Mar 3, 2016
I haven’t yet heard or read the Thursday Mitt Romney speech as I write this Blog, but as long as the terms Fraud, False Promises, Uninformed, etc. will be headline news this afternoon and all over television tonight, I thought I would expand the theme to which I read and see about misrepresentation when it comes to Cellular Orthopedics. When my computer fired up this morning, one of the first bullets advertised an international stem cell company offering Exosomes if you travel outside of the United States for care. For those of you unfamiliar with the term, Exosomes are extracellular vesicles that have the potential to do good things to your cartilage and soft tissues. As I read the stem cell ad, I noted the following:
“Exosome Injection is a human induced pluripotent stem cell-derived mesenchymal stem cell treatment, which has emerged as a promising supplement to stem cell transplantation therapies. Exosomes derived from mesenchymal stem cells can play an important role in repairing injured tissues. Exosome injection is also utilized as a complement to bone marrow stem cell extractions.”
Thank goodness for the FDA. While the governmental agency has been frequently criticized, the FDA is there to protect us; that’s why you have to travel outside the US for unproven “promising” interventions. To continue the “promising” discussion, the web site promoting Exosomes also invites you to travel outside of the United Sates for Stem Cell assistance with Cancer, Parkinson’s Disease, Alzheimer’s, Cerebral Palsy, etc. 60 Minutes, we need you.
There is a better option to help avoid or postpone a joint replacement, diminish pain, increase motion and improve your functional capacity. At the same time it falls under the standard of practice and thus is FDA compliant; namely the Bone Marrow Aspirate Concentrate/ Stem Cell approach. Not only does Bone Marrow contain Adult Mesenchymal Stem Cells, anti-inflammatory molecules termed, as a group, Cytokines, as well as multiple cellular molecular secretions called Growth Factors; you guessed it, Bone Marrow Concentrate is a great source of those extra cellular vesicles, Exosomes. My Regenexx affiliation and the International Orthopedics Foundation offer quality assurance and safety in an otherwise poorly regulated environment. While the FDA had an April meeting scheduled for testimony and Regenerative Medicine review; that meeting is now set back six months because of a change in leadership at the FDA. Until that delayed meeting, for quality assurance and evidence based cellular orthopedics, seek what is safe, what has been shown to work and forget about “promising supplements.”
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Feb 22, 2016
While skiing last week in Vail, Colorado, I had the opportunity to sit down with Mitchell Sheinkop, MD, Fellow of the American Academy of Orthopedic Surgery and Fellow of the American College of Surgeons, to learn about the emerging field of Interventional Orthopedics. In 2007, Dr Sheinkop received the Shaare Zedek International Humanitarian Award in recognition of his global orthopedic educational endeavors.
Question: Do stem cells really work?
Answer: There is a misconception regarding joint restoration as it is not the adult mesenchymal stem cell alone that is responsible for postponing or even avoiding a joint replacement in the arthritic setting.
Question: All I read and hear about are stem cells?
Answer: Unfortunately, ad placement hype is competing with good science for the patient’s attention and owing to advertising and marketing; the real message may be getting lost.
Question: Would you please explain?
Answer: When I “graduated” from a knife to a needle, I too believed that it was the stem cell that would morph into cartilage. We now know that the Adult Mesenchymal Stem cell orchestrates the regenerative process and directs other cells and molecules to help reverse the arthritic process, effect healing and improve function.
Question: Who are the members of the orchestra, so to speak?
Answer: When injury occurs, platelets aggregate to initiate the healing process. The activated platelet recruits the cells lining capillaries (pericytes) that then function as stem cells. Control of the bio-immune response and the regeneration affected by anti-inflammatory molecules termed Cytokines and cellular secretions known as Growth Factors are directed by the stem cell.
Question: Where do all of these stem cells, cytokines and growth factors come from?
Answer: When it comes to the musculoskeletal system, we look to the patient’s own Bone Marrow Aspirate Concentrate as the only FDA tolerated resource .While you may be aware of the potential of adipose tissue as a stem cell resource, in order to liberate the stem cell, fat has to be digested with an enzyme, collagenase. As of this interview, enzymatic digestion is not approved by the FDA nor are there significant scientific studies to support adipose derived stem cells for arthritis.
Question: I am aware of plastic surgeons offering fat graft for arthritis, is it effective and legal?
Answer: Neither but it is expensive. Fat graft is not a source of regeneration; it is filler for cosmetic surgery.
Question: I am aware of a media blitz promoting Amniotic Fluid Concentrate as a source of stem cells?
Answer: The research at the Interventional Orthopedic Foundation demonstrated that while there are stem cells in amniotic fluid along with Hyaluronic acid, anti-inflammatory Cytokines, and Growth Factors when that fluid is harvested in conjunction with a Cesarean section; after processing, freezing and the quick thaw, there are few if any viable stem cells remaining.
Last Question: How might a patient seeking to manage arthritis without surgery make the right therapeutic decision?
