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
Nov 30, 2015
The title of the Blog this week is taken from a review article appearing this month in The Journal of Osteoarthritis and Cartilage focused on reviewing the state of the art and perspectives, authored in Montpellier, France. As I have indicating over the past several months, the original regenerative medicine concept had been that we would take your bone marrow via aspiration, concentrate it in our laboratory and inject the concentrate into an arthritic knee thereby introducing adult mesenchymal stem cells. The belief had been that those stem cells would morph into cartilage. Now we know there is a lot more happening in the joint following the introduction of bone marrow aspirate concentrate/stem cells.
We know that Osteoarthritis is the most common form of arthritis mainly characterized by the degradation of articular cartilage and associated with subchondral bone lesions. Whereas I had spent the vast majority of my orthopedic career on joint replacement for grade 4 osteoarthritis, over the past four years, I have focused my initiative on cell based interventions for stages two and three arthritis; although next month, I am introducing a novel cell-based therapy for grade 4 osteoarthritis of the hip and knee. Stromal Cells (MSCs) have gained much interest on their trophic and immunomodulatory functions that can help tissue repair/regeneration. The review article from France focuses on the anti-inflammatory effect of Mesenchymal Stem cells on Mitochondrial RNA modulation in OA. With continued cellular science advances, the notion that stem cell management of your arthritic knee and hip still is in the future is erroneous. Four years ago, there may have been some basis for your physician to minimize the possibilities of interventional orthopedic in lieu of a joint replacement because there wasn’t enough clinical proof of efficacy; and, the understanding was that the MSCs would morph into cartilage. As a result of our continued data collection coupled with better understanding of the anti-inflammatory effect of bone marrow aspirate concentrate, there is every reason for an arthritic patient to attempt to avoid a joint replacement.
This past weekend, we had every reason to give thanks and I am no different. I give thanks to my family, to my health, and to my profession for allowing me to help my patients enjoy a pain free active lifestyle. To learn about our non-operative approach to reversing the pain and limitations of arthritis, call to see if you are a candidate or to schedule an appointment. 847 390 7666
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
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
