Mar 21, 2016
Physicians should be in a constant state of education to keep their skills and knowledge at the forefront so that their patients get the best care possible. At the same time, I personally have devoted over 40 years to integrating patient care with research and education be it directed to joint replacement, and for the past four years, to postponing and at times, avoiding joint replacement. As the vast majority of health professionals, I strive on a daily basis to meet the need of my patients. Each and every patient for whom I provide care is entered into a HIPAA compliant outcomes database. From time to time, results are extracted from that data-base and presented at Cellular Orthopedic meetings. Soon we will be submitting the outcomes of several clinical trials for statistical analysis and publication. Almost every therapeutic intervention I recommend is based on science and statistically significant outcomes; rarely on anecdote.
The emerging field of regenerative medicine aims to deal with arthritis and cartilage injury by providing the required elements (cells, inductive molecules, and local environment) to promote true joint and cartilage regeneration. Cellular Regenerative Medicine is rapidly evolving and changing on an almost weekly basis. This is both good news and bad news as there are those who would try to prosper through marketing rather than science. Witness the invitation I received last week to travel to the Bahamas for stem cell care based on anecdote; or the advertisement for the “opportunity” to attend a weekend course to teach me how to use adipose tissue for every malady in the human body. How is it possible to track outcomes from medical tourism or to teach adipose related cellular orthopedic intervention when the latter is not FDA approved?
To assure you that I remain in the forefront of Cellular Orthopedics, from March 31-April 2, 2016, I will be participating in a Continuing Educational course, Articular Cartilage Restoration: The Modern Frontier, sponsored by the American Academy of Orthopedic Surgeons. This is a premier skills course that provides hands-on exposure and practice for the most updated techniques in cartilage restoration while allowing for a contemporary overview of established and new procedures to treat the entire knee joint for cartilage damage ranging from focal defects to arthritis.
Although I no longer am involved with orthopedic resident education, as Professor Emeritus at Rush, I have taken the Interventional Orthopedics Foundation pledge to continue to integrate my clinical interventions with outcomes surveillance. Several scientific presentations at the early March meeting of the American Academy of Orthopedic Surgeons resulted because of my ongoing initiatives. I am the orthopedic surgeon who four years ago, exchanged a scalpel for a stem cell.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Hip, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Mar 10, 2016
The 2016 annual meeting of the American Academy of Orthopedic Surgeons has ended and the Orthopedic Surgical community is now very aware of what we have been accomplishing in Cellular Orthopedics for almost four years. In Orlando, Orthopedic Surgeons, “Camp Followers”, and the health care industry in general was updated on that for which we have been gathering data for four years in my Chicago office and seven to eight years at Regenexx. The orthopedic surgeon is unique in the field of surgery as the entire specialty is voluntarily governed by Evidence-Based Medicine. Such is not necessarily the case in others who are licensed to treat musculoskeletal disease and injury. Now that the outcomes are being reported with up to four years of Data to support what I do, patients should anticipate a marked increase in those offering cellular orthopedic alternatives to sports injury and arthritic limiting disease without proper acknowledgement behind the basis of their recommendations.
First and foremost, if you have a musculoskeletal based impairment of any kind, the first step is an accurate diagnosis starting with a history and physical examination. Next follow the X-ray and then the MRI if needed. Once the diagnosis is clearly and accurately defined and graded, then should a discussion ensue about the role of pain management, surgery or cellular orthopedic interventions. I am very concerned about the increasing frequency of media placements by those not educated, or for that matter, licensed to complete cellular orthopedic interventions.
My other concern is that once the orthopedic surgeon becomes aware of our non operative stem cell successes; there will occur (actually it has already started) a rush to get involved in Regenerative Medicine; wherein up until now, the same professionals have refused to acknowledge our successes. In any new undertaking, the term “learning curve” may be applied. Patient heed my warning, don’t fall victim to the learning curve. A cellular orthopedic intervention is a complex process; much more than several needle sticks. A successful Regenerative Medicine procedure requires a proper six week patient preparation, an understanding by the professional of what pharmaceutical agents might disrupt a stem cell success, the proper management of the Bone marrow Aspirate, the timely introduction, preparation, and management of adjunctive Platelet Rich Plasma with all of the above carried out in an appropriate environment. There is no place for “bedside” machines and the FDA may put an end to office based procedures in the near future. Last of all, only experience may lead to the most appropriate recommendation as to whom is a proper candidate for stem cells.