Answer: Just as our presidential campaigns, paraphrasing Dahleen Glanton in the Chicago Tribune, Monday, February 22, are a cesspool of empty promises and lies, so too is the marketing of stem cells; witness the advertisement featuring a chiropractic spokesperson in The Chicago Tribune, Tuesday, February 9, 2016, placed by The Stem cell Institute of America.
When you seek a Regenerative Medicine consultation, make sure that physician is fellowship trained, board certified and integrates clinical research with his or her practice. Don’t depend on anecdote; inquire about outcomes data. In my practice as well as in those other members of the Regenexx Network, we base our clinical decisions and therapeutic recommendations for Cellular Orthopedics on Documented Results.
Mitchell Sheinkop, MD accepted Emeritus Professor status as the director of the joint replacement program at Rush University Medical Center six years ago where he had played a major role over 37 years in the development of the department of orthopedics and in the founding and growth of Midwest Orthopedics. Since that time he has played a major role in the emerging field of Interventional Orthopedics.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Feb 8, 2016
Every week, I receive updates via brochures and journals concerning the clinical and basic science orthopedic research being done around the country at the various university medical centers. I like to read them to understand how Cellular Orthopedics is emerging and is being accepted in academic institutions. When I retired from Rush and joint replacement surgery five years ago, my colleagues had a very jaundiced view of my new endeavors telling me and then my patients that Regenerative Medicine was unproven, was ten years away, and was not a reasonable alternative to a joint replacement. It is with great pleasure that I am able to announce the American Academy of Orthopedic Surgery Surgical Skills update will include a three day course next month on Articular Cartilage Restoration: The Modern Frontier, as a continuing educational initiative. The title of one particular lecture really caught my attention Move-Over PRP/Viscosupplementation: Stem cells are in and why.
Taking it a step further, the latest bulletin from Jefferson Medical College’s department of orthopedic surgery reviews the basic science being done in the Laboratory of Theresa Freeman, PhD, Associate Professor of Orthopedic Surgery. “The development of Osteoarthritis can often be attributed to a trauma that occurs in youth, which begins the slow degeneration of cartilage. By reducing cartilage damage immediately after an injury, the development of osteoarthritis can be dramatically slowed.”
I have been making the case for an affirmative stem cell intervention every time an anterior cruciate surgical repair takes place or for that matter, when an individual undergoes an arthroscopic procedure. Two weeks ago, I completed a Bone Marrow Aspirate Concentrate Stem cell procedure three weeks after a young middle aged man had undergone micro fracture for a cartilage defect on the weight bearing part of his femur at the knee. On Friday, I scheduled a 72 year old gentleman for a stem cell procedure ten days after he had undergone arthroscopic surgery for a degenerative tear of his medial meniscus during the course of which degenerative changes were documented in the weight bearing zone at the inner compartment of his knee.
A webinar is scheduled by the American Academy of Orthopedic Surgeons next month in order to introduce its orthopedic membership to what may be possible through Cellular Orthopedics. I have already advised you about the Continuing Education Course next month on Articular Restoration. The orthopedic academy membership is only now being introduced to what I have been practicing for almost four years. There are now close to 750 patients in my data base who have undergone Cellular Orthopedic procedures for arthritic joints to relieve pain, increase function and avoid, certainly postpone a joint replacement. On Saturday, I am headed out to Colorado to ski with family for a week. For readers of my blog, you may recall I have undergone a regenerative procedure for my left knee. While I am realistic and I don’t dwell on being who I used to be, I believe anything is possible at any age. If you want to continue or possibly return to skiing, biking, hiking, climbing, fly fishing, skating, fitness, etc, and the limitation is arthritis, schedule a consultation
847 390 7666
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
Dec 29, 2015
I won’t look back so let’s see what’s coming in 2016. The clinical Regenexx Knee Trial introduced in 2014 will start providing information here-to-for unavailable in Cellular Orthopedics. Many times in the last several years I had written about my observation that there is a paucity of science and a plethora of marketing without support in the world of Regenerative Medicine. Last week, a patient came to my office for a second opinion after having attended a seminar on amniotic fluid concentrate. The patient had carried away a notion that amniotic fluid concentrate contains viable stem cells that will regenerate an arthritic knee. Several months ago, I had reviewed the subject in my Blog after having attended the first Interventional Orthopedics Foundation meeting in Broomfield, Colorado. After extensive testing in a laboratory setting, it was documented that while there may have been stem cells in the amniotic fluid when recovered, by the time the material was processed, frozen, and fast-thawed, the amniotic fluid commercially available has no regenerative potential. The role of amniotic fluid concentrate in 2016 will be to replace visco-supplementation in the marketplace as more and more insurance carriers will withdraw coverage based on publications from the American Academy of Orthopedic Surgeons on the benefit or lack thereof from visco-supplementation. If there are no stem cells in the amniotic fluid concentrate, what is there that may be helpful? The scientific laboratory studies did confirm that the Growth Factors and anti-inflammatory cytokines do survive processing and may be of equal or even greater importance in the long run than the stem cells. My plan is to replace visco-supplementation with amniotic fluid by mid 2016 in my practice.
