Superbowl Winner Emerges; Eight-Month Long Physical Demolition Derby Comes to an End

Superbowl Winner Emerges; Eight-Month Long Physical Demolition Derby Comes to an End

On Monday, the annual migration for attempts at the physical Restoration and Regeneration of the NFL players injured bodies began. While in the past, the losers would chant “wait ‘til next year”; very soon, the NFL winners and losers alike will take flight to Orthopedic Surgeons around the USA and world, on occasion, some will even find their way to my office, seeking both operative and non-operative repair of the injuries incurred over the last eight months. What I will offer is Regenerative and Restorative initiatives using either the patient’s bone marrow, circulating blood or body fat. While I use a needle and not a knife in my practice, at times it takes arthroscopy and open surgical procedures to assist the athlete in returning to play or extending a career.  The fall NFL 2019 schedule is already on line; there is a sense of urgency. These attempts at restoring and regenerating anatomic and physical well-being are not limited to the professional football player. To the best of my recollection, it was Tiger Woods in 2008, who brought regenerative medicine to the attention of the American public. When in 2011, Kobe Bryant traveled to Dusseldorf, Germany for a highly publicized orthobiologic treatment of his arthritic knee, returning to play for another six seasons, he was soon after followed by the professional golfer Fred Couples, baseball player Alex Rodriguez, and NFL star Payton Manning. All returned to their respective sport and extended playing careers; many more have followed. Now Cellular Orthopedics, Regenerative Medicine and Joint Restoration are available around our country as well as at my office for professional, college, high school, amateur athletes and fitness enthusiasts of any age.  

Orthobiologics and Cellular Orthopedics are a dynamic approach to body injury and arthritis using the individual’s own (autologous) platelets, molecules and proteins circulating in the blood (Cytokines and Growth factors), adipose tissue, or bone marrow to effect healing and eliminate pain. At this time, it is FDA Compliant to use such in the care and treatment of injury and arthritis as long as that which is to be used has been harvested from the patient herself or himself, not cultured or expanded, and not treated with additional agents. The successes are no longer merely anecdotal; there is an ever-increasing body of scientific evidence to validate the emerging discipline of Cellular Orthopedics. For instance, in my office, I integrate patient care with documenting outcomes and that has led to several recent scientific publications contributing to an evidence-based orthobiologics practice. You may find those publications and more at my web site  www.sheinkopmd.com.  To schedule a consultation call (847) 390-7666.

There is a way of still being an athlete and significantly reducing your risk of injury, take up esports. Marquette University is adding varsity esports, a competitive video gaming team in the fall of 2019. The team will have tryouts, coaches and regular practices just like any intercollegiate sport

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When will the “Stem Cell” charlatans be prosecuted?     

When will the “Stem Cell” charlatans be prosecuted?     

My Blog has frequently addressed the false ads claiming Amniotic Fluid, Chord Blood, Wharton’s Jelly and the like contain living stem cells emphasizing that the processes of preservation and sterilization followed by freezing kills off any living cells. Sylvia Perez first addressed the issue on Fox News’ Conversation in Health, January 29, 2018 and Pam Zekman posted her investigative report on WBBM-TV, the week before Thanksgiving. Yet patients continue falling for the hoax.

In contrast, let’s address the positive, cellular orthopedics; the ongoing practice of evidence- based medicine. Below are two statistically significant scientific studies that play a role in helping determine the best possible outcomes to a regenerative intervention

November 21, 2018 

Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Osteoarthritis

New research published by TOBI Faculty suggests autologous, micro-fractured, minimally manipulated adipose tissue may represent a nonsurgical treatment option for knee osteoarthritis patients seeking alternatives to total knee replacement.

Congratulations Jay Panchal, MD, Gerard Malanga, MD, Mitchell Sheinkop, MD on this new publication in The American Journal of Orthopedics.

Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees

To download or read the publication: https://www.amjorthopedics.com/article/safety-and-efficacy-percutaneous-injection-lipogems-micro-fractured-adipose-tissue

Treatment of Knee Osteoarthritis with Autologous Bone Marrow Concentrate and Cytokine Concentrate – A Prospective Clinical Case Series Study

 

Abstract submitted to the Orthopedic Research Society Annual Meeting, 2019

Mitchell B. Sheinkop1 , Marry Langhenry2 , Jizong Gao3 1. Orthopedic Surgery, Rush University, Chicago, IL.2. Cellular Orthopedics, Chicago, IL  3. Celling Biosciences, Austin, Texas.

