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
Oct 29, 2015
In spite of what a patient may be told by the physician and what salesmen tell the doctors, research by the Interventional Orthopedics Foundation laboratories found no viable stem cells in Amniotic Fluid Concentrate once shock thawed. While there may have been living stem cells in amniotic fluid when harvested, part of the commercial preparation and storage requires freezing. Once shipped for clinical use, the preparation is quickly thawed (shock thawing) as required for injection. While a slow thaw over 24 to 48 hours will preserve stem cells, shock thawing kills cells although the hyaluronic acid content and the Cytokine/Growth Factor content is maintained. The net conclusion is that Amniotic Fluid Concentrate may be beneficial as a symptom altering intervention but with no regenerative potential.
Analysis of the available enzymatic means of liberating stem cells from fat is a violation of FDA restrictions. The Interventional Orthopedics Foundation has been aware of the increasing claims that adipose derived stem cells are superior to Bone Marrow Aspirate Concentrate derived stem cells in various orthopedic conditions. As such, the Foundation studied the law and the proprietary claims. The conclusions reached are that there is no scientific data or publications to support the claims of superior outcomes of fat over bone marrow and the use of the enzyme, collagenase to liberate the stem cell from the adipose tissue is violation of FDA guidelines. By the same token, the introduction of a mechanical means to liberate biologically active molecules from fat may fall within FDA guidelines but the impact in arthritis has yet to be clinically documented.
No consensus has yet been reached regarding the substitution of Amniotic Fluid Concentrate for hyaluronic acid in relieving the symptoms of degenerative arthritis. The necessary clinical evidence to support a change in skeletal muscular practice guidelines is still being collected. As of January 1, 2016, I will be participating in that latter initiative in my interventional orthopedic practice. The Interventional Orthopedics Foundation also recognizes the absence of a scientific based means of helping a patient delay or even avoid a joint replacement for advanced arthritis. What we are able to do now and for which we have supporting data is to successfully intervene in Grades two and three osteoarthritis. Beginning in December, I will be initiating a clinical trial that is designed to meet the challenge in advanced arthritis but we will not have statistical evidence of a successful outcome for some time.
If you want more information regarding proven methods using Interventional Orthopedics for delaying or even avoiding a joint replacement in Grades 2 and 3 arthritis or what may be possible for advanced osteoarthritis to avoid a joint replacement, schedule your consultation at 847 390 7666. For those patients who have been told they have too serious a co-morbidity to allow for a joint replacement, let us try to help you as well using needle instead of a scalpel.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, technology, treatment
Oct 8, 2015
Why our Regenerative Medicine/Interventional Orthopedic clinical practice is where you should consult before undergoing a Cellular Medicine intervention:
I am an orthopedic surgeon, Professor Emeritus at Rush, who for 37 years, performed Joint Replacement Surgery for arthritis before “graduating” into Cellular Orthopedics. Basically, I exchanged my knife for a needle. As a Fellow of the American Academy of Orthopedic Surgeons, I am required to partake in the Mandatory Disclosure Policy requiring me to update disclosures and potential conflicts of interest at least semiannually (April and October). All AAOS members involved as continued medical education faculty and authors, orthopedic volunteers in organizational governance, clinical practice guidelines, appropriate use criteria, and performance measures development, and editors-in-chief and members of editorial boards are required to complete disclosure in the AAOS Orthopedic Disclosure Program. My membership and active participation in the American Academy of Orthopedic Surgeons, my Fellowship in the American College of Surgeons, and my membership in the American Medical Association is your quality assurance that I subscribe to evidence based clinical practice guidelines. As such, it is my responsibility to offer Regenerative Medicine interventions to only those who meet Inclusion Criteria and educate patients who I can’t help about joint replacement alternatives. Furthermore, I also am bound by professional ethics not to add unproven treatments to my range of services.
Inclusion criteria are based on a medical history and physical examination, first and foremost and secondarily, after a look at an X-ray or MRI. Conversely, we employ a relatively strict list of exclusion criteria for those patients who just won’t benefit from Cellular Orthopedic interventions. Admittedly, while our practice is based on the scientific evidence, from time to time there are new treatment options. Unlike many who offer stem cell treatments, when a new regenerative option is brought to my attention, if I feel that it falls within FDA approved guidelines, I will investigate, apply for an IRB centered scrutiny and provide exhaustive informed consent to a patient. Your quality assurance of my standards of practice should also be reinforced by my participation as a member of the Regenexx Network and my involvement in the recently formed Regenexx Board of Advisors. In addition, I have made a commitment to my patients that I would become familiar with any new clinical trial initiatives and participate if I feel there is a role for such in my practice.
