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
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
Jul 30, 2015
As I have written in this Blog, the explanation of how a Stem Cell orchestrates change is dynamic with a shift in scientific thinking from the stem cell as a progenitor to the stem cell acting as a Bio-immune moderator and as a Medicinal Drug Store affecting lots of other cells. So too is there an evolution in the role of Amniotic Fluid Concentrate and that of Adipose Derived Stem Cells.
I will start with Amniotic Fluid Concentrate (AFC). In the beginning, the AFC was introduced in the marketplace as a source of viable stem cells to be positioned as an alternative to Bone Marrow Aspirate Concentrate. That introduction of Amniotic Fluid Concentrate followed success in healing chronic wounds associated with Diabetes and vascular insufficiency. The producers and manufacturers of AFC recognized an opportunity to introduce their product as an alternative for treating arthritis. At first, the commercial approach was to market the concentrate as a source of viable stem cells. Within six months though, reason prevailed and the Amniotic Fluid Concentrate was repositioned in the marketplace as an alternative to Visco-supplementation; a joint gel so to speak with longer term and a higher percent success rate than that with Hyaluronic Acid options.
Three years ago, the notion of Adipose Derived Stem Cells (ADSC) was rarely researched or commented on as an option for arthritis since the FDA had made it clear that in order to not be classified as a Pharmaceutical, an orthobiologic could not be manipulated or expanded. Until recently, in order to liberate the stem cell from adipose tissue and make the cells biologically available, the product of lipo-aspiration would have to be treated with an enzyme, collagenase for four hours. This would violate the FDA mandate of no manipulation and the four hour rule for reintroduction into the body. Over the last several months, at least two companies from Europe have introduced a mechanical means of allegedly liberating Mesenchymal Stem Cells from Lipo-Aspirate and thereby making it readily available and FDA compliant. How the FDA ultimately interprets mechanical emulsification cannot be predicted. Additionally, how MSCs from adipose tissue clinically perform when compared to MSCs derived from Bone Marrow Aspirate will be a matter of great debate. This alternative could be directed to those too far advanced to benefit from Bone Marrow Aspirate Concentrate.
What is subchondroplasty? For another Blog.
My office has been asked to play a role in clinical investigation of the several alternatives I have reviewed in this Blog. Protocols are under development and await IRB approval. To learn more about the present and future of the non –operative care of arthritis at any stage, make an appointment
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, 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 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
