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 1, 2016
Actually, that future started last week when we used a more aggressive PRP adjunct at the time of two Bone Marrow Concentrate/ Stem Cell interventions; one for an arthritic hip and the other, in an arthritic knee. More accurate and descriptive would be a Bone Marrow Concentrate/Adult Mesenchymal Stem Cell/ Hematopoietic Stem Cell/ Growth Factor Concentrate/Platelet Rich Plasma/Interleukin-1 Receptor Antagonist cellular orthopedic intervention to an arthritic joint but even I get confused, so I will stick to cellular orthopedics and Bone Marrow Concentrate.
It would seem from current Regenerative Medicine Science, that while concentrated and activated Platelet Rich Plasma alone has not been provided a predictable and reliable independent approach to arthritis, when aggressively used in conjunction with stem cell interventions, PRP significantly enhances the results in the short term. It will require another several years to determine if what we are seeing in the short term will continue to improve our outcomes in the long run. I am not waiting as concentrating and activating the platelets will cause no harm; and if there is the promise of long term benefits when used as an adjunct both at the time of the Bone Marrow collection, concentration and intervention as well as again in two to five days, there is no reason not to proceed.
What about the future? While we have been great advocates of counting cells at the time of the stem cell intervention, new tools are being introduced to allow us to better customize that which we inject after concentrating and processing of the bone marrow. We now will be able to get a more accurate count of that which is present in the concentrated and processed injectate prior to the intervention and add bone marrow or platelets if indicated.
Are Mesenchymal Stem cells really Stem Cells? Professor Arnold Caplan of Case Western Reserve is widely considered the father of mesenchymal stem cells. He now takes the view that MSCs aren’t stem cells and that he should have never given them that name. He also believes that the primary function of these cells is paracrine, so he calls them “medicinal signaling cells”. To save you the trouble, paracrine is defined as “a form of cell-cell communication in which a cell produces a signal to induce changes in nearby cells.” I am not negating the importance of mesenchymal stem cells, rather I want the reader to better understand the role of each component involved with regenerative medicine. It was Professor Caplan’s prodding that in part is responsible for my having entered the discipline of interventional orthopedics. Long ago, we became friends as team mates of the Roosevelt High School championship football team in Chicago; and our professional paths, while parallel, he in basic orthopedic research while I chose orthopedic surgery finally crossed again five years ago.
To learn more about the basic science behind Cellular Orthopedics or to find out about how you might postpone or avoid a Total Joint replacement for an arthritic joint, schedule a consultation (312) 475 1893
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, cellular orthopedics, Clinical Studies, Concentrated Stem Cell Plasma, Growth Factor Concentrate, Growth Factors, Hematopoietic Stem Cell, Hip Replacement, Interleukin-1 Receptor Antagonist, knee arthritis, Mesenchymal Stem Cell, Mitchell B. Sheinkop MD, Orthopedics, Osteoarthritis, paracrine, Platelet Rich Plasma, Professor Arnold Caplan, PRP, Regenerative Pain Center, stem cells
Nov 21, 2016
The current marketing of amniotic fluid as a regenerative approach to arthritis based on delivery of
viable stem cells falls is no different than the bending of the truth behavior we recently experienced
in the run up to the presidential election. Did the campaigns of the candidates reinforce some
notion that facts don’t necessarily matter? It seems that every office session, a patient shares with
me their having accepted a free lunch in exchange for the promise that for $7,000 to $9,000,
Amniotic Fluid containing living stem cells may be injected into an arthritic joint to regenerate that
joint.
During my entire 40-year plus orthopedic surgical and now regenerative medicine career, I never
accepted a free lunch from the army of pharmaceutical and orthopedic sales personnel who show
up daily as these gifts are contrary to corporate compliance requirements; and obligate me to listen
to sales pitches, Medical decisions must be based on evidence based medicine. At this time, there is
no scientific evidence of living stem cells in amniotic fluid once that fluid has been harvested,
sterilized, fast frozen for storage and fast thawed when used.
Before going any further, I will make it clear that, when indicated, I use amniotic fluid in my practice; but I also will make it clear, not as a source of stem cells or regeneration. Amniotic Fluid contains 15
times more hyaluronic acid than any available drug; hyaluronic acid is marketed under many trade
names starting with SynVisc. When I believe a patient with an arthritic joint might benefit from
hyaluronic acid, the best methodology is amniotic fluid. As well, the latter may contain viable
growth factors that play a role in controlling the limitations imposed by arthritis. At issue is the
question as to whether it is worth $7,000 to $9,000 for “generic” hyaluronic acid; when in fact, in a
proprietary form is covered by health insurance and Medicare?
There is another alternative if you are interested in Amniotic Fluid as a source of Hyaluronic Acid
and Growth Factors for which there is no charge to you if you meet the clinical trial inclusion
criteria. I am the principal investigator in a national amniotic fluid clinical trial underwritten by a
large pharmaceutical company that started working with amniotic fluid in 2006. Their focus now is
the use of amniotic fluid in the arthritic knee and determining dose and the duration of efficacy.
Facts do matter and the company is willing to underwrite the costs for gathering medical evidence.