Would you want a family practitioner to do your Total Joint Replacement? Would you let a chiropractor do your arthroscopy? Do you want to be the first to receive a new treatment and be part of a clinician’s “learning curve”? The Regenexx Network of Physicians has been involved with an innovation and alternative to surgery for Afflictions of the Musculoskeletal System; we have already learned.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, joint replacement, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
Feb 4, 2016
Description of Procedure or Service
Mesenchymal stem cells (MSCs) have the capability to orchestrate cell differentiate into a variety of tissue types, including various musculoskeletal tissues. Potential uses of MSCs for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs. Stimulation of endogenous MSCs is the basis of procedures such as bone marrow stimulation (e.g., microfracture) and harvesting. Bone marrow aspirate is considered to be the most accessible source and thus the most common place to isolate MSCs for treatment of musculoskeletal disease. The U.S. Food and Drug Administration (FDA) has stated that cell-based therapies are one of the most rapidly advancing approaches intended to repair, replace, restore, or regenerate cells, tissues and organs
While concentrated autologous MSCs do not require approval by the U.S. Food and Drug Administration (FDA); Mesenchymal stem cell therapy is considered investigational for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue. Since as of this writing, the Corporate Insurance world does not cover investigational services or procedures, Cellular Orthopedic interventions are not indemnified. It is a self pay undertaking.
The use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite this research into the methods of treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Current available evidence on procedures using autologous bone-marrow-derived mesenchymal stem cells (MSCs) for orthopedic indications in humans consists primarily of case series and small non-randomized comparative trials with insufficient data to evaluate health outcomes. In addition, expanded MSCs for orthopedic applications are not FDA approved (concentrated autologous MSCs do not require FDA approval). Due to the lack of evidence that clinical outcomes are improved and the lack of regulatory approval, use of stem cells for orthopedic applications is considered investigational.
The above is in part taken from information to be found by searching Corporate Medical Insurance Policy via the internet. As you are aware if you are a reader of this Blog or as you will become aware after reading this Blog, the members of the Regenexx Network are gathering outcomes data that could result in a future change of Corporate Indemnification Policy for Regenerative Medicine. Actually, a corporate policy review for BCBS is scheduled next month.
In the mean time, a mailing from the AARP last week put everything into perspective and it came as an offering from AARP-Advantages having to do with protection for your pet, Petplan. “Every six seconds a pet parent is faced with a vet bill for more than $3,000.” What follows are some of the costs associated with your pet, the cost of caring:
Ear Infection—– ————–$4,048
Hip Dysplasia——————-$9,808
Ingestion of foreign body—-$9,389
Periodontal disease————-$2,651
Motor vehicle accident——-$11,695
I think you get the message. It is my job to make sure you get as good care and as good an outcome as you seek for your pet and we certainly cost less. 847 390 7666 to schedule appointment
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, 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
Dec 7, 2015
To determine if your quality of life may be improved by a Cellular Orthopedic intervention, a look at an X-ray or MRI is not the answer; a physical examination or several assessments may be needed in addition to reviewing an image.
In a Study: Hip pain and radiographic OA may not correlate reprinted in AAOS Headline News Now-December 4, 2015, Data from a study published online in the journal The BMJ suggest that hip pain and radiographic OA may not correlate in some patients. The research team assessed pelvic radiographs for hip OA among two cohorts: the Framingham Osteoarthritis Study and the Osteoarthritis Initiative. They found that in the Framingham study (n = 946), 15.6 percent of hips in patients with frequent hip pain displayed radiographic evidence of hip OA, while 20.7 percent of hips with radiographic hip OA were frequently painful. In the Osteoarthritis Initiative study (n = 4,366), 9.1 percent of hips in patients with frequent pain displayed radiographic hip OA, and 23.8 percent of hips with radiographic hip OA were frequently painful. The research team writes that hip pain was not present in many hips with radiographic OA, and many painful hips did not show radiographic hip OA. Thus, the evidence suggests that in many cases, hip OA might be missed if diagnosticians rely solely on hip radiographs.
In yet another article featured in the same publication
Study: Worsening lesion status may predict higher risk of knee OA.
According to a study published online in the journal Annals of the Rheumatic Diseases, worsening lesion status as determined via magnetic resonance imaging (MRI) may predict a significantly higher risk of developing knee osteoarthritis (OA) or painful symptoms for patients with at-risk knees. The researchers used MRI to assess cartilage damage, bone marrow lesions (BMLs), and menisci at 12 months (baseline) and 48 months for 849 participants in the Osteoarthritis Initiative who had been determined to be Kellgren-Lawrence Grade-0 in both knees. They found that from baseline to 48-month status, worsening of cartilage damage, meniscal tear, meniscal extrusion, and BMLs was associated with concurrent incident radiographic OA and subsequent persistent symptoms. The researchers write that the findings suggest that such lesions may represent early stages of OA.
In this Blog, I am giving you some of the scientific basis for my reasoning that you allow me to complete a physical examination before I advance a therapeutic recommendation. You may also better understand why one intervention alone may not be the answer as arthritis silently progresses and may not necessarily allow for predictability. It takes an office visit or two or three and maybe yearly to help a patient enjoy the highest quality of life and a menu of services starting with a cortisone injection, next visco-supplementaion and ultimately, stem cell intervention. Some years down the line, that stem cell intervention may need to be repeated.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
