaluronic acid (Gels) and slowly the insurance industry is dropping coverage as well.
There is no question that the Osteo Relief Institute marketing campaign is attractive to a patient but what about a scientific foundation? Don’t get me wrong, I too can succumb to well done advertising. The Most Interesting Man in the World ad campaign caused me to switch to Dos Equis beer. Your arthritic related limitation is a totally different matter and your choice of treatment should not be influenced by an advertising campaign. Seek out that which is evidence based and available through board certified physicians and surgeons.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Mar 10, 2016
The 2016 annual meeting of the American Academy of Orthopedic Surgeons has ended and the Orthopedic Surgical community is now very aware of what we have been accomplishing in Cellular Orthopedics for almost four years. In Orlando, Orthopedic Surgeons, “Camp Followers”, and the health care industry in general was updated on that for which we have been gathering data for four years in my Chicago office and seven to eight years at Regenexx. The orthopedic surgeon is unique in the field of surgery as the entire specialty is voluntarily governed by Evidence-Based Medicine. Such is not necessarily the case in others who are licensed to treat musculoskeletal disease and injury. Now that the outcomes are being reported with up to four years of Data to support what I do, patients should anticipate a marked increase in those offering cellular orthopedic alternatives to sports injury and arthritic limiting disease without proper acknowledgement behind the basis of their recommendations.
First and foremost, if you have a musculoskeletal based impairment of any kind, the first step is an accurate diagnosis starting with a history and physical examination. Next follow the X-ray and then the MRI if needed. Once the diagnosis is clearly and accurately defined and graded, then should a discussion ensue about the role of pain management, surgery or cellular orthopedic interventions. I am very concerned about the increasing frequency of media placements by those not educated, or for that matter, licensed to complete cellular orthopedic interventions.
My other concern is that once the orthopedic surgeon becomes aware of our non operative stem cell successes; there will occur (actually it has already started) a rush to get involved in Regenerative Medicine; wherein up until now, the same professionals have refused to acknowledge our successes. In any new undertaking, the term “learning curve” may be applied. Patient heed my warning, don’t fall victim to the learning curve. A cellular orthopedic intervention is a complex process; much more than several needle sticks. A successful Regenerative Medicine procedure requires a proper six week patient preparation, an understanding by the professional of what pharmaceutical agents might disrupt a stem cell success, the proper management of the Bone marrow Aspirate, the timely introduction, preparation, and management of adjunctive Platelet Rich Plasma with all of the above carried out in an appropriate environment. There is no place for “bedside” machines and the FDA may put an end to office based procedures in the near future. Last of all, only experience may lead to the most appropriate recommendation as to whom is a proper candidate for stem cells.
Would you want a family practitioner to do your Total Joint Replacement? Would you let a chiropractor do your arthroscopy? Do you want to be the first to receive a new treatment and be part of a clinician’s “learning curve”? The Regenexx Network of Physicians has been involved with an innovation and alternative to surgery for Afflictions of the Musculoskeletal System; we have already learned.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, joint replacement, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
Mar 3, 2016
I haven’t yet heard or read the Thursday Mitt Romney speech as I write this Blog, but as long as the terms Fraud, False Promises, Uninformed, etc. will be headline news this afternoon and all over television tonight, I thought I would expand the theme to which I read and see about misrepresentation when it comes to Cellular Orthopedics. When my computer fired up this morning, one of the first bullets advertised an international stem cell company offering Exosomes if you travel outside of the United States for care. For those of you unfamiliar with the term, Exosomes are extracellular vesicles that have the potential to do good things to your cartilage and soft tissues. As I read the stem cell ad, I noted the following:
“Exosome Injection is a human induced pluripotent stem cell-derived mesenchymal stem cell treatment, which has emerged as a promising supplement to stem cell transplantation therapies. Exosomes derived from mesenchymal stem cells can play an important role in repairing injured tissues. Exosome injection is also utilized as a complement to bone marrow stem cell extractions.”
Thank goodness for the FDA. While the governmental agency has been frequently criticized, the FDA is there to protect us; that’s why you have to travel outside the US for unproven “promising” interventions. To continue the “promising” discussion, the web site promoting Exosomes also invites you to travel outside of the United Sates for Stem Cell assistance with Cancer, Parkinson’s Disease, Alzheimer’s, Cerebral Palsy, etc. 60 Minutes, we need you.
