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.
Plain Language Summary of Regenerative Medicine

Plain Language Summary of Regenerative Medicine

Cellular Orthopedics for the Musculoskeletal injury and Degenerative Arthritis

What is the problem?

Trauma and Osteoarthritis are part of the cycle of life. Muscle, ligament and tendon injuries frequently occur during sports related activities or accidents; degenerative arthritis may be post traumatic by many years or occur as part of the aging process

What treatments are available?

As of today, it includes Platelet Rich Plasma (PRP) following several protocols and Bone Marrow Aspirate Concentrate (BMAC) rich in stem cells, growth factors and anti-inflammatories called Cytokines. As of next week, all may change as the Orthobiologic update taking place in Las Vegas over the weekend will potentially introduce an entire new menu of therapeutic intervention alternatives for musculoskeletal injury and disease.

What is Platelet Rich Plasma?

Platelets are part of your circulating blood producing growth factors that assist in repair and regeneration of tissue. When a high concentration of platelets are created via the centrifuge, healing may progress more quickly and pain may be reduced

What is Bone Marrow Aspirate Concentrate?

Taken form the back of your pelvis, aspirated bone marrow may be concentrated and prepared allowing for pain relief, improved function, a more rewarding quality of life, and possibly influence the Bio-immune response of degenerative arthritis

What is Amniotic Fluid Concentrate?

The source is the pregnant woman coming to term and delivering via Cesarean section. The recovered amniotic fluid is processed, concentrated, and now available as an alternative to Visco-supplemenation with hyaluronic acid. It is a new option and data concerning the length of pain relief is still being determined.

Do these Regenerative Medicine alternatives work?

When properly applied the answer is yes. What we don’t know is for how long? The effect of Platelet Rich Plasma in injury is intended to speed up the repair process. In the case of Amniotic Fluid, the outcomes are still being studied without a known end point. I have been involved in studying the clinical outcomes of Bone Marrow Aspirate Concentrate intervention for osteoarthritis. The paper I will be presenting this weekend confirms satisfactory results up to two years. The data collection continues.

Is there a downside side to Regenerative Medicine and Cellular Orthopedics?

In my experience the answer is yes and no. Yes because there is no indemnification for the new world of regenerative medicine; care is an out of pocket self pay undertaking because the field is new and five year outcomes data still not available. On the other hand, at three years, I have seen no adverse events and the vast majority have responded well with improved function and quality of life. Out of over 600 knees and over 100 hips, to the best of my knowledge, seven have gone on to a total joint replacement.

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Plain Language Summary of Regenerative Medicine

Continuing Stem Cell and Regenerative Medicine Education for the Patient

Education seems to be on the mind of a growing list of presidential hopefuls so I decided to focus on the continuing educational theme. Today, you can complete a college degree and even grad school on line; this week. I am offering a tuition free short course in cellular orthopedics.

To protect the viability of stem cells and maximize their ability to restore well being to an arthritic joint, clinical studies over the last decade have clearly shown that direct injection is the preferred method to transplant cells. Those same clinical studies have documented that these stem and progenitor cells contained in bone marrow have immense potential to improve tissue and organ function. The key is to keep them viable after harvesting as laboratories and my studies have correlated symptomatic relief with higher cell counts and higher viability. Regenexx has contributed to what it takes to maximize stem cell viability; namely, avoidance of smoking, certain categories of pharmaceuticals such as statins, minimal alcohol consumption, and exercise with healthy eating. To summarize, stem cells cannot be transported from state to state, city to city, or even from facility to facility. Now you understand the Regenexx directive regarding what to do and what to consume prior to and for six weeks following a Bone Marrow Aspirate Concentrate intervention. See the Regenexx Web Site for more information at:  www.Regenexx.com

As I have written in my blog many times, top researchers are increasingly concluding that “stem cells” are not the main event but rather part of a multi-dimensional therapeutic solution. Osteoarthritis is caused by any number of triggers including trauma, disease, aging cartilage programmed to die (apoptosis), mechanical forces and congenital predilection to name a few. Your joints’ enemies are called metalloproteinases (MMPs) and aggrecanases which don’t only just degrade the cartilage; they also contribute to a toxic joint environment. Stem cells have been shown not only to restore damaged cartilage, but to inhibit inflammation; they are one component though of a more complex treatment approach with Bone Marrow Aspirate Concentrate.  To summarize, while adipose tissue may contain stem cells (Stromal Vascular Fractions), fat doesn’t come close to comparing with the the Growth factors and Cytokines to neutralize the MMPs and the aggrecanases when compared to Bone Marrow Aspirate Concentrate.

The major scientific work we depend on for basic science guidance comes from Mark F. Pittenger, Ph.D. Simply put, Dr. Pittenger said that Mesenchymal Stem Cells reduce inflammation and lay the foundation for tissue regeneration and repair. Since his landmark publication, we have learned that there is more in the Bone Marrow Aspirate Concentrate than mesenchymal stem cells that may alter the bio-immune response of arthritis. To summarize, there is science and there are false claims by charlatans and those with proprietary interests and hidden agendas. We need to do more scientific studies and that’s why I have integrated patient care with clinical research; a cellular orthopedic practice based on Outcomes and not undocumented claims.

