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.

Is it the stem cells or the growth factors?

The New York Times: 2019/05/13 “Stem cell Treatments Flourish with Little Evidence That They Work”

Several years ago, I asked a question of a cellular biologist as to how is Bone Marrow Concentrate effective if the number of adult mesenchymal stem cells diminish as we age? His response: “Bone Marrow contains lots of things including stem cells and proteins called cytokines or growth factors. It may be that the growth factors are most important in joint restoration and blocking pain.”

Let’s take for example, inflammatory arthritis such as Rheumatoid and Psoriatic arthritis. The common denominator is a pro-inflammatory cytokine called Tissue Necrosis Factor found in the body’s immune system.  The growth factor, TNF-alpha blocker is now used to control the inflammation and alter the body’s immune response to the proinflammatory protein. As a result of TNF-alpha blockers, Phil Mickelson is a very competitive golf professional, (You have seen him as a spokes person for Psoriatic Arthritis treatment with Humira). Since the introduction of TNF alpha blockers in Scandinavia five years ago, there has been a 40% reduction in Total Knee Replacements for inflammatory arthritis. When Kobe Bryant traveled to Dusseldorf, Germany almost nine years ago, he received treatment for a very arthritic knee with Interleukin -1 Receptor Antagonist Protein, along with other blockers. Shortly thereafter, he returned to play another five years in the NBA. The IRAP that Bryant received was and is an anti-inflammatory, a growth factor blocker, a cytokine.

As I agree in part with the  criticism in the New York Times concerning Stem Cells, those who read this Blog will recall that I don’t “sell” stem cells. Bone Marrow is used in part because of the fact that it contains stem cells; but more importantly as we age, Bone Marrow contains Growth Factors, the anti-inflammatory protein Cytokines that restore a joint by minimizing pain and improving function. Over the last eight years, we have accumulated the evidence that Bone Marrow Concentrate works for arthritis via stem cells, growth factors, or all of the above. Recently we have taken a major step forward by filtering high concentrations of Growth Factors from the Platelet Poor Plasma, previously discarded, that remained after we centrifuge the bone marrow and add the filtrate to that which is injected into the painful joint. Stem Cells maybe, highly concentrated Growth Factors that act to block pain and improve function, for certain.

You may learn more by visiting my web site at www.sheinkopmd.com  or call for a consultation (847)390-7666

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“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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Opening Day Coming Soon! For Major League Baseball on March 28; for Golf, Even Sooner

The basic principles behind the golf swing and the swing at home plate are not that much different. While the preferences may vary, when you break down the mechanics, there is similarity. Certainly there are differences between laying down a bunt and a 230-yard drive off the first Tee. The same differences are in play when putting is contrasted to the swing driving a 385-foot home run out of the park. In the several scenarios, the swing should look like one smooth, continuous motion that culminates with you holding a nicely balanced finish as the ball sails through the air. Within that motion however, is a series of techniques that each must be executed properly in order to produce the desired outcome.

Concentrating on golf swing mechanics, there is the Takeaway, Back swing, Transition, Impact, and Follow through. Continuing to explore the swing mechanics, backward movement of the shoulders and arms is followed by backward rotation of the spine, cocking of the hips, cocking of the wrists, timing, rotation of the pelvis, forward rotation of the spine, pushing and pulling of the arms and shoulders, guiding action and follow through.

Even if the physics behind my explanation is not perfect, the point here is that any pain and altered motion caused by injury or arthritis will affect your game. If you haven’t been able to play since last fall, now is the time to head out to the gym to catch up on strength training, stretching, with emphasis on spinal and pelvic rotation. Then there are the golf simulators and indoor driving ranges in and around Chicago. 

If you experience pain in your muscles and joints along with limited motion, recent legislative changes in Illinois allow you direct access to the physical therapist. If after several sessions with the physical therapist, you haven’t realized the improvement you seek, it is time for an evaluation by an orthopedic surgeon. She or he, perhaps me, will complete a medical history and physical examination and review X-ray and MRIs of the effected anatomy. The end result of that intake may be a prescription for further PT, a prescription of pharmacologic management or in my case, a Regenerative Medicine/ Stem Cell procedure; that is a needle and not a knife.  

