Jun 30, 2020
The TOBI meeting was held June 12 and 13. Annually, it is the largest gathering of physicians who dedicate their practices to Regenerative Medicine. I have been contributing yearly to the scientific program almost since its inception; and I did so again this year. The evidence I present is based on my having pioneered the integration of clinical practice with outcomes documentation. This year, I focused on the results of an initiative I started four years ago by combining the placement of Bone Marrow Derived Stem Cells and Biologics both into the joint and into the bone adjacent to the joint. In so doing, our team had statistically documented improved outcomes when contrasted to placement of the biologics into the joint alone.
Orthobiologic Options for Patients
Not every patient with arthritis is a candidate for the approach described in the above paragraph. There are inclusion and exclusion criteria and those can only be assessed at the time of an office visit. For those who are not able to undergo the harvest of either bone marrow derived stem cells or adipose derived stem cells, we have several excellent alternatives to help control the discomfort of osteoarthritis and improve functional capacity. I will devote the remainder of this Blog to explaining two of the alternatives.
The term PRP (Platelet Rich Plasma) has become familiar to the public; but patient beware. The generic product has less than a 50% success rate and only after repeated administration. My proprietary approach, not much more costly than the usual and customary fee schedule for the generic PRP, provides a much greater concentration of biologics including growth factors in addition to six times the concentration of the generic PRP option. It is the intervention that I have personally undergone, and I still consider myself a senior athlete.
The second option is that of a growth factor and anti-inflammatory option; that in many cases, will be covered by Medicare and private indemnification. While our proprietary Platelet Rich Plasma is autologous, that it is prepared from your circulating blood but is available on a self-pay basis; the growth factor/anti-inflammatory option is provided by donors. The processing of the acellular product eliminated the risk of disease transfer and it is an excellent starting point for the use of biologics in the treatment of an arthritic joint.
Help for Patients in Pain
Yesterday, I assessed a 56-year old woman for biologic treatment of her left knee arthritic generated pain and altered functional capacity. Four years ago, she had undergone a right Total Knee Replacement followed 18 months thereafter by a revision procedure. That was followed in a year by yet a third surgical attempt to make the right knee pain free and functional and it is still problematic. The history of a failed knee prosthesis is three surgeries in four years. The natural history of a patient with an arthritic joint who undergoes a biologic intervention is a repeat injection in 18 to 36 months should pain recur.
You may learn more by visiting my web site www.sheinkopmd.com
You may schedule an office visit by calling (312) 475-1893
Tags: cellular therapy, human allograft tissue, orthobiologic treatments, orthobiologics
May 20, 2020
Actually, we never closed, but many patients stopped coming for care due to the Covid-19 Pandemic, and the Surgicenter that I depend on temporarily shut down. The good news is that patients are returning and the Surgicenter has reopened allowing me to offer arthritic patients a full menu of services. Most readers of this Blog are aware of our minimally invasive, outpatient procedures for those limited by an arthritic joint and hope to postpone, perhaps to avoid a major surgical procedure. If you have forgotten or are a new patient, I will restate our unique regenerative medicine approaches to a symptomatic joint that limits your function.
Regenerative Medicine Approaches for Treatments
- Proprietary Platelet Rich Plasma (PRP) and Growth Factors. When indicated, the procedure is done in the office using your platelets and plasma
- Acellular Amniotic Fluid. Since this alternative became available without cells, I have embraced it, again when indicate for a patient in lieu of cortisone of hyaluronic acid. The proteins in amniotic fluid may provide four to eight months of pain relief. In many cases, Medicare and private insurance offerings, not all, will cover the cost of care
- Stem Cells and Bone Marrow Concentrate. Actually, it is the Stem Cell in Bone Marrow Concentrate that remains the mainstay of my approach to an arthritic joint for patients who meet the inclusion criteria.