To learn if you meet inclusion criteria, make an appointment at 312 475 1893
Tags: amniotic fluid, arthritis, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, hyaluronic acid, Knee, Orthopedic Surgeon, stem cells
Nov 16, 2016
This week, I am repeating stem cell/growth factor interventions in two patients; one with arthritis of the
hip, and the other with osteoarthritis of both knees. Four years ago, at the initiation of my interventional
orthopedic practice, I spoke of adult mesenchymal stem cells alone but now we know that Bone Marrow
Concentrate has in addition to the adult mesenchymal stem cells, hematopoietic stem cells, growth
factors and platelets all playing a role in managing the symptoms and the altered functional impairment
attributable to osteoarthritis. The outgrowth is in new speak; namely, Bone Marrow Concentrate and not
just mesenchymal stem cells. When the two patients I alluded to were initially cared for, we had not yet
gained the understanding of the importance of platelets in the regenerative process. Platelets contain
the growth factors and those growth factors are responsible, in addition to Mesenchymal and
Hematopoietic Stem Cells, for regulating cartilage well-being. By having become aware of the
contribution following concentrated platelet rich plasma in conjunction with the bone marrow
concentrate intervention, I believe we are already seeing improved outcomes.
As well, subchondroplasty has been added to our menu of services and the latter is proving very
beneficial in the knee. To refresh your knowledge base, subchondroplasty is a procedure popularized in France where in bone marrow concentrate is injected into the bone marrow adjacent to a joint at the
same time that the stem cell, growth factors and platelet containing concentrate is intervention of the
joint itself is being completed. The value of intervening into the bone supporting the joint is the fact that
there is communication between the joint itself and the supportive subchondral environment. I have
addressed Adult Mesenchymal Stem Cells many times in previous Blogs as the orchestrater of the
healing process. Now we know that Hemopoietic Stem Cells from the marrow contribute as well. Growth
Factors such as Interlukin-1 Receptor Antagonist Protein (IRAP) are present in bone marrow and
circulating blood; It was IRAP alone that extended the professional basketball career of Kobe Bryant by
seven years for an arthritic knee. With an improved means of extracting and activating the growth
factors contained in platelets, the two patients I introduced in the opening sentences of this blog should
enjoy a very satisfactory return to function and recreation.
Interventional Orthopedics is a dynamic process and I continue to learn from the integration of clinical
research and my clinical practice. On Thursday, I will host two very interested scientists dedicated to
customizing biologic preparations and together we will explore how to further leverage scientific
advancements in creating autologous biologic preparations thereby optimizing the practice of
Regenerative Medicine.
Call 312 475 1893 to schedule your consultation
Tags: arthritis, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hematopoietic Stem Cells, Interlukin-1 Receptor Antagonist Protein, IRAP, joint replacement, Osteoarthritis, Platelet Rich Plasma, PRP, Regenerative Pain Center
Nov 1, 2016
The FDA again held a meeting to address issues pertaining to Regenerative Medicine. At the conclusion of the meeting, an updated set of guidelines was developed for patient protection in the use of stem cells, growth factors, and platelet rich plasma. While still being interpreted by the Regenerative Medicine community, what becomes clear is the call for better self-regulation. It is not ethical or acceptable for anyone holding themselves out to be practicing cellular medicine to hold a seminar, recruit a patient, inject some substance into a joint and request payment. Equally important are the credentials of that practitioner.
For the past four and a half years, I have followed the outcomes of all my patients using the same subjective and objective parameters in my practice of Interventional Orthopedics that I used to follow the results during my joint replacement career. Over that 37-year span, because of my data collection initiative, many new generations of Hip and Knee Prostheses were introduced into adult reconstructive orthopedic surgery. Statistical analysis of data allows for progress in care and development of new product. Today, I still gather outcomes data for each patient. That initiative has led to refinement and advances in the emerging subspecialty of Regenerative Medicine; both in my own practice and around the globe.
Anticipating the future, I am headed off this upcoming weekend to join a small group of those looking to the future in advancing the practice of cellular medicine. Up until now, our data collection and Outcomes registry was clinical in nature; in a short time, that data will also include cellular data. This latter is the next way to refine the practice of regenerative medicine.
By having tighter control over the composition of autologous PRP and BMC preparations for use in my practice of regenerative medicine, through comprehensive analysis of autologous patient samples, I will have a chance to see what levels of important constituents like Stem Cells, Growth Factors, Platelets, RBCs, WBCs, and so on are present in the preparation.
How might I take advantage of the data? The most obvious use would be for me to record values of your sample analysis in a spreadsheet and enter in demographic and clinical outcomes data. I will continue to enter your results of outcomes assessments obtained during follow-up visits that I routinely use to monitor your recovery. By applying this strategy to all patients I treat, an internal database will inform me about optimization strategies for treating my patients, allowing me to modify and customize the make-up of that which will be injected. Why go to the trouble, you might be asking yourself? Having a detailed knowledge of what I am injecting into my patient puts me in a position to refine my practice of regenerative medicine. And that is a good thing, since you the patient ultimately will benefit from my optimizing the use of autologous materials like PRP and BMC.
To schedule your appointment call 312 475 1893
Tags: arthritis, BMC, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, knee replacement, Osteoarthritis, Pain Management, Platelet Rich Plasma, platelets, PRP, regenerative medicine, stem cells, Ultrasound Guided Injection
