Nov 5, 2013
Ski season is here and I am planning ahead. Who doesn’t want a joint replacement for arthritis? For one, count me out as long as there are other options for dealing with my symptoms. As you will learn, I was head of a joint replacement program at a major medical center for the last 15 years of my orthopedic surgical life and performed over 20 thousand hip and knee replacements over my 38-year surgical career. Yet, every orthopedic surgeon has an ethical and professional obligation to stay abreast of the accelerating knowledge expansion occurring in the musculoskeletal sciences. The covenant that exists between surgeon and patient requires acceptance of this obligation; that’s why I am sharing with you these advances in the care of the aging athlete.
Recognizing that Arthritis is a normal physiologic effect of aging and assuming you have applied all of aforementioned non-operative treatment plans, what is the current state of cartilage regeneration before considering a joint replacement? Allow me to introduce you to the new world of Cellular Orthopedics (Regenerative Medicine). By using your own stem cells normally present in your bone marrow, we are now able to control the symptoms of osteoarthritis, improve joint mobility, increase your functional capacity, possibly reverse the progression of the arthritic changes, delay or eliminate the need for the joint replacement and perhaps, regenerate your cartilage. Those are a lot of goals; how might your adult stem cells make it possible? Bone Marrow Concentrate contains mesenchymal stem cells that serve both an anti-inflammatory and bio-immune modulating function. They can facilitate regeneration of tissue and cartilage damaged by arthritis. Following aspiration of bone marrow from your pelvis, the marrow is centrifuged and available for a same –day procedure with minimal manipulation of cells following FDA Guidelines. The fundamental science supports great scientific potential of stem cells. Over the past 18 months, I have used this approach in over 200 arthritic patients with no adverse affects. There has been over 75% patient satisfaction at the knee, hip, shoulder and ankle including two wrist interventions as well. That was in the first year. The numbers improved in the second year as we gained experience and insight into those who would most likely benefit. My Blog, www.sheinkopmd.com will update you weekly on new developments in Cellular Orthopedics. The Regenexx web site www.regenexx.com will educate you further about the new world of cellular medicine and announce the introduction of clinical trials. Think stem cells before a joint replacement to maintain and restore a healthy joint.
Tags: arthritis, bone marrow, Bone Marrow Concentrate, FDA, joint replacement, Osteoarthritis, stem cells
Oct 9, 2012
The exciting discoveries indicate that specialized cells can turn back the developmental clock under certain circumstances using the Induced Pluripotent Stem Cell (iPS). The journey of a cell from immature to specialized was previously considered to be irreversible. We now know that under certain circumstances, it is possible for the cell to return to an immature, pluripotent stage. The discoveries of Drs Gurdon and Yamanaka have shown that specialized cells can turn back the developmental clock. While it is hoped their technique will enable replacement tissues to be generated from a patient’s own cells, that remains a distant prospect.
In the meantime, our present application of adult mesenchymal stem cells from bone marrow aspirated concentrate has shown excellent preliminary clinical results. Question: What would be a “meaningful “ improvement” for a biologic treatment compared to an active control group? Does stem cell treatment outcomes need to be as good as or better than surgical intervention; the joint replacement?
My standards concerning outcome surveillance for a joint replacement and that of regenerative care are one and the same. I am applying the same methods of scrutiny in the new world of stem cell management as I used for over 38 years as a joint replacement surgeon. There is one member of my staff who responsible for gathering and recording outcome metrics on all the patients I treat over a lifetime. That database is expanding and in about six months, we will begin gathering preliminary results for scientific presentation and publication. Until that time, I am reporting in my blog on a case-by-case basis. Incidentally, the bicyclist who I featured last week, was in a big cross cycle race on Sunday, and came in 23rd out of 79 riders-amazing. Last night he posed this question: “ I went on a very short run at week 7,and felt practically no pain. Can I begin to jog now? Light, short distances to start?”
As my database is short lived and relatively small, and I continually update my knowledge base concerning stem cell orthopedic issues. What I discovered is that those of us working with bone marrow aspirate concentrate are the only ones who truly meet FDA guidelines and for whom there is a scientific foundation of information. Bone marrow nucleated cells, adipose stromal vascular fraction (SVF), adipose fat grafts, and amniotic fluid stem cells are the most common stem cell procedure types being used. A handful of Internet sites are also offering cultured bone marrow or adipose mesenchymal stem cells. Please keep in mind that the risk of stem cell therapy increases as the source changes. The safest cells are your own.
The published research or published FDA trials have the following number of patients treated for arthritis or bone disease:
Bone Marrow Cultured Mesenchymal Stem cells…………………………549
Bone Marrow Nucleated Cells……………………………………………………..624
SVF Adipose Stromal Vascular Fraction…………………………………………..4
Amniotic Fluid Stem Cells………………………………………………………………0
Synovial Fluid Stem Cells………………………………………………………………..0
Cord Stem Cells………………………………………………………………………………1
Embryonic Stem Cells……………………………………………………………………..0
Tags: bone marrow, FDA, stem cells
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
Feb 14, 2012
Musculoskeletal Care of the Mature Patient
Forbes , 02/10/2012 Gergana Koleva
Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as drugs, in a landmark case that has far-reaching implications for the future of regenerative medicine.
At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.
Despite the controversy, a number of clinics from coast to coast have licensed their physicians as recently as last month to provide the cell therapy, called Regenexx. This should have meant that some settlement had taken place (like in the case of Physiomesh lawsuit settlements), as well as has led to renewed interest by consumers and would-be patients, and prompted the company to publish a sharply worded blog post on its website condemning the FDA’s reasoning.
The lawsuit is “concerning for every American who considers their body not to be an FDA regulated drug factory,” the blog says.
While the treatment that is the focus of the lawsuit is not used for life-threatening injuries, the company claims this case goes beyond a particular procedure to shed light on a misguided push by the FDA to establish authority over aspects of medicine never allowed it by Congress.
Regenexx works by taking a blood sample and a bone marrow sample from a patient and separating out the stem cells via centrifuge, then re-injecting those cells directly into the injured area, where they assimilate into the bone or cartilage and begin to regenerate it. Physicians for the company have shown in clinical studies cataloged at the U.S. National Library of Medicine that the therapy produces fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.
You may read the entire article on the Forbes web site. On March 2, I will be visiting Regenexx to explore my joining their network of physicians using stem cells.
Tags: Clinical Studies, drug, FDA, medicine, Regenerative, Regenexx, stem cells