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Plain Language Summary of Regenerative Medicine

The Case for Amniotic Fluid Treatment in Osteoarthritis of the Knee

Osteoarthritis of the knee is one of the leading causes of functional limitation and progressive deterioration in the quality of life. Nonsurgical treatment of the osteoarthritic knee has been the usual and customary weight reduction directive, recommendation for physical therapy, prescription for non-steroidal anti-inflammatories, followed by injections with corticosteroids and hyaluronic acid. The goal is to reduce pain and improve function but the classical non operative approach is not universally successful or long lasting. Alternatives are continually sought to provide pain relief and improve functional outcomes.

Recently, there has been a major initiative to introduce Amniotic Fluid in the treatment of the osteoarthritic knee. Allograft (from a third party) amniotic tissues have a long history of clinical use having been first reported in 1938. It is thought to be a homologue to synovial fluid, acting as a cushion to protect and lubricate in the closed environment of the knee. A recent study measured the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated outcomes measurement tools. In the registry review, early outcomes suggest that the use of processed amniotic fluid allograft may offer a safe and effective treatment for OA of the knee for 90 days. The suggestion is that this treatment may be more durable than single corticosteroid injections and perhaps hyaluronic acid treatments. The study providing the background for this blog is still in progress. Of interest is the fact that no claim is made in the article supported by the pharmaceutical company that amniotic fluid is chondrogenic or contains stem cells. The latter is an extremely important consideration; beware of those who promote amniotic fluid on their web sites as providing viable stem cell content. As of this time, while amniotic fluid may contain cytokines (anti-inflammatories) and growth factors, it is only to be considered in the same category and comparable, perhaps longer lasting than a corticosteroid injection or a hyaluronic acid intervention.

The standard of Regenerative Medicine and Cellular Orthopedics remains Bone Marrow Aspirate Concentrate as the best source of anti-inflammatory cytokines, growth factors and only FDA approved source of viable adult mesenchymal stem cells. In spite of the FDA approval mandate, as recent as this morning, I received an invitation to attend a course that would teach me how to use adipose derived stem cells in my practice. Let me emphasize two points, Amniotic Fluid does not have viable stem cells until proven otherwise and adipose derived stem cells are illegal for use in the musculoskeletal system. That being said, even if adipose derived stem cells were FDA approved and thus available; bone marrow aspirate concentrate provides  the Cytokines and the growth factors not found in fat while bone marrow aspirate concentrate provides stem cells not found in processed amniotic fluid.

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Plain Language Summary of Regenerative Medicine

“Stem cell treatments take root in US”

Headline on page 14 of the Wednesday, May 20, 2015 edition of the Chicago Tribune. The Associated Press journalist, Matthew Perrone then goes on, “But critics point to dangers of a largely unregulated trade.” This is a well written article in which Perrone highlights the charlatans doing the wrong thing, breaking the law, and doing harm. He did his home- work and focuses on the quackery, false claims and almost wholly unregulated mushrooming adipose derived business not unlike what  Pope Brock did in his 2008 novel, Charlatan. Perrone brings into focus the quacks that prey on desperate patients seeking miracles in treating progressive neurologic disorders and the like. As my good friend opined after having read the article, “when ever a new avenue opens, the easy money guys stream in.”Incidentally, the exposure of those who state” if I am breaking the law, how come I haven’t been arrested yet?” isn’t new; 60 Minutes exposed those who seek to enrich themselves no matter the price to society several years ago. Last night, at the Goodman Theater, my wife and I saw Lillian Hellman’s The Little Foxes; very timely. The play takes place circa 1900, in a small Alabama town where the accumulation of wealth by the Hubbard family takes precedence over family, loyalty, decency, honor and morality. Toward the end of the play, the crowning statement in my mind was something to the effect that there are many Hubbard families out there in the mainstream America.

This lack of professional integrity and opportunism is engrained in our society so how do you protect yourself as a patient, be it Bone Marrow Aspirate Concentrate to postpone or avoid a joint replacement or any other area of medical care? The list of reasons to seek out Cellular Orthopedics and Regenerative Medicine is really the lengthy list of contraindications to surgery because of co-morbidities that preclude a total joint replacement surgical procedure. In addition, there are those patients who want to maintain or return to the highest level of recreational endeavor. The answer is quality assurance by your Regenerative Medical specialist assuring you the recommendations and the intervention are evidence based. That evidence comes from ongoing clinical research integrated with clinical care, not just completing a procedure and handing out a bill. You will find that level of evidence based care within the Regenexx Network of physicians located now thoughout the United States. These are not doctors who took a weekend seminar offered by a training company. At Regenexx, we do not treat anything outside the realm of orthopedic diseases. I partake in many week-long courses over the calendar year in which I not only learn but present my data collected on an ongoing basis. Next month, I am off to present my data at TOBI; a four day international program limited to arthritis and sports related injuries. That’s what I do and that’s your assurance that what I do is based on clinical outcomes research and is evidence based.

