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 23, 2015
When a patient presents with advanced arthritis of the knee as confirmed by physical assessment and radiographic findings classified as Kellgren/Laurence 3 or 4, the standard approach has been a Total Knee Recommendation (TKR). Inherent in the outcome of any large group of patients who have undergone a Total Knee Replacement is a 40% dissatisfaction rate because of continued pain and failure to restore a functional range of motion. In addition, there is the risk of infection, blood clot (check the source) and repeat (revision) surgery starting at three years. The Regenerative Medicine alternative carries with none of the adverse potential consequences and unsatisfactory potential outcomes when compared to the surgical option. By using a needle and syringe rather than a scalpel, implant and complex surgical intervention, Cellular Orthopedics offers the patient a minimally invasive outpatient solution with virtually no risk. No bridges are burned and instead of a complex and costly revision associated with failure of a knee replacement ,the Regenerative Medicine recipient has the option at some time in the future of repeating the minimally invasive procedure or crossing over to a primary Total Knee Replacement. Our research data while tracking patient outcomes with other regenerative medicine options documents superior outcomes when compared to the result of a knee replacement. What we offer is the stem cell option for patients with advanced osteoarthritis for whom here-to-fore there have been few choices.
At our Center, we offer a range of minimally invasive options starting with cross-linked hyaluronic acid. Should the result of such prove unsatisfactory or not long lasting, the next step may fall under the world of Amniotic Fluid Concentrate. There is then the Platelet-Rich-Plasma series of options followed by the Bone Marrow Aspirate Concentrate intervention process. What is new and very exciting is the concept of Subchondroplasty (SCP). This latter intervention has proven a marvelous adjunct in Europe and now is available to us in the United States. The role of SCP is to improve outcomes of intervention for arthritis and to extend the indications for Regenerative Medicine. We are now introducing the latter in our treatment algorithm. Wherein we will differ in incorporating Subchondroplasty into our Minimally Invasive approaches is that we will use orthobiologics rather than synthetics to help rebuild the bone supporting the joint while addressing the arthritis with Bone Marrow Concentrate. To learn more, schedule a consultation.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Jul 13, 2015
Cartilage is known to be damaged by Interleukin-1B (IL-1B), a cell signaling protein responsible for blood-induced cartilage damage. When there is trauma to a joint and a hematoma ensues, the faster the hematoma is evacuated, the less damage to cartilage long term. The blood in the joint now provides an explanation as to why some years after an injury, a patient will present with an osteoarthritic joint. An example is the tear of the Anterior Cruciate Ligament. Findings in the research laboratory also indicate that the faster the blood is removed from the injured joint, the less damage to the cartilage. To emphasize the harm from IL-B1, we are experiencing increased number of patients with a history of an ACL tear who are in need of intervention for post traumatic arthritis at younger ages than in the past even when the ACL has been successfully repaired.
Turning our attention to fractures within the joint, it is important for orthopedic surgeons to realize the impact of blood on cartilage. There is an upregulation of cartilage-degrading enzymes suggesting that the indications for surgical repair of an intra-articular fracture should be expanded and the surgery considered urgent and not delayed. There is an additional adjunct that should be introduced into the algorithm of care of the joint injury and resulting hematoma; namely, Bone Marrow Aspirate Concentrate. Interleukin-1B Receptor Antagonist Protein serves as a dose- and time-dependent protection from blood-induced damage. The higher the concentration and the earlier the introduction, the less cartilage damage sustained. When Bone Marrow is aspirated, recovered with the Mesenchymal Stem Cells (MSCs) are those cells in the bone marrow that produce Interleukin-1 Receptor Antagonist Proteins (IRAP). When the aspirate is concentrated, included in the centrifugate along with the MSCs is a therapeutic quantity of IRAP and that means stopping the degradation of cartilage by the harmful blood born Il-1B.
So what is my take home message? The swollen joint after trauma needs to be aspirated as quickly as possible to remove blood. The intra-articular injury to a joint must be addressed either by surgery or non-operative means on an urgent basis; intervention should not be considered elective. Bone Marrow Aspirate Concentrate should be increasingly used as an adjunct in the care of a joint injury. Should you experience that joint injury, discuss using Bone Marrow Aspirate Concentrate as an adjunct. If your orthopedic surgeon is unfamiliar, once the damage is acutely addressed, call us to see if there is a place for Cellular Orthopedics as a means of improving your long term outcome.
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, Knee, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, 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 29, 2015
As written a week ago, I attended a Regenerative Medicine International Conference in Las Vegas for the purpose of presenting a scientific paper that has generated a lot of interest and may influence how others practice Regenerative Medicine for arthritis. The meeting also served as a vehicle of continuing Cellular Orthopedic Education. The science of cellular biology is dynamic. It has been a major undertaking for me these past several years not only to have exchanged the scalpel for a trochar needle when managing arthritis but to reeducate in the basic science cellular biology.
Three years ago, the Adult Mesenchymal Stem Cell was thought of as a precursor cell directly responsible for replacing cartilage in the arthritic joint. The thought at the time was that the Stem Cell would take on the characteristics of whatever environment into which it happened to be placed and morph into that tissue or organ. In just three years, scientists have changed their thinking based on continuing research. The Mesenchymal Stem Cell (MSC) is no longer looked at as a progenitor but rather, a Medicinal Signaling Cell directing the body’s response to injury. When placed into a joint, it signals molecules and cells from the local environment and from distant locations to alter the bio-immune response of osteoarthritis, act as an anti-inflammatory, relieve pain, improve function and perhaps regenerate cartilage. We have also learned that while one Bone Marrow Aspirate Concentrate intervention causes improvement, several may be the answer over an 18 to 36 month period. In addition, there is increasing evidence that not only should the joint itself be addressed but the bone immediately adjacent to the joint as well. In the orthopedic community, Subchondroplasty has been applied over the past several years for the patient with a painful joint, relatively “normal” X-ray and an MRI compatible with bone marrow changes in the bone adjacent to the painful joint. That core decompression might be visualized as a dentist relieving the pain and pressure of a cavity by drilling. In the case of the dentist, the resultant void is filled with a synthetic material. In the case of the orthopedic surgeon, the cavity created by drilling is filled with calcium phosphate. At Regenexx Chicago, – my practice, I will introduce the subchondroplasty, a minimally invasive needling for the bone adjacent to the joint in addition to the joint itself filling the voids created in the bone as I fill the arthritic joint with Bone Marrow Aspirate Concentrate. The Europeans have documented success and I will be able to improve results and extend indications with Bone Marrow Aspirate Concentrate for the arthritic joint and now the surrounding bone.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Osteochondritis Dissecans, Pain Management, 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