- Adipose Derived Stem Cells. For the past eight months, I have been one of seven centers approved by the FDA for a clinical Trial wherein, stem cells recovered from your adipose tissue via liposuction, are sent to a designated laboratory for manipulation and returned as a drug to treat an arthritic knee. As of next week, we will be recruiting patients again for The Trial as well returning to the Surgicenter for performance of the Liposuction with an advanced methodology.
There are several additional interventions that I perform in the office; but the latter are only intended for short term relief. For the interested patient or the one whose treatment cycle was postponed due to the Pandemic, call (312) 475-1893. You may visit my web site and watch a webinar www.sheinkopmd.com
Be assured that we practice social isolation in the office and waiting room, cleanse offices between patients, and wear Personal Protective Equipment.
Tags: cellular therapy, orthobiologics, regenerative medicine, regenerative orthopedics
Jan 3, 2020
The complexities inherent in biologics, cellular therapies, and stem cells as therapeutic entities are being been addressed at a number of levels. Thoughtful editorials, consensus statements, and even actions by state licensing boards, the FDA and the FTC for unprofessional conduct are starting to “drain the swamp.”
A large part of this growing industry consists of off-label uses; many in Regenerative Medicine seem to practice without FDA compliance. There are some indications where biologics and cellular therapies show genuine promise such as osteoarthritis, and my ongoing clinical research is conformational. Still owing to the bad actors, charlatans, and camp followers, substantive questions remain, including some basic concerns about safety, efficacy, cell sourcing and delivery, host response, and mechanism of action. There is only one way to approach this problem, and that is research with FDA governance (Personalizedstemcells.com).
In general, people thrive on novelty. We look for the latest and newest forms of treatment, hoping that the just-released remedy with the special formula will be the one to cure our problems and ease our pains. We do this as patients, and we do it as physicians. My major concern is that anyone licensed by the Department of Education and Registration may attend a weekend course, upload a web site, and begin fleecing an unsuspecting public.
Musculoskeletal disease and the resulting pain and loss of function are an invitation to the charlatans and camp followers: 20% of the population experiences arthritis and other serious musculoskeletal diseases. it’s not surprising that patients (and providers) will look anywhere for relief, and the bad actors will take advantage of an opportunity.
In the past, this approach has not worked well for many patients. The list of failed treatments for common musculoskeletal diseases is a long and sad one, from nutraceuticals to chelation therapy, and diets from alfalfa to zinc. At times, orthopaedic surgeons have not been careful stewards of clinical evidence—we continue to use viscosupplementation, despite the paucity of good evidence and we continue to use arthroscopic knee surgery in patients who should not have it. It would be nice, after all this, to get it right vis-à-vis stem cells and related treatments.
It appears that government sanctions, editorial sermons, and statements from specialty groups have not arrested the many dubious practice patterns we’ve all seen and too many patients experience. Witness the Amniotic Fluid debacle in Illinois last year perpetrated by the Bad Actors wherein patients were paying astonishing amounts of money (and taking yet-unquantified risk) for treatments that were of no benefit. The Amniotic Fluid marketed at seminars had and has no viable stem cells or biologics and cell therapies for regeneration of musculoskeletal tissues. The same holds true for Cord Blood and Wharton’s Jelly as evidenced by the epidemic of infections experienced in 2018 and 2019.
In this new decade, be informed, protect yourself, and seek out Board Certified Specialists in Regenerative Medicine if you want to postpone, perhaps avoid a joint replacement; or if you want to maintain or return to a fully active lifestyle. To schedule an appointment, call (312) 4745-1893. You may learn more at www.sheinkopmd.com.
