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
Jul 9, 2015
There has been a major change in thinking about how a Mesenchymal Stem Cell functions as I have touched on in recent blogs. The focus of research has been on their potential to differentiate into multiple tissues such as cartilage and bone. This has led to a vast body of work dedicated to the potential of the MSC for tissue engineering or regenerative medicine in musculoskeletal applications. More recently, the emphasis has changed from the Mesenchymal Stem Cell’s functional differentiation to a greater emphasis on a secretor of molecules. As recent as three years ago it was thought that the MSC when concentrated and placed into a joint would survive and become a dynamic part of that tissue. The survival of implanted cells is now viewed with increasing doubt but we continue to observe major benefits to the arthritic joint from intervention with Bone Marrow Concentrate. It is becoming clearer that the real function of the MSC is to regulate the immune system and to secrete molecules that direct the behavior of the resident cells. In this role, the Mesenchymal Stem Cell serves as a conductor, a medicinal stem cell effectively acting like a growth factor factory or drug store.
It is what the cells secrete rather than the cell actually morphing into cartilage in an arthritic joint. When Bone Marrow Aspirate is concentrated, the implanted cells produce several soluble mediators that initiate or enhance the healing process. The exact growth factors and cytokines being expressed by the cells still haven’t been defined.
Let’s explore how this coincides with the Regenexx SD algorithm. We anticipated the future when we introduced the Same Day Bone Marrow Aspirate Concentrate program three years ago. It is well accepted that an acute inflammation is needed to initiate a healing response; hence the first step in the Regenexx-SD program. The Bone Marrow Aspirate Concentrate intervention that follows then intervenes so the acute inflammation doesn’t become chronic by secreting anti-inflammatory factors. Next the healing process begins with immune modulation and cytokines explaining the mechanism of relatively immediate pain relief reported by most patients. Lastly, the follow-up injection of activated Concentrated Platelet Rich Plasma modifies the cellular behavior enhancing the secretory profile of the Mesenchymal Stem Cells. When all is said and done, the vast majority of patients presenting with grades 2 and 3 osteoarthritis are enjoying pain relief and restoration of function more than two years after an intervention. What will follow next is a new approach for those with stage four osteoarthritis who have been told they need a Total Joint Replacement.
Stay Tuned.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenexx, Regenexx-SD, 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
Jun 11, 2015
Cellular Orthopedics for the Musculoskeletal injury and Degenerative Arthritis
What is the problem?
Trauma and Osteoarthritis are part of the cycle of life. Muscle, ligament and tendon injuries frequently occur during sports related activities or accidents; degenerative arthritis may be post traumatic by many years or occur as part of the aging process
What treatments are available?
As of today, it includes Platelet Rich Plasma (PRP) following several protocols and Bone Marrow Aspirate Concentrate (BMAC) rich in stem cells, growth factors and anti-inflammatories called Cytokines. As of next week, all may change as the Orthobiologic update taking place in Las Vegas over the weekend will potentially introduce an entire new menu of therapeutic intervention alternatives for musculoskeletal injury and disease.
What is Platelet Rich Plasma?
Platelets are part of your circulating blood producing growth factors that assist in repair and regeneration of tissue. When a high concentration of platelets are created via the centrifuge, healing may progress more quickly and pain may be reduced
What is Bone Marrow Aspirate Concentrate?
Taken form the back of your pelvis, aspirated bone marrow may be concentrated and prepared allowing for pain relief, improved function, a more rewarding quality of life, and possibly influence the Bio-immune response of degenerative arthritis
What is Amniotic Fluid Concentrate?
The source is the pregnant woman coming to term and delivering via Cesarean section. The recovered amniotic fluid is processed, concentrated, and now available as an alternative to Visco-supplemenation with hyaluronic acid. It is a new option and data concerning the length of pain relief is still being determined.
Do these Regenerative Medicine alternatives work?
When properly applied the answer is yes. What we don’t know is for how long? The effect of Platelet Rich Plasma in injury is intended to speed up the repair process. In the case of Amniotic Fluid, the outcomes are still being studied without a known end point. I have been involved in studying the clinical outcomes of Bone Marrow Aspirate Concentrate intervention for osteoarthritis. The paper I will be presenting this weekend confirms satisfactory results up to two years. The data collection continues.
Is there a downside side to Regenerative Medicine and Cellular Orthopedics?
In my experience the answer is yes and no. Yes because there is no indemnification for the new world of regenerative medicine; care is an out of pocket self pay undertaking because the field is new and five year outcomes data still not available. On the other hand, at three years, I have seen no adverse events and the vast majority have responded well with improved function and quality of life. Out of over 600 knees and over 100 hips, to the best of my knowledge, seven have gone on to a total joint replacement.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, C-SCP, Clinical Studies, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
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
Oct 20, 2014
We have been inundated with the fear of Ebola infections; the media has treated this as if each posting is to be a sensational headline in the National Inquirer. If the truth be told, your chance of acquiring an Ebola infection here in the US is about as likely as my winning the mega jackpot in the lottery. Fear Strikes Out was a marvelous film from the 50’s about a ball player overcoming mental disease; caution, you are being given mental disease by the sensationalism regarding Ebola and will succumb if not careful. What you should really be frightened about are hospital acquired infections. It has been estimated that in excess of one million MRSA infections take place in the US each year with in excess of 100,000 deaths. That doesn’t include the community acquired MRSA infections estimated last year at an additional 14%. The cost of Methicillin Resistant Staph Aureus infection last year exceeded 45 Billion Dollars Now what about C-Diff infections superimposed on those receiving antibiotics for hospital acquired infections, over 14,000 deaths last year according to governmental sources?
Regenexx published a study earlier this year in which not one single deep infection could be attributed to the minimally invasive methodology associated with a stem cell or similar cellular orthopedic procedure. In my practice, not only have I not recorded a deep infection, there hasn’t even been a superficial one reported. That’s not to say it may not happen in the future as I deal with Diabetics from time to time and patients with other immunosuppressive disorders; but I haven’t seen an infection yet in what is now approaching 400 procedures. I perform Bone Marrow Concentrate/ Stem Cell and related Cellular Orthopedic-Regenerative interventions in a surgi-center with all fluid manipulations in a sterile environment and under a sterile hood with a fully gowned RN. A joint replacement carries with a known infection rate. That incidence no longer is accurately recorded as the patient is promptly discharged from the hospital and the subsequent readmission for infection is not reported as associated with the recent joint replacement surgery
I have posted my results of Bone Marrow Aspirate Concentrate /Stem Cell interventions in this Blog on many occasions and compared the 18 month results to those of a knee replacement noting a lot more activity and recreational pursuits in the Cellular Orthopedic recipient group being realized. When a patient has advanced arthritis, a joint replacement is the treatment of choice. For those who want to continue or return to the highest possible age related profile, why not consider a stem cell procedure?
Tags: arthritis, Benefits and Risk, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative Pain Center, Regenexx, stem cells, treatment
