The progress in the emerging discipline, Orthobiologics, in part, is the result of the FDA and FTC taking on a stronger oversite role; but additionally, the data I gather contributes to these scientific advances. I will elaborate in this blog.
In order to be FDA compliant, the use of stem cells must be autogenous; that is, the cells must come from you. The orthobiologic industry finally complied so those providers with integrity have made available acellular growth factors. Three weeks ago, I learned that is some cases, Medicare and certain insurance companies will preauthorize said usage. Stay tuned on this one as to whether the product works and whether its use is indeed reimbursed.
Last week, I was made aware that the FDA had served notice to Chara Biologics and Liveyon for marketing biologic products that are unapproved. Stay tuned as more bad actors will be shut down.
Biologic Interventions to Avoid Joint Replacements
This past Friday, I received biologic interventions into my right and left hip and my right and left knee. It worked for me two years ago and I believe the biologics will help postpone, maybe avoid joint replacements while allowing me to keep skiing, fly fishing, cycling, and keeping fit. There were no appreciable amounts of stem cells in that which was processed from my own blood and injected. The anticipation is that the Platelets and Growth Factor Proteins will diminish the pain of arthritis, and assist in restoring full motion to my hips and knees, allowing me to continue my recreational profile.
In the presence of a single arthritic knee joint, I would have enrolled in the FDA approved Personalized Stem Cell Clinical Trial. You may learn about the Trial at www.Personalizedstemcells.com or on my web site at www.sheinkopmd.com. In the upcoming months, it is hoped that the FDA will expand approval of the PSC Trial to both knees and eventually, the hips. At this time, there are only two FDA compliant methods of allowing physicians to provide a patient with “stem cells,” one is via your bone marrow and the other via your adipose tissue. In my case, with the several joints involved and given realistic outcome possibilities, I opted for the Growth factor approach. My next step will be the Stem Cell option.
I will be testing my outcomes of the Biologic interventions next week on a bone fishing trip four-five days in Punta Allen, Mexico. While my schedule is full prior to departure, there are still some office openings available on Tuesday, December 31. To schedule an appointment at any time call (312) 475-1893
Tags: biologic intervention, orthobiologics, regenerative medicine, stem cell research, stem cell trials
“THE GOOD NEWS IS THAT MY 80-YEAR-OLD TEAM ‘CHICAGO GEEZERS’ WON THE WINTER NATIONALS FOR OUR AGE GROUP IN FT MYERS 11/6 – 11/8. I RAN FOR MYSELF AND HIT .710. THE BAD NEWS IS MY LEFT KNEE IS A BIT MORE ACHY NOW, EVEN WHEN I AM SLEEPING OR NOT PLAYING SOFTBALL. IT IS NOT REALLY PAINFUL BUT IT DOES ACHE MORE THAN IT USED TO. HOPEFULLY, AFTER A FEW MORE MONTHS WE WILL NOTICE A REAL IMPROVEMENT” J.H.
While growing up in Albany Park, 16-inch softball was a way of life starting at the Haugan Grammar School playground in early February and continuing until the football season in the late fall while basketball went on all year round. Weather permitting, we relocated to Jensen Park and later during high school years to Eugene Field Park, River Park and eventually the Hibbard School Yard. Softball teams with such names as the Torpedoes, Majestics, Olympians, Phaetons, Regular Fellows, Little Gents, Jovens, and Aristocrats, to name a few, competed for the highly coveted Ned Singer softball championship. Teams were comprised of teenagers representing Amundsen, Austin, Roosevelt Sullivan, Senn, Von Steuben High Schools and more. The soft ball leagues diminished in numbers after high school but several individuals continued playing wherever and whenever possible. I for one played until age 40, ending my career with a triple play and fractured finger at Union Park in the Hospital league. A new 16-inch clincher is hard as rock. There are few remaining players of that generation; I am privileged to serve as a treating physician to two. Jimmy, someone I met when he beat out a ground ball over 00 years ago, (I was a first baseman) practices law and continues to play. Though he had overcome many softball related injuries during his playing days, he was ready to quit three or four years ago out of embarrassment at the pinch runner until I intervened with a Cellular Orthopedic intervention and he regained the ability to beat out a ground ball. Jerry, middle row in the photo, second from the left, continues to play. Two years ago, also very concerned about his ability to run around the bases, he presented to my office seeking an alternative to a Total Knee Replacement for his arthritic knees. One picture says it all; he is already making plans for next year. In Jerry’s case, it took several biologic interventions; but he is a champion.
To schedule an appointment and learn about the biologic options for your joints call (312) 475-1893. You may visit my web site at www.Sheinkopmd.com.
Tags: arthritic knee, biologic intervention, cellular orthopedic, injection, joint pain, joint replacement, Orthopedic Surgeon, PRP, regenerative medicine, stem cell, Total Knee Replacement
I write this Blog as an Orthopedic Surgeon following the 2018 annual meeting of the American Academy of Orthopedic Surgeons, just concluded in New Orleans. The topic matter is of sufficient concern that Use and Abuse of Biologics became an agenda focus receiving several hours of attention.
Clinical use of biologics to treat all health problems has greatly outpaced the evidence. Every office day, patients bring advertisements about Stem Cells appearing in the print media. The enticing cure all claims and testimonials are quite seductive. Concerns over misinformation from direct-to-consumer marketing of unproven treatments have led to recent calls to action from government and scientific agencies, including the National Academy of Sciences and the American Association for the Advancement of Science.
These calls to action are of special relevance to orthopedics because a recent study showed that more than 85 percent of 351 businesses, which represent 570 clinics across the country, were marketing “stem cell” treatments for musculoskeletal problems. Analyses of these treatments show a diversity of offerings with most clinics using preparations that do not contain clinically significant numbers of stem cells. Widespread use of these cash-for-service, unproven, and poorly described treatments raise concerns for public health and safety.
The Academy collaborated with the National Institutes of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) and held a think tank symposium on “Optimizing Clinical Use of Biologics in Orthopedic Surgery” on Feb. 15–17. 2018, at Stanford University to accomplish the following objectives:
- establish a clear, collective impact agenda for the clinical evaluation, use, and, optimization of biologics in orthopedics
- develop a guidance document on clinically meaningful endpoints and outcome metrics for the evaluation of biologics for common orthopedic problems
The symposium addressed key issues including poor definition of treatments and mechanisms of action; lack of standardized data and outcomes collection and reporting in existing clinical studies; and minimal evidence to support the myriad of ailments treated with these products. Leaders from clinical medicine, research, and government, as well as young investigators selected through a competitive process, participated in the event.
I am happy to be one of the first orthopedic surgeons in the Midwest limiting my practice to cellular orthopedics. Additionally, based on my model of having integrated patient care with outcomes surveillance as a joint replacement surgeon, anticipating and contributing to the new world of evidence-based regenerative medicine, I already have in place a cooperative venture allowing me to measure the platelets, growth factors and now stem cells that have been injected into a joint or the bone adjacent to that joint. I don’t know of any other practice or center that can make this claim. My team has entered into discussions to designate our model as the foundation for the future methodology of clinical evaluation, use and optimization of biologics in orthopedics.
As a patient, you have a choice to make: either respond to a marketing scheme or be educated and seek evidence before undergoing a “stem cell” procedure.
To schedule an appointment call 312 312 475 1893
Visit my web site and watch the webinar www.ilcellulartherapy.com
Tags: biologic intervention, cellular orthopedics, National Institutes of Arthritis
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