“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
How long will the benefits last?
Yesterday, an individual presented in the office on a professional matter for a scheduled business meeting and during our discussions, related that he had undergone right hip arthroscopy, eight weeks earlier. He had an antalgic (painful) gait while walking into the meeting room so I discussed the rationale for undergoing a Platelet Rich Plasma concentrate/Growth Factor Concentrate intervention when he returned to his home base. The individual elected to become my patient on the spot so I performed a physical assessment and noted asymmetrical hip motion with limitation on the right side. His pre-arthroscopic diagnosis was a torn acetabular labrum. In 45 minutes, my team had drawn his blood and prepared the concentrated injectate followed by my completing an ultrasound guided intraarticular right hip injection. Within five minutes, his inability to fully spread his legs, flex and extend his hip, and tolerate internal and external rotation had been corrected. This is not an infrequent observation following a Cellular Orthopedic intervention to the hip; yet I have no explanation for the immediate pain relief and return of joint function. He left the office with almost no discernable limp.
This past Monday, the office received this communication from a patient who began treatment with Bone Marrow Concentrate to her knees about four years ago; returning on several occasions until she reached maximum medial improvement at 18 months post intervention.
“I wanted to write to you and Dr Sheinkop to congratulate you on the published study in the Journal of Translational Medicine in which I was a participant. It is really satisfying to see that results finally in print. I want to thank you both for allowing me to participate, even though I was outside of the Chicago area.
Just to follow up, my knees have been doing really well for the past year. I enjoyed a long summer of bicycling, including regular 20-30 mile rides as well as a 40 and 50-mile ride, without significant pain. I also have been able to use the elliptical pain free and just in the past two weeks I started running on the treadmill (alternating one minute of running & walking for about 20-25 minutes on a 4% incline). I’m starting really slow -but I never thought I would be able to run relatively pain-free again”.
There is no way of predicting how soon and for how long a cellular orthopedic intervention will have an effect. Our ongoing outcomes observations for over six years may eventually help answer the question; but in the meantime, we ask our patients to return periodically so we may learn from them and intervene if needed.
To learn how you may benefit from a Cellular Orthopedic intervention schedule a consultation by calling (847)-390-7666. My web site is at www.sheinkopmd.com.
Tags: Adult Mesenchymal Stem Cells, arthritis, Bone Marrow Concentrate, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Interventional Orthopedics, Knee Pain Relief, Mesenchymal Stem Cell, micro-fractured fat, Orthopedics, Platelet Rich Plasma, Platelet Rich Plasma concentrate/Growth Factor Concentrate, stem cells, Subchondroplasty, torn labrum
You may recall from my last several Blogs that The American Journal of Orthopedics published my paper in November: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis. While surfing the internet this morning, I noted that many physicians are labeling the procedure a source of stem cells; it is not.
Lipogems is now U.S. Food and Drug Administration (FDA) approved for use in Orthopedics. The proprietary name is applied to a Micro-fragmented Adipose Tissue Transplant System that was the technology I introduced and monitored in a scientific clinical trial dating back three years leading to the publication. Federal regulators have now cleared the way for the device and technology that uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process. Lipogems is attractive to orthopedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopedics. Unfortunately, clinics and physicians are erroneously, describing the procedure as a source of stem cells; I will emphasize again it is not. Even the Lipogems company uses term reparative and not regenerative.
The Power of Fat
When I grew up, my grandmother and mother fed me chicken soup for whatever ailed me. Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Micro fragmented adipose tissue may be an option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”
To schedule an evidence-based consultation for your arthritic joint, call (847) 390-7666.
You may access my website at www.sheinkopmd.com
If you schedule before the end of the year, I will share my wife’s chicken soup recipe on request
Tags: arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, knee pain, lipogems, Micro-fragmented Adipose Tissue Transplant, Osteoarthritis, stem cells
For one, to the best of my knowledge, he doesn’t ski but I did earn a letter as a member of the Roosevelt High, basketball team. No, the common ground is the fact that we both have undergone a similar intervention for osteoarthritis of the knee. Six years or so before Bryant’s retirement, he traveled to Dusseldorf, Germany to undergo an orthobiologic intervention for an arthritic knee that was threatening to prematurely end his playing career. That orthobiologic intervention was unavailable at the time in the United States; but professional athletes were traveling to Dusseldorf to help prolong their careers. I closely followed the outcomes and was amazed to see Kobe Bryant’s return to professional basketball following his procedure for five more years, given he had stage four Osteoarthritis of his knee. His knee X-Ray was available on the internet. At the same time, I postponed my surgical procedures knowing that both of my knees and both of my hips were problematic, waiting for access to a treatment similar to that which the professional athletes were having in Europe. Last September, as an invited speaker at the Russian Orthopedic Society annual meeting, I was able to gain access to the treatment regimen very much available by now in Western Europe and Great Britain. My hope was to partake in a family ski vacation from February 17 to 24. On December 27, I underwent biologic intervention into both of my knees; and on January 11, both of my hips.
On Saturday, I returned from a ski week in Vail, including my wife, three children, one daughter-in-law and five grandchildren. Two other spouses don’t ski. I skied six consecutive days with my wife, children and at times, grandchildren. It was an opportunity for returning to the thrilling days of yesteryear as far as skiing was concerned, made possible by Orthobiologics. Imagine, three months ago I was experiencing painful limitations in both hips and in both knees; now I am planning a return four-day skiing visit at the end of March to catch the spring powder. I don’t know if I can help you ski; but I can help you overcome limitations imposed by arthritic joints.
Citing Oliver Wendel Holmes; “We do not quit playing because we grow old; we grow old because we quit playing”.
To learn more visit: www.ilcellulartherapy.com or call for an appointment 312 475 1893
Tags: arthritis, biologic intervention, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip pain, Interventional Orthopedics, knee pain, Knee Pain Relief, Kobe Bryant, Orthopedics, Osteoarthritis