“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
My column regarding ACL ruptures appeared last Friday. That afternoon, I received the following inquiry and comment from a reader, regarding the prognosis and possible early preventive interventions for a significant knee injury.
“I am one of relatively few patients who has had the Bone Marrow Concentrate treatment for a fully-torn (not-retracted) ACL tear and to date, I’ve had what I’d consider to be an amazing recovery. I read your latest blog post and just thought I’d let you know that I’m back to very aggressive skiing (including small but non-trivial jumps). However, I did want to ask, if you would be willing to comment, if there are actions or periodic diagnostics, you’d recommend to maximize the chances that I’m still happy skiing 10,20,30 years after the injury? I understand you probably can’t comment but nevertheless wanted to let you know I was also a real-life person who had a significant knee trauma with multiple surgical consults all agreeing it was fully torn and required surgery (to return to high-level skiing) and now have a fairly normal looking ACL in MRI (per independent radiologist) and am back to 100% with activities that require a lot of knee stability. I did do two rounds of same-day BMA reinjections and a bunch of platelet injections but no surgery.”
The answer is an orthopedic assessment at three-year intervals to look for markers of post traumatic osteoarthritis such as loss of terminal extension and asymmetrical flexion. The MRI is helpful in detecting moderate arthritic changes but the latest development, the needle scope, allows an orthopedic surgeon to directly examine the meniscus and cartilage in an office setting. The concern is post traumatic arthritis, cartilage defects that will progress, and meniscal damage not always seen on the MRI. Here are some thoughts on early intervention with Cellular Orthopedic and Regenerative Medicine options.
A recent Study Compared the Efficiency of Needle Arthroscopy Versus MRI for Meniscal Tears and Cartilage damage. Needle arthroscopy (NA) may be a less costly and more accurate option for diagnosis and treatment of meniscal tears and early onset post traumatic arthritis than MRI, according to a study published in the February issue of Arthroscopy. Researchers collected data on costs for care and accuracy, including procedures for both false-positive and false-negative findings well as private payer reimbursement rates. They compared outcomes using the global knee injury and osteoarthritis outcome score (KOOS). Patients were followed and evaluated over a two-year period.
There are several restorative options now available when conservative therapies for the treatment of knee degenerative processes, such as non-pharmacological interventions, systemic drug treatment, and intra-articular therapies offer only short-term benefits or fail. Before resorting to surgery; be aware that encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. My clinical published research documents success with using your Bone Marrow Concentrate for joint restoration and combating progression of posttraumatic arthritis. Additionally, I have published an article concerning another source for joint restoration, micro-fractured adipose tissue. The latter has created a huge interest in the context of cartilage regeneration due to its wide availability, ease to harvest and richness in mesenchymal cell elements within the so called stromal vascular fraction. Moreover, MSCs from adipose tissue are characterized by marked anti-inflammatory and regenerative properties, which make them an excellent tool for regenerative medicine purposes.
Tags: ACL tear, Adult Mesenchymal Stem Cells, arthritis, Arthroscopy, biologics, bone marrow, cartilage damage, cellular orthopedics, hip pain orthopedic surgeon, joint pain, joint restoration, knee pain, KOOS, meniscal tears, MSC, orthobiologic, Osteoarthritis, PRP, sports medicine, therapy, treatment
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
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