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 22, 2015
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
Oct 16, 2015
Tissue Regeneration has become the new standard for Grades 2 and 3 arthritis. Three years ago, I anticipated the future recognizing that the risks of joint replacement surgery were not fully taken into account when a surgeon recommended a new hip, knee or shoulder. Certainly, in advanced arthritis (Grade 4) there is little alternative for pain relief and restoration of function; but for Grades 2 and 3, do the risks outweigh the benefits? What is not taken seriously enough are the risks inherent in a surgical procedure. A recent scientific article reminds us of those risks.
“Knee, hip replacements might be bad for the heart short-term.”
“Contrary to some recent research, Boston-based researchers found osteoarthritis patients who had total knee or hip arthroplasty procedures were at increased risk of myocardial infarction in the early post-operative period. Their findings, published Aug. 31 in Arthritis & Rheumatology, a journal of the American College of Rheumatology, indicate long-term risk of heart attack did not persist, while the risk for venous thromboembolism remained years after the procedure.”
Up until 2001, the patient undergoing a joint replacement was discharged on post operative day four or five. Any complications taking place were reported as a postoperative morbidity, rarely, as a mortality. Today, a patient will leave the hospital between 23 and 36 hours following a joint replacement. Should, if, or when a complication ensues, it may never be recorded as a readmission to another hospital if not registered. Medicare has started penalizing hospitals for high readmission rates within 30 days of a discharge but this is only a recent development and doesn’t as of yet, include readmissions to a second location.
Last time, I indicated I would start updating the reader with new developments in the field of Regenerative Medicine. The goal of regenerative therapies is to modulate the stages of healing including inflammation, cell migration and proliferation. We do this though use of tissue grafts such as Bone Marrow Aspirate Concentrate.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, 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
Oct 1, 2015
As I have previously indicated in my Blog, the world of Cellular Orthopedics is growing at an exponential pace. Evidence Based Medicine supports weight reduction, physical therapy, anti-inflammatories, analgesics, and cortisone injections for symptomatic relief. Evidence Based Medicine no longer supports the use of Hyaluronic Acid injections (visco-supplementation). Historically, the next step is a joint replacement when the aforementioned conservative measures no longer have an effect. When I initiated my practice of Interventional Orthopedics as part of the Regenexx Network, their patient satisfaction surveys supported the use of Bone Marrow Aspirate Concentrate interventions for osteoarthritic joints. Since my entry into the sub-discipline of Regenerative Medicine, we have gathered data on every patient seeking consultation and care and, have expanded the Outcomes measurement intake to include objective data points in addition to those of a subjective nature. Along the way, we have gained a better understanding as to how a patient might better respond to Interventional orthopedic options. The evidence is growing.
Just as my practice has grown and the Regenexx Outcomes Data base has grown, so too have the Interventional Orthopedic treatment alternatives increased. Now there is Amniotic Fluid Concentrates available to replace Hyaluronic Acid as a six to 12 month anti-inflammatory. As of July of this year, two companies have introduced Adipose derived stem cell alternatives claiming a mechanical means of emulsifying fat and eliminating the need for the enzyme collagenase; the latter not approved by the FDA when it comes to the musculoskeletal system. As of this time, there is no scientific evidence to support the claims of success in arthritis with both Amniotic Fluid Concentrate and Adipose Derived Stem Cells. Those studies will take several years before there is clinical evidence to support said use in arthritis.
What we have learned and is supported by clinical evidence is how to better plan and prepare for a Bone Marrow Aspirate Concentrate intervention. First a clinician must rule out referral of pain from other sources; this is accomplished by a thorough history and physical examination. The status of a meniscus, labrum, and the articular cartilage must be taken into account. Mechanical malalignment –a bowed leg or knock knee-must be ascertained and excesses corrected. Ligamentous deficiencies will contribute to the end result and must be corrected before any Intervention of an orthopedic nature.
I have provided a lot for a reader to digest. If you want clarification or to learn if you are a candidate for INTERVENTIONAL ORTHOPEDIC to postpone or eliminate a joint replacement for osteoarthritis, call for an appointment:.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, 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, stem cells, Subchondroplasty, treatment
