We certainly are living in changing times and daily uncertainties, but my practice continues. Over the years, I have noted that when there is public angst, I have a bit freer time to review our outcomes. Alfred E. Neuman, the mascot for Mad Magazine during its heyday, had a motto “What, me worry?”; and I try to live by that motto. What I have learned from review of outcomes is that More Is Better; both in the quantity of biologics administered and the number of times repeated over a period of years.
Stem Cells Clinical Trial Update
By the end of July, we will have completed recruiting our Personalized Stem Cells Clinical Trial allotted number of patients. While the Adipose based Stem Cell Trial had started in the fall of 2019, all was put on hold until about a month ago owing to the Pandemic. Our initial observation is that there has been a significant decrease of symptoms and improved function in those who underwent liposuction and the knee intervention prior to the February temporary suspension of the Trial. The hope is that sometime this fall, the PSC Trial will allow recruitment of patients with significant symptoms and limitations generated by bilateral knee osteoarthritic involvement. At the same time, PSC will seek approval from the FDA for permission to expand the number of stem cells available for a patient by culturing.
Regenerative Medicine Update
While all this is taking place, please be reminded that our practice offers several options that have proven successful over time or with repeat procedures. First and foremost is the use of bone marrow derived stem cells, growth factors (cytokines), platelets and precursor cells in the arthritic joint. Many patients have returned both for a repeat intervention after some years or for attention to an additional symptomatic and function limiting joint. The patients, including myself, who have undergone several biologic injections be it proprietary, compounded, platelet rich plasma or the more recently available acellular amniotic fluid, have really benefited from the repeated series.
Last of all, I want to remind the reader that interested patients may access Adipose derived Stem cells outside of the PSC Clinical Trial if interested on a fee for service basis. The advantage of such is that several joints may be treated at the same sitting. In the latter scenario, a mini liposuction is completed and the recovered adipose tissue is prepared for immediate joint intervention via a methodology introduced by Lipogems. The end result of the Lipogems process is micronized adipose tissue; it has become quite popular in several biologic practices around the United States.
If you wish to explore these Regenerative and Orthobiologic options for an arthritic joint or joints, you may visit my web site and access my webinar at www.sheinkopmd.com. Even better would be to seek consultation in my office; you may schedule by calling (847) 390-7666.
Tags: orthobiologics, regenerative medicine, stem cell therapy
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 (847) 390-7666
Tags: cellular therapy, human allograft tissue, orthobiologic treatments, orthobiologics
In my last blog, I used anecdote and two patient experiences to justify my treatment recommendations. This blog will feature a scientific and statistically significant outcomes study that I will be presenting next week at the Orthobiologic Institute Symposium (TOBI) taking place virtually in Las Vegas, Nevada. Since I am the first author of the study, I will claim an author’s license to paraphrase and attempt to simplify.
Cellular Orthopedic Recommendations
Knee osteoarthritis (OA) increasingly is considered to be a whole-joint disease, of which degeneration of the articular cartilage is a critical component of OA pathology, along with alterations to the synovial membrane and changes to the subchondral bone supporting the cartilage. Compounding the treatment of OA is the slow and usually limited recovery of damaged articular cartilage. Conventional therapies, including viscosupplementation, steroids, physical therapy, and non-steroidal anti-inflammatory agents, have shown some benefit in reducing OA-associated knee pain, and improving quality of life/functionality, at least for some period of time, but lack evidence of regenerative or long-lasting benefits. Orthobiologics such as Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) also have been used in treating OA, with variable degrees of success. Although most publications concerning treatment of knee OA use an intraarticular (into the joint) route of injection, there are a few recent publications that have described an intraosseous (into the bone adjacent to the joint) route for injecting an orthobiologic.
The current study was structured to assess the safety and potential therapeutic benefit of treating patients with mild to moderate knee osteoarthritis with a split injection of BMC, such that approximately 80% of the injectate was delivered intraosseous to the tibial plateau, and 20% was delivered intraarticular. Each BMC preparation was analyzed for Total Nucleated Cells (TNC), and culture-based Stem Cells. Clinical outcomes were recorded for the Knee Society Score; Lower Extremity Functional -activity-Scale (LEFS); and Visual Analog Scale-pain- (VAS). We also assessed for correlations with patient factors, including cellularity (Total Nucleated Cells) and Stem Cells) and pre-treatment clinical outcome values.
The results reported in this study demonstrate the safety of intraosseous delivery of BMC to treat mild-moderate knee OA. Equally important, study participants reported a mean change in VAS (pain scale) at the 1-year milestone of -2.6, which is slightly larger than the commonly reported VAS of -2.5, suggesting that the treatment protocol resulted in a meaningful decrease in pain out to 1-year post-treatment. The mean change at 1-year of the LEFS (activity) outcome was +15.8 points, which is 2.3x larger than that commonly for LEFS of 9 points, while marked improvements in KSS-Knee and KSS-Function also were observed.
I understand that which I have attempted to explain may be confusing but the results of this trial should be understood. For clarification, call and schedule a consultation (847) 390-7666. You may visit my website and watch a webinar at www.sheinkopmd.com
Tags: cellular orthopedics, orthobiologics, regenerative medicine, regenerative orthopedics, TOBI conference
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 (847) 390-7666. 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
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