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
Feb 28, 2019
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
Feb 21, 2019
We read about it in the sports pages every day; the player presenting after twisting a knee, feeling a “pop” and going down in a heap. The knee is swollen, the first indication that bleeding has occurred inside the joint. Physical examination of the knee to test the ligaments leads to a suspected tear of the anterior cruciate ligament; the MRI is ordered and confirms the diagnosis.
Because of its poor blood supply and location inside the knee, the ACL has little healing potential. It’s an unfortunate reality, as they are occurring at increasing rates over the past two decades. In part, it’s because more children are playing competitive sports and doing so at a younger age while we seniors are still skiing or playing and competing all year. What are the future implications of a torn ACL? Lindsey Vonn came back after ACL surgery; so did Tiger Woods, Julian Edelman, Tom Brady and Derrick Rose to name a few. so how bad can it be? The truth is that surgery can restore knee function, but it does little to diminish the risk of arthritis 10 to 15 years down the line or less. Lindsey Vonn announced retirement five years later because of arthritis. Kids who tear their ACL today are often left with 60-year-old knees when they’re 30; and as has been recently stated, Knee Replacement is not necessarily a panacea.
Secondary damage may occur in patients who have repeated episodes of instability due to ACL injury. With chronic instability, a large majority of patients will have meniscus damage when reassessed 10 or more years after the initial injury. Similarly, the prevalence of articular cartilage lesions increases in patients who have a 10-year-old ACL deficiency. It is common to see ACL injuries combined with damage to the menisci, articular cartilage, collateral ligaments, joint capsule, or a combination of the above; the “unhappy triad,” especially in football players, soccer players, basketball players and skiers.
Certainly, modern ACL surgery means it’s no longer a career-ender, but recovery ranges still vary widely. In cases of combined injuries, surgical treatment is warranted and generally produces better outcomes. As many as half of meniscus tears may be repairable and may heal better if the repair is done in combination with the ACL reconstruction. Some athletes come back in as little as nine months, while it can take well more than a year for others. Then comes the mental battle, that is the silent war waged after tearing an ACL. Derrick Rose, we are watching you.
Recent clinical evidence suggests surgery is not your only option; interventional or cellular orthopedics may be a non-surgical alternative that uses your own cells to repair the incompletely damaged ligament. A cellular orthopedic intervention for those who meet the inclusion criteria may substitute for surgery. Those who offer the non-operative option when appropriate, use Bone Marrow or Adipose Tissue harvested from your skeleton or abdomen, process the recovered cells and growth factors with particular attention to FDA compliance, and inject the concentrate into the remaining Anterior Cruciate Ligament cumented incomplete tears with success in returning athletes to a sport.
While intervention and cellular orthopedics may have a role in a torn ACL at times, Joint Restoration, perhaps even Regeneration adjuncts at the time of an ACL repair or for the ensuing arthritis have an absolute evidence-based role. To schedule an appointment call (312) 475-1893. You may visit my web site at www.sheinkopmd.com
Tags: ACL, ACL Injury, anterior cruciate, arthritic knee, cellular orthopedic
Feb 14, 2019
Following injury or wear, limitations need not be limited to professional, college and high school athletes
Last week, my column focused on the post traumatic ravages of the National Football League season; and getting ready for next cycle of body demolition. Those who watched the championship game saw several players assisted off the field following violent trauma. Even the President announced that he would prefer his son not play football. While professional, college and high school competitive sports enjoy high profile, there are the average recreational sports and fitness enthusiasts who progressively experience a diminution of ability to participate in a sought-after activity by virtue of injury or wear and tear; be it basketball, running, cycling, skiing, hockey, fitness endeavors, volleyball, golf, soccer, sailing; so, on and so forth.
