This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (847) 390-7666 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
Owing to the broad indications for statin medications, an ever increasing number of patients are using these therapies. Certainly, there is a benefit to statin use as a means of decreasing cardiovascular disease; but by the same token, there is the observation of decreased athletic performance, muscle injury, myalgia (muscle pain), joint pain, and fatigue. The type of statin, the dose, drug interactions, genetic variants, coenzyme Q10 deficiency, vitamin D deficiency, and underlying muscle diseases are among the factors that may predispose patients to intolerance of statins. When it comes to those seeking Cellular Orthopedic interventions, their fitness and exercise endeavors may result additionally in an intolerance of the combined approach decreasing and treating cardiovascular disease.
Although in general, statins are well tolerated, they can affect skeletal muscle producing symptoms that range from myalgia (muscle pain) to creatine phosph kinase (CPK)-muscle enzyme marker- elevation and rhabdomyolysis (rapid breakdown of skeletal muscle). These statin associated musculoskeletal side effects can be exacerbated by physical activity. Now comes a recently published study reinforcing previous findings that certain types of cholesterol lowing drugs called statins, inhibit Mesenchymal Stem Cells. As you know, MSCs are the body’s reservoir of regenerative potential and are capable of orchestrating regeneration of a wide variety of skeletomscular tissue. In the laboratory and now documented in patients, statins not only interfere with MSC function, the drug increases the aging and death rate of Adult Mesenchymal Stem Cells. Basically, statins are a kind of stem cell poison.
It is important for you, the potential patient to understand that those undergoing a bone marrow aspirate concentrate intervention for arthritis are not only receiving stem cells. The bone marrow concentrate contains in addition to the mesenchymal stem cell, a category of anti-inflammatory molecules called Cytokines and another category of cellular messengers termed Growth Factors. Recent science suggests that latter two groups may be equally or perhaps more important than stem cells in introducing pain relief, increased motion, improved function and reversal of the arthritic progression.
For those of you considering a Bone Marrow Aspirate Concentrate procedure for an arthritic joint, please don’t act without discussing the use of statins with your physician. Strategies include a reassessment of the need for statin prescription, a decrease in dosage, a change to a hydrophilic statin, a statin holiday prior to and after the Cellular Orthopedic intervention followed by a rechallenge after six weeks, vitamin D replacement, coenzyme Q10 supplementation and/ or L-carnitine supplementation.
There are alternatives for those who are statin dependent and in whom a holiday might be contraindicated. To learn about our full menu of Cellular Orthopedic options, make an appointment
847 390 7666
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, technology, treatment
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
Autograft is a tissue or organ that is grafted into a new position in or on the body of the individual from whom it was removed; whereas allograft is the transplantation of tissue taken from one individual to another. Bone Marrow Aspirate Concentrate is an autograft while Amniotic Fluid Concentrate is an allograft. Autograft, at this time serves as the gold standard for almost all situations in which the use of orthobiologics is indicated. Bone Marrow Aspirate Concentrate (BMAC) offers nearly every essential component involved in reversing the damage caused by arthritis including Adult Mesenchymal Stem Cells, Growth Factors, Cytokines, and Vascular Progenitor Cells. Because of the inherent value of Bone Marrow, my first interventional thought is BMAC; in addition it is virtually free of risks and side effects.
The U.S. Food and Drug Administration (FDA) has approved certain growth factors and allied substances for specific indications. Platelet Rich Plasma falls into this category. In addition to BMAC, Autogenous PRP contains many growth factors as well. Stem Cells are at this time, the ideal biological treatment because they recreate the original microenvironment and supply paracrine factors (a type of hormone which binds to receptors in nearby cells influencing their function). Bone Marrow Aspirate contains a variety of cell types such as endothelial progenitor cells (EPCs), osteoprogenitor cells (OPCs), stem cell niche-supporting cells, and cytokines.
You bet this is confusing and not easy to understand. That’s why I try to clarify by writing the Blog. At the same time, it demands that a clinician stays well informed and not depend on the hype of marketing from the start-ups in the field of orthobiologics to influence a potential patient intervention. On Thursday, I travel to Broomfield, Colorado for the first meeting of the Interventional Orthopedics Foundation, the first not for profit dedicated to Regenerative Interventional Orthopedics: The Next Frontier. My presentation will be based on the 24 month outcomes of Bone Marrow Concentrate in knee arthritis. Another issue will be addressed, are there viable stem cells in Amniotic Fluid Concentrate? The Regenexx Advisory Board of which I am a member, will review the challenges presented by the patient with Grade 4 Osteoarthritis for whom until now, we have had little to offer other than referral for a joint replacement. Next week, I will be in a position to upgrade the reader about the present role, if any for mechanically liberated, adipose derived, stem cells as this subject as well will be studied by the advisory panel.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, PRP, Regenerative, Regenexx, stem cells, technology, treatment
The New York Times recently published a story about a lawsuit brought against an orthopedic prosthetic company for distributing their product without appropriate FDA approval. The story calls into question not only the process by which new technology is brought into practice, but the choices the clinician must make when deciding the best options to use on a patient. We need to study every new technology with evidence based means and make critical decisions on the outcomes resulting from those studies. We clinicians strive to always do better.
As I am sure you realize, the FDA and other parties are anxious to have more data, especially when it comes to the newer technologies in Regenerative Medicine. To the best of my knowledge and based on my ongoing scrutiny of the scientific and orthopedic medical literature, Regenexx is the only scientific laboratory to date that has repeatedly met with the FDA and their agents and been allowed to offer regenerative technology under the highest level of scrutiny. My particular targets are arthritis and synovitis. My therapeutic approach to pain, altered function, reduced motion, delaying and even avoiding a joint replacement, and reversing the natural progression of arthritis is mostly based on the research and publications of Regenexx; and in addition more recently, on the outcomes from the continuing monitoring of our own Regenexx Chicago data base.
When it comes to patient care, I explain risks and benefits in generic terms citing percentages from my understanding of the information presented at scientific meetings, that which I read in the medical literature, the publications from Regenexx, and information gleaned from my own investigations. The Decision-Making process should be and at Regenexx is based on registries. The governments of countries outside the United States have required participation in registries for many years; there is no such requirement in the United States. Regenexx for the past seven years has maintained such a registry, and when I joined the Network three years ago, added to the comprehensive nature of those outcome measurements.
Innovation is important to advance patient care. Regenerative Medicine is truly a transformational innovation. We want patients to respect our ability to make decisions about what is in their best interests. This foundation of respect will only result from unbiased decisions and will be strengthened when more recent entries into the field of stem cell care present scientific data and not “this is how I do it” or criticism based on market place competition. Regenexx has introduced a stable and stem cell methodology with a proven track record. This being the case, others should be careful when choosing to forgo that approach. In a spin on the words of the immortal Jerry Maguire, Show Me Your Data.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, technology, treatment