Dec 5, 2018
As interest in biologic therapies for arthritis-a needle, not a knife-continues to expand; patients increasingly are turning to the ads in newspapers or searching the Internet to gather information on this topic. While there is still a lack of scientific consensus on the use of biologics, it is most important for those seeking information not to be misled. My own analysis of resources for patients seeking on line information about biologic therapies for arthritis is that the overall quality is very poor and anything but scientific. Even worse, is a seminar, neither a reliable or credible source of scientific evidence.
Biologic therapies consist of stem cells, platelet rich plasma product and bone marrow aspirate concentrate. New research, I co-authored and that was published last month in The American Journal of Orthopedics: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis, is indicative of the ever-evolving nature of Regenerative Medicine. Biologic therapies and their use in arthritis or musculoskeletal injury in general are an area of vast research and interest within the medical field. Understanding the information online and the misinformation provided at seminars pertaining to biologics allows me to tailor my conversation and address commonly found inaccuracies.
The use of Biologic Therapies is expected to significantly increase in the coming years as our knowledge advances on the use of such. That initiative will be led by well informed, well-educated Board Certified, and Fellowship trained specialists. Unfortunately owing to the relative lack of oversite at present, every type of charlatan, parasite and camp follower can buy an ad for a seminar or produce a web site on the internet. How then should a patient with pain and limited function from arthritis seek to postpone or avoid surgery without becoming a victim of the cord blood or amniotic fluid hoax?
- Your physician must complete a comprehensive medical history, physical examination and review of diagnostic studies.
- Explain the disease process and grade of progression,
- Discuss possible treatment options,
- Present a balanced assessment of the current scientific evidence.
Woe, while writing this Blog, I was just notified about acceptance of yet another scientific article by a peer reviewed medical journal in which I am the senior author: A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis; a Randomized Control Trial with 2 Year Follow-up.
Hopefully some time soon, a Biologic Arthroplasty will be possible; but until then, a Total Joint Replacement is still a necessary option for those not meeting specified inclusion criteria for biologics. To see what treatments may be possible for your arthritic generated pain call (312) 475-1893 to schedule a consultation. Visit my website www.SheinkopMD.com for additional information.
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, ankle pain, arthritic pain, autologous bone marrow concentrate, biologic, biologics, cellular orthopedics, Cord blood, Hip pain, injury, joint pain, knee pain, lipogems, Osteoarthritis, PRP, regenerative medicine, rupture, shoulder pain, sports injury, stem cell, tear, tendinitis
Nov 29, 2018
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 (312) 475-1893
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.
Tags: autologous bone marrow concentrate, biologics, BMC, cellular orthopedics, cytokine concentrate, Growth Factors, knee pain, lipogems, Micro-Fractured Adipose, MSC, OA, Orthopedic Surgeon, Osteoarthritis, PRP, regenerative medicine, stem cells, suchondral, TOBI
Nov 15, 2018
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 (312) 475-1893.
Tags: arthritis, biologics, cytokines, Exosomes, Growth Factor Concentrate, Growth Factors, Mesenchymal Stem Cell, MSC, OA, viscosupplementation
Aug 30, 2018
Evidence for the efficacy of Platelet Rich Plasma, a blood-derived formulation, and bone marrow derived biologics in osteoarthritis continues to grow in the orthopedic community. On the other hand, as I continually monitor the current landscape of indiscriminate and sometimes inappropriate marketing and use of biologics by the non-orthopedic opportunists, I doubt if the charlatans and camp followers have an overview of what is known about these agents. The increased presence of clinics Is driven by the popularity of PRP and its biologic cousins:
- consumer demand
- aggressive marketing
- a low regulatory bar for many of these regenerative medicine clinics
- the autologous nature that makes many approaches largely safe
- positive data from centers such as ours demonstrating functional and symptom modification
PRP works by activating cellular pathways; more than 3,000 genes are related to these and other pathways, suggesting that PRP probably acts by inducing a transitory inflammatory event, which then triggers tissue regeneration. Bone Marrow Concentrate, does more and addresses the subchondral bone when appropriately injected as well as initiate joint preservation and possible regeneration.
Taking aim
I use a hemoanalyzer to characterize a dose of PRP or Bone Marrow Concentrate allowing me to quantify the composition and biologic activity of these agents. Soon, I will begin pretreatment assessment of the synovial fluid of the arthritic joint so as to best determine who is the optimal candidate for a particular procedure
What do we know?
- Knee osteoarthritis: white blood cell-poor PRP has a positive effect on symptoms, not structure; while Bone marrow Concentrate affects symptoms and structure. I identify what I am putting into the patient. My goal is to have reliable predictors of outcome; that is, do the composition and biologic activity of the material implanted in the patient predict the clinical/imaging outcomes? My PRP contains a high concentration of anti-inflammatory cytokines and anabolic growth factors whereas my use of Bone Marrow Concentrate inside the bone adjacent to the joint in addition to the joint itself is improving the outcomes of the patients I treat.
- To learn more, call my office to schedule an appointment at (312) 475-1893
- You may view my Web site at WWW.Sheinkopmd.com
Tags: anit-inflammatory, biologics, bone marrow, cellular orthopedic, cellular therapy, cytokines, knee osteoarthritis, Orthopedic Surgeon, PRP, regenerative medicine, stem cell