Well not really Stem Cells, but certainly Platelet Rich Plasma and Growth Factor Protein Concentrate. Knowing that the term Stem Cells attracts attention, I used it here so hopefully, you would read this Blog.
On Saturday, February 15, I departed for a week of skiing in Vail, Colorado. In anticipation of the sojourn, in Late December, I underwent an intervention into both of my hips and knees using Platelet Rich plasma derived Proteins termed Growth Factors. My last Blog explored The Recreational Impact of Biologics: Stem cells, Growth Factors and Platelet Rich Plasma. While I dedicate about 5 to 6 hours a week in pursuit of conditioning; two weeks ago, I returned to spin class at the gym after a five-year hiatus substituting the demands of one-hour spin class for the stationary bicycle. While the late December interventions provided pain relief in my hips and knees, I didn’t feel that I would stand up to the demands of Vail, even with my customary rowing ergometer and strength training routines. It took several classes but here I am in Vail returning to the thrilling days of yester-year on spectacular powder and runs.
Returning to the office this morning, it was time to sit down and finish writing this blog. My first act, en route, was to pick up a copy of the February 24, edition of Crain’s Chicago Business, anticipating the appearance of A ROUNDTABLE DISCUSSION ORTHOPEDIC MEDICINE. I had been selected as one of four Orthopedic Surgeons taking part in a question and answer platform. You may find the article quite informative and find it at CHICAGOBUSINESS.COM or find Crain’s Chicago Business wherever you purchase the daily newspaper. One particular question and answer is worth repeating. In response to the question “What new technologies and surgical techniques are you using?”; I responded “Biologics is the new technology that I use with a needle rather than a knife.” A second question and answer are worth repeating. “What insurance issues and concerns are common with orthopedic treatment?” “Recognizing the financial burdens imposed by some of my advanced technology offerings, I’ve created several affordable care alternatives.” Here is the link to the entire article: https://www.chicagobusiness.com/crains-custom-media/roundtable-discussions.
Now comes the readers’ choice. You may read the entire article by buying a newspaper; click the highlighted above; visit my web site at www.sheinkopmd.com or call and schedule a consultation (312) 475-1893.
Download Full Article Here
Tags: biologics, growth factors protein concentrate, regenerative medicine, stem cell intervention
This past Sunday morning, I was reading the Chicago Tribune sports section to learn about the pundits’ opinions regarding the basketball game played by Duke and North Carolina on Saturday night, one of the most amazing basketball games I have ever seen, (incidentally, Auburn versus LSU was great, as well) when I came across the Golf Headline “Mickelson’s short game pays off big”. Why my interest? Phil Mickelson has psoriatic arthritis controlled by TNF-Alpha blocker, a Growth Factor. Another golfer whose career was restored by Growth Factors is Tiger Woods. In Woods’ case, he had received Platelet Rich Plasma (PRP) with Growth factors; Platelets produce those biologic agents. Then there is the story of Kobe Bryant, who had traveled to Germany in 2012 to extend his professional career for seven years with Interleukin One Receptor Antagonist Growth Factors recovered from circulating blood. At the time, Bryant travelled to Germany, the treatment he was to receive was not FDA approved in the United States. There is now an innumerable list of professionals and amateurs who have returned to the game or prolonged a career through Growth Factors thanks to the recreational impact of biologics.
If you surf the internet for Regenerative Medicine and Biologic alternatives, you encounter the term “Stem Cells”. The reality is that as of this time, there is no FDA or legal way to avail yourself of Stem Cells alone; the only access is by concentrating your bone marrow and injecting the concentrate into the arthritic joint since there are Adult Mesenchymal Stem Cells in your bone marrow.
Concentrated Platelets, Growth Factors, and Concentrated Bone Marrow have been the regenerative and restorative mainstays in my practice until now.
Looking to the future, because I have been involved with several Cellular Orthopedic Clinical Trials over the past five years, my practice is assisting in the creation of pathways for yet another biologic trial in 2020. Most exciting is the FDA approved Personalized Stem Cell Clinical Trial in which ours is one of seven designated and FDA approved centers. The PSC FDA-approved Clinical Trial was launched in August of last year. In September of 2017, the FDA warned that by November of 2020, all biologics would be reclassified as drugs. Personalized Stem Cells was granted FDA approval to create a drug from your own adipose tissue. The abdominal fat is recovered by Liposuction and processed in a facility that has met all FDA and Good Practice Management governmental requirements. The resultant Stromal Vascular Fraction (Stem Cells recovered from fat) number in the tens of millions and are made available for injection into an arthritic knee. You may learn more at WWW.PSC.Com or on my web site www.SheinkopMD.com. To schedule an appointment or consultation, call (312) 475-1893
Tags: biologics, orthobiologics, recreational impact of biologics
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
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
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
- 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