 

INTRODUCTION: Osteoarthritis (OA) is an organ disease that affects most structures of the joints including cartilage, synovium and subchondral bone. The pathophysiology of knee osteoarthritis can be broken down into pathoanatomy, cell biology, and genetics. Although fibrillation of articular cartilage is regarded as the primary changes and potential cause of clinical symptoms, the synovium and capsule undergo progressively inflammatory changes and secrete proteolytic enzymes that may contribute to the progression of OA. Meanwhile, the subchondral bone tissue develops lytic lesions with edema, sclerosis, and cyst formation. Therefore, it has been recommended that the treatment of OA should be a comprehensive approach to create a homeostatic environment to facilitate the OA treatment with a long-lasting outcome. Bone marrow contains mesenchymal stem cells (MSCs). Different cytokines such as alpha 2-macroglobulin (A2M) (Wang et al) and growth factors have been identified in the blood and bone marrow aspirate. Either bone marrow concentrate (BMC) or MSCs have been injected into the knee joint to treat OA with promising clinical outcomes. Hernigou et al reported that injection of BMC into the subchondral bone area was able to delay or eliminate the need for total knee arthroplasty (TKA) and clinical outcome was comparable to TKA in the contralateral knee. Cytokines and growth factors in the blood or bone marrow aspirate were concentrated by filtering method to prepare autologous therapeutic biologics. In the current study, a consecutive series of patients with moderate to severe OA were treated by intra-articular and intra-subchondral bone injection of BMC and autologous concentrated cytokines/growth factors. The quantity of representative cytokines and growth factors in the concentrate were also measured. Patients were evaluated for the improvement of systems and knee functions by following up to 6 months after injection. METHODS: This prospective case series study was approved by the Institutional Review Board.

To learn more or to schedule an evidence-based consultation call (847) 390-7666

You may visit my web site and read my blogs at www.sheinkopmd.com

Regenerative Medicine is an option for those with arthritis but don’t be fleeced by the hucksters and camp followers.

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Why the variability in Clinical Response to Stem Cell intervention for arthritis

Mesenchymal Stem Cells, or MSCs, are multipotent stromal cells that can differentiate into a variety of cell types or affect other cells by releasing the proteins categorized as Cytokines and Exosomes. Cytokines are small proteins that are important in cell signaling. The process is quite complex but this introduction allows me to help you better understand the Regenerative Medicine world.

The patient who called this morning indicated that she had not experienced any benefit form an orthobiologic intervention she had several weeks ago; yet on Friday, several patients reported satisfaction and our outcomes surveillance documented significant functional improvement as well. Why the variability in response? Perhaps it might or could be explained by the genetic makeup of the individual’s cartilage or the nature of the biologic intervention. In the current regenerative marketplace, I note advertisements for Amniotic Fluid, Cord Blood, Wharton’s Jelly, Exosomes, Adipose derived and bone marrow derived interventions.

The long-term durability of our cellular orthopedic treatment has been documented in patients for at least five years. The observation of this response is significant, as steroids and viscosupplementation have typically shown to be effective in relieving pain respectively for up to 6 weeks and 6 months. Our earlier research has documented a six-month average response to amniotic fluid and an average 18-month improvement to mechanically processed adipose tissue. Our current biologic interventions contain high concentrations of anti-inflammatory cytokines and anabolic growth factors in addition to Mesenchymal Stem Cells, all modifying the course of disease progression. The short-term pain relief observed is due to the anti-inflammatory effects of the biologics used in the interventions. The long-term pain relief is attributed to potential disease-modifying properties by improving joint homeostasis and cartilage quality. We believe our biologic interventions to be disease-modifying.

What is next? While most readers of this Blog are familiar with the regenerative alternatives, Exosomes are new and there is little if any clinical data available to allow me to opine about clinical usage including safety and efficacy at this time. They are cell-derived vesicles (a small membrane-bound sack that stores and transports substances though out the cell or outside the cell) present in bodily fluids as well as in extracellular matrix. Evidence is accumulating that they play a key role in signaling between cells and may function as a potent anti-inflammatory and disease modifier depending on the environment from which the Exosome is recovered. While the use of non-autologous stem cells is not FDA compliant, to the best of my knowledge, Exosomes produced by Mesenchymal Stem Cells are not restricted and are now being made available for clinical use in arthritis. Stay tuned as we continue to document successes, safety and efficacy in the world of Orthobiologics. To learn more, schedule a consultation by calling (847) 390-7666. 

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What are Growth Factors?

What are Growth Factors?

In general, a Growth Factor is a term used to describe a protein produced be a variety of different cell types that binds to specific receptors on different cellular surfaces. They may on the one hand stimulate cell growth; on the other hand, some growth factors may block actions on target cells of a different protein. Cytokines are another class of signaling proteins more closely related to hormones. The subject matter is quite complex; but, I wanted to introduce the subject of Growth Factors into my Blog as growth factors are increasingly gaining attention in combating and reversing the progression of arthritis.

