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.

Must yesterday’s joint injury lead to tomorrow’s arthritis?  

My column regarding ACL ruptures appeared last Friday. That afternoon, I received the following inquiry and comment from a reader, regarding the prognosis and possible early preventive interventions for a significant knee injury.

“I am one of relatively few patients who has had the Bone Marrow Concentrate treatment for a fully-torn (not-retracted) ACL tear and to date, I’ve had what I’d consider to be an amazing recovery.  I read your latest blog post and just thought I’d let you know that I’m back to very aggressive skiing (including small but non-trivial jumps).  However, I did want to ask, if you would be willing to comment, if there are actions or periodic diagnostics, you’d recommend to maximize the chances that I’m still happy skiing 10,20,30 years after the injury?  I understand you probably can’t comment but nevertheless wanted to let you know I was also a real-life person who had a significant knee trauma with multiple surgical consults all agreeing it was fully torn and required surgery (to return to high-level skiing) and now have a fairly normal looking ACL in MRI (per independent radiologist) and am back to 100% with activities that require a lot of knee stability.  I did do two rounds of same-day BMA reinjections and a bunch of platelet injections but no surgery.”

The answer is an orthopedic assessment at three-year intervals to look for markers of post traumatic osteoarthritis such as loss of terminal extension and asymmetrical flexion. The MRI is helpful in detecting moderate arthritic changes but the latest development, the needle scope, allows an orthopedic surgeon to directly examine the meniscus and cartilage in an office setting. The concern is post traumatic arthritis, cartilage defects that will progress, and meniscal damage not always seen on the MRI. Here are some thoughts on early intervention with Cellular Orthopedic and Regenerative Medicine options.

A recent Study Compared the Efficiency of Needle Arthroscopy Versus MRI for Meniscal Tears and Cartilage damage. Needle arthroscopy (NA) may be a less costly and more accurate option for diagnosis and treatment of meniscal tears and early onset post traumatic arthritis than MRI, according to a study published in the February issue of Arthroscopy. Researchers collected data on costs for care and accuracy, including procedures for both false-positive and false-negative findings well as private payer reimbursement rates. They compared outcomes using the global knee injury and osteoarthritis outcome score (KOOS). Patients were followed and evaluated over a two-year period. 

There are several restorative options now available when conservative therapies for the treatment of knee degenerative processes, such as non-pharmacological interventions, systemic drug treatment, and intra-articular therapies offer only short-term benefits or fail. Before resorting to surgery; be aware that encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. My clinical published research documents success with using your Bone Marrow Concentrate for joint restoration and combating progression of posttraumatic arthritis. Additionally, I have published an article concerning another source for joint restoration, micro-fractured adipose tissue. The latter has created a huge interest in the context of cartilage regeneration due to its wide availability, ease to harvest and richness in mesenchymal cell elements within the so called stromal vascular fraction. Moreover, MSCs from adipose tissue are characterized by marked anti-inflammatory and regenerative properties, which make them an excellent tool for regenerative medicine purposes.

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Regenerative Medicine in 2019

Nonobstructive meniscal tears

There is increasing evidence to suggest that patients with meniscal tears at the knee that do not cause “clunking”, giving way, or locking; hence nonobstructive, may benefit from Cellular Orthopedic intervention coupled with physical therapy. Previous studies involving patients over 45 years of age comparing arthroscopy with physical therapy for nonobstructive meniscal tears as seen on an MRI justify an initial conservative approach; but patient satisfaction may require 24 months to achieve. For those patients who undergo arthroscopic surgery, there is a significant increased risk of repeat knee surgery. In our practice, those patients electing to use the Physical Therapy option without surgery but with a Cellular Orthopedic intervention minimized the length of time needed to return to full activity.

Number of stem cells in amniotic fluid

The functionality of stem cells in amniotic fluid as sold today is a myth. Research shows that 250cc of fresh C-section delivered amniotic fluid, when introduced immediately into culture, only yields 40 stem cells. This means there are 0.16 stem cells per 1 cc of full-term amniotic fluid. Scientific literature referred to by the amniotic fluid marketing forces is based on amniotic fluid collected early in pregnancy.

Acetabular Labral Tear

A hip (acetabular) labral tear is damage to cartilage and tissue in the hip socket. In some cases, it causes no symptoms. In others it causes pain in the groin. Just because a tear is seen in the hip labrum on an MRI, it does not mean the tear is necessarily the cause of the pain. Before initiating treatment, the orthopedic surgeon must exclude that an underlying arthritic condition within the hip is not the real pain generator. More recently recognized is predisposition for a tear in those with abnormal acetabular architecture.

On biologics for knee osteoarthritis

Orthobiologics may become a mainstream treatment for knee osteoarthritis. While Platelet-rich plasma and hyaluronic acid injections are the most established biologics-based treatments for knee osteoarthritis so far, it’s not too early to make confident use of stem cells. At the same time, I must continually warn patients to be particularly careful about claims for these substances. All recommendations for intervention must be FDA compliant and evidence based. (To learn about my contributions to the cellular orthopedic scientific evidence, visit www.sheinkopmd.com. Under the information bullet on the top, you will find published articles)

Eventually, I believe the science and FDA will triumph over quackery and orthobiologics will become an essential part of every knee surgeon’s armamentarium. Available orthobiologics, include:

  • Hyaluronic acid
  • Platelet-rich plasma
  • Cytokine modulation 
  • Stem Cells
  • Exosomes
  • Adipose tissue

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

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Patient Online Resources for Biologic Therapies

Patient Online Resources for Biologic Therapies

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?

  1. Your physician must complete a comprehensive medical history, physical examination and review of diagnostic studies.
  2. Explain the disease process and grade of progression,
  3. Discuss possible treatment options,
  4. 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 (847) 390-7666 to schedule a consultation. Visit my website www.SheinkopMD.com for additional information. 

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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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