I want to return to our Regenexx Knee Clinical Trial. It is the largest of which I am aware in the world as far as the methods used in determining the success of a stem cell intervention for Grades Two and Three Osteoarthritis of the knee. I was chosen to execute this three to five year outcomes study because of my background as director of the joint replacement program at Rush, one of the five largest joint replacement programs in the country. In addition, over my 40-year joint replacement career, I had published many studies on the outcomes of a hip and knee replacement at five and ten years. Our preliminary observations concerning those who met the trial inclusion criteria are that the vast majority, are very satisfied and active. Certainly, we will have to wait another year before our numbers allow for statistical analysis; but so far, the outcomes are excellent. Please keep in mind the methodology for the intervention is not a single injection but rather a carefully designed treatment program. To learn more, call for a consultation
847 390 7666 with offices in Des Plaines and Lincoln Park
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenexx, Regenexx-SD, stem cells, treatment
Nov 30, 2015
The title of the Blog this week is taken from a review article appearing this month in The Journal of Osteoarthritis and Cartilage focused on reviewing the state of the art and perspectives, authored in Montpellier, France. As I have indicating over the past several months, the original regenerative medicine concept had been that we would take your bone marrow via aspiration, concentrate it in our laboratory and inject the concentrate into an arthritic knee thereby introducing adult mesenchymal stem cells. The belief had been that those stem cells would morph into cartilage. Now we know there is a lot more happening in the joint following the introduction of bone marrow aspirate concentrate/stem cells.
We know that Osteoarthritis is the most common form of arthritis mainly characterized by the degradation of articular cartilage and associated with subchondral bone lesions. Whereas I had spent the vast majority of my orthopedic career on joint replacement for grade 4 osteoarthritis, over the past four years, I have focused my initiative on cell based interventions for stages two and three arthritis; although next month, I am introducing a novel cell-based therapy for grade 4 osteoarthritis of the hip and knee. Stromal Cells (MSCs) have gained much interest on their trophic and immunomodulatory functions that can help tissue repair/regeneration. The review article from France focuses on the anti-inflammatory effect of Mesenchymal Stem cells on Mitochondrial RNA modulation in OA. With continued cellular science advances, the notion that stem cell management of your arthritic knee and hip still is in the future is erroneous. Four years ago, there may have been some basis for your physician to minimize the possibilities of interventional orthopedic in lieu of a joint replacement because there wasn’t enough clinical proof of efficacy; and, the understanding was that the MSCs would morph into cartilage. As a result of our continued data collection coupled with better understanding of the anti-inflammatory effect of bone marrow aspirate concentrate, there is every reason for an arthritic patient to attempt to avoid a joint replacement.
This past weekend, we had every reason to give thanks and I am no different. I give thanks to my family, to my health, and to my profession for allowing me to help my patients enjoy a pain free active lifestyle. To learn about our non-operative approach to reversing the pain and limitations of arthritis, call to see if you are a candidate or to schedule an appointment. 847 390 7666
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Nov 5, 2015
My last Blog brought you greetings and discussed some of the issues reviewed at the first meeting of the Interventional Orthopedic Foundation. This not for profit foundation was founded to help facilitate the transfer of scientific regenerative medicine developments into clinical practice. One challenge is how to improve the outcomes of what is now the gold standard of Interventional Orthopedics, Bone Marrow Aspirate Concentrate in managing arthritis of major joints. We seek to see longer effect and better results. While there are all kinds of claims being made for amniotic fluid concentrate and adipose (fat) derived stem cells, as of now, there is no data to support said claims.
I have played a large role in documenting the success of Bone Marrow Concentrate intervention for arthritis. Now I want to see if I can improve those results. At the Interventional Orthopedic Foundation meeting, various means of improving outcomes were discussed including, hyperbaric oxygen, ultrasound, lasers, ultraviolet light and finally, electro-stimulation. I was reminded of a study in which I was involved five years ago using an electronic pulse joined to a knee brace to try to regenerate cartilage. The study was based on animal models who when subjected to an electronic pulse grew cartilage. It occurred to me that the answer to improving the quantity and the quality of a Bone Marrow Aspirate Concentrate/ Stem cell intervention for an arthritic knee might be the pulsed brace. If every patient who undergoes a stem cell intervention for arthritis is prescribed a brace post treatment, since we know that the pulse is safe and potentially helpful, why not add the pulse to the post intervention protocol. To that end, I am happy to announce the introduction of this methodology to our post intervention protocol via a clinical trial starting in December
We will follow each patient for up to a year with our standard clinical objective and subjective means and periodic X-Rays with no added fiscal burden to the patient. The results of this study will then be presented to the 2016 meeting of the Interventional Orthopedic Foundation as I continue to integrate patient care with research. There is no question that patients who wore the brace and used the pulse for arthritis without stem cell intervention in the past were improved; imagine the potential leap forward by adding the pulse to the brace after a Bone marrow Aspirate Concentrate/ Stem Cell intervention.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenerative Pain Center, Regenexx, Regenexx-SD, stem cells, treatment
