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
Jan 6, 2017
In reviewing the plethora of proliferating Regenerative Medicine web sites, I found one with multiple points of service in metropolitan Chicago offering platelet rich plasma, fat graft, adipose derived stem cells and bone marrow derived stem cells in an office setting for the treatment of ALS, Alzheimer’s, Erectile Dysfunction, Alopecia, Autism, Cerebral Palsy, Aesthetic improvement and so on and more. There was no end to the promises advanced. At no time was there any evidence of success posted and absolutely no data.
For the first 37 years of my orthopedic practice, I collected outcomes data for every patient in whom I performed a hip or knee replacement. Prior to a surgical procedure, I provided the patient with meaningful outcomes data concerning success and length before a revision surgery might be required. That scientific documentation was scientifically published and used globally for informed consent by orthopedic surgeons around the world. Anticipating the future, actually the present if you live in Alabama, not only do I quantitate that which is injected into an arthritic joint, I am able to qualitate the injectate. I refer to Alabama because that State requires a physician to know exactly what is being injected into a patient when a she or he administers such or the physician is not complaint with that state’s law. With the incorporation of Abbott’s Ruby hemoanalyzer into my Cellular Orthopedic practice, I meet ethical, moral, legal and scientific guidelines and anticipate what I believe will shortly become an FDA compliance requirement. My practice is limited to that which has data to support my recommendations for a symptomatic, arthritic joint; while at the same time documenting the quality and quantity of the combination of Bone Marrow Concentrate, Growth Factors and Platelet Rich Plasma I am injecting.
There is the beginning of an initiative to comply with an anticipated more stringent oversite by the FDA concerning the developing subspecialty of Interventional Orthopedics and I am thrilled to be part of that small group. The FDA is a governmental agency responsible for the well-being, health and safety of the public. While likesome charlatans might get by in the short term, I am thrilled to be part of this initial group of responsible Board Certified Orthopedic Surgeons, Physiatrists and Pain Management specialists providing scientifically supported, FDA compliant, Cellular Orthopedic and Regenerative Medicine options in Sports Medicine and for management of an arthritic joint.
You may schedule an appointment by calling 312 475 1893
My Website is reached at www.Sheinkopmd.com
You may watch my webinar at www.ilcellulartherapy.com
Tags: Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Knee Pain Relief, Platelet Rich Plasma, PRP, stem cells
Dec 26, 2016
On October 28, 2013, I received IRB approval for a clinical trial with Regenexx Sciences, LLC as the sponsor and me as the Principal Investigator. The study, A Randomized Controlled Trial of Regenexx SD versus Exercise Therapy for Treatment of Knee Osteoarthritis with Historical Comparison to Total Knee Arthroplasty, was undertaken by me because of my recent “graduation” from joint replacement surgery to the new world of interventional orthopedics and because of my 37-year history as a joint replacement pioneer. Earlier this month, I was able to begin forwarding outcomes data to Regenexx in Broomfield, Colorado, for statistical tabulation. The results of this trial will not only impact what and how the Regenexx Network will make interventional recommendations, as the first and most comprehensive study of its kind, it will serve as the basis for comparison of all ongoing and future Regenerative Medicine methodologies for the care and treatment of the arthritic knee.
From Stem cells to Growth factors, the integration of our clinical research and clinical practice is having a major impact within the field of interventional orthopedics. Our results are allowing patients to return to activities they enjoy using a needle instead of a knife. I do not claim to be a cellular biologist but my network now allows me insight into the latest cellular advances. With the incorporation of the Abbott’s Ruby cell counting system into my clinical practice, I now customize the Bone Marrow Concentrate to the individual needs of a patient and thus not only quantitate but qualitate that which I inject into an arthritic joint.
Many Musculoskeletal injuries and certainly arthritis, do not heal with conservative management and historically required surgical intervention. The most contemporary method of effecting healing and regeneration is both Platelet Rich Plasma and Bone Marrow Concentrate. If you take a second look at the title of the clinical trial cited above, you will see the complete title ends with “Historical Comparison to Total Knee Arthroplasty”. The control group for the trial were patients with an arthritic knee in whom I had performed Total Knee Replacements during my surgical years. I am one of the few Orthopedic Surgeons who have experiences both in joint replacement surgery and interventional orthopedics. The majority of stem cell recipients have returned to activities they enjoy; the majority of Total Knee recipients are couch potatoes. When the numbers become available after statistical tabulation, I will post the data on my Blog.
Recently, I became aware of a relatively new web site www.Desirelist.com. The web site allows you to discover, capture and list all you may desire with a high probability of realizing your desires. So, I went on line and listed that which I want for my patients in 2017; namely, Internal Peace in a World at Peace. Where I can make a difference for those limited by arthritis of a major joint , and deliver on your desire for an improved quality of life is through Regenerative Medicine and Interventional Orthopedics.
Happy Chanukah, Merry Christmas and Happy and Healthy New Year
Tags: ACL Injury, arthritis, athletes, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Hip Replacement, Orthopedic Care, stem cells, treatment
Dec 19, 2016
I use bone marrow derived stem cells because they have been proven to be most effective at treating orthopedic conditions when compared to adipose derived stem cells. There have been 13 papers published showing bone marrow superiority to adipose tissue in regards to treating orthopedic conditions and to the best of my knowledge, none reporting adipose derived results for arthritis. In addition to Adult Mesenchymal Stem Cells, bone marrow has 1,000-10,000x more hematopoietic stem cells than adipose tissue; the former is necessary for muscle repair. Recently, we learned that bone marrow also has osteochondral reticular cells which are not found in adipose tissue and serve as orthopedic repair cells. While adipose tissue and bone marrow both have stem cells, the skeletomuscular specific cells only found in bone marrow make it the best at treating orthopedic conditions. I don’t have a stake in doing bone marrow derived stem cells, I practice evidence based medicine and do what’s been shown to provide the best results. If with continued research something superior to bone marrow derived stem cells becomes available, then I will gladly adopt that protocol.
http://www.regenexx.com/fat-vs-bone-marrow-stem-cell-video/
- As I have reported on this Blog many times, research has shown the amniotic fluid samples being marketed as having stem cells actually do not have any viable stem cells when received and viewed in the laboratory. I do use amniotic fluid concentrate from time to time for its concentrated hyaluronic acid effect.
http://www.regenexx.com/amniotic-stem-cells-great-deception/
- Since we manually process bone marrow when aspirated, I am able to customize PRP which we call SCP or super concentrated platelets. The ubiquitous beside centrifuge only has one setting for volume and concentration so those using this approach are treating every patient without concern for individual differences. With the addition of the Abbott Ruby Hemocytometer, I am able to customize the treatment of the individual patient. We can concentrate our SCP from 3-40X over baseline-with or without red or white blood cells. From my outcomes data base, I know what volume and concentration works best for treating the various body parts.
- We’ve developed HD BMC or high dose bone marrow concentrate which is far superior to that produced with bedside centrifuges used by most claiming expertise in Regenerative Medicine
- I perform BMAs in compliance with the peer-reviewed literature recommendations as well as in keeping with my internal best practices research to maximize MSC yield. As stated, I count cells and know the quality in addition to the quantity of the injectate. Most doctors don’t count cells and have no idea what dose they are giving their patients
Tags: adipose tissue, amniotic fluid, arthritis, BMA, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Mesenchymal Stem Cell, MSC, PRP, Regenerative, SCP, stem cells