There is a better option to help avoid or postpone a joint replacement, diminish pain, increase motion and improve your functional capacity. At the same time it falls under the standard of practice and thus is FDA compliant; namely the Bone Marrow Aspirate Concentrate/ Stem Cell approach. Not only does Bone Marrow contain Adult Mesenchymal Stem Cells, anti-inflammatory molecules termed, as a group, Cytokines, as well as multiple cellular molecular secretions called Growth Factors; you guessed it, Bone Marrow Concentrate is a great source of those extra cellular vesicles, Exosomes. My Regenexx affiliation and the International Orthopedics Foundation offer quality assurance and safety in an otherwise poorly regulated environment. While the FDA had an April meeting scheduled for testimony and Regenerative Medicine review; that meeting is now set back six months because of a change in leadership at the FDA. Until that delayed meeting, for quality assurance and evidence based cellular orthopedics, seek what is safe, what has been shown to work and forget about “promising supplements.”
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Feb 8, 2016
Every week, I receive updates via brochures and journals concerning the clinical and basic science orthopedic research being done around the country at the various university medical centers. I like to read them to understand how Cellular Orthopedics is emerging and is being accepted in academic institutions. When I retired from Rush and joint replacement surgery five years ago, my colleagues had a very jaundiced view of my new endeavors telling me and then my patients that Regenerative Medicine was unproven, was ten years away, and was not a reasonable alternative to a joint replacement. It is with great pleasure that I am able to announce the American Academy of Orthopedic Surgery Surgical Skills update will include a three day course next month on Articular Cartilage Restoration: The Modern Frontier, as a continuing educational initiative. The title of one particular lecture really caught my attention Move-Over PRP/Viscosupplementation: Stem cells are in and why.
Taking it a step further, the latest bulletin from Jefferson Medical College’s department of orthopedic surgery reviews the basic science being done in the Laboratory of Theresa Freeman, PhD, Associate Professor of Orthopedic Surgery. “The development of Osteoarthritis can often be attributed to a trauma that occurs in youth, which begins the slow degeneration of cartilage. By reducing cartilage damage immediately after an injury, the development of osteoarthritis can be dramatically slowed.”
I have been making the case for an affirmative stem cell intervention every time an anterior cruciate surgical repair takes place or for that matter, when an individual undergoes an arthroscopic procedure. Two weeks ago, I completed a Bone Marrow Aspirate Concentrate Stem cell procedure three weeks after a young middle aged man had undergone micro fracture for a cartilage defect on the weight bearing part of his femur at the knee. On Friday, I scheduled a 72 year old gentleman for a stem cell procedure ten days after he had undergone arthroscopic surgery for a degenerative tear of his medial meniscus during the course of which degenerative changes were documented in the weight bearing zone at the inner compartment of his knee.
A webinar is scheduled by the American Academy of Orthopedic Surgeons next month in order to introduce its orthopedic membership to what may be possible through Cellular Orthopedics. I have already advised you about the Continuing Education Course next month on Articular Restoration. The orthopedic academy membership is only now being introduced to what I have been practicing for almost four years. There are now close to 750 patients in my data base who have undergone Cellular Orthopedic procedures for arthritic joints to relieve pain, increase function and avoid, certainly postpone a joint replacement. On Saturday, I am headed out to Colorado to ski with family for a week. For readers of my blog, you may recall I have undergone a regenerative procedure for my left knee. While I am realistic and I don’t dwell on being who I used to be, I believe anything is possible at any age. If you want to continue or possibly return to skiing, biking, hiking, climbing, fly fishing, skating, fitness, etc, and the limitation is arthritis, schedule a consultation
847 390 7666
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
Dec 14, 2015
The December 2015, Journal of the American Academy of Orthopedic Surgery, featured a Review Article titled Establishing Realistic Patient Expectations Following Total Knee Arthroplasty. The abstract begins with the following sentence “nearly 20% of patients are dissatisfied following well-performed total knee arthroplasty with good functional outcomes.” It continues, “surgeons must understand the drivers of dissatisfaction to minimize the number of unhappy patients following surgery.” There are several studies that have shown unfulfilled expectations are a principal source of patient dissatisfaction following a joint replacement including a failure to relieve pain, improve walking ability, return a patient to sports, and improve psychological well-being. In my previous career as a joint replacement surgeon, it became all too apparent that patients were overly optimistic with regard to expected outcomes following surgery. Published data on clinical and functional outcomes following joint replacement show that persistent symptoms such as pain, stiffness, and failure to return to preoperative levels of function, are common and normal. I thought I should repeat realistic expectations after a Bone Marrow Aspirate/Stem Cell intervention for an arthritic joint based on my data over three and a half years of said procedures for arthritis allowing you to decide which is the next best procedure for you.