I have documented in several recent scientific publications that Regenerative Medicine using either Bone Marrow Concentrate or Micro-fragmented Adipose tissue recovered by Liposuction will allow you to play 18 holes of golf this upcoming season. At times concentrated and then processed Platelets offer an opportunity for a patient afflicted with arthritis or limited by bodily injury to return to an active lifestyle and enjoy a full schedule of outdoor recreational pursuits. Please make note that my regenerative menu of services is based on your own cells and proteins that have been proven to work and meet FDA and FTC guidelines.

The weather forecast is improving and the sun was out today; the opening of both the baseball and golf season is only a about a week or so away.  I say “Play ball.” 

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“Why bother with the truth when you can make it all up”
David Baldacci

“As practicing physicians, scientists, and regulatory experts we have increasingly observed aggressive advertising and sales tactics being used by alternative health clinics (chiropractors, naturopaths, and acupuncturists) as well as physicians and mid-level providers to market “stem cell” treatments derived from birth tissues. One example is full-page print ads in major newspapers used to recruit elderly patients and others desperate for effective treatments to seminars where prospective patients are informed that they can be injected with millions of live and functional stem cells to relieve their symptoms. The products used are derived from birth tissues such as umbilical cord blood and/or Wharton’s Jelly or amniotic fluid/membrane. Many patients spend thousands of dollars on these therapies to treat orthopedic problems and/or a myriad of other incurable diseases. The seminars typically state that there are robust clinical data supporting the safety and efficacy of these products, regardless of the condition or pathology being treated, when no such clinical evidence exists. In addition, some manufacturers of birth tissues claim that their products contain live and functional stem cells, while other manufacturers do not make these same claims. Claims of live cells are not compliant with FDA regulations, which require this type of donor tissue to be non-viable.

To date, two research investigations have been conducted which document the content of commercially available amniotic and cord blood products sold by FDA-registered manufacturers (those regulated solely under section 361 of the Public Health Service (PHS) Act). We are aware of additional investigations that are in progress. Both Berger, et al. and Becktell from the Fortier laboratory at Cornell University, found that these amniotic and cord blood products did not contain live or functional stem cells. In addition, both research groups found that many of the growth factor levels in these products were significantly lower than those found in common autologous orthobiologic products like platelet-rich plasma. Fortier et al. did report that these products do contain proteins like lumican and cytokines, which may positively impact orthopedic injuries, but concluded that more research is needed before any claims can be made. While there are early clinical data on stem cells that are isolated from fresh birth tissues and culture expanded, these studies used treatments which are not analogous to the commercially available, cryopreserved, FDA registered birth tissue products. In addition, it should be noted that while the clinical evidence in this area is evolving and one day may support the clinical efficacy of cryopreserved birth tissues for some orthopedic applications, no such evidence exists at this time. In particular, we are aware of FDA approved clinical trials that use these tissues for diseases such as knee osteoarthritis, which are ongoing.

Consensus Statement: The aggressive marketing approach currently used by practitioners and clinics regarding various birth tissue products as safe and effective “stem cell therapy” is not supported by the existing scientific literature.”

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Fake news and illegal advertising of stem cell therapies

Fake news and illegal advertising of stem cell therapies

Why Should This  Blog Matter To You?

  • Stem cell treatments are NOT FDA cleared in the United States
  • FDA is scrutinizing physicians and centers that are marketing stem cells

Beware of centers that are offering to:

  • Relieve pain
  • “Regeneration” of tissues
  •  Avoid surgery
  • Treating a variety of inflammatory, degenerative, or autoimmune conditions

Beware of Stem Cells Clinics!

  • Many of these “stem cell clinics” are operated by chiropractors or providers that do NOT have a specialty or advanced training in the musculoskeletal system.
  • They simply do not have the training necessary to perform these injections nor are they licensed to so do.
  • In some cases, surgery is needed. These providers may not evaluate the need for a surgical procedure.

