Apr 7, 2017
I have purposely used the terms interventional orthopedics and cellular orthopedics when referring to regenerative medicine to remind my reader that I am an orthopedic surgeon. Later in life, I graduated into my present role as a clinician seeking to assist a patient in postponing, at times avoiding a major surgical procedure for an arthritic or otherwise compromised joint. You will note that I limit my discussion and topic matter to the musculoskeletal system and, do not allow vanity or greed to suggest that I am willing to expand my scope of care directed to conditions and diseases for which I am willing to provide treatment. In my 37-year commitment to reconstructive orthopedics and joint replacement surgery, I did not increase my scope of services outside the musculoskeletal system and I won’t consider anything more in my regenerative medicine undertakings, today.
To take things a bit further, when it comes to cartilage damage in any joint and from any causation, there are three categories of care: Palliative, Reparative and Restorative. In the first category, palliative, I do offer anti-inflammatory prescription, cortisone injection and hyaluronic intervention. At times, for those who meet inclusion criteria, I even enroll patients in an amniotic fluid clinical trial for pain management when deemed appropriate knowing there is no regenerative or even reparative potential therein. Reparative may take place during a Bone Marrow Concentrate procedure; but my goal is Restorative (Regeneration). The only FDA complaint method for delivering stem cells to an arthritic joint is the use of your aspirated and then concentrated bone marrow from your pelvis. In spite of the misleading and false news to be found on the various web sites, in order for stem cells to be separated from fat, an enzymatic digestion must take place and that manipulation renders adipose derived stem cell usage contrary to FDA mandates. Furthermore, there is no published scientific literature demonstrating adipose derived stem cells are of value in the care and treatment of an arthritic or otherwise altered joint function.
When you decide to seek out a provider of regenerative services, a very important part of the decision- making process should be to question that provider as to whether services are limited to the musculoskeletal system and what outcomes and data of that particular practice experiences? I have noted recently that my data and outcomes are being posted on web sites around the country as if the results were being achieved in settings other than mine.
If you want to learn more about postponing or perhaps even avoiding surgery for a joint that alters your quality of life, call 312-475-1893.
To learn more, check out my web site at www.Sheinkopmd.com
View my webinar at www.ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, joint pain, joint replacement, Knee, knee pain, regenerative medicine, stem cells
Mar 16, 2017
As most readers of this Blog already know, for more than 37 years, I was a reconstructive joint replacement surgeon at a major Chicago medical center, where I served as the director of the joint replacement program. I retired as emeritus professor seven years ago; after having pioneered the integration of a clinical practice with joint replacement research and education. While I had completed over 20,000 hip and knee replacements during my career and played a major role in authoring over 85 major orthopedic publications, one of the highlights of my career was the recognition by the resident staff of awarding me the teacher of the year award in orthopedic surgery. At the same time, I had the opportunity to share my joint replacement knowledge around the world. I addition, many orthopedic surgeons from across the globe would come to observe and learn my techniques. One such group came from Norway. What I learned from them during their visit was that no procedure would be allowed within the scope of the government health care system for which there wasn’t a ten-year outcome data base. Their health care system wouldn’t pay for that which didn’t have a track record and for which there wasn’t safety and efficacy studies.
I am continually amazed at the epidemic of web sites promising regenerative medicine treatments for which there is no data of success and for which there are no safety and efficacy studies. This false news seems to be an increasingly common phenomenon; more bothersome though are anecdotal outcomes cited in media placements without a scientific foundation. Last week, a major news outlet focused on a patient who had received stem cells in amniotic fluid. The hospital PR division scored a major success by placing the ad; but the Television Channel that broadcast the story apparently failed to do any independent scientific investigation to support the claims of living stem cells in commercially available amniotic fluid concentrate. The center behind the placement and the physician involved must have been influenced by the false news now commonplace; namely, amniotic fluid has living stem cells when concentrated, sterilized, irradiated, cryopreserved and fast thawed. Certainly, the video of the patient climbing stairs was a tribute to the success of the procedure; however, the success of unknown duration had nothing to do with the claim that the end result was based on regeneration attributable to stem cells.