First and foremost, the fall back position of an unsatisfactory Bone Marrow Aspirate/Stem Cell intervention at any joint is a repeat procedure for which we have supporting data that a second intervention actually does better than a first. Compare the latter to the rescue of a failed or unsatisfactory joint replacement, a complex major surgical procedure called a revision. The outcome of a repeat Bone Marrow Aspirate/Stem Cell intervention is a better result. Compare that to the outcome of a revision hip or knee replacement; namely, a better X-ray, Even though we have experiencing higher than average temperatures in the Midwest for now, my thoughts turn to skiing. My patients, who have undergone a stem cell procedure with arthritic hips and knees are either on the slopes or headed that way. While after a hip replacement, I will admit that some patients return to the slopes, almost none do so after a total knee prosthesis. After a revision hip or knee, forget it and plan for a cane.
While the world of joint replacement surgery is really not changing, what has been still is; I am able to get you on the slopes or at least relieve your pain with a needle and not a knife without burning any bridges. Joint replacements have a place for advanced arthritis; although Cellular Orthopedics may even now help grade four osteoarthritis. To learn more about realistic expectations and avoid disappointment following a total joint replacement, call for an appointment 847 390 7666
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment, Ultrasound Guided Injection
Oct 29, 2015
In spite of what a patient may be told by the physician and what salesmen tell the doctors, research by the Interventional Orthopedics Foundation laboratories found no viable stem cells in Amniotic Fluid Concentrate once shock thawed. While there may have been living stem cells in amniotic fluid when harvested, part of the commercial preparation and storage requires freezing. Once shipped for clinical use, the preparation is quickly thawed (shock thawing) as required for injection. While a slow thaw over 24 to 48 hours will preserve stem cells, shock thawing kills cells although the hyaluronic acid content and the Cytokine/Growth Factor content is maintained. The net conclusion is that Amniotic Fluid Concentrate may be beneficial as a symptom altering intervention but with no regenerative potential.
Analysis of the available enzymatic means of liberating stem cells from fat is a violation of FDA restrictions. The Interventional Orthopedics Foundation has been aware of the increasing claims that adipose derived stem cells are superior to Bone Marrow Aspirate Concentrate derived stem cells in various orthopedic conditions. As such, the Foundation studied the law and the proprietary claims. The conclusions reached are that there is no scientific data or publications to support the claims of superior outcomes of fat over bone marrow and the use of the enzyme, collagenase to liberate the stem cell from the adipose tissue is violation of FDA guidelines. By the same token, the introduction of a mechanical means to liberate biologically active molecules from fat may fall within FDA guidelines but the impact in arthritis has yet to be clinically documented.
No consensus has yet been reached regarding the substitution of Amniotic Fluid Concentrate for hyaluronic acid in relieving the symptoms of degenerative arthritis. The necessary clinical evidence to support a change in skeletal muscular practice guidelines is still being collected. As of January 1, 2016, I will be participating in that latter initiative in my interventional orthopedic practice. The Interventional Orthopedics Foundation also recognizes the absence of a scientific based means of helping a patient delay or even avoid a joint replacement for advanced arthritis. What we are able to do now and for which we have supporting data is to successfully intervene in Grades two and three osteoarthritis. Beginning in December, I will be initiating a clinical trial that is designed to meet the challenge in advanced arthritis but we will not have statistical evidence of a successful outcome for some time.
If you want more information regarding proven methods using Interventional Orthopedics for delaying or even avoiding a joint replacement in Grades 2 and 3 arthritis or what may be possible for advanced osteoarthritis to avoid a joint replacement, schedule your consultation at 847 390 7666. For those patients who have been told they have too serious a co-morbidity to allow for a joint replacement, let us try to help you as well using needle instead of a scalpel.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, technology, treatment