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Plain Language Summary of Regenerative Medicine

Best Brain Exercise May Be Physical

That’s the name of the lead article in the Wednesday, May 13 edition of the Health and Family Section in the Chicago Tribune. “The brain loves it when we move and will reward us handsomely if we do, researchers say.” That’s what Julie Deardorff has to say in the article. “Work out for the brain”, not just the body. “Physical activity is crucial to mind and body alike.”

I think you understand the point so let’s look at which arthritic complaint is your problem and how stem cells may help. It is too early in the scientific process to suggest clinically, that Regenerative Medicine can reverse changes in the brain though the scientific evidence supports exercise as having such impact. By the same token, it is not too early to state that Cellular Orthopedics can reverse and benefit your knee and hip. This morning, I am finalizing the talk I will be delivering next month, at The Orthopedic and Biologic Institute International Regenerative Medicine scientific meeting to be held in Las Vegas. My data clearly supports the statement that Bone Marrow Aspirate Concentrate will diminish pain and increase activity in those with arthritis of the major weight bearing joints. We have 187 patients in the data base on whom I have gathered evidence over a 24 month period. All were patients who presented for orthopedic cellular intervention of an arthritic knee. While space does not allow for a complete presentation of the outcomes, the studies clearly document, less pain, better motion, increased functional capacity, and a better state of emotional and physical well-being when compared to pretreatment baselines. The return to high impact recreational activity was statistically significant in the study group of 187 patients.

Bone marrow aspirate concentrate does contain mesenchymal stem cells but there is more to the success story. More recently almost on a monthly basis, molecules and proteins are being identified in the bone marrow in addition to the stem cells that all act together to diminish pain, increase motion, eliminate inflammation , and perhaps even regenerate cartilage. There is even a possibility of reversing or diminishing the bio-immune response of osteoarthritis. At this time, I am unable to document how long these benefits will be realized; my studies will continue as I integrate patient care with research. The latter allows me to determine what number of nucleated cells at the time of the bone marrow aspiration predicts the best chance of a successful outcome. I now have statistically significant evidence that age and BMI do not adversely influence the outcome of a Cellular Orthopedic procedure. By the same token, I can predict success based on the physical examination and history prior to an intervention and advise a patient as to the chance of success based on the combination of the pretreatment consultation and imaging. If you want to learn your chances of postponing or avoiding a joint replacement for arthritis using now scientifically documented results, call for a consultation:

847 390 7666

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Plain Language Summary of Regenerative Medicine

A Potpourri of Regenerative Medicine Offerings without Scientific Evidence

Prolotherapy

In spite of what you may read and hear about repeated injections of 12 ½ % dextrose into your joint or in the soft tissues surrounding your joint, there is no scientific evidence to support the claims regarding a regenerative influence from Prolotherapy. That is not to say it might or could lessen pain around a joint; but the benefits, if any, are anecdotal in nature and fall under the realm of homeopathy. It belongs under the same classification as Acupuncture; there are followers, anecdote and practitioners but an absence of scientific proof as to how it works. Yet, even with paucity, if not absence of scientific evidence, there is no end to web sites extolling the regenerative nature of Prolotherapy.

From science to tabloid

This week, my office and email were inundated following the headline in the Monday Wall Street Journal concerning a 3D printing of a medial meniscus lattice into which stem cells had been injected. A total of one patient was featured who had an experimental meniscus surgically introduced to replace a previously torn medial meniscus. While in years to come, this may become common place, there are limited indications and many more years of clinical trial ahead before an artificial meniscus becomes a standard of practice. After age 40 or so, meniscal injury as documented on an MRI is more often than not accompanied by arthritis. Post traumatic arthritis and degenerative arthritis are contraindications to meniscal replacement and even are associated with a less than satisfactory outcome to existing arthroscopic interventions. I must remind the reader that degenerative and post traumatic knee arthritis may be reflected on the MRI as an abnormal meniscus but in addition, physical examination is compatible with an altered range of joint motion and mechanical axis deformities.

A Regenerative Medicine Offering with emerging Scientific Evidence

I am finishing up my statistical analysis concerning 170 patients with degenerative and post traumatic knee arthritis who have undergone Bone marrow Aspirate Concentrate/Stem Cell knee care  in preparation for my presentation at the June meeting of The Orthopedic and Biologic  Institute.  After two years of follow-up, there is a statistically significant improvement in diminishing pain, increasing range of motion, enhancing well-being, and facilitating return to or maintenance of a highly active recreational profile. This is scientific evidence and the basis for my Regenerative Medicine approach to helping a patient manage arthritis.

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