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.
Cellular Orthopedics versus The Regenerative Medicine Charlatans

Cellular Orthopedics versus The Regenerative Medicine Charlatans

In reviewing the plethora of proliferating Regenerative Medicine web sites, I found one with multiple points of service in metropolitan Chicago offering platelet rich plasma, fat graft, adipose derived stem cells and bone marrow derived stem cells in an office setting for the treatment of ALS, Alzheimer’s, Erectile Dysfunction, Alopecia, Autism, Cerebral Palsy, Aesthetic improvement and so on and more.  There was no end to the promises advanced. At no time was there any evidence of success posted and absolutely no data.

For the first 37 years of my orthopedic practice, I collected outcomes data for every patient in whom I performed a hip or knee replacement. Prior to a surgical procedure, I provided the patient with meaningful outcomes data concerning success and length before a revision surgery might be required. That scientific documentation was scientifically published and used globally for informed consent by orthopedic surgeons around the world. Anticipating the future, actually the present if you live in Alabama, not only do I quantitate that which is injected into an arthritic joint, I am able to qualitate the injectate. I refer to Alabama because that State requires a physician to know exactly what is being injected into a patient when a she or he administers such or the physician is not complaint with that state’s law. With the incorporation of Abbott’s Ruby hemoanalyzer into my Cellular Orthopedic practice, I meet ethical, moral, legal and scientific guidelines and anticipate what I believe will shortly become an FDA compliance requirement. My practice is limited to that which has data to support my recommendations for a symptomatic, arthritic joint; while at the same time documenting the quality and quantity of the combination of Bone Marrow Concentrate, Growth Factors and Platelet Rich Plasma I am injecting.

There is the beginning of an initiative to comply with an anticipated more stringent oversite by the FDA concerning the developing subspecialty of Interventional Orthopedics and I am thrilled to be part of that small group. The FDA is a governmental agency responsible for the well-being, health and safety of the public. While likesome charlatans might get by in the short term, I am thrilled to be part of this initial group of responsible Board Certified Orthopedic Surgeons, Physiatrists and Pain Management specialists providing scientifically supported, FDA compliant, Cellular Orthopedic and Regenerative Medicine options in Sports Medicine and for management of an arthritic joint.  

You may schedule an appointment by calling 312 475 1893

My Website is reached at www.Sheinkopmd.com

You may watch my webinar at www.ilcellulartherapy.com

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Cellular Orthopedics versus The Regenerative Medicine Charlatans

Discovering new pathways to healing with stem cells

On October 28, 2013, I received IRB approval for a clinical trial with Regenexx Sciences, LLC as the sponsor and me as the Principal Investigator. The study, A Randomized Controlled Trial of Regenexx SD versus Exercise Therapy for Treatment of Knee Osteoarthritis with Historical Comparison to Total Knee Arthroplasty, was undertaken by me because of my recent “graduation” from joint replacement surgery to the new world of interventional orthopedics and because of my 37-year history as a joint replacement pioneer. Earlier this month, I was able to begin forwarding outcomes data to Regenexx in Broomfield, Colorado, for statistical tabulation. The results of this trial will not only impact what and how the Regenexx Network will make interventional recommendations, as the first and most comprehensive study of its kind, it will serve as the basis for comparison of all ongoing and future Regenerative Medicine methodologies for the care and treatment of the arthritic knee.

From Stem cells to Growth factors, the integration of our clinical research and clinical practice is having a major impact within the field of interventional orthopedics. Our results are allowing patients to return to activities they enjoy using a needle instead of a knife. I do not claim to be a cellular biologist but my network now allows me insight into the latest cellular advances. With the incorporation of the Abbott’s Ruby cell counting system into my clinical practice, I now customize the Bone Marrow Concentrate to the individual needs of a patient and thus not only quantitate but qualitate that which I inject into an arthritic joint.

Many Musculoskeletal injuries and certainly arthritis, do not heal with conservative management and historically required surgical intervention. The most contemporary method of effecting healing and regeneration is both Platelet Rich Plasma and Bone Marrow Concentrate. If you take a second look at the title of the clinical trial cited above, you will see the complete title ends with “Historical Comparison to Total Knee Arthroplasty”. The control group for the trial were patients with an arthritic knee in whom I had performed Total Knee Replacements during my surgical years. I am one of the few Orthopedic Surgeons who have experiences both in joint replacement surgery and interventional orthopedics. The majority of stem cell recipients have returned to activities they enjoy; the majority of Total Knee recipients are couch potatoes. When the numbers become available after statistical tabulation, I will post the data on my Blog.

Recently, I became aware of a relatively new web site www.Desirelist.com. The web site allows you to discover, capture and list all you may desire with a high probability of realizing your desires. So, I went on line and listed that which I want for my patients in 2017; namely, Internal Peace in a World at Peace. Where I can make a difference for those limited by arthritis of a major joint , and deliver on your desire for an improved quality of life is through Regenerative Medicine and Interventional Orthopedics.