Amniotic Fluid Concentrate has good things in it but not viable, living stem cells and there is no regenerative potential. I am able to so state as I am the principal investigator in a national ongoing amniotic fluid clinical trial to determine safety, efficacy, duration of effect and appropriate dosage.
To schedule an appointment call (312) 475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com
Tags: amniotic fluid, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, cryopreserved, Interventional Orthopedics, Osteoarthritis, regenerative medicine, stem cell treatment, stem cells
Feb 4, 2017
Options for treating patients with osteoarthritis of their joints are historically limited to pain medication, anti-inflammatory medications, steroids, physical therapy, chiropractic care, or any combination thereof. These treatments provide temporary symptom relieving care, but do not offer therapeutic benefit in altering the degenerative disease progression. While pain medication, steroids and anti-inflammatories may help temporarily with pain management, they do not have a long-lasting impact on healing of articular cartilage in the arthritic joint. Without a regenerative therapy, the osteoarthritis will continue to progress, and ultimately will result in a total joint replacement as the only option to manage pain. While the majority of joint replacements have proven successful, there is an inherent complication risk; sufficiently significant enough that a patient prior to surgery might want to look for a means of postponing, perhaps avoiding a joint replacement. A treatment that might slow or even reverse the degenerative process. Four and a half years into my Cellular Orthopedic initiative, I believe the evidence I have compiled supports the use of the patient’s own concentrated bone marrow derived cells (BMC) in combination with the patient’s own concentrated Platelets and Plasma as an alternative to a major joint replacement.
Accomplished in a surgi-center under local anesthesia, an intra-articular injection, with image confirmation of needle and orthobiologic placement, is performed with Concentrated Bone Marrow mixed with concentrated Platelets and Plasma. Recently, based on publications in the scientific literature, I have added a subchondroplasty, that is an injection of some Bone Marrow Concentrate and Platelet Rich Plasma Concentrate into the bone adjacent to the joint. After six months of having introduced the subchondroplasty when indicated to the intra-articular injection, the presumptive evidence encourages me to continue the combined procedure. I started with the knee and I have extended subchondroplasty to the hip and shoulder.
When I began the combined procedure, that is injecting Bone Marrow Concentrate into the joint as well as into the bone adjacent to the joint, I limited the indication to patients under age 60. In August of 2016, a clinical paper was published reviewing the results of said interventions into patients older than 60; Total Knee Arthroplasty versus cell therapy in bilateral knee osteoarthritis in patients older than 85 years. Space doesn’t allow me to reproduce the entire article but in those patients who had a TKR on one side and a combined intervention into the knee and into the bone supporting the knee with Bone Marrow Concentrate, the majority of patients expressed a preference for the stem cell therapy.
To learn more or schedule an appointment, call (312) 475-1893
You may visit my blog posted on my website www.sheinkopmd.com
You may view my webinar at www.ilcellulartherapy.com
Tags: arthritic pain, arthritis, Bone Marrow Concentrate, Interventional Orthopedics, Osteoarthritis, stem cells
Jan 27, 2017
There are approximately 2,500 Adult Mesenchymal Stem Cells per mL of Bone Marrow Concentrate on average according to the work of Dr. Phillipe Hernigou in Paris. It leads me to conclude that unconcentrated bone marrow aspirate doesn’t have enough MSCs per unit volume to contribute to a therapeutic potential in a consistent manner. The way MSC counts are done is by assaying Colony Forming Unit-Fibroblasts (CFU-F) from samples taken from the BMC at the time of an arthritic intervention. This is a retrospective look as the CFU-F assay is done by culturing for seven to ten days with a sample of the injectate at the time the intervention with concentrated bone marrow is completed.