Tags: biologics, cellular therapy, clinical trials, opinion on stem cell threeapy, stem cell therapy
Sep 13, 2018
I rode my bike this past Saturday and Sunday through the Chicago Forest Preserve bike trails and I had some time to reflect. Just as in fly fishing, cycling is meditation time. I tried to answer questions that came to mind such as how could Abraham have fathered both Izsak and Ishmael in his late 90s? Was it the triumph of stem cells or something more? I reflected on this through the Monday service without resolution other than we are still dealing with the ramifications.am
On Tuesday morning, the usual and customary ad in the Chicago Tribune paid for by the Stem Cell Institutes of America appeared inviting readers to a seminar to learn more about their approach to pain from arthritis and assuring the reader that their techniques are FDA compliant. Their approach is based on Amniotic Fluid injection. What I do know is FDA compliance requires that the stem cells must be yours (autologous) and that amniotic fluid once processed, sterilized, frozen and fast thawed has no viable stem cells. I also am cognizant of the large body of scientific evidence supporting the notion that pain of arthritis is generated by the supporting bone as cartilage has no nerve supply. How does a single and costly injection of amniotic fluid result in long term benefit? I have to deal on a daily basis with the fallout of this marketing campaign.
Next the Wednesday, September 12, addition of the Chicago Sun Times carried an ad sponsored by The Pain Relief Institute headlining Stem Cell Recruitment. As I understand the approach, Amniofix, a placental derivative, micronized, is reconstituted and injected into the arthritic joint. Reader please note that the first bullet states “FDA Regulated”. Of interest is the fact that I refused and still refuse to use Amniofix in my practice as there are no evidence based clinical trials to support any clinical claims. Those trials are taking place now. Amniofix is a product rushed to market before there was scientific proof to support use. You may learn more about Amniofix by searching the product online. If you don’t count cells with a hemoanalyzer, how could you know what is being “recruited”?
My commitment is to stand up for my patient in this regenerative medicine chaos. I resolve to do better in the upcoming year with introspection and ongoing review of the discipline.
With best wishes for a happy and healthy 5779
You may visit the website at www.sheinkopmd.com
Schedule an appointment by calling (312) 475-1893
Tags: amniofix, amniotic fluid, autologous, cellular therapy, FDA, regenerative medicine, stem cell
Aug 30, 2018
Evidence for the efficacy of Platelet Rich Plasma, a blood-derived formulation, and bone marrow derived biologics in osteoarthritis continues to grow in the orthopedic community. On the other hand, as I continually monitor the current landscape of indiscriminate and sometimes inappropriate marketing and use of biologics by the non-orthopedic opportunists, I doubt if the charlatans and camp followers have an overview of what is known about these agents. The increased presence of clinics Is driven by the popularity of PRP and its biologic cousins:
- consumer demand
- aggressive marketing
- a low regulatory bar for many of these regenerative medicine clinics
- the autologous nature that makes many approaches largely safe
- positive data from centers such as ours demonstrating functional and symptom modification
PRP works by activating cellular pathways; more than 3,000 genes are related to these and other pathways, suggesting that PRP probably acts by inducing a transitory inflammatory event, which then triggers tissue regeneration. Bone Marrow Concentrate, does more and addresses the subchondral bone when appropriately injected as well as initiate joint preservation and possible regeneration.
Taking aim
I use a hemoanalyzer to characterize a dose of PRP or Bone Marrow Concentrate allowing me to quantify the composition and biologic activity of these agents. Soon, I will begin pretreatment assessment of the synovial fluid of the arthritic joint so as to best determine who is the optimal candidate for a particular procedure
What do we know?
- Knee osteoarthritis: white blood cell-poor PRP has a positive effect on symptoms, not structure; while Bone marrow Concentrate affects symptoms and structure. I identify what I am putting into the patient. My goal is to have reliable predictors of outcome; that is, do the composition and biologic activity of the material implanted in the patient predict the clinical/imaging outcomes? My PRP contains a high concentration of anti-inflammatory cytokines and anabolic growth factors whereas my use of Bone Marrow Concentrate inside the bone adjacent to the joint in addition to the joint itself is improving the outcomes of the patients I treat.
- To learn more, call my office to schedule an appointment at (312) 475-1893
- You may view my Web site at WWW.Sheinkopmd.com
Tags: anit-inflammatory, biologics, bone marrow, cellular orthopedic, cellular therapy, cytokines, knee osteoarthritis, Orthopedic Surgeon, PRP, regenerative medicine, stem cell
