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
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
Sep 17, 2015
In the last week, I have become aware of four companies developing new regenerative medicine product for Musculoskeletal Care of the Aging Athlete. What I find extremely interesting is the fact that three years ago, when I entered the practice of using bone marrow aspirate concentrate in an attempt to postpone or possibly avoid a joint replacement in an arthritic knee or hip, the orthopedic community was very critical telling patients that regenerative medicine was still ten years away. Fast forward three years and four new initiatives into the emerging field of regenerative medicine have come to my attention; underwritten by orthopedic surgeons or companies that have produced prosthetic joints for over 30 years. All of the product in development has not yet been approved by the FDA and many developing products are still being tested in Europe. What we at the Regenerative Pain Center offer is within FDA guidelines and approved by all regulatory agencies of the government. At the same time, I am very much aware of what is taking place nationally and internationally; when a newer regenerative medicine product is made available and FDA approved, we at the Regenerative Pain Center will be aware and closely evaluate as to whether it should be incorporated into our service line.
Let me be candid, our success rate is not 100 per cent. There have been three or four hip patients that have not provided the outcome the patient sought or that I hoped to provide; namely, avoidance of a hip replacement. On the other hand, the vast majority of hip bone marrow aspirate concentrate procedures are still allowing the patient a very full return to activities with about 70% percent patient satisfaction at a minimum of one year. When it comes to those who sought help for an arthritic knee, we have done even better with an 85% patient satisfaction outcome at a minimum of one year. Several of those patients had reached a plateau at six months but realized a marked improvement in the pain score with a Platelet Rich Plasma refresher. When a patient elects to under go a bone marrow aspirate concentrate hip or knee intervention at the Regenerative Pain Center, that patient may be assured that what we are doing is based on FDA guidelines and our clinical outcomes research. In addition, each patient should recognize that Regenexx continually statistically reviews our outcomes data. Last week, we recognized that those who underwent Cellular Orthopedic interventions for an arthritic knee did best when the cell count of mononuclear cells exceeded 400 million. Be aware that we count the cells in every Regenerative Medicine procedure. Our approach is no longer “this is the way we do it.” Our approach is based on experience and outcomes research, the same that I used in a long joint replacement career.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
Jun 18, 2015
That’s the headlines in several orthopedic articles recently appearing in scientific journals and that’s what is predicted for the future. I have been using that syringe in lieu of a scalpel for three years. Four years ago, it was a four-inch incision for a knee and a ten-inch incision for a hip. A revision required more than double that length with major muscle disruption of life and a marginally successful outcome.
Let’s return to the alternative for a joint replacement in an arthritic joint, Bone Marrow Aspirate Concentrate. This past weekend, I presented the 12 to 24 month outcomes of Bone Marrow Aspirate Concentrate for knee arthritis in 172 patients I have treated, at the Orthopedic and Biological Institute 5th annual meeting held in Las Vegas. More than 500 physicians from around the world attended it. The paper was very well received as indicated by a continual flow of e-mail commentary, and will influence how the attendees approach osteoarthritis in their respective patient populations in the immediate future. While I educated the audience, I also learned something from several French and Spanish Orthopedists speaking at the meeting. In addition to treating the arthritic joint, three studies were delivered in which the bone immediately adjacent to the arthritic joint was injected with stem cells in addition to placing BMAC in the joint itself. Called a subchondroplasty, it adds little extra to the procedure and to date, seems to have significantly improved results. As of July 1, the modified approach will be included in my treatment protocol for the osteoarthritic knee when I deem appropriate. It takes a team and a lot of time and effort to complete these outcome studies. That’s why most clinicians don’t partake. At most, some do it by telephone or forms to be completed by the patient and mailed in. That’s not the way of a joint replacement surgeon. Our outcome scoring is objective and includes hard end points such as reproducible measurements. My having incorporated clinical research into my patient care efforts has resulted in a continual improvement with better and longer lasting outcomes in my management alternatives for arthritis. I have the data to prove it.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment, Ultrasound Guided Injection
May 28, 2015
Osteoarthritis of the knee is one of the leading causes of functional limitation and progressive deterioration in the quality of life. Nonsurgical treatment of the osteoarthritic knee has been the usual and customary weight reduction directive, recommendation for physical therapy, prescription for non-steroidal anti-inflammatories, followed by injections with corticosteroids and hyaluronic acid. The goal is to reduce pain and improve function but the classical non operative approach is not universally successful or long lasting. Alternatives are continually sought to provide pain relief and improve functional outcomes.
Recently, there has been a major initiative to introduce Amniotic Fluid in the treatment of the osteoarthritic knee. Allograft (from a third party) amniotic tissues have a long history of clinical use having been first reported in 1938. It is thought to be a homologue to synovial fluid, acting as a cushion to protect and lubricate in the closed environment of the knee. A recent study measured the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated outcomes measurement tools. In the registry review, early outcomes suggest that the use of processed amniotic fluid allograft may offer a safe and effective treatment for OA of the knee for 90 days. The suggestion is that this treatment may be more durable than single corticosteroid injections and perhaps hyaluronic acid treatments. The study providing the background for this blog is still in progress. Of interest is the fact that no claim is made in the article supported by the pharmaceutical company that amniotic fluid is chondrogenic or contains stem cells. The latter is an extremely important consideration; beware of those who promote amniotic fluid on their web sites as providing viable stem cell content. As of this time, while amniotic fluid may contain cytokines (anti-inflammatories) and growth factors, it is only to be considered in the same category and comparable, perhaps longer lasting than a corticosteroid injection or a hyaluronic acid intervention.
The standard of Regenerative Medicine and Cellular Orthopedics remains Bone Marrow Aspirate Concentrate as the best source of anti-inflammatory cytokines, growth factors and only FDA approved source of viable adult mesenchymal stem cells. In spite of the FDA approval mandate, as recent as this morning, I received an invitation to attend a course that would teach me how to use adipose derived stem cells in my practice. Let me emphasize two points, Amniotic Fluid does not have viable stem cells until proven otherwise and adipose derived stem cells are illegal for use in the musculoskeletal system. That being said, even if adipose derived stem cells were FDA approved and thus available; bone marrow aspirate concentrate provides the Cytokines and the growth factors not found in fat while bone marrow aspirate concentrate provides stem cells not found in processed amniotic fluid.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenexx, stem cells, Synvisc, treatment
