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.

Accuracy, Ethics and Corrections

The last Blog posted in 2015 indicated that I wouldn’t look back; but after its posting, I received this correction form Dr Chris Centeno, arguably, the best informed Regenerative Medicine expert in the North America.

“Mitch,

The discussion of amniotic injections isn’t correct. We found that amniotic tissue hurt stem cells. While we did find a weak growth factor/cytokine effect, it was less than PRP. So extrapolating that data, it would be stem cells>PRP>amniotic. Please correct.

Chris”

I very much appreciate his input as well as invite his ongoing constructive criticism, additions and recommended corrections. Let me add, the PRP he is referring to is not the usual and customary office based 15 minute procedure; but rather a proprietary process developed in the Regenexx laboratories and available from those physician members of the Regenexx network.

 

Changing my focus, in a review article appearing in the January 2016, volume of the Journal of the American Academy of Orthopedic Surgeons, an article appeared Risk Prediction Tools for Hip and Knee Arthroplasty. It is easier for me to quote rather than extrapolate:  “After arthroplasty, complications such as infection, venous thromboembolism, acute myocardial infarction, pneumonia and many others are associated with poorer patient outcomes and represent a substantial cost burden to the American healthcare system”. The article continues: “Total joint arthroplasty is thus an appropriate target for quality improvement and cost containment via pay-for-performance initiatives.” For someone such as myself, an orthopedic surgeon who devoted a 37 year career after nine years of post graduate education and training performing Total Joint Replacements, I feel that my professional evolution into cellular orthopedics is again validated.  In reviewing our data base, following a cellular orthopedic intervention for arthritis, we have not recorded one infection, venous thromboembolism, acute myocardial infarction, case of pneumonia, or any other complication. While 100% of my patients do not experience a successful or satisfactory outcome following the first cellular orthopedic intervention for arthritis, those numbers increase from 75% to 85% with a booster or repeat procedure. Once again, the end result of an unsuccessful Total Joint Replacement is a revision surgery; after a revision, it was not unusual to hear a patient volunteer “give me back my arthritis”. After a less than optimal outcome of a cellular orthopedic intervention, the fallback position is a repeat procedure followed by a patient’s “thank you doctor.”

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Final Blog of 2015

Final Blog of 2015

I won’t look back so let’s see what’s coming in 2016. The clinical Regenexx Knee Trial introduced in 2014 will start providing information here-to-for unavailable in Cellular Orthopedics. Many times in the last several years I had written about my observation that there is a paucity of science and a plethora of marketing without support in the world of Regenerative Medicine. Last week, a patient came to my office for a second opinion after having attended a seminar on amniotic fluid concentrate. The patient had carried away a notion that amniotic fluid concentrate contains viable stem cells that will regenerate an arthritic knee. Several months ago, I had reviewed the subject in my Blog after having attended the first Interventional Orthopedics Foundation meeting in Broomfield, Colorado. After extensive testing in a laboratory setting, it was documented that while there may have been stem cells in the amniotic fluid when recovered, by the time the material was processed, frozen, and fast-thawed, the amniotic fluid commercially available has no regenerative potential. The role of amniotic fluid concentrate in 2016 will be to replace visco-supplementation in the marketplace as more and more insurance carriers will withdraw coverage based on publications from the American Academy of Orthopedic Surgeons on the benefit or lack thereof from visco-supplementation. If there are no stem cells in the amniotic fluid concentrate, what is there that may be helpful? The scientific laboratory studies did confirm that the Growth Factors and anti-inflammatory cytokines do survive processing and may be of equal or even greater importance in the long run than the stem cells. My plan is to replace visco-supplementation with amniotic fluid by mid 2016 in my practice.

I want to return to our Regenexx Knee Clinical Trial. It is the largest of which I am aware in the world as far as the methods used in determining the success of a stem cell intervention for Grades Two and Three Osteoarthritis of the knee. I was chosen to execute this three to five year outcomes study because of my background as director of the joint replacement program at Rush, one of the five largest joint replacement programs in the country. In addition, over my 40-year joint replacement career, I had published many studies on the outcomes of a hip and knee replacement at five and ten years. Our preliminary observations concerning those who met the trial inclusion criteria are that the vast majority, are very satisfied and active. Certainly, we will have to wait another year before our numbers allow for statistical analysis; but so far, the outcomes are excellent. Please keep in mind the methodology for the intervention is not a single injection but rather a carefully designed treatment program. To learn more, call for a consultation

847 390 7666 with offices in Des Plaines and Lincoln Park

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Final Blog of 2015

Realistic Patient Expectations

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

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Mesenchymal Stem Cells for the Management of Inflammation in Osteoarthritis

The title of the Blog this week is taken from a review article appearing this month in The Journal of Osteoarthritis and Cartilage focused on reviewing the state of the art and perspectives, authored in Montpellier, France. As I have indicating over the past several months, the original regenerative medicine concept had been that we would take your bone marrow via aspiration, concentrate it in our laboratory and inject the concentrate into an arthritic knee thereby introducing adult mesenchymal stem cells. The belief had been that those stem cells would morph into cartilage. Now we know there is a lot more happening in the joint following the introduction of bone marrow aspirate concentrate/stem cells.

