“Why bother with the truth when you can make it all up”
“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
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:
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
I swear to tell the truth, the whole truth, so help me G_d. Injured cartilage in a skeletally mature adult typically doesn’t heal on its own; surgical techniques are needed in an attempt to repair and replace cartilage. These latter procedures are appropriate for specific cartilage injury, rather than the widespread cartilage changes found in the osteoarthritic joint. That is not to say that someday soon, we may have the ability to regenerate cartilage. Research is ongoing in regenerative medicine with continual progress as evidenced by preliminary success in spinal cord injured patients:
StemCyte gets FDA green light to continue studying spinal cord injury treatment stem cells.
Now for the bad news. In spite of false news generated by the charlatans, parasites, camp followers and hucksters in their Regenerative Medicine seminars, print media and television adds; there is no scientific evidence to support their claims of cartilage regeneration, hair restoration, cure of erectile dysfunction, so on and so forth.
Stem cell fraud? Couple says therapy gave them ‘false hope’
“Unfortunately, what I had hoped to be a hard-hitting expose turned into limp-noodle babbling. Another missed opportunity.” Continuing the commentary about regenerative medicine clinic charlatans and fraud started by NBC, when a patient showed me a brochure from yet another group that holds itself out to treat every abnormal medical condition from A to Z with “Stem Cells”, I suggested that he request data regarding their successes. Please bear in mind the self- contradicting adage that Always and Never statements are always false and never true. They are frequently used by people who suffer from personality disorders. On Friday he sent me the response to his inquiry regarding outcomes at a one of the national stem cell clinics.
“success rates per our clinical research network are VERY encouraging: Orthopedic: knee 83%, hip 80%, back (cervical, thoracic, lumbar, sacral 80% ave., ED 77%, Cataracts 100%” Remember what I just wrote about Always and Never?
The good news though is that there is emerging scientific evidence to justify Joint Restoration with a cellular orthopedic procedure. While an image of an arthritic joint allows for identification of cartilage and meniscal changes, that same image will frequently be consistent with bone marrow edema, and thickening of the bone adjacent to a joint (subchondral sclerosis) as well as loose bodies within the joint. As cartilage does not have a nerve supply, the pain generation in Osteoarthritis more probable than not is the result of inflammation of the synovial joint lining and the subchondral bone. While there is no scientific means of re-growing cartilage after age 40 at this time-defects may be filled by surgery-orthopedic surgeons focusing on Cellular Orthopedics have developed methods to restore the joint function by blocking the pain generators, restoring healthy subchondral bone, and reversing bone marrow edema.
To schedule an Evidence Based Consultation, call (847) 390-7666
You may read my Blog and explore my published research articles on the website www.sheinkopmd.com
Tags: arthritis, bone marrow edema, cartilage regeneration, cellular orthopedic, Hip pain, inflammation, joint health, joint pain, knee pain, medicine, meniscus tear, Osteoarthritis, restoration, soft tissue repair, stem cell, stem cell injection, subchondral bone
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
- Adipose tissue
To learn more or to schedule an evidence based consultation, call (847) 390-7666
Tags: adipose tissue, amniotic fluid, biologics, bone marrow, cytokine modulation, Exosomes, fat, hyaluronic, joint, labral tear, Micro-Fractured Adipose, orthobiologics, Osteoarthritis, pain, Platelet Rich Plasma, PRP, renovation, stem cell, torn meniscus
The truth about reparative medicine in orthopaedics and why it matters to you is that in the USA, millions of people suffer from orthopedic conditions and are looking for options to major surgery. At the same time, there is a segment of the population that can’t safely undergo a major joint replacement procedure. Then there are those who are highly active and are looking to keep up with their sporting activities and an unlimited life style. The older generation is living longer and very active. The younger generation is also participating in sports and playing for a longer period. The wear and tear in joints cause pain and ultimately may cause or aggravate an arthritic process. There is an option to surgery and a means of postponing, perhaps avoiding a Total Joint Replacement. While Cellular Orthopaedics (Regenerative Medicine), offers a reparative technology, it is important to recognize that all therapies in the marketplace are not equal. There are many different types of tissues: fat, bone marrow, amniotic fluid, placental tissue, cord blood, Wharton’s Jelly, and circulating blood marketed for intervention but only concentrate from your own bone marrow, concentrate and filtered platelet product from your own blood, and now micro-fractured fat from your own adipose tissue meet FDA compliance requirements.
Over the past ten years, advances in reparative medicine have resulted from science and research behind the different options. You may read about my role at www.sheinkopmd.com/published-research-articles/ to learn more. I was one of the first orthopaedic surgeons to study the effects of Micro-fractured Fat (Lipogems) in patients with Grade 4 Osteoarthritis of the knee who were en route to a Total Knee Replacement. Now that the FDA has granted clearance, many physicians are showing up with claims of offering adipose stem cells. While fat has reparative qualities and can help promote a healing environment, it is not a resource for cartilage regeneration.
As always though in the current health marketing environment, a patient must guard against misrepresentation of product, effect and outcomes. The article I published in November of 2018, is the only scholarly article of which I am aware that has true clinical adipose outcomes data. https://www.amjorthopedics.com/article/safety-and-efficacy-percutaneous-injection-lipogems-micro-fractured-adipose-tissue. Those clinics offering a type of fat technology that is processed using enzymes and manipulates the cells are doing so by failing to abide by FDA Guidance. Additionally, some providers are offering “Stem Cell Treatments” at very high costs and thus mislead the public along with the parasites, camp followers and charlatans promoting amniotic fluid, cord blood and Wharton’s jelly. Our goal is to provide the right treatment options for a patient with solutions that have strong scientific evidence behind the technology and are cleared by the FDA. I am happy to be a leader in the Evidence Based initiative.
To schedule a consultation call (847) 390-7666 You may visit my web site at www.sheinkopmd.com
Tags: adipose stem cell, fat, lipogems, micro fracture, orthopaedic, PRP, stem cell