Jan 12, 2015
That quote comes from University of Chicago Economist and Nobel Laureate, Gary Becker, who died in 2014. Central to his work was the concept that economics can help explain behavior. As seems to be happening more and more, this Blog will expand on the evidence concerning Bone Marrow Aspirate Concentrate/Stem cell outcomes for intervention in the arthritic joint. The Data and my experience clearly document success at all stages of arthritis in a major joint for some period of time. What I am unable to conclude is in whom we are actually regenerating cartilage or in whom we are seeing pain relief and improved functional capacity owing to concentrated Growth Factors and Cytokines. Whereas my initial interventions two and a half years ago were limited to a “younger” arthritic demographic, the successes resulted in my expanding the inclusion criteria last year without age exclusion as I observed Outcomes success in those approaching 80 years of age. What I don’t know yet is in whom the improvements are related to the stem cells in the Bone Marrow Aspirate Concentrate or whether to the Growth Factors influencing your own stem cells or the Cytokines acting as anti-inflammatories, accompanying the stem cells in the Bone Marrow Aspirate Concentrate. What the evidence does indicate is that the older the patient or the more advanced the arthritis at the time of BMAC intervention, the better the outcome with a second or even third procedure. What I don’t know yet is a predictor of the survivorship of an outcome. I do know that the best chances of long-term benefits are in those with less than Grade 4 arthritis. For those who experience something less than hoped either in the initial result or extent of benefit, let’s explore the economics.
Just as our health care indemnification is undergoing change, so is my understanding of the scope of services that may be beneficial in this evolving discipline of Cellular Orthopedics. The good news is that unlike the insurance world where less health care coverage seems to be associated with greater cost for indemnification to the patient, I have identified a means of decreasing the economic burden to a patient for a repeat Bone Marrow Aspirate Concentrate/Stem cell intervention or related Regenerative Medicine injection, if a single procedure doesn’t provide the degree of relief or survivorship of outcome desired. It may well be that Cellular Orthopedics involves a range of approaches and not a single intervention. My office will work with you to provide you a scope of Evidence Based Care with an economic approach that allows the patient to avoid or at least delay a joint replacement.
Tags: arthritis, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Hip, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedics, Osteoarthritis, Pain Management, Regenexx, Regenexx-SD, 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
Dec 29, 2014
Actually it is closer to stem cell misrepresentations and is being propagated by the uninformed clinician, clever marketing schemes, and out and out charlatans. Last week, the FDA made a very strong statement warning against the use of Adipose Derived Stem Cells in the treatment of arthritis. The Government Health Care oversight process stated that there would be large fines and perhaps imprisonment for those health care providers who do not comply with the law. The regulations clearly state that your stem cells may be used if not manipulated or expanded. In order to liberate stem cells from adipose tissue, the adipose tissue has to be treated with an enzyme collagenase, a clear violation of the law. Yet, there are the web sites too numerous to list marketing adipose derived stem cells for arthritis. I am aware of several clinics that circumvent the law by performing liposuction and injecting the fat into the joint without liberating the stem cells with collagenase. My response, beware and take care.
Then come those providers who use local anesthetics to expand the Bone Marrow Aspirate Concentrate when Regenexx has documented the death of stem cells if mixed with local anesthetics. Don’t stop reading, I have yet another alert. The latest addition to the field of Regenerative Medicine comes from Amniotic Fluid that is marketed as an allograft. The pregnant woman at term donates her amniotic fluid that is then processed and made available for wound healing or as an injectate for the arthritic joint in either a concentrated or powder form. While the early outcomes are promising for pain relief, no one has more than four months of outcomes monitoring for amniotic fluid preparations in arthritis. The processing laboratories claim an abundance of stem cells in the concentrate as well as large quantities of Cytokines and Growth Factors; but this is yet to be corroborated by independent researchers. The good news here is the latter research is taking place and more being planned; there should be preliminary data by mid 2015.
