May 21, 2015
Headline on page 14 of the Wednesday, May 20, 2015 edition of the Chicago Tribune. The Associated Press journalist, Matthew Perrone then goes on, “But critics point to dangers of a largely unregulated trade.” This is a well written article in which Perrone highlights the charlatans doing the wrong thing, breaking the law, and doing harm. He did his home- work and focuses on the quackery, false claims and almost wholly unregulated mushrooming adipose derived business not unlike what Pope Brock did in his 2008 novel, Charlatan. Perrone brings into focus the quacks that prey on desperate patients seeking miracles in treating progressive neurologic disorders and the like. As my good friend opined after having read the article, “when ever a new avenue opens, the easy money guys stream in.”Incidentally, the exposure of those who state” if I am breaking the law, how come I haven’t been arrested yet?” isn’t new; 60 Minutes exposed those who seek to enrich themselves no matter the price to society several years ago. Last night, at the Goodman Theater, my wife and I saw Lillian Hellman’s The Little Foxes; very timely. The play takes place circa 1900, in a small Alabama town where the accumulation of wealth by the Hubbard family takes precedence over family, loyalty, decency, honor and morality. Toward the end of the play, the crowning statement in my mind was something to the effect that there are many Hubbard families out there in the mainstream America.
This lack of professional integrity and opportunism is engrained in our society so how do you protect yourself as a patient, be it Bone Marrow Aspirate Concentrate to postpone or avoid a joint replacement or any other area of medical care? The list of reasons to seek out Cellular Orthopedics and Regenerative Medicine is really the lengthy list of contraindications to surgery because of co-morbidities that preclude a total joint replacement surgical procedure. In addition, there are those patients who want to maintain or return to the highest level of recreational endeavor. The answer is quality assurance by your Regenerative Medical specialist assuring you the recommendations and the intervention are evidence based. That evidence comes from ongoing clinical research integrated with clinical care, not just completing a procedure and handing out a bill. You will find that level of evidence based care within the Regenexx Network of physicians located now thoughout the United States. These are not doctors who took a weekend seminar offered by a training company. At Regenexx, we do not treat anything outside the realm of orthopedic diseases. I partake in many week-long courses over the calendar year in which I not only learn but present my data collected on an ongoing basis. Next month, I am off to present my data at TOBI; a four day international program limited to arthritis and sports related injuries. That’s what I do and that’s your assurance that what I do is based on clinical outcomes research and is evidence based.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, Knee, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenexx, Regenexx-SD, stem cells, treatment
Apr 20, 2015
We are dealing in a field of science that aims to restore or establish normal functional capacity and eliminate, certainly reduce pain from arthritic inflammation by replacing or influencing human cells. Advances in cell biology have led to new options for cellular therapies and new strategies to stimulate endogenous repair and regeneration. Stem Cell populations have been identified in perinatal and adult tissues including amniotic fluid, placenta, bone marrow, and blood vessels. The US Department of Health and Human Services, in its report “2020: A New Vision-A Future for Regenerative Medicine” published in 2006, calls regenerative medicine “the next evolution of medical treatments” and predicts that regenerative medicine will be the “vanguard of 21st century healthcare.”
So what about costs and reimbursements? Government has made it clear that there is a relative lack of clinical science in this area and it will not pay at this time. We at Regenexx are making progress in gathering data and educating our patients and the medical profession as how to postpone or perhaps eliminate the need for a joint replacement when the symptoms and functional limitations of arthritis affect an individual. We believe that our data documents that Bone Marrow Aspirate Concentrate does reverse the course of osteoarthritis, relieve symptoms, restore function and allow the patient an improved recreational and athletic capacity. As an orthopedic surgeon dealing with a mixed patient population, I strive to deliver what matters most and that which will make the most profound difference in a patient’s life. First and foremost is the history and physical examination in the office. I won’t treat an image. For instance, a study presented at the recent Annual Meeting of the American Academy of Orthopedic Surgeons found a high incidence of Superior Labral Tears diagnosed by MRI in patients without shoulder symptoms or functional shoulder limitation. While the image was abnormal, the patient wasn’t limited in any functional way nor did they have a shoulder related complaint.
This morning, I am working on the scientific paper, I will be delivering at the June Meeting of the Ortho and Biologic Institute which is attended by the majority of scientists and clinicians involved in skeletal muscular Regenerative Medicine. It will scientifically and statistically document our successes; at Regenexx, we integrate clinical care with research and education. It is evidence based medicine helping to mold the future of Regenerative Medicine.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenerative, shoulder, stem cells, treatment
Jan 5, 2015
This time of year always brings with retrospection, reviews and prophecy, no matter what area of interest. As my area of professional concern is arthritis and assisting a patient avoid or at least delay a joint replacement, I thought it would be helpful to look at what Outcomes we recorded in our Data Base. Unlike the majority of Regenerative “experts” marketing themselves on the internet, I don’t cite the results of others or make unsupported claims, I document what I learn from having treated patients with Bone Marrow Aspirate Concentrate over two and a half years. Imagine if you would the complexity of having integrated patient care with clinical research using all the parameters I applied to development of new generations of total hip and total knee prosthetics during my almost 40 year joint replacement career. That’s why there are few if any involved in musculoskeletal care via Regenerative Medicine who are able to provide a patient the comprehensive experience I offer.