Over the next several weeks, I will share with you my review of new Regenerative Offerings, especially for those who might otherwise not meet our Regenexx inclusion criteria.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, joint replacement, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
Apr 16, 2015
Thursday, April 16, 2015 9:51 am
“Stem Cells working great. 4 days of skiing and 90,000 vertical feet already. Knees only slightly swollen. Using the new braces seems to really help. Last 4 to 5 runs of the day, it is very hard to get in and out of the heli-knees very sore by then. Hard to get up from a fall (so skiing carefully so as not to fall anymore). Pure powder last 2 days, so skiing itself has been easy. Biking every morning and after skiing, using Voltaren 2x’s/day, hot tub and ice-water on legs 3x’s after skiing and knee massage every day. Gary made his 3 million suit on Tuesday, and I missed mine yesterday by just 90 feet!! Huge Day of skiing yesterday-everyone exhausted. Skiing a half day today. Will see about tomorrow (only if all powder)”
This report was sent by a friend and patient who is helicopter skiing with CMH in British Columbia this week. I had originally planned to join the trip but work load prevented me. The skier-writer of the message had been unable to ski any longer until I completed a Bone Marrow Aspirate Concentrate/Stem cell intervention to his right knee two years ago; and for the left, last year. He is 70 years of age
Dwight Howard returns to Houston in time for NBA playoffs
In February, The Houston Rockets star center was sidelined by knee pain for which he underwent a Bone Marrow Aspirate Concentrate/Stem cell intervention. As I wasn’t his treating physician, I am not familiar with the details of his diagnosis, but suffice it to say from what I have gleaned from ESPN on the internet, it was cartilaginous damage with continued pain and inflammation. Last week, he returned to action and will be very much part of the Rockets quest for an NBA championship.
The Anti-Aging Movement Continues to Rise
By Terry Stanton
From the April, 2015 edition of AAOS Now/Clinical News and Views.
“During an Annual Meeting Symposium on considerations in treating the aging athletic patient, a panel of surgeons covered both injuries and treatment for “weekend warriors” and the science of aging.” I enjoyed the article in that it once again underscores how Regenexx is ahead of the pack with non operative, minimally invasive interventions with a needle for those sports injuries and the arthritic progression that alters function. The article cited above concludes “Field though legitimate, lacks science to support health benefits of treatment”. That this is partially true was emphasized by a patient from Hong Kong this week who had written me to tell me all the promises she had found while surfing the internet to seek non surgical options for her recently torn ACL. Her experience underscores the need for the Aging Athlete to ask the question: “show me your evidence”. There is only one Regenerative Medical Network that has the Data based on which your questions may be truthfully answered. It is called Regenexx and I am not only a part of, but a contributor to their scientific Outcomes process.
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenexx, stem cells, treatment
Mar 27, 2012
British Hip Society recommends against use of stemmed, large diameter, metal-on-metal implants in primary total hip replacements.
Based on discussions held at its annual meeting, the British Hip Society (BHS) has issued a statement on the use of large diameter metal-on-metal bearing total hip replacements. BHS advises that stemmed, large diameter metal-on-metal primary total hip replacements using bearings of 36 mm or greater should no longer be performed until more evidence is available, except in properly conducted and ethically approved research studies. The advice does not apply to hip resurfacing. In addition, BHS endorsed guidance recently issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), calling for annual monitoring for the life of the implant, as a precautionary measure.
Other News
FDA committee to discuss reports of joint destruction associated with anti-NGF drugs.
The U.S. Food and Drug Administration (FDA) plans to hold a meeting next week to discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development, along with safety issues possibly related to the drugs. Anti-NGF drugs are being developed for the treatment of chronic painful conditions such as osteoarthritis, chronic lower back pain, cancer pain, and other conditions. An advisory committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk-benefit balance for these drugs favors their continued development as analgesics.
Sheinkop meets with Regenexx in Colorado to evaluate new office based needle arthroscopic system
While it is true that I was skiing last week in Vail, while I vacationed, I still worked on assuming a leadership position in the new world of regenerative medicine. What I as an individual am able to contribute is my background and experience in research and clinical practice of treating arthritis with joint replacement surgery. Now I am dedicating myself as an orthopedic surgeon to avoiding or postponing joint replacement. When arthritis is debilitating and the X-ray is that of bone on bone, there is still an indication for a new hip or a new knee. But patient beware, there are restrictions inherent in a new joint. My life-long biking, skiing and fly fishing buddy, has relatively severe arthritis of his left knee. Yet he still can bike faster and ski better than me-I out fish him-because he has taken my counsel and postponed, maybe avoid a knee replacement via Regenerative Medicine.
To learn if you are a candidate for regenerative medicine, feel free to call
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. LaSalle St, Chicago, IL 60610
Tags: bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Osteoarthritis, Pilot Study, Regenerative, Regenerative Pain Center, Regenexx, stem cells