Is this too much information? Many patients ask me relevant questions so I thought I would try to clarify. Why don’t I just inject bone marrow concentrate into a vein? Mice were injected in a laboratory using both a vein or an artery and the cells were tracked over time. When using a vein, a significant entrapment of cells was found in the lungs. When using an artery, the entrapment of cells was at a site of injury or disease but not in a joint. Finally, delivering cells directly to the arthritic joint kick starts the repair process offering the best possible outcome.
Why don’t I use or even recommend cultured cells? If cultured cells are used, this procedure goes beyond the realm of minimal manipulation and proves contrary to FDA guidelines. In addition, culturing cells can potentially alter the properties of the cells. It is also important to remember that Mesenchymal Stem Cells have better homing capabilities, compared to their culture-expanded counterparts.
Why is Bone Marrow Concentrate so much more effective than Platelet Rich Plasma? Recent publications have documented that interleukin 1 receptor antagonist protein (IL1-ra), an anti-inflammatory protein is over 22 times higher in BMC than PRP. Additionally, the immune capacity of bone marrow is such that infection is rare when Bone Marrow Concentrate is used.
We are dedicated to providing patients the best possible care in regenerative medicine. The laboratory I use is registered with the FDA. The process I employ has cleared two FDA audits with no issues. Based on the platform I employ, we offer our patients customized interventions, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 27 parameters) which I review prior to injection. The knowledge allows me to make adjustments based on almost five years of experience in Interventional Orthopedics and 37 years as a joint replacement surgeon. No other Regenerative Medical program or practice may make this claim.
To learn more call (312) 475-1893 to schedule a consultation
View my web site at www.sheinkopmd.com
Watch my webinar at www.ilcellulartherapy.com
Tags: Bone Marrow Concentrate, PRP, stem cells
Jan 20, 2017
Last week, a patient who had enrolled in the initial Regenexx Stem Cell Clinical Trial for an arthritic knee visited the office for his five year follow up. He had never paid a nickel out of pocket other than obligatory office co-pays for the intervention. Five years after the administration of concentrated bone marrow, he shared his dissatisfaction with the five-year outcome indicating he had scheduled a total knee replacement because of the ” failure”. The same week, four years after another patient had undergone a bone marrow concentrate intervention for his arthritic hip on a fee for service basis, the patient thanked me for having assisted his return to an active lifestyle. With the return of some symptoms, he asked that I repeat the procedure and help him delay a total hip replacement for another four years, perhaps longer.
What is the benchmark of success when it comes to a cellular orthopedic intervention? On the one hand, five-year postponement and electing to undergo a joint replacement or four years of enabling an active lifestyle and then repeating the intervention. From the humanistic side, the unhappy patient always had a demand and a complaint when seen over the five years while the positive patient always had a smile and a thank you.
Over the several years since beginning my Interventional Orthopedic Practice, I have significantly improved the techniques and technology. In addition, over the last month, I have added the technology enabling customization of the injectate with the addition of the Hemoanalyzer to our algorithm. As in any outcomes analysis, there is the subjective component and the objective component. The ultimate determinant as I see it is the activity profile and scoring.
My Interventional Orthopedic practice is focused on protecting my patients from unproven treatments that may be harmful and unethical, financially exploiting the public; First No Harm. Witness the seductive newspaper ads placed by non-MDs offering stem cells for regeneration using amniotic fluid. I am compliant with federal regulations and the Principal Investigator in a national Amniotic Fluid Clinical Trial. From a scientific perspective, while amniotic fluid may be beneficial for six to 18 months, the proper dosage has yet to be determined and there are insignificant living stem cells in that which is being offered. Also, note that tissue-based stem cell products may not be administered in the absence of an FDA approved indications or approved research protocol.
My Regenerative Medicine, Interventional Orthopedic practice is evidence based and everything that I do is under IRB protocols; that is FDA oversite.
To learn more, you may schedule a consultation by calling 312 475 1896
View my website www.sheinkopmd.com
View my webinar at www.ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, stem cells