We know that Osteoarthritis is the most common form of arthritis mainly characterized by the degradation of articular cartilage and associated with subchondral bone lesions. Whereas I had spent the vast majority of my orthopedic career on joint replacement for grade 4 osteoarthritis, over the past four years, I have focused my initiative on cell based interventions for stages two and three arthritis; although next month, I am introducing a novel cell-based therapy for grade 4 osteoarthritis of the hip and knee. Stromal Cells (MSCs) have gained much interest on their trophic and immunomodulatory functions that can help tissue repair/regeneration. The review article from France focuses on the anti-inflammatory effect of Mesenchymal Stem cells on Mitochondrial RNA modulation in OA. With continued cellular science advances, the notion that stem cell management of your arthritic knee and hip still is in the future is erroneous. Four years ago, there may have been some basis for your physician to minimize the possibilities of interventional orthopedic in lieu of a joint replacement because there wasn’t enough clinical proof of efficacy; and, the understanding was that the MSCs would morph into cartilage. As a result of our continued data collection coupled with better understanding of the anti-inflammatory effect of bone marrow aspirate concentrate, there is every reason for an arthritic patient to attempt to avoid a joint replacement.

This past weekend, we had every reason to give thanks and I am no different. I give thanks to my family, to my health, and to my profession for allowing me to help my patients enjoy a pain free active lifestyle. To learn about our non-operative approach to reversing the pain and limitations of arthritis, call to see if you are a candidate or to schedule an appointment.     847 390 7666

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Final Blog of 2015

A Renewal of Body; a Renewal of Spirit

And Let us say Amen. You may not have noticed, but last Thursday, the weekly Blog I write was not posted; because I was off for a week with my two sons fishing the flats of Ascension Bay along the eastern cost of Mexico. While I practice Regenerative Medicine and Interventional Orthopedics, I am very much aware that accompanying the notion of physical well being is spiritual well being. Every year at this time I repeat the “pilgrimage” because just as the spiritual reminds us, your knee joint is connected to your thigh bone and your hip joint is connected to your back, so too is your body connected to your mind. Regeneration and Renewal are like love and marriage; you can’t have one without the other.

I am reminded of the patient I treated two years ago with a bone marrow aspirate concentrate intervention for his arthritic knees. At the time of his first office consultation, though he only lived six blocks from my office; because he couldn’t walk that far, he took a cab. Six weeks later, he returned for follow-up and complained about his ongoing pain and his disappointment in the outcome although in preparation for the procedure, I had informed him it might take up to 18 months to reach maximum medical improvement. When I inquired as to his mode of transportation to my office, he responded that he had walked. Physically, he was enjoying an excellent outcome but spiritually, he needed renewal as well.

As I look at the storefronts in my neighborhood and in downtown Chicago, I am reminded that the holidays are not far away. As I look at the weather forecast, I see that a high of 32 degrees is forecast for November 23 and my thoughts turn to skiing and your hips and knees. What Regenexx does is renew your hips and knees for the outdoors or indoors, holidays and more. If you want a renewal of spirit, try living without pain and increasing your functional capacity. We can make this happen with our Bone Marrow Aspirate Concentrate/ Stem Cell interventions. This morning, a patient contacted me via e-mail to tell me about his friend who before age 55, is on his third hip replacement at the same joint. While my patient has not been totally relieved of his hip pain by my BMAC intervention, he play golf and is fully active whereas his buddy, after a third hip replacement, lives a painful, inactive life dependent on a cane. When coping with the limitations of arthritis, give the opportunity for renewal of body leading to renewal of spirit some thought and then give me a call for an appointment:  847 390 7666

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Final Blog of 2015

News from the Interventional Orthopedic Foundation Meeting Continued

My last Blog brought you greetings and discussed some of the issues reviewed at the first meeting of the Interventional Orthopedic Foundation. This not for profit foundation was founded to help facilitate the transfer of scientific regenerative medicine developments into clinical practice. One challenge is how to improve the outcomes of what is now the gold standard of Interventional Orthopedics, Bone Marrow Aspirate Concentrate in managing arthritis of major joints. We seek to see longer effect and better results. While there are all kinds of claims being made for amniotic fluid concentrate and adipose (fat) derived stem cells, as of now, there is no data to support said claims.

I have played a large role in documenting the success of Bone Marrow Concentrate intervention for arthritis. Now I want to see if I can improve those results. At the Interventional Orthopedic Foundation meeting, various means of improving outcomes were discussed including, hyperbaric oxygen, ultrasound, lasers, ultraviolet light and finally, electro-stimulation. I was reminded of a study in which I was involved five years ago using an electronic pulse joined to a knee brace to try to regenerate cartilage. The study was based on animal models who when subjected to an electronic pulse grew cartilage. It occurred to me that the answer to improving the quantity and the quality of a Bone Marrow Aspirate Concentrate/ Stem cell intervention for an arthritic knee might be the pulsed brace. If every patient who undergoes a stem cell intervention for arthritis is prescribed a brace post treatment, since we know that the pulse is safe and potentially helpful, why not add the pulse to the post intervention protocol. To that end, I am happy to announce the introduction of this methodology to our post intervention protocol via a clinical trial starting in December

We will follow each patient for up to a year with our standard clinical objective and subjective means and periodic X-Rays with no added fiscal burden to the patient. The results of this study will then be presented to the 2016 meeting of the Interventional Orthopedic Foundation as I continue to integrate patient care with research. There is no question that patients who wore the brace and used the pulse for arthritis without stem cell intervention in the past were improved; imagine the potential leap forward by adding the pulse to the brace after a Bone marrow Aspirate Concentrate/ Stem Cell intervention.

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