Dec 26, 2016
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
Tags: ACL Injury, arthritis, athletes, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Hip Replacement, Orthopedic Care, stem cells, treatment
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
Oct 27, 2016
I recently received the yearly publication from the Orthopedic and Rheumatology Institute of the Cleveland Clinic; the latter recognized as one of the 10 most prestigious orthopedic centers in the nation. Every year the publication, a marketing exercise by the Cleveland Clinic, focuses on certain subspecialty areas within the discipline of the care and treatment of the musculoskeletal system. The obvious purpose of such a yearly event is to recruit referrals from practicing orthopedic surgeons and rheumatologists as well as the medical community in general.
This year the focus was on Adult Total Hip Arthroplasty for Osteoarthritis and Adult Unilateral Total Knee Arthroplasty for Osteoarthritis. I will summarize the results; let’s start with the hip:
“Hip-Related Pain 1 Year After Surgery: “on average, 92% of patients reported clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain).”
“On average, 90% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function).”
The knee doesn’t fare as well:
“On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain).”
“On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function).”
The data was derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed.
In my practice, every patient who undergoes a Bone Marrow Concentrate intervention is entered into an outcomes data base with both subjective and objective data points measured. It is quite comprehensive and numbers over 500 patients extending over a span now of 4 and ½ years. While the Cleveland Clinic report is based on subjective parameters and ours on both subjective and objective scores, I am able to extract subjective measures alone. I am pleased to report that in the case of the hip and the knee, our outcomes with a needle are equal to or better than those of the major surgery with a scalpel. Then factor in the prompt rehabilitation of a stem cell procedure compared with the prolonged rehabilitation inherent in a joint replacement. Lastly, consider the relative absence of complications of a stem cell intervention compared to the morbidity and mortality of a joint replacement.
Perhaps of greater significance to the stated advantage of a Bone Marrow Concentrate procedure for Osteoarthritis is the fact that no bridges are burned. If the patient is not satisfied at one year or five, a stem cell procedure may be repeated with a needle. If the arthritis progresses to an advanced stage, the fall back option is a joint replacement. The only choice following an unsatisfactory joint replacement is to accept the surgically induced impairment or undergo a risky revision surgery with a high likelihood of a complication or less than satisfactory outcome. Call 312 475 1893 to schedule an appointment today.
For more information watch my Regenerative Medicine Webinar Video
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, knee replacement, Orthopedic Care, Orthopedics
