“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
As interest in biologic therapies for arthritis-a needle, not a knife-continues to expand; patients increasingly are turning to the ads in newspapers or searching the Internet to gather information on this topic. While there is still a lack of scientific consensus on the use of biologics, it is most important for those seeking information not to be misled. My own analysis of resources for patients seeking on line information about biologic therapies for arthritis is that the overall quality is very poor and anything but scientific. Even worse, is a seminar, neither a reliable or credible source of scientific evidence.
Biologic therapies consist of stem cells, platelet rich plasma product and bone marrow aspirate concentrate. New research, I co-authored and that was published last month in The American Journal of Orthopedics: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis, is indicative of the ever-evolving nature of Regenerative Medicine. Biologic therapies and their use in arthritis or musculoskeletal injury in general are an area of vast research and interest within the medical field. Understanding the information online and the misinformation provided at seminars pertaining to biologics allows me to tailor my conversation and address commonly found inaccuracies.
The use of Biologic Therapies is expected to significantly increase in the coming years as our knowledge advances on the use of such. That initiative will be led by well informed, well-educated Board Certified, and Fellowship trained specialists. Unfortunately owing to the relative lack of oversite at present, every type of charlatan, parasite and camp follower can buy an ad for a seminar or produce a web site on the internet. How then should a patient with pain and limited function from arthritis seek to postpone or avoid surgery without becoming a victim of the cord blood or amniotic fluid hoax?
- Your physician must complete a comprehensive medical history, physical examination and review of diagnostic studies.
- Explain the disease process and grade of progression,
- Discuss possible treatment options,
- Present a balanced assessment of the current scientific evidence.
Woe, while writing this Blog, I was just notified about acceptance of yet another scientific article by a peer reviewed medical journal in which I am the senior author: 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.
Hopefully some time soon, a Biologic Arthroplasty will be possible; but until then, a Total Joint Replacement is still a necessary option for those not meeting specified inclusion criteria for biologics. To see what treatments may be possible for your arthritic generated pain call (847) 390-7666 to schedule a consultation. Visit my website www.SheinkopMD.com for additional information.
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, ankle pain, arthritic pain, autologous bone marrow concentrate, biologic, biologics, cellular orthopedics, Cord blood, Hip pain, injury, joint pain, knee pain, lipogems, Osteoarthritis, PRP, regenerative medicine, rupture, shoulder pain, sports injury, stem cell, tear, tendinitis
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
Last week, I assessed three different patients for Cellular Orthopedic joint restoration; and each patient asked about the reason behind my fee schedules? One patient had told me of a friend who had attended a seminar by the Stem Cell Institutes of America and who was quoted a fee somewhat lower than my charges. As I have previously emphasized, the Stem cell Institutes of America use Amniotic Fluid that is concentrated and once processed and thawed, has no viable stem cells or regenerative potential. There may be proteins that survive but basically, a patient receives an injection of hyaluronic acid that cushions the joint for up to six months at best and for which there is no supportive outcomes data.
The second patient had been quoted a fee for cord blood. The latter is provided in frozen form and much of the value is lost during the thawing process. While significantly less costly than a bone marrow concentrate and growth factor concentrate intervention, there is no outcomes data to support usage. The FDA has warned against the use of “stem Cells” derived from anyone or anything other than your own (autologous). So if amniotic fluid and cord blood did deliver viable stem cells, their use would be contrary to FDA guidelines; but let’s move on since neither has living cells when thawed.
Then there are the adipose derived globules, notice I didn’t use the term stem cells. Fat globules are prepared after liposuction and the fat is mechanically broken down but the stem cells aren’t released. In order to release stem cells from the fat, the tissue has to be treated with collagenase. The FDA prohibits use of collagenase in fat unless it is for a cosmetic indication.
My knowledge base is the result of first having completed three clinical trials using Amniotic Fluid for arthritis and in each trial, the outcomes were not satisfactory after six months. I next traveled to Southern California to investigate cord blood. I was skeptical at best but tried the product in three knees, all with very unsatisfactory results. Two years ago, I completed a clinical trial on a mechanically derived adipose based product; the manuscript for that study was accepted by highly regarded orthopedic journal and will be published later this year.
When all is said and done, you may save money with the bottom feeders who advertise and market without data or outcomes to support their claims or you can avail yourself of my knowledge, expertise and statically proven outcomes. To schedule a consultation, call 847 390 7666. You may visit my web site at WWW.SheinkopMD.com
Tags: amniotic fluid, Cord blood, joint pain, joint restoration, regenerative medicine, stem cell