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
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
Mar 16, 2017
As most readers of this Blog already know, for more than 37 years, I was a reconstructive joint replacement surgeon at a major Chicago medical center, where I served as the director of the joint replacement program. I retired as emeritus professor seven years ago; after having pioneered the integration of a clinical practice with joint replacement research and education. While I had completed over 20,000 hip and knee replacements during my career and played a major role in authoring over 85 major orthopedic publications, one of the highlights of my career was the recognition by the resident staff of awarding me the teacher of the year award in orthopedic surgery. At the same time, I had the opportunity to share my joint replacement knowledge around the world. I addition, many orthopedic surgeons from across the globe would come to observe and learn my techniques. One such group came from Norway. What I learned from them during their visit was that no procedure would be allowed within the scope of the government health care system for which there wasn’t a ten-year outcome data base. Their health care system wouldn’t pay for that which didn’t have a track record and for which there wasn’t safety and efficacy studies.
I am continually amazed at the epidemic of web sites promising regenerative medicine treatments for which there is no data of success and for which there are no safety and efficacy studies. This false news seems to be an increasingly common phenomenon; more bothersome though are anecdotal outcomes cited in media placements without a scientific foundation. Last week, a major news outlet focused on a patient who had received stem cells in amniotic fluid. The hospital PR division scored a major success by placing the ad; but the Television Channel that broadcast the story apparently failed to do any independent scientific investigation to support the claims of living stem cells in commercially available amniotic fluid concentrate. The center behind the placement and the physician involved must have been influenced by the false news now commonplace; namely, amniotic fluid has living stem cells when concentrated, sterilized, irradiated, cryopreserved and fast thawed. Certainly, the video of the patient climbing stairs was a tribute to the success of the procedure; however, the success of unknown duration had nothing to do with the claim that the end result was based on regeneration attributable to stem cells.
Amniotic Fluid Concentrate has good things in it but not viable, living stem cells and there is no regenerative potential. I am able to so state as I am the principal investigator in a national ongoing amniotic fluid clinical trial to determine safety, efficacy, duration of effect and appropriate dosage.
To schedule an appointment call (312) 475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com
Tags: amniotic fluid, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, cryopreserved, Interventional Orthopedics, Osteoarthritis, regenerative medicine, stem cell treatment, stem cells
