Dec 16, 2016
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
Tags: bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, joint replacement, Orthopedics, Osteoarthritis, Regenerative, Regenerative Pain Center, stem cell certification, stem cells, training
Dec 9, 2016
I started the day by reading the Steve Chapman article appearing in the Perspective Section of the Chicago Tribune, Thursday December 8. The title of my Blog this week is influenced by the header of his article and I admit I am paraphrasing some of that content. While his intent was not necessarily directed at the discipline of Regenerative Medicine, his statement” since the advent of the internet, truth doesn’t have a chance” really resonates with me. He goes on to state that in many of these internet claims, the idea of objective reality is obliterated. “The chief product is fiction masquerading as fact.”
Unfortunately, while Chapman was rendering his opinion in the political arena, what he opines is just as applicable in the world of Regenerative; but there are exceptions. As many readers of this Blog are aware, I have an existing web site www.sheinkopmd.com. I have tried to continually emphasize and repeat the Regenexx message; namely, that which we do is based on data, the integration of a clinical practice with a clinical research initiative. Yesterday, we forwarded our two-year outcomes data to Regenexx for statistical analysis. That data has been compiled in a clinical knee trial over the past four years wherein the Regenexx SD procedure was used in 50 patients with grades two and three osteoarthritis of the knee who met the inclusion criteria. Once statistically analyzed, I will submit that data for scientific publication, scientific presentation and it will be published on the Regenexx and my web sites.
To emphasize why it is so important for a patient experiencing arthritic related limitations be fully educated, let me share with you a relevant research letter recently published:
Survey: Many treatments prescribed despite little evidence of high value to patients.
Information from a research letter published in the Dec. 6 issue of the journal Annals of Surgery wherein researchers randomly surveyed 5,000 members of the American College of Physicians found that many prescribe costly treatments despite a lack of evidence supporting their use.
In surveying the internet this morning to see how badly fiction is masquerading as fact, I didn’t have to surf too far. The number of camp follower, non-specialist stem cell related web sites are of great concern. I hope the FDA shares my opinion. You can find treatment for arthritis, cancer, aesthetics, hair loss, sexual enhancement, and neurologic diseases all with one stop shopping. The web sites offer adipose derived stem cells and amniotic fluid containing stem cells. Missing from the offerings are outcomes data, scientific support and FDA compliance. Regenexx does it and so do I; namely, practice cellular orthopedics on a scientific basis under IRB oversite (a function of the FDA) with all intervention recommendations supported by scientific evidence.
To learn more, schedule an appointment 312 475 1893. You may view my webinar at ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Platelet Rich Plasma, Regenerative, regenerative medicine
Dec 1, 2016
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
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, cellular orthopedics, Clinical Studies, Concentrated Stem Cell Plasma, Growth Factor Concentrate, Growth Factors, Hematopoietic Stem Cell, Hip Replacement, Interleukin-1 Receptor Antagonist, knee arthritis, Mesenchymal Stem Cell, Mitchell B. Sheinkop MD, Orthopedics, Osteoarthritis, paracrine, Platelet Rich Plasma, Professor Arnold Caplan, PRP, Regenerative Pain Center, stem cells
Nov 10, 2016
I am receiving increased requests for my Outcomes Data following a Bone Marrow Concentrate intervention for osteoarthritis of the hip. There is a paucity of said outcomes data in the scientific literature in part because of the relatively recent introduction of Regenerative Medicine for Osteoarthritis. I believe equally important is the fact that I was one of the first orthopedic surgeons to embrace the practice and remain one of the few in the subspecialty who practices evidence based medicine through the integration of clinical research with a clinical practice. Perhaps the recent presidential campaign, where honesty took a beating across the US, is responsible for the heightened patient awareness of the charlatans victimizing the public when it comes to Regenerative Medicine.
There is no question that there is value in facts and that is why my cellular orthopedic initiative is evidence based. Earlier this week, owing to these patient inquiries about my particular data base results when it comes to stem cells and growth factor for the hip, I reviewed my data base. There are now just over 150 patients with osteoarthritis of the hip who have undergone a Bone Marrow Concentrate intervention of the hip. The introduction of those bone marrow derived Mesenchymal Stem Cells and Growth factors has the potential to relieve pain, improve function, increase motion, regenerate the cartilage, alter the natural history of the arthritic joint, and delay, perhaps help avoid a hip replacement.
