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 312-475-1893 for details. Click here to learn more.
“There is no such thing as a free lunch”

“There is no such thing as a free lunch”

I will let the scientific facts speak for themselves. Keep this in mind the next time you see the advertisement from the Stem Cell hustlers of America. There is no such thing as a free lunch.

From: The American Journal of Sports Medicine

Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells with Bone Marrow Comparison

Alberto J. Panero, DO*, Alan M. Hirahara, MD, FRCSC, Wyatt J. Andersen, ATC,
First Published 7, 2019 Research Article https://doi.org/10.1177/0363546519829034

Abstract
Background:
In vivo amniotic fluid is known to contain a population of mesenchymal stem cells (MSCs) and growth factors and has been shown to assist in healing when used as an adjunct in procedures across multiple medical specialties. It is unclear whether amniotic fluid products (AFPs) contain MSCs and, if so, whether the cells remain viable after processing.
Purpose: To determine whether MSCs, growth factors, and hyaluronan are present in commercially available Amniotic Fluid Products.

Study Design:
Descriptive laboratory study.

Methods:
Seven commercial companies that provide amniotic fluid were invited to participate in the study; 3 companies (the manufacturers of PalinGen, FloGraft, and Genesis AFPs) agreed to participate and donated AFPs for analysis. The AFPs were evaluated for the presence of MSCs, various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1), and hyaluronan by enzyme-linked immunosorbent assay and culture of fibroblast colony-forming units. These products were compared with unprocessed amniotic fluid and 2 separate samples of MSCs derived from human bone marrow aspirates. All groups used the same culture medium and expansion techniques. Identical testing and analysis procedures were used for all samples.

Results:
MSCs could not be identified in the commercial AFPs or the unprocessed amniotic fluid. MSCs could be cultured from the bone marrow aspirates. Nucleated cells were found in 2 products (PalinGen and FloGraft), but most of these cells were dead. The few living cells did not exhibit established characteristics of MSCs. Growth factors and hyaluronan were present in all groups at varying levels.

Conclusion:
The Amniotic Fluid Products studied should not be considered “stem cell” therapies, and researchers should use caution when evaluating commercial claims that products contain stem cells. Given their growth factor content, however, AFPs may still represent a promising tool for orthopaedic treatment.

Clinical Relevance:
Amniotic fluid has been proposed as an allogenic means for introducing MSCs. This study was unable to confirm that commercial AFPs contain MSCs.

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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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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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