Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.

On Published Regenerative Medicine Articles in Scientific Journals

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.

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Don’t Fall Victim to The Stem Cell “Learning Curve”

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.

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False Stem Cell Promises

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.”

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An exclusive interview with a Cellular Orthopedic Pioneer

While skiing last week in Vail, Colorado, I had the opportunity to sit down with Mitchell Sheinkop, MD, Fellow of the American Academy of Orthopedic Surgery and Fellow of the American College of Surgeons, to learn about the emerging field of Interventional Orthopedics. In 2007, Dr Sheinkop received the Shaare Zedek International Humanitarian Award in recognition of his global orthopedic educational endeavors.
Question: Do stem cells really work?
Answer: There is a misconception regarding joint restoration as it is not the adult mesenchymal stem cell alone that is responsible for postponing or even avoiding a joint replacement in the arthritic setting.

Question: All I read and hear about are stem cells?
Answer: Unfortunately, ad placement hype is competing with good science for the patient’s attention and owing to advertising and marketing; the real message may be getting lost.

Question: Would you please explain?
Answer: When I “graduated” from a knife to a needle, I too believed that it was the stem cell that would morph into cartilage. We now know that the Adult Mesenchymal Stem cell orchestrates the regenerative process and directs other cells and molecules to help reverse the arthritic process, effect healing and improve function.

Question: Who are the members of the orchestra, so to speak?
Answer: When injury occurs, platelets aggregate to initiate the healing process. The activated platelet recruits the cells lining capillaries (pericytes) that then function as stem cells. Control of the bio-immune response and the regeneration affected by anti-inflammatory molecules termed Cytokines and cellular secretions known as Growth Factors are directed by the stem cell.

Question: Where do all of these stem cells, cytokines and growth factors come from?
Answer: When it comes to the musculoskeletal system, we look to the patient’s own Bone Marrow Aspirate Concentrate as the only FDA tolerated resource .While you may be aware of the potential of adipose tissue as a stem cell resource, in order to liberate the stem cell, fat has to be digested with an enzyme, collagenase. As of this interview, enzymatic digestion is not approved by the FDA nor are there significant scientific studies to support adipose derived stem cells for arthritis.

Question: I am aware of plastic surgeons offering fat graft for arthritis, is it effective and legal?
Answer: Neither but it is expensive. Fat graft is not a source of regeneration; it is filler for cosmetic surgery.

Question: I am aware of a media blitz promoting Amniotic Fluid Concentrate as a source of stem cells?
Answer: The research at the Interventional Orthopedic Foundation demonstrated that while there are stem cells in amniotic fluid along with Hyaluronic acid, anti-inflammatory Cytokines, and Growth Factors when that fluid is harvested in conjunction with a Cesarean section; after processing, freezing and the quick thaw, there are few if any viable stem cells remaining.

Last Question: How might a patient seeking to manage arthritis without surgery make the right therapeutic decision?

Answer: Just as our presidential campaigns, paraphrasing Dahleen Glanton in the Chicago Tribune, Monday, February 22, are a cesspool of empty promises and lies, so too is the marketing of stem cells; witness the advertisement featuring a chiropractic spokesperson in The Chicago Tribune, Tuesday, February 9, 2016, placed by The Stem cell Institute of America.

When you seek a Regenerative Medicine consultation, make sure that physician is fellowship trained, board certified and integrates clinical research with his or her practice.  Don’t depend on anecdote; inquire about outcomes data. In my practice as well as in those other members of the Regenexx Network, we base our clinical decisions and therapeutic recommendations for Cellular Orthopedics on Documented Results.

Mitchell  Sheinkop, MD  accepted Emeritus Professor status as the director of the joint replacement program at Rush University Medical Center six years ago where he had played a major role over 37 years in the development of the department of orthopedics and in the founding and growth of Midwest Orthopedics. Since that time he has played a major role in the emerging field of Interventional Orthopedics.

 

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Stem cells and Statin recommendations during stem cell procedures

Owing to the broad indications for statin medications, an ever increasing number of patients are using these therapies. Certainly, there is a benefit to statin use as a means of decreasing cardiovascular disease; but by the same token, there is the observation of decreased athletic performance, muscle injury, myalgia (muscle pain), joint pain, and fatigue. The type of statin, the dose, drug interactions, genetic variants, coenzyme Q10 deficiency, vitamin D deficiency, and underlying muscle diseases are among the factors that may predispose patients to intolerance of statins.  When it comes to those seeking Cellular Orthopedic interventions, their fitness and exercise endeavors may result additionally in an intolerance of the combined approach decreasing and treating cardiovascular disease.

Although in general, statins are well tolerated, they can affect skeletal muscle producing symptoms that range from myalgia (muscle pain) to creatine phosph kinase (CPK)-muscle enzyme marker- elevation and rhabdomyolysis (rapid breakdown of skeletal muscle). These statin associated musculoskeletal side effects can be exacerbated by physical activity. Now comes a recently published study reinforcing previous findings that certain types of cholesterol lowing drugs called statins, inhibit Mesenchymal Stem Cells. As you know, MSCs are the body’s reservoir of regenerative potential and are capable of orchestrating regeneration of a wide variety of skeletomscular tissue. In the laboratory and now documented in patients, statins not only interfere with MSC function, the drug increases the aging and death rate of Adult Mesenchymal Stem Cells.  Basically, statins are a kind of stem cell poison.

It is important for you, the potential patient to understand that those undergoing a bone marrow aspirate concentrate intervention for arthritis are not only receiving stem cells. The bone marrow concentrate contains in addition to the mesenchymal stem cell, a category of anti-inflammatory molecules called Cytokines and another category of cellular messengers termed Growth Factors. Recent science suggests that latter two groups may be equally or perhaps more important than stem cells in introducing pain relief, increased motion, improved function and reversal of the arthritic progression.

For those of you considering a Bone Marrow Aspirate Concentrate procedure for an arthritic joint, please don’t act without discussing the use of statins with your physician. Strategies include a reassessment of the need for statin prescription, a decrease in dosage, a change to a hydrophilic statin, a statin holiday prior to and after the Cellular Orthopedic intervention followed by a rechallenge after six weeks, vitamin D replacement, coenzyme Q10 supplementation and/ or L-carnitine supplementation.

There are alternatives for those who are statin dependent  and in whom a holiday might be contraindicated.  To learn about our full menu of Cellular Orthopedic options, make an appointment

847 390 7666

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Stem Cells and Basic Science

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

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