Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.
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 (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.

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 A Stem Cell Thanksgiving message of proof

 A Stem Cell Thanksgiving message of proof

“THE GOOD NEWS IS THAT MY 80-YEAR-OLD TEAM ‘CHICAGO GEEZERS’ WON THE WINTER NATIONALS FOR OUR AGE GROUP IN FT MYERS 11/6 – 11/8. I RAN FOR MYSELF AND HIT .710. THE BAD NEWS IS MY LEFT KNEE IS A BIT MORE ACHY NOW, EVEN WHEN I AM SLEEPING OR NOT PLAYING SOFTBALL. IT IS NOT REALLY PAINFUL BUT IT DOES ACHE MORE THAN IT USED TO. HOPEFULLY, AFTER A FEW MORE MONTHS WE WILL NOTICE A REAL IMPROVEMENT”  J.H.

While growing up in Albany Park, 16-inch softball was a way of life starting at the Haugan Grammar School playground in early February and continuing until the football season in the late fall while basketball went on all year round. Weather permitting, we relocated to Jensen Park and later during high school years to Eugene Field Park, River Park and eventually the Hibbard School Yard. Softball teams with such names as the Torpedoes, Majestics, Olympians, Phaetons, Regular Fellows, Little Gents, Jovens, and Aristocrats, to name a few, competed for the highly coveted Ned Singer softball championship. Teams were comprised of teenagers representing Amundsen, Austin, Roosevelt Sullivan, Senn, Von Steuben High Schools and more. The soft ball leagues diminished in numbers after high school but several individuals continued playing wherever and whenever possible. I for one played until age 40, ending my career with a triple play and fractured finger at Union Park in the Hospital league. A new 16-inch clincher is hard as rock. There are few remaining players of that generation; I am privileged to serve as a treating physician to two. Jimmy, someone I met when he beat out a ground ball over 00 years ago, (I was a first baseman) practices law and continues to play. Though he had overcome many softball related injuries during his playing days, he was ready to quit three or four years ago out of embarrassment at the pinch runner until I intervened with a Cellular Orthopedic intervention and he regained the ability to beat out a ground ball. Jerry, middle row in the photo, second from the left, continues to play. Two years ago, also very concerned about his ability to run around the bases, he presented to my office seeking an alternative to a Total Knee Replacement for his arthritic knees. One picture says it all; he is already making plans for next year. In Jerry’s case, it took several biologic interventions; but he is a champion.  

To schedule an appointment and learn about the biologic options for your joints call (312) 475-1893. You may visit my web site at www.Sheinkopmd.com.  

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Innovations in Orthopedics: Stem Cell and other Orthobiologic treatments and outcomes research for osteoarthritis

Innovations in Orthopedics: Stem Cell and other Orthobiologic treatments and outcomes research for osteoarthritis

We are speaking of stem cell therapy integrated with clinical research, and the resultant evidence-based stem cell intervention. Osteoarthritis is becoming more prevalent as I am seeing younger patients with arthritis as a consequence of sporting injuries such as ACL tears. The baby boomer population is experiencing accelerated onset of arthritis; their joints are prematurely aging in large numbers. At the same time, the master population is aging and living longer.  As a result, I continually research biologic interventions to best address the ever-increasing number of those effected.

Why should a patient choose an orthopedic surgeon to manage their Osteoarthritic related symptoms and functional impairment? Our world is evidence based.

Study Observes Better Outcomes for OA Patients Treated by an Orthopaedic Specialist 

In a retrospective study published online in BMC Musculoskeletal Disorders, shoulder osteoarthritis (OA) patients received faster and more invasive treatment when they received a new diagnosis from an orthopaedic specialist (OS) versus a nonorthopaedic physician (NOP). Patients with shoulder OA (n = 572) received care from either an OS (n = 474) or NOP (n = 98) on the date of their index shoulder visit. OS patients received their first treatment significantly quicker than the NOP cohort (16.3 days versus 32.3 days, respectively). The OS group also had higher rates of operative treatment within one year following their initial visit.

Study: Patients Report Similar Improvements for Nonobstructive Meniscal Tear with PT and Early Surgery

 Physical therapy (PT) may not be inferior to early operative treatment of arthroscopic partial meniscectomy (APM) for improving knee functionality in patients with nonobstructive meniscal tears, according to a study published online inJAMA. The randomized clinical trial included 321 patients with nonobstructive meniscal tears aged 45 to 70 years who were treated at nine hospitals in the Netherlands between July 17, 2013, and Nov. 4, 2015. Patients were treated with APM (n = 159) or a predefined PT protocol (n = 162) that included 16 exercise therapy sessions over eight weeks. PT sessions focused on coordination and closed kinetic chain strength exercises. At 24-month follow-up, knee functionality in the PT group improved by 20.4 points compared to 26.2 points in the APM group. The difference did not exceed the noninferiority margin.

In order to maximize the benefits, Orthobiologics, that is stem cell therapy must be integrated with clinical research, and the resultant evidence-based stem cell intervention followed long term. In my practice, I am researching biologic interventions to address the ever-increasing number of those effected, not one and done. To learn more or schedule a consultation, Call (312)475-1893. You may visit my web site and read my blogs at www.sheinkopmd.com

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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.  (312) 475-1893 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 (312) 475-1893.  You may visit my website www.Sheinkopmd.com

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