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.

“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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Joint Rejuvenation and Restoration

Joint Rejuvenation and Restoration

Following injury or wear, limitations need not be limited to professional, college and high school athletes

Last week, my column focused on the post traumatic ravages of the National Football League season; and getting ready for next cycle of body demolition. Those who watched the championship game saw several players assisted off the field following violent trauma. Even the President announced that he would prefer his son not play football. While professional, college and high school competitive sports enjoy high profile, there are the average recreational sports and fitness enthusiasts who progressively experience a diminution of ability to participate in a sought-after activity by virtue of injury or wear and tear; be it basketball, running, cycling, skiing, hockey, fitness endeavors, volleyball, golf, soccer, sailing; so, on and so forth.

As an example, a 67-year-old man presented in my office last week after having read my column, with progressive pain in his left knee and inability to partake in his long-time recreational passion, volleyball. I completed his intake centered on the taking of his medical history, completed an orthopedic physical examination, and ordered X-rays. He brought a recent MRI study to the appointment. The physical therapist who assists me objectively documented his physical findings so we would have pretreatment measurements. Additionally, my therapeutic recommendation is always based on more than an X-Ray and MRI, but also includes the objective and reproducible Range of Joint Motion and assessment of joint stability.

After review of all the above, I administered informed consent for a Bone Marrow Concentrate intervention into his left knee as a means of postponing, perhaps avoiding a Total Knee Replacement and assisting in his return to recreational volleyball. While there are several options for intervention into the arthritic or injured joint including adipose and blood-based alternatives, I recommended Bone Marrow Concentrate for his moderately arthritic knee as a means of providing Concentrated Platelets, Concentrated Growth Factors, anti-inflammatory Cytokines, Adult Mesenchymal Stem Cells, Precursor Cells, Marrow Adipose Tissue, and Hematopoietic Cells, all consistent with FDA compliance requirements. There are mandatory Federal Drug Administration and Federal Trade Commission regulatory standards of compliance in Regenerative Medicine; patients must be cautious when choosing the minimally invasive Cellular Orthopedic option. It takes an office visit, physical assessment and review of images by a board-certified specialist in the regenerative medicine decision making process; not merely attendance at a seminar. Some patients will not meet inclusion criteria, their needs would be better served by accepted surgical norms.

At age 67, there is little chance at Cartilage Regeneration for my patient, but there is a high probability of Joint Restoration; that is increased motion, diminution of pain and the return of ability, in this patient’s case to play volleyball. He will wear an off-loader brace for six weeks, partake in physical therapy and then gradually return to his Chicago Park District three games a week routine. The patient will have reached his competitive goals through care based on the scientific evidence and outcomes documentation. As long as I introduced the subject of competitive goals, off I go to ski in Colorado next week; about a year after having undergone Cellular Orthopedic interventions to both of my arthritic hips and both of my arthritic knees. Without the biologics, not only would I be unable to ski, I would be ready for two knee replacements and two hip replacements. I should have listened to my mother and stuck to the piano and violin.

To learn more about continuing to reach your competitive goals, visit my web site www.sheinkopmd.com or call and schedule a consultation 312-475-1893).

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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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Chicken Soup for Arthritis or Micro-Fractured Adipose Tissue

Chicken Soup for Arthritis or Micro-Fractured Adipose Tissue

You may recall from my last several Blogs that The American Journal of Orthopedics published my paper in November: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis. While surfing the internet this morning, I noted that many physicians are labeling the procedure a source of stem cells; it is not. 

Lipogems is now U.S. Food and Drug Administration (FDA) approved for use in Orthopedics. The proprietary name is applied to a Micro-fragmented Adipose Tissue Transplant System that was the technology I introduced and monitored in a scientific clinical trial dating back three years leading to the publication. Federal regulators have now cleared the way for the device and technology that uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process. Lipogems is attractive to orthopedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopedics. Unfortunately, clinics and physicians are erroneously, describing the procedure as a source of stem cells; I will emphasize again it is not. Even the Lipogems company uses term reparative and not regenerative. 

The Power of Fat 

When I grew up, my grandmother and mother fed me chicken soup for whatever ailed me. Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Micro fragmented adipose tissue may be an option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.

In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products.  The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”

To schedule an evidence-based consultation for your arthritic joint, call (312) 475-1893.

You may access my website at  www.sheinkopmd.com

If you schedule before the end of the year, I will share my wife’s chicken soup recipe on request

 

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Resolving a regenerative medicine dilemma

I rode my bike this past Saturday and Sunday through the Chicago Forest Preserve bike trails and I had some time to reflect. Just as in fly fishing, cycling is meditation time. I tried to answer questions that came to mind such as how could Abraham have fathered both Izsak and Ishmael in his late 90s? Was it the triumph of stem cells or something more? I reflected on this through the Monday service without resolution other than we are still dealing with the ramifications.am

On Tuesday morning, the usual and customary ad in the Chicago Tribune paid for by the Stem Cell Institutes of America appeared inviting readers to a seminar to learn more about their approach to pain from arthritis and assuring the reader that their techniques are FDA compliant. Their approach is based on Amniotic Fluid injection. What I do know is FDA compliance requires that the stem cells must be yours (autologous) and that amniotic fluid once processed, sterilized, frozen and fast thawed has no viable stem cells. I also am cognizant of the large body of scientific evidence supporting the notion that pain of arthritis is generated by the supporting bone as cartilage has no nerve supply. How does a single and costly injection of amniotic fluid result in long term benefit? I have to deal on a daily basis with the fallout of this marketing campaign.

Next the Wednesday, September 12, addition of the Chicago Sun Times carried an ad sponsored by The Pain Relief Institute headlining Stem Cell Recruitment. As I understand the approach, Amniofix, a placental derivative, micronized, is reconstituted and injected into the arthritic joint. Reader please note that the first bullet states “FDA Regulated”. Of interest is the fact that I refused and still refuse to use Amniofix in my practice as there are no evidence based clinical trials to support any clinical claims. Those trials are taking place now. Amniofix is a product rushed to market before there was scientific proof to support use. You may learn more about Amniofix by searching the product online. If you don’t count cells with a hemoanalyzer, how could you know what is being “recruited”?

My commitment is to stand up for my patient in this regenerative medicine chaos. I resolve to do better in the upcoming year with introspection and ongoing review of the discipline.  

With best wishes for a happy and healthy 5779

You may visit the website at www.sheinkopmd.com

Schedule an appointment by calling (312) 475-1893

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