Happy Chanukah, Merry Christmas and Happy and Healthy New Year

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Cellular Orthopedics versus The Regenerative Medicine Charlatans

Evidence Based Medicine and Looking Back at 2016 Interventional Orthopedics

I use bone marrow derived stem cells because they have been proven to be most effective at treating orthopedic conditions when compared to adipose derived stem cells.  There have been 13 papers published showing bone marrow superiority to adipose tissue in regards to treating orthopedic conditions and to the best of my knowledge, none reporting adipose derived results for arthritis. In addition to Adult Mesenchymal Stem Cells, bone marrow has 1,000-10,000x more hematopoietic stem cells than adipose tissue; the former is necessary for muscle repair. Recently, we learned that bone marrow also has osteochondral reticular cells which are not found in adipose tissue and serve as orthopedic repair cells.  While adipose tissue and bone marrow both have stem cells, the skeletomuscular specific cells only found in bone marrow make it the best at treating orthopedic conditions. I don’t have a stake in doing bone marrow derived stem cells, I practice evidence based medicine and do what’s been shown to provide the best results.  If with continued research something superior to bone marrow derived stem cells becomes available, then I will gladly adopt that protocol.  

http://www.regenexx.com/fat-vs-bone-marrow-stem-cell-video/

  • As I have reported on this Blog many times, research has shown the amniotic fluid samples being marketed as having stem cells actually do not have any viable stem cells when received and viewed in the laboratory. I do use amniotic fluid concentrate from time to time for its concentrated hyaluronic acid effect.

http://www.regenexx.com/amniotic-stem-cells-great-deception/

  • Since we manually process bone marrow when aspirated, I am able to customize PRP which we call SCP or super concentrated platelets.  The ubiquitous beside centrifuge only has one setting for volume and concentration so those using this approach are treating every patient without concern for individual differences. With the addition of the Abbott Ruby Hemocytometer, I am able to customize the treatment of the individual patient.  We can concentrate our SCP from 3-40X over baseline-with or without red or white blood cells. From my outcomes data base, I know what volume and concentration works best for treating the various body parts.  
  • We’ve developed HD BMC or high dose bone marrow concentrate which is far superior to that produced with bedside centrifuges used by most claiming expertise in Regenerative Medicine
  • I perform BMAs in compliance with the peer-reviewed literature recommendations as well as in keeping with my internal best practices research to maximize MSC yield. As stated, I count cells and know the quality in addition to the quantity of the injectate. Most doctors don’t count cells and have no idea what dose they are giving their patients

 

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What next?

You no longer will even need a physician, and I have been wasting my Blog space crusading about quality assurance; making certain your Regenerative Medicine specialist is Board Certified and willing to provide outcomes data.  According to a recent email I received, all one needs is “Online Training” to practice Regenerative Medicine:If you believe this is FDA compliant, no longer does stem cell treatment need to be done by a highly trained, highly experienced specialist; you won’t even have to use a physician.“Everything gets commoditized, including training to do stuff” (personal communication).

I believe the most effective approach is to direct a patient with joint pain to my credentials—37.5 years of joint replacement experience, Board-certified, Emeritus Professor, four and a half years of Cellular Orthopedic experience, the largest most comprehensive outcomes data base on which to base my recommendations for care, while introducing an analytical program based on a FDA-audited analytical laboratory for assessing the quality of regenerative preparations. As for the latter point, I am now working with a team using a FDA consultant to create approved text that I will post on my website, highlighting the standards I have adopted for all phases of therapy.

I hate to conclude that the current practice of interventional orthopedics and regenerative medicine ultimately comes down to how flashy the website may be or a free lunch from the camp followers.

To watch my Webinar, access www.ilCellulartherapy.com

To make an appointment, call 312 475 1893

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A Word on the Future of Cellular Orthopedics

A Word on the Future of Cellular Orthopedics

Actually, that future started last week when we used a more aggressive PRP adjunct at the time of two Bone Marrow Concentrate/ Stem Cell interventions; one for an arthritic hip and the other, in an arthritic knee. More accurate and descriptive would be a Bone Marrow Concentrate/Adult Mesenchymal Stem Cell/ Hematopoietic Stem Cell/ Growth Factor Concentrate/Platelet Rich Plasma/Interleukin-1 Receptor Antagonist cellular orthopedic intervention to an arthritic joint but even I get confused, so I will stick to cellular orthopedics and Bone Marrow Concentrate.

It would seem from current Regenerative Medicine Science, that while concentrated and activated Platelet Rich Plasma alone has not been provided a predictable and reliable independent approach to arthritis, when aggressively used in conjunction with stem cell interventions, PRP significantly enhances the results in the short term. It will require another several years to determine if what we are seeing in the short term will continue to improve our outcomes in the long run. I am not waiting as concentrating and activating the platelets will cause no harm; and if there is the promise of long term benefits when used as an adjunct both at the time of the Bone Marrow collection, concentration and intervention as well as again in two to five days, there is no reason not to proceed.

What about the future? While we have been great advocates of counting cells at the time of the stem cell intervention, new tools are being introduced to allow us to better customize that which we inject after concentrating and processing of the bone marrow. We now will be able to get a more accurate count of that which is present in the concentrated and processed injectate prior to the intervention and add bone marrow or platelets if indicated.

Are Mesenchymal Stem cells really Stem Cells? Professor Arnold Caplan of Case Western Reserve is widely considered the father of mesenchymal stem cells. He now takes the view that MSCs aren’t stem cells and that he should have never given them that name. He also believes that the primary function of these cells is paracrine, so he calls them “medicinal signaling cells”. To save you the trouble, paracrine is defined as “a form of cell-cell communication in which a cell produces a signal to induce changes in nearby cells.” I am not negating the importance of mesenchymal stem cells, rather I want the reader to better understand the role of each component involved with regenerative medicine. It was Professor Caplan’s prodding that in part is responsible for my having entered the discipline of interventional orthopedics. Long ago, we became friends as team mates of the Roosevelt High School championship football team in Chicago; and our professional paths, while parallel, he in basic orthopedic research while I chose orthopedic surgery finally crossed again five years ago.

To learn more about the basic science behind Cellular Orthopedics or to find out about how you might postpone or avoid a Total Joint replacement for an arthritic joint, schedule a consultation (312) 475 1893

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