Mar 7, 2019
“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.”
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, Cornell University, cryopreserved, FDA, Federal Trade Commission, Food and Drug Administration, FTC, joint pain, joint regeneration, joint replacement, Osteoarthritis, Public Health Service, Regenerative, research, stem cell, stem cell seminar, stem cell shot, surgery, umbilical cord blood, umbilical cord stem cells, Wharton’s Jelly
Feb 4, 2019
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 (312) 475-1893.
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
Tags: arthritis, athletes, autologous, avascular necrosis, bone marrow, cellular orthopedics, cytokines, esports, Growth Factors, injury, joint pain, joint replacement, joint restoration, knee pain, meniscus tear, MSC, OA, orthobiologic, Orthopedic Surgeon, Osteoarthritis, Pain Management, pain reduction, patyon manning, platelets, PRP, sports injury, sports medicine, stem cells, superbowl, surgery, tiger woods, torn labrum
Jan 24, 2019
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
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, FDA, joint pain, joint regeneration, joint replacement, Osteoarthritis, Regenerative, research, stem cell, surgery
Nov 19, 2018
“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.
Tags: arthritic knee, biologic intervention, cellular orthopedic, injection, joint pain, joint replacement, Orthopedic Surgeon, PRP, regenerative medicine, stem cell, Total Knee Replacement
Nov 8, 2018
My goal is to inform each and every patient who presents with a painful joint, the cause of their pain; and based on our scientific and clinical evidence, that intervention which will have the greatest chance of short term and long-term success. While inflammation in the joint is a proximate cause of pain, that pain is not generated by cartilage deterioration as cartilage doesn’t have a nerve supply. While joint pain in part is generated by the synovial tissue lining the arthritic or traumatized joint, the subchondral bone supporting the joint may be even more important when it comes to the pain and limitations resulting from the arthritic affliction.
Bone pathologies resulting from acute or chronic injury presenting as bone marrow lesions associated with insufficiency fractures, persistent bone bruises, osteoarthritis and early stages of avascular necrosis are too often neglected by those holding themselves out to be regenerative medicine specialists. Options for the treatment of these subchondral conditions require a core decompression of the problematic bone and direct application of either bone marrow aspirate or a synthetic orthobiologic. The biologic treatment of bone marrow lesions with these techniques that encourage physiologic bone remodeling and repair when combined with Stem Cell and Protein/Growth Factor concentrates into an arthritic joint offers the best chance for joint preservation and a successful outcome for the patient undergoing a Stem Cell procedure.
Are there Stem Cells in Cord Blood, Wharton’s Jelly or Amniotic Fluid? These three alleged sources of Stem cells are processed when collected. The tissues are then cryopreserved with DMSO or some other cryopreservant. When thawing takes place, the few cells contained do not survive the thawing process. Additionally, DMSO is cytotoxic, a cell killer at room temperature.
As many of my patients are aware, I began my Cellular Orthopedic journey some years ago as an early member of the Regenexx Network. While my personal and practice ethos as the only orthopedic surgeon caused me to leave the network, I still follow the Blog and I find the one posted today most appropriate.
I was on a local radio show this week and a woman called in and claimed that she had been defrauded by a local chiropractic clinic. She paid big bucks for what she was told were “millions of young stem cells” injected intravenous. As I will show you this morning, as a medical expert in this area, I can show you that she is more likely than not the victim of consumer fraud. Let me explain.
The Problem of the Chiro Clinic Bait and Switch
I’ve blogged extensively about how chiropractic, acupuncture, naturopathic, and some physician clinics are defrauding patients by claiming to inject millions of live and young stem cells from amniotic fluid or cord blood (or other products). The problem is that none of these 361 registered tissue products has any significant number of live stem cells.
Tags: ACL Injury, bone edema, bone lesion, bone marrow, Cartilage, chondromalacia, chronic pain, Cord blood, cryopreserved, Hip, joint pain, joint replacement, Knee, meniscus tear, naturopathic, Osteoarthritis, osteochondral defect, regenerative medicine, shoulder, stem cell, subcondral bone
