“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
The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells.
Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.
“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”
The clinic is one of many around the country that claim to use stem cells derived from a person’s own fat to treat a variety of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says. The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration. Stem-cell researchers praised the FDA’s actions.
“This is spectacular,” says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. “This is the right thing to do.”
Daley praised the FDA’s promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on “snake-oil salesmen” marketing unproven treatments.
Stem-cell research is “a major revolution in medicine. It’s bound to ultimately deliver cures,” Daley says. “But it’s so early in the field,” he adds. “Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven’t been proven to work and may be unsafe. “Others agreed “I see this is a major, positive step by the FDA,” says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell “treatments” that may not be real treatments,” Knoepfler says.
“Don’t stop now”. Say I. This Blog has been asking for FDA intervention in those settings where Amniotic Fluid is being marketed as a source of stem cell regeneration for over a year. There is only one way to be safe and not sorry:
You may access my web site Ilcellulartherapy.com and watch my webinar Or call for an appointment — 847-390-7666
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Growth Factors, Orthopedics, Osteoarthritis, Pain Management, Regenerative, stem cell treatment, stem cells, treatment
Patients receiving either Hyaluronic Acid (HA- Synvisc, Supartz, Euflexxa) or Platelet Rich Plasma (PRP) injections will experience modest-term pain relief according to an article appearing in Orthopedics Today, August, 2017. In the study reviewed, Ultrasound Guided injections were given weekly for three weeks and patient-reported outcome measures (PROMS) were recorded for up to one year. “Both the PRP and HA groups demonstrated an improvement in PROMS at 24 weeks that declined to near baseline levels at one year” according to the article. “Patients with lower grade Osteoarthritis and lower weight responded more favorably to intra-articular injections”. The effect of both Hyaluronic Acid and Platelet Rich Plasma appeared to be modest and temporary.
Why I chose this topic this week for my Blog has to do with my preparation for the upcoming talks I am invited to give September 21st and 22nd in St. Petersburg, Russia at the meeting of 1200 orthopedic surgeons from Russia, Ukraine and neighboring countries both in Europe and Asia. As I indicated last week, this will be the first time a non-operative intervention of a cellular orthopedic, regenerative nature, as I practice, will have been introduced into this region of the world. While Hyaluronic Acid and Platelet Rich Plasma may offer short term pain diminution for individuals limited in function by the symptoms of Osteoarthritis, it becomes clear by scrutinizing my data base that not only does concentrated bone marrow afford long term relief, the Mesenchymal Stem Cells and Growth Factors found in bone marrow when concentrated participate in regenerative possibility thereby delaying and perhaps even avoiding a joint replacement. My presentations will be evidence based without the false news and unsupported marketing claims ever present in the media.
What we have learned about Amniotic Fluid (AF) from my role as principal investigator in several multisite studies is that AF does have concentrated Hyaluronic Acid and therein may offer six to 12 months decrease in symptoms and increase in function, the effect is limited in duration; and with no viable stem cells in Amniotic Fluid Concentrate, there is no regenerative potential. Owing to the absence of inherent absence of stem cells and hence regenerative potential, I will not include amniotic fluid in my presentations.
As a scientific invitee, my responsibility is to introduce that for which we have scientific support and clinical evidence. If you want to gain a better understanding of Regenerative Medicine and Cellular Orthopedic and learn how you may postpone or perhaps avoid a joint replacement for the symptoms and limitations imposed by osteoarthritis, make an appointment, visit my web site and watch my webinar.
Tags: arthritis, hyaluronic acid, Interventional Orthopedics, Knee Pain Relief, Orthopedics, Osteoarthritis, PRP, Regenerative, stem cells
Last week, we traveled to Israel to celebrate the wedding of our youngest son. Israel became the destination for the event as Eric and Judith had met there while his music business was subcontracting to Coke and Judith led the International Marketing initiatives for Coke. The event took place on July 5th, at an organic farm in the outskirts of Jerusalem. In such a majestic and historical setting prior to and after the ceremony, there took place several organized tours including one of Jerusalem, another at the Dead Sea and for several, a trip to Petra. It was a relatively small group of the attendees; one in particular, a very close and long-time friend has been the subject of my Blog in years past as I described his return to skiing, biking and fly fishing following a Bone Marrow Concentrate/Growth Factor Concentrate/Stem Cell concentrate intervention. Prior to those procedures, he had been forced to give up his athletic passions for several years because of the limitations imposed by arthritis of both knees.
Above is his activity score from Monday, July 3, when Bob and his wife toured Jerusalem’s Old City including a hike on the ramparts of the wall surrounding the Christian Quarter, the stop and prayer at the Temple Mount and a shopping spree at the Arab Suk (bazaar).
What Bob represents is the potential for continued improvement over several years following a regenerative intervention, a process of which I am continually reminded as time passes and I have a longer follow up of my patients. Our mission and ethos is to help patients with arthritic joints enjoy an active life style and postpone, perhaps avoid joint replacements when arthritic impairment ensues. The documentation from the patient above is one of improving outcome as time passes. While his is an anecdote, our data base increasingly reflects similar happenings for the majority of our patients.
There are now many providers for those with arthritic impairment seeking improved function and less symptoms; and who are not candidates for a joint replacement or who do not want to undergo the major surgical undertaking. In your choice of an Interventional Cellular specialist, inquire about her or his long-term outcomes; not just “will I get a free lunch if I attend a seminar?”
To learn more, call for a consultation 847 390 7666
You may watch my webinar and learn more by visiting my website at Ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, joint replacement, Knee Pain Relief, Orthopedic Surgeon, Regenerative, stem cells