Already in use is Tissue Necrosis Factor-alpha blocker, frequently prescribed in a proprietary form as Humera, for inflammatory arthritis and arthropathy such as Rheumatoid Arthritis, Psoriatic Arthropathy and Ankylosing Spondylitis. It works by blocking a protein (TNF-Alpha), found in the body’s immune system and responsible for joint swelling and inflammation. By so doing, Humera reduces symptoms, prevents bone and cartilage damage and improves physical function.

Outside of the United States, Interleukin 1 Receptor Antagonist Protein (IRAP) is used for the symptoms of grades 2 and 3 Osteoarthritis by binding to the cell surface and preventing IL-1 from sending a proinflammatory message to that cell. IRAP is currently the basis for a clinical trial taking place in the United States to document its safety and efficacy. The sponsors of the trial hope for full enrollment and outcomes analysis in the not too distant future; so, the Growth Factor might be used with FDA approval in clinical practice. It was for IRAP that one-time basketball great Kobe Bryant, travelled to Dusseldorf Germany, ten years ago with grade 4 osteoarthritis of the knee thereby prolonging his career by six years.

On Tuesday of this week, I received a call form a company exploring a safety and feasibility trial for yet another growth factor approach with the latter derived from another human biologic resource. Last March, there was a contact from a global pharmaceutical company asking my help in developing a trial for yet another type of a growth factor approach in dealing with the symptoms and limitations of arthritis. I introduce the Growth Factor subject matter now to better update my reader as well as prepare you for the coming debate that Growth Factors are equal to; perhaps more important as we age than stem cells for dealing with the symptoms, functional limitations and progression of arthritis.  

To learn more, you may call for a consultation.  (847) 390-7666 or visit my web site at WWW.Sheinkopmd.com

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How long might a regenerative medicine intervention work

Until 2002, the patient seeking a joint replacement consultation would ask me “how long will new joint last”? Then came the era of minimally invasive surgery -I played a major role in the introduction-and now the question became “how long is the incision?” and “how long will I stay in the hospital?” While the number of “Regenerative Medicine” options for the treatment of osteoarthritis continues to increase, in the current medical marketplace, it is via direct to consumer advertising that “breakthroughs” are brought to the attention of those impacted by the symptoms and limitations of Degenerative Joint Disease. Whereas patients historically would base their personal medial decision making on consultation and guidance from the medical community, such is no longer the case. Media marketing is now the primary reason a patient makes the decision for which Regenerative option to choose. The problem is there is little if any scientific evidence to support the ad claims. In the one or two approaches where there is a paucity of evidence, the latter is on a handful of subjects at less than six months. Witness the recent reversal on insurance reimbursement for several placental derived products because of the absence of benefit at six months in clinical trials.

Included among the reasons featured in ads promoting Stem cells for arthritis, you will find,” it worked for me”. More recently it is a product that “recruits” your Stem Cells. On it goes with promotions for Stem Cells in cord blood, Stem Cells in Wharton’s Jelly, and Stem cells derived from your adipose tissue (fat). Missing from the entire marketing campaign in almost every scenario is outcomes data. I am an orthopedic surgeon who, prior to my Cellular Orthopedic initiative, played a major role in joint replacement surgery as Professor of Orthopedics and head of a prominent joint replacement program at a large Medical Center in Chicago. While performing clinical trials with new generations of hip and knee implants, it was well accepted in the orthopedic community that a minimum of two year follow up would be required before a scientific paper would be considered for publication. When I entered the emerging specialty of Cellular Orthopedics, I continued the integration of clinical practice with clinical research so that my interventional recommendations would be evidence based. Below are two of the manuscripts I co-authored; one having been accepted for publication and the other recently submitted for publication.

Safety and Efficacy of Percutaneous Injection of Lipogems Micro fragmented Adipose Tissue for Severe Osteoarthritic Knees

A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial with 2 Year Follow-Up

What I won’t promote is anything wherein there is not two years minimum of evidence concerning safety, efficacy and satisfactory clinical outcomes. I am not opposed to progress but best practices demand clinical trials of new options and those trials should be underwritten by the pharmaceutical company; not by a patient paying relatively large sums without meeting inclusion criteria and without follow-up leading to minimum two-year outcomes evidence.

To learn more, schedule an appointment (847) 390-7666.  You may visit my website www.Sheinkopmd.com

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Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-767-5761 for details. Click here to learn more.