In order to qualify for submission to an orthopedic journal or scientific meeting, orthopedic data must be statistically significant with greater than a two-year follow-up. Our numbers will reach those criteria by January 1, so I thought I would present the preliminary data in this Blog format.
Of the 150 arthritic hips with grade 2 and 3 osteoarthritis at the time of the intervention over the past four years, 92% of patents on average, reported a clinically important improvement in hip-related pain after 1 year while 1% reported worsening. To the best of my knowledge, one patient in the group progressed to grade 4 osteoarthritis and elected to undergo a Total Hip Replacement. As far as Hip-Related function after a minimum of 1 year, 90% of patients reported a clinically significant improvement while 1% reported worsening. Of importance is the fact that of the 9% who initially showed no detectable change in hip-related function, all 9 were significantly improved by a booster intervention.
During my four and one half year, Interventional Orthopedic practice, I have learned that when a patient doesn’t reach a sought-after goal while under observation, a repeat intervention be it Platelet Rich Plasma or a Bone Marrow Concentrate, is a very important part of achieving success. Herein is the basis for my integration of a clinical research initiative with timely follow-up as contrasted with a procedure, a bill and a goodbye. If you want to learn more about evidence based Cellular Orthopedics be it for an arthritic hip or knee, call and schedule a consultation.
312 475 1893
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Arthritis, Hip pain, Hip Replacement, hip surgery, Interventional Orthopedics, Orthopedic Care, Osteoarthritis
Nov 1, 2016
The FDA again held a meeting to address issues pertaining to Regenerative Medicine. At the conclusion of the meeting, an updated set of guidelines was developed for patient protection in the use of stem cells, growth factors, and platelet rich plasma. While still being interpreted by the Regenerative Medicine community, what becomes clear is the call for better self-regulation. It is not ethical or acceptable for anyone holding themselves out to be practicing cellular medicine to hold a seminar, recruit a patient, inject some substance into a joint and request payment. Equally important are the credentials of that practitioner.
For the past four and a half years, I have followed the outcomes of all my patients using the same subjective and objective parameters in my practice of Interventional Orthopedics that I used to follow the results during my joint replacement career. Over that 37-year span, because of my data collection initiative, many new generations of Hip and Knee Prostheses were introduced into adult reconstructive orthopedic surgery. Statistical analysis of data allows for progress in care and development of new product. Today, I still gather outcomes data for each patient. That initiative has led to refinement and advances in the emerging subspecialty of Regenerative Medicine; both in my own practice and around the globe.
Anticipating the future, I am headed off this upcoming weekend to join a small group of those looking to the future in advancing the practice of cellular medicine. Up until now, our data collection and Outcomes registry was clinical in nature; in a short time, that data will also include cellular data. This latter is the next way to refine the practice of regenerative medicine.
By having tighter control over the composition of autologous PRP and BMC preparations for use in my practice of regenerative medicine, through comprehensive analysis of autologous patient samples, I will have a chance to see what levels of important constituents like Stem Cells, Growth Factors, Platelets, RBCs, WBCs, and so on are present in the preparation.
How might I take advantage of the data? The most obvious use would be for me to record values of your sample analysis in a spreadsheet and enter in demographic and clinical outcomes data. I will continue to enter your results of outcomes assessments obtained during follow-up visits that I routinely use to monitor your recovery. By applying this strategy to all patients I treat, an internal database will inform me about optimization strategies for treating my patients, allowing me to modify and customize the make-up of that which will be injected. Why go to the trouble, you might be asking yourself? Having a detailed knowledge of what I am injecting into my patient puts me in a position to refine my practice of regenerative medicine. And that is a good thing, since you the patient ultimately will benefit from my optimizing the use of autologous materials like PRP and BMC.
To schedule your appointment call 312 475 1893
Tags: arthritis, BMC, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, knee replacement, Osteoarthritis, Pain Management, Platelet Rich Plasma, platelets, PRP, regenerative medicine, stem cells, Ultrasound Guided Injection
