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
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 (847) 390-7666
Tags: amniofix, amniotic fluid, autologous, cellular therapy, FDA, regenerative medicine, stem cell
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.
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 (847) 390-7666
- 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
It happens every year since the day I was born, there is a birthday celebration in my home and it happens again this week. Sure, I have a little more graying of my hair; but fortunately, I have my hair. I also have an activity level that would not have been possible, given the arthritis in my knees and hips, unless I had undergone restorative and regenerative intervention taking advantage of Bone Marrow Concentrate and Platelet Rich Plasma Offerings as I write about in these blogs.
To give you some insight of what is possible no matter your age and before you become a couch potato owing to pain and functional limits imposed by arthritis, let me describe what I have planned for the Memorial Day weekend. You might recall that I was experiencing progressive functional limitation until a regenerative procedure was completed on my knees, December, 27, 2017 followed by a similar procedure in my hips on January 11, 2018. On this upcoming Thursday, I will begin planting a relatively large vegetable garden in the mid-day when we arrive in Southwest Wisconsin followed by a late afternoon 30-mile bike ride. First, we stop at the Amish Greenhouse in our neck of the woods to collect the vegetables and Herbs. On Friday the cycling and planting will continue; Saturday will be a half day of fly fishing followed by more planting and then another 30-mile bike ride. Sunday will be a repeat of Saturday after the evening outdoor barbecue. Monday morning is another half day of fly fishing, then planting of the herb plot after which we return to Chicago and office patients on Tuesday.
I felt your pain until I took advantage of the possibility for functional restoration and joint regeneration that I offer my patients. No more kvetching from me. The way I want to live is the way I practice. I am not ready to slow down even though birthdays are being celebrated each year; and I don’t have to alter my way of life; having enjoyed symptom relief and functional restoration via Bone Marrow Concentrate and Platelet Rich Plasma offerings.
To learn about how you might continue to enjoy or perhaps return to an active, symptom free lifestyle, call (847) 390-7666 To schedule an appointment. You may visit my blog at HTTP://www.ILcellulartherapy.com where you may watch the webinar
Tags: autologous injection, autologous platelet and growth factor concentrate, autologous platelet concentrate, Bone Marrow Concentrate, cellular orthopedics, cellular therapy, Hip Arthritis, Hip pain, joint health, joint regeneration, joint replacement, joint restoration, knee arthritis, knee pain, Platelet Rich Plasma, Regenerative Pain Center, Regenexx