Federal Trade Commission Press Release: https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic

FTC Court Documents: https://www.ftc.gov/enforcement/cases-proceedings/172-3062/regenerative-medical-group-inc

The Complaint filed by the FTC on October 12th states the following:

Defendant Henderson is aware that the vast majority of amniotic clinical studies in the scientific literature has been conducted on animal models. There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases of health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. (p. 4)

The representations set forth in Paragraph 21 […Defendants have represented…that their stem cell therapy: cures [everything]…Is comparable to or superior to conventional medical treatments in curing, mitigating, or treating specific diseases or health conditions including [everything]…] are false or were not substantiated at the time the representations were made. (p. 21)

The FTC essentially has said that there is no clinical basis to claim a therapeutic benefit to treating patients with amniotic stem cells, so the claims and representations by Dr. Henderson constitute deceptive practices and false advertisement.

If you connect the dots, it would suggest that Dr. Henderson engaged in fraud by taking money from patients and treating them with a preparation for which there is no clinically valid proof of therapeutic benefit. Regardless of whether the Department of Justice gets after him for a criminal complaint of fraud or not, I think organizations that offer up a worthless therapy consisting of amniotic stem cells (until proven otherwise with Level 1 studies) could be good targets for class action lawsuits by defrauded patients. The same situation doesn’t apply to PRP and BMC, (what I do) since there is plenty of clinical evidence of therapeutic benefit including my scientific article published in December, 2018.

Sheinkop, et.al Transnational Medicine – published Dec. 13 2018
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.

If you want to complain to the FDA about having received Amniotic Fluid without benefit, use this link:

https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118859.htm

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Show and Tell: Regenerative Medicine vs Outcomes Based Cellular Orthopedics

As many readers know, I personally became a patient at the end of 2017 when I underwent a cellular orthopedic procedure to my knees. In January of 2018, I underwent a similar intervention for my hips. Included in my decision making was the desire to maintain an unlimited professional commitment, a full recreational athletic schedule, and continue to have the capacity to expand my clinical, research and educational integration. One week ago, I hosted two leading orthopedic surgeons from St. Petersburg, Russia for a full day of Cellular Orthopedic instruction. On Tuesday, I continued the initiative while performing a Bone Marrow Concentrate /Stem cell intervention into the arthritic right hip of one of my visitors. On Saturday, I participated in a full day workshop focused on subchondroplasty; an area where I have gained recognition because of my Prospective Clinical Study on the particular treatment alternative when indicated.

This past Sunday and Monday, I met with a project director of a start-up regenerative medicine company seeking to have me design and carry out a clinical trial for a next-generation Amniotic Fluid derivative. There are no published outcomes studies at this time to support the use of Amniotic Fluid offerings advertised in the newspaper. The claims regarding viable stem cells following collection, sterilization, processing, freezing and fast thawing have not withstood scientific scrutiny nor has any benefit been statistically proven. The new company behind the contemporary manufacturing process does not want to show and tell; but rather, scientifically document efficacy and that is why I am interested.

I guess the message behind this blog is that I have experienced a fabulous result in my arthritic knees and hips allowing me to enjoy a relatively symptom-free, fully active lifestyle, based on a Cellular Orthopedic option, scientifically and clinically proven to succeed. The next question is then why isn’t cellular orthopedics affective on all? While there have been several publications regarding a genetic basis for success or failure of biologic interventions, there have been few actual studies to measure Molecular Biomarkers of Knee Pathology. To that end, I am determining the fiscal reality, of recovering a patient’s synovial fluid prior to treatment and measuring those biologic markers. Lots going on, for sure; however, remember that everything I do is based on science, my previous career as an orthopedic surgeon pioneering joint replacements, and my present and ongoing efforts at evidence-based Cellular Orthopedics.

To see how I might help you postpone or avoid a total joint replacement while returning to a pain-free active lifestyle call (312) 475-1893 to schedule an appointment or view my website at WWW.SheinkopMD.com.

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