As an example, a 67-year-old man presented in my office last week after having read my column, with progressive pain in his left knee and inability to partake in his long-time recreational passion, volleyball. I completed his intake centered on the taking of his medical history, completed an orthopedic physical examination, and ordered X-rays. He brought a recent MRI study to the appointment. The physical therapist who assists me objectively documented his physical findings so we would have pretreatment measurements. Additionally, my therapeutic recommendation is always based on more than an X-Ray and MRI, but also includes the objective and reproducible Range of Joint Motion and assessment of joint stability.
After review of all the above, I administered informed consent for a Bone Marrow Concentrate intervention into his left knee as a means of postponing, perhaps avoiding a Total Knee Replacement and assisting in his return to recreational volleyball. While there are several options for intervention into the arthritic or injured joint including adipose and blood-based alternatives, I recommended Bone Marrow Concentrate for his moderately arthritic knee as a means of providing Concentrated Platelets, Concentrated Growth Factors, anti-inflammatory Cytokines, Adult Mesenchymal Stem Cells, Precursor Cells, Marrow Adipose Tissue, and Hematopoietic Cells, all consistent with FDA compliance requirements. There are mandatory Federal Drug Administration and Federal Trade Commission regulatory standards of compliance in Regenerative Medicine; patients must be cautious when choosing the minimally invasive Cellular Orthopedic option. It takes an office visit, physical assessment and review of images by a board-certified specialist in the regenerative medicine decision making process; not merely attendance at a seminar. Some patients will not meet inclusion criteria, their needs would be better served by accepted surgical norms.
At age 67, there is little chance at Cartilage Regeneration for my patient, but there is a high probability of Joint Restoration; that is increased motion, diminution of pain and the return of ability, in this patient’s case to play volleyball. He will wear an off-loader brace for six weeks, partake in physical therapy and then gradually return to his Chicago Park District three games a week routine. The patient will have reached his competitive goals through care based on the scientific evidence and outcomes documentation. As long as I introduced the subject of competitive goals, off I go to ski in Colorado next week; about a year after having undergone Cellular Orthopedic interventions to both of my arthritic hips and both of my arthritic knees. Without the biologics, not only would I be unable to ski, I would be ready for two knee replacements and two hip replacements. I should have listened to my mother and stuck to the piano and violin.
To learn more about continuing to reach your competitive goals, visit my web site www.sheinkopmd.com or call and schedule a consultation 312-475-1893).
Tags: arthritis, board-certified, Bone Marrow Concentrate, bone marrow edema, cellular orthopedics, FDA, football, Growth Factors, hematopoietic cell, joint pain, Mesenchymal Stem Cell, OA, Orthopedic Surgeon, Osteoarthritis, Physical Therapy, soccer, sports injuries, sports medicine, tear, volleyball
Jan 10, 2019
Nonobstructive meniscal tears
There is increasing evidence to suggest that patients with meniscal tears at the knee that do not cause “clunking”, giving way, or locking; hence nonobstructive, may benefit from Cellular Orthopedic intervention coupled with physical therapy. Previous studies involving patients over 45 years of age comparing arthroscopy with physical therapy for nonobstructive meniscal tears as seen on an MRI justify an initial conservative approach; but patient satisfaction may require 24 months to achieve. For those patients who undergo arthroscopic surgery, there is a significant increased risk of repeat knee surgery. In our practice, those patients electing to use the Physical Therapy option without surgery but with a Cellular Orthopedic intervention minimized the length of time needed to return to full activity.
Number of stem cells in amniotic fluid
The functionality of stem cells in amniotic fluid as sold today is a myth. Research shows that 250cc of fresh C-section delivered amniotic fluid, when introduced immediately into culture, only yields 40 stem cells. This means there are 0.16 stem cells per 1 cc of full-term amniotic fluid. Scientific literature referred to by the amniotic fluid marketing forces is based on amniotic fluid collected early in pregnancy.
Acetabular Labral Tear
A hip (acetabular) labral tear is damage to cartilage and tissue in the hip socket. In some cases, it causes no symptoms. In others it causes pain in the groin. Just because a tear is seen in the hip labrum on an MRI, it does not mean the tear is necessarily the cause of the pain. Before initiating treatment, the orthopedic surgeon must exclude that an underlying arthritic condition within the hip is not the real pain generator. More recently recognized is predisposition for a tear in those with abnormal acetabular architecture.
On biologics for knee osteoarthritis
Orthobiologics may become a mainstream treatment for knee osteoarthritis. While Platelet-rich plasma and hyaluronic acid injections are the most established biologics-based treatments for knee osteoarthritis so far, it’s not too early to make confident use of stem cells. At the same time, I must continually warn patients to be particularly careful about claims for these substances. All recommendations for intervention must be FDA compliant and evidence based. (To learn about my contributions to the cellular orthopedic scientific evidence, visit www.sheinkopmd.com. Under the information bullet on the top, you will find published articles)
Eventually, I believe the science and FDA will triumph over quackery and orthobiologics will become an essential part of every knee surgeon’s armamentarium. Available orthobiologics, include:
- Hyaluronic acid
- Platelet-rich plasma
- Cytokine modulation
- Stem Cells
- Exosomes
- Adipose tissue
To learn more or to schedule an evidence based consultation, call (312) 475-1893
Tags: adipose tissue, amniotic fluid, biologics, bone marrow, cytokine modulation, Exosomes, fat, hyaluronic, joint, labral tear, Micro-Fractured Adipose, orthobiologics, Osteoarthritis, pain, Platelet Rich Plasma, PRP, renovation, stem cell, torn meniscus
Aug 16, 2018
From the front page of the September, 2018 issue of GOLF “This Tiger is for real. He’s faster, sharper-and an up-and-down machine.” Then, from the September/October issue of Tennis, “Juan Martin del Potro He’s back…. and ready to once again conquer”. His once promising career was reaching the end owing to wrist injuries. Quoting Del Potro in the article “one doctor would say something to me; another would say something different. It was difficult to believe one or the other”; however, he demanded excellence and eventually found it
I could go on citing and quoting from all sports and recreational resources but you get the idea. These are recovery and come back examples of what motivated individuals may accomplish. Now, if you tune in to upcoming US Open later this month, you will be able to follow Rafael Nadal, another super athlete who was able to return to compete at the top of his game owing to cellular orthopedics for several potentially career ending injuries over recent years. I could go on with the examples in each and every recreational pursuit or from those who wished to regain a pain free and very active life even if not at the aforementioned level of demand. Suffice it to say, the common denominator for those with skeletomuscular restrictions is a combination of physical training, mental motivation and timely medical care.
You can put some of this Tiger in your tank and reignite your enjoyment of activities at any level if arthritic or traumatic injury of your bone and joints is holding you back. The new world, (actually it is not so new anymore) of Cellular Orthopedics may allow for a return to a virtually unlimited lifestyle with a needle instead of a knife. I choose to define myself as a Cellular Orthopedist so a patient might not be trapped in the web of so called regenerative medicine specialists. An orthopedic surgeon has dedicated many years to understand the musculoskeletal system whereas a regenerative medicine clinic frequently is populated by those who attended a two-day training seminar. While my own recreational pursuits and fitness profile is far removed from those of the famous professionals noted earlier in this blog, following cellular orthopedic interventions into my own knees in December of 2017, and for my hips in January, 2018, I returned to skiing last winter, cycling and fly fishing this summer, and I am able to enjoy a full fitness commitment in doing my part to maintain the highest possible level of performance.
You may access my website at WWW.SheinkopMD.com or call (312) 475-1893 to schedule a consultation.
Tags: BMC, Bone Marrow Concentrate, cellular orthopedis, golfers elbow, injection, Platelet Rich Plasma, PRP, regenerative medicine, sports injury, stemcell, tendon repair, tendon tear, tennis elbow