Assume if you will that you have an arthritic joint, and are not yet ready for a joint replacement or the extent of your arthritis still lends itself to non-operative management. How can you be sure that you are protected from the abuses I describe above? Regenexx initiated outcomes surveillance over five years ago and as an orthopedic surgeon, I joined and expanded those data points Regenexx studies two and a half years ago. No other Cellular Orthopedic or Regenerative Medicine initiative has the comprehensive Outcomes Data or basic research to support a clinical intervention recommendation, as do the members of the Regenexx Network. Beware here as well of non Regenexx Network web sites that post Regenexx Outcomes as if the patient is too uninformed to recognize the deception. If you want the truth, make an appointment: 847 390 7666
Tags: Amniotic, arthritis, athletes, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, joint replacement, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Regenerative, Regenexx, stem cells, treatment
Dec 22, 2014
Last week, a call was placed to my office by the sponsor of a multicenter knee replacement clinical trial in which I had taken part since 2004.The FDA mandated Post Release Requirement for the Zimmer Mobile Knee had been fulfilled. Because of my world wide teaching and visiting professorships starting in 2001, I had been asked to be a co-investigator in that initiative. My participation in part led to the release of the High-Flex Zimmer Mobile Bearing Knee in 2007 and several major clinical papers in which I was the Co-Author. As many readers of this Blog are aware, I had dedicated 37 years of my professional endeavors to integrating joint replacement research with my clinical practice at Rush for the care and treatment of the arthritic hip and knee. For the past two and a half years, I have dedicated my professional energies to assisting patients with osteoarthritis avoid or at least postpone the joint replacement.
I want to go on record; when a patient has altered function, unrelenting pain, and an image with a Kellgren/Lawrence Grade 4 osteoarthritic hip or knee, that patient needs a joint replacement. While I have called the readers’ attention to inherent risks of a joint replacement, the effected patient with medical approval will benefit from the joint replacement. On the other hand, the ever increasing evidence and my experience confirm that the patient with Grade 2 and 3 Osteoarthritis of a major joint may significantly benefit from a Bone Marrow Aspirate Concentrate /Stem cell intervention. The end result of an uncomplicated major joint replacement is pain relief, improved function, better motion, and correction of a deformity. The potential risks of a joint replacement gone badly require a revision or major reconstruction with major medical interventions for associated complications. The end result of a Bone Marrow Aspirate Concentrate /Stem Cell intervention is pain relief, improved function, better motion and continuation of or return to a very active recreational profile without risk of complication. While the stem cell procedure will not correct a deformity, it may alter the natural history of the arthritic process at the molecular level. Actually, the presence of deformity puts a patient in a Grade 4 setting and is an indication for a joint replacement; Grade 4 is a predictor of a poor result from stem cells.
Well it’s the week of Chanukah and Christmas so let’s celebrate this week of miracles with a wonderful stem cell story; it concerns hockey great Gordie Howe to be found in the Detroit Free Press. Freep.com:
http://on.freep.com/16AQIIO
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Dec 16, 2014
Let’s enter the new world of Cellular Orthopedics into which I graduated three years ago. Several months, ago, a long time friend was visiting his family in Chicago and stopped by to say hello. He told me about his skiing last winter and his hiking over the summer and fall. He also related he was seeing an orthopedic surgeon in the state where he now lived and that he had “bone on bone” in his knee. I launched into my customary spiel about his current level of athleticism, my cellular orthopedic initiative and the limits and risks of a knee replacement. Last week, a mutual friend told me that the out of state visitor had related “Mitch was right, I shouldn’t have done it”. He had undergone the Total Knee Replacement in spite of there being no limit in his recreational capacity and was now readmitted with an infected total knee prosthesis that might have to be removed to clear up the infection. Not being one to suggest “I told you so” but that’s what I am trying to get across to the patients I advise.
The Stem Cell Solution, Using the body’s almost magical repair kit to fix bad knees and hips-no surgery required is the title of an article appearing in the December, 2014, edition of The Saturday Evening Post, written by Sharon Begley, the senior U.S. health and science correspondent at Reuters. Last spring, the author had contacted me for an interview after having followed my Blogs unbeknownst to me. Ms Begley introduced herself and told me about an article she was writing for The Post to be published in June. I had forgotten about the interview until a patient came in last week and told me that she had read the article in the December issue. What I didn’t recognize at the time of the interview was that not only is the bone marrow a source of Adult Mesenchymal Stem Cells but of Growth factors and Cytokines as well that may be of equal importance. The opening of the article features my patient. In 2011,”I was in a bad way.” ”He was diagnosed with osteoarthritis, a degenerative disease eating away at the cartilage in his knees writes Begley.”The patient: ”and now I’m climbing stairs, have gone on two skiing trips, planning another, and playing golf in the summer.” “I am way beyond pleased.”
Tags: arthritis, athletes, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, treatment