As of this morning, we have registered over 525 patients in our comprehensive Data Base with measurement pre and post Bone Marrow Aspirate Concentrate/Stem Cell intervention in 125 hips and almost 400 knees. Of the hips, three have gone on to a joint replacement; of the knees, two have gone on to a total knee replacement to the best of my knowledge. What I have defined from my experience is who will benefit from a BMAC intervention and who should undergo a joint replacement. Note the absence of reference to adipose derived stem cells. The explanation is simple; the FDA views such as a drug and hence does not approve the use of fat in the management of arthritis. I am also beginning to get a better understanding about how long the benefits of the intervention will maintain and how to best manage and extend those benefits. In the joint replacement world, the benchmark parameter is survivorship, how long until the prosthesis fails? In the stem cell world, I am interested in observing and prolonging the pain relief and functional improvement after the Bone Marrow Aspirate Concentrate Stem Cell procedure.
Evidence Based Medicine and Best Practices require maintenance of an outcomes data base; not an injection without ongoing follow-up. As I perused the internet this morning, other than Regenexx, I find a paucity of clinical data and a predominance of unsupported claims. In my lifetime of joint replacement surgery, there were many others performing large numbers of procedures around the country. We would meet periodically and present our own scientific outcomes and the evidence and learn from each other, all leading to the best possible clinical practices of total joint replacements. When it comes to the seductive claims from Stem Cell clinics found all over the Web, my challenge this year: Show Me Your Evidence
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Pain Management, Regenexx, Regenexx-SD, stem cells, treatment
Oct 20, 2014
We have been inundated with the fear of Ebola infections; the media has treated this as if each posting is to be a sensational headline in the National Inquirer. If the truth be told, your chance of acquiring an Ebola infection here in the US is about as likely as my winning the mega jackpot in the lottery. Fear Strikes Out was a marvelous film from the 50’s about a ball player overcoming mental disease; caution, you are being given mental disease by the sensationalism regarding Ebola and will succumb if not careful. What you should really be frightened about are hospital acquired infections. It has been estimated that in excess of one million MRSA infections take place in the US each year with in excess of 100,000 deaths. That doesn’t include the community acquired MRSA infections estimated last year at an additional 14%. The cost of Methicillin Resistant Staph Aureus infection last year exceeded 45 Billion Dollars Now what about C-Diff infections superimposed on those receiving antibiotics for hospital acquired infections, over 14,000 deaths last year according to governmental sources?
Regenexx published a study earlier this year in which not one single deep infection could be attributed to the minimally invasive methodology associated with a stem cell or similar cellular orthopedic procedure. In my practice, not only have I not recorded a deep infection, there hasn’t even been a superficial one reported. That’s not to say it may not happen in the future as I deal with Diabetics from time to time and patients with other immunosuppressive disorders; but I haven’t seen an infection yet in what is now approaching 400 procedures. I perform Bone Marrow Concentrate/ Stem Cell and related Cellular Orthopedic-Regenerative interventions in a surgi-center with all fluid manipulations in a sterile environment and under a sterile hood with a fully gowned RN. A joint replacement carries with a known infection rate. That incidence no longer is accurately recorded as the patient is promptly discharged from the hospital and the subsequent readmission for infection is not reported as associated with the recent joint replacement surgery
I have posted my results of Bone Marrow Aspirate Concentrate /Stem Cell interventions in this Blog on many occasions and compared the 18 month results to those of a knee replacement noting a lot more activity and recreational pursuits in the Cellular Orthopedic recipient group being realized. When a patient has advanced arthritis, a joint replacement is the treatment of choice. For those who want to continue or return to the highest possible age related profile, why not consider a stem cell procedure?
Tags: arthritis, Benefits and Risk, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative Pain Center, Regenexx, stem cells, treatment
Feb 6, 2014
There are several reasons behind the subject matter of this Blog. First, recent scientific studies have indicated that 2% of patients who have a joint replacement will have undergone a corrective revision within the first three years. Two percent isn’t a large number until it affects you. Approximately 20% of knee replacement recipients have significant pain and another 30 % fail to regain the desired motion confirming an earlier Canadian study in addition to those who fail outright at three years or less. Lastly, clinical studies at Regenexx have documented an average 15-point pain score improvement following a second stem cell intervention. Assume if you will that 100 points indicate a patient is pain free and prior to the Bone Marrow Aspirate Concentrate procedure, that patient had a score of 60. The average improvement after a stem cell procedure is to about 80 points. If you assume an additional 15 points will be gained by the second stem cell intervention, you will understand why I am writing this Blog.
We in the Regenerative Medicine world have been waiting a ruling by the DC Circuit Court regarding stem cell expansion and manipulation. The FDA allows Stem Cell intervention as long as those cells are not cultured or manipulated with external adjuncts. That is why we follow the Same Day Procedure in its present format. The Regenexx algorithm is FDA compliant. On February 5th, The DC Circuit sided with the FDA regarding stem cell culturing and manipulation with external agents. If you go stem cell “surfing” on the web, watch out for those sites marketing stem cell expansion and use of Adipose Derived Stem cells (SVF). I expect the FDA to go after several new SVF clinic networks within the year.
Meanwhile let’s return to the issue of a second stem cell intervention. If we can’t culture, we certainly may repeat. The Regenexx Data clearly support an average 15-point increase in a patient’s pain score when that second intervention is completed within a year of the index procedure. As many of my patients have experienced, to date, I have offered a booster PRP injection within three to six months when that patient wants more from the Same Day Stem cell undertaking. My approach has been helpful; although as of this time, I don’t know to what degree and for how long? For those contemplating a Bone Marrow Aspirate Concentrate minimally invasive treatment of an arthritic joint, be aware that there is now a way to predictably improve the ultimate outcome at 18 months with a second Stem Cell procedure.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Mature Athlete, Microfracture surgery, Platelet Rich Plasma, Regenerative Pain Center, Regenexx, stem cells
