Dec 16, 2016
You no longer will even need a physician, and I have been wasting my Blog space crusading about quality assurance; making certain your Regenerative Medicine specialist is Board Certified and willing to provide outcomes data. According to a recent email I received, all one needs is “Online Training” to practice Regenerative Medicine:
If you believe this is FDA compliant, no longer does stem cell treatment need to be done by a highly trained, highly experienced specialist; you won’t even have to use a physician.“Everything gets commoditized, including training to do stuff” (personal communication).
I believe the most effective approach is to direct a patient with joint pain to my credentials—37.5 years of joint replacement experience, Board-certified, Emeritus Professor, four and a half years of Cellular Orthopedic experience, the largest most comprehensive outcomes data base on which to base my recommendations for care, while introducing an analytical program based on a FDA-audited analytical laboratory for assessing the quality of regenerative preparations. As for the latter point, I am now working with a team using a FDA consultant to create approved text that I will post on my website, highlighting the standards I have adopted for all phases of therapy.
I hate to conclude that the current practice of interventional orthopedics and regenerative medicine ultimately comes down to how flashy the website may be or a free lunch from the camp followers.
To watch my Webinar, access www.ilCellulartherapy.com
To make an appointment, call 312 475 1893
Tags: bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, joint replacement, Orthopedics, Osteoarthritis, Regenerative, Regenerative Pain Center, stem cell certification, stem cells, training
Dec 9, 2016
I started the day by reading the Steve Chapman article appearing in the Perspective Section of the Chicago Tribune, Thursday December 8. The title of my Blog this week is influenced by the header of his article and I admit I am paraphrasing some of that content. While his intent was not necessarily directed at the discipline of Regenerative Medicine, his statement” since the advent of the internet, truth doesn’t have a chance” really resonates with me. He goes on to state that in many of these internet claims, the idea of objective reality is obliterated. “The chief product is fiction masquerading as fact.”
Unfortunately, while Chapman was rendering his opinion in the political arena, what he opines is just as applicable in the world of Regenerative; but there are exceptions. As many readers of this Blog are aware, I have an existing web site www.sheinkopmd.com. I have tried to continually emphasize and repeat the Regenexx message; namely, that which we do is based on data, the integration of a clinical practice with a clinical research initiative. Yesterday, we forwarded our two-year outcomes data to Regenexx for statistical analysis. That data has been compiled in a clinical knee trial over the past four years wherein the Regenexx SD procedure was used in 50 patients with grades two and three osteoarthritis of the knee who met the inclusion criteria. Once statistically analyzed, I will submit that data for scientific publication, scientific presentation and it will be published on the Regenexx and my web sites.
To emphasize why it is so important for a patient experiencing arthritic related limitations be fully educated, let me share with you a relevant research letter recently published:
Survey: Many treatments prescribed despite little evidence of high value to patients.
Information from a research letter published in the Dec. 6 issue of the journal Annals of Surgery wherein researchers randomly surveyed 5,000 members of the American College of Physicians found that many prescribe costly treatments despite a lack of evidence supporting their use.
In surveying the internet this morning to see how badly fiction is masquerading as fact, I didn’t have to surf too far. The number of camp follower, non-specialist stem cell related web sites are of great concern. I hope the FDA shares my opinion. You can find treatment for arthritis, cancer, aesthetics, hair loss, sexual enhancement, and neurologic diseases all with one stop shopping. The web sites offer adipose derived stem cells and amniotic fluid containing stem cells. Missing from the offerings are outcomes data, scientific support and FDA compliance. Regenexx does it and so do I; namely, practice cellular orthopedics on a scientific basis under IRB oversite (a function of the FDA) with all intervention recommendations supported by scientific evidence.
To learn more, schedule an appointment 312 475 1893. You may view my webinar at ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Platelet Rich Plasma, Regenerative