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.

Are Birth Tissues a form of Orthobiologics?

Those who regularly read my blogs are aware that for the past several years, I have stated that there are no living stem cells in Birth Tissues such as Wharton’s Jelly. Umbilical Cord Blood, Placental Tissue and Amniotic Fluid. Nevertheless, as recently as last winter, the Stem Cell Institutes of America continued to hold seminars and make claims regarding cartilage regeneration after an injection of Amniotic Fluid. Ultimately, it was investigative Reporter Pam Zekman, at WBBM-TV in Chicago who exposed the fraud. At the about the same time, The Interventional Orthopedics Foundation published a position statement after investigating the many birth tissue products in the marketplace and found virtually no living stem cells in the many alternatives after processing, freezing, storing and thawing at the time of use. On currently, an article was published in the American Journal of Sports Medicine, again indicating that Birth Tissues were acellular-lacked living stem cells when processed and thawed.

My practice is based on Orthobiologics so misleading statements, bad actors, charlatans and liars for that matter are not my favorite people to say the least. Let’s update where the Birth Tissue purveyors have taken their most recent marketing campaigns now that the FDA and FTC are closing in. My favorite misleading statement is the Stem Cell Recruitment headline boldly appearing on the multiple outdoor advertising billboards ringing Chicago Tollways. There is no such thing as stem cell recruitment. A product introduced by a large pharmaceutical company several years ago had to be withdrawn when no such recruitment was scientifically demonstrated in an arthritic joint.

Now the marketing of Birth Tissues, that is Wharton’s Jelly, Umbilical Cord Blood, Placental Tissue and Amniotic Fluid has evolved from stem cells to Growth Factors. After all these years of claims to the contrary, the Birth Tissue Pharmaceutical manufacturers have admitted their products are acellular. The FDA and FTC have not yet taken a position on Growth Factors; these naturally occurring substances capable of stimulating cellular growth, proliferation, healing and cellular differentiation. In the past ten days, no less than four different orthobiologic distributors have admitted to me that Birth Products are acellular, that is lacking in stem cells, but it really isn’t significant because they have Growth Factors. I practice evidence-based medicine and to date, there is not one statistically significant, scientific trial documenting more than three months of pain relief with Birth Tissues, most recently marketed as a source of Growth Factors.

Will the attempt at making Birth Tissues great again by a change in marketing strategies result in relief of your joint pain and improve your function? Perhaps but it will take several years to document the results. In the meantime, we have published scientific evidence to support our approaches to relieving pain and improving function of the arthritic joint. To schedule a consultation, call (312) 475-1893.

You may visit my web site at sheinkopmd.com.

“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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“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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ACL injury is a concern in athletes at all levesFrom adolescence to my age

We read about it in the sports pages every day; the player presenting after twisting a knee, feeling a “pop” and going down in a heap. The knee is swollen, the first indication that bleeding has occurred inside the joint. Physical examination of the knee to test the ligaments leads to a suspected tear of the anterior cruciate ligament; the MRI is ordered and confirms the diagnosis.

Because of its poor blood supply and location inside the knee, the ACL has little healing potential. It’s an unfortunate reality, as they are occurring at increasing rates over the past two decades. In part, it’s because more children are playing competitive sports and doing so at a younger age while we seniors are still skiing or playing and competing all year. What are the future implications of a torn ACL? Lindsey Vonn came back after ACL surgery; so did Tiger Woods, Julian Edelman, Tom Brady and Derrick Rose to name a few.  so how bad can it be? The truth is that surgery can restore knee function, but it does little to diminish the risk of arthritis 10 to 15 years down the line or less. Lindsey Vonn announced retirement five years later because of arthritis. Kids who tear their ACL today are often left with 60-year-old knees when they’re 30; and as has been recently stated, Knee Replacement is not necessarily a panacea.

Secondary damage may occur in patients who have repeated episodes of instability due to ACL injury. With chronic instability, a large majority of patients will have meniscus damage when reassessed 10 or more years after the initial injury. Similarly, the prevalence of articular cartilage lesions increases in patients who have a 10-year-old ACL deficiency. It is common to see ACL injuries combined with damage to the menisci, articular cartilage, collateral ligaments, joint capsule, or a combination of the above; the “unhappy triad,” especially in football players, soccer players, basketball players and skiers.

Certainly, modern ACL surgery means it’s no longer a career-ender, but recovery ranges still vary widely. In cases of combined injuries, surgical treatment is warranted and generally produces better outcomes. As many as half of meniscus tears may be repairable and may heal better if the repair is done in combination with the ACL reconstruction. Some athletes come back in as little as nine months, while it can take well more than a year for others. Then comes the mental battle, that is the silent war waged after tearing an ACL.  Derrick Rose, we are watching you.

Recent clinical evidence suggests surgery is not your only option; interventional or cellular orthopedics may be a non-surgical alternative that uses your own cells to repair the incompletely damaged ligament. A cellular orthopedic intervention for those who meet the inclusion criteria may substitute for surgery. Those who offer the non-operative option when appropriate, use Bone Marrow or Adipose Tissue harvested from your skeleton or abdomen, process the recovered cells and growth factors with particular attention to FDA compliance, and inject the concentrate into the remaining Anterior Cruciate Ligament cumented incomplete tears with success in returning athletes to a sport.

While intervention and cellular orthopedics may have a role in a torn ACL at times, Joint Restoration, perhaps even Regeneration adjuncts at the time of an ACL repair or for the ensuing arthritis have an absolute evidence-based role. To schedule an appointment call (847) 390-7666.  You may visit my web site at  www.sheinkopmd.com

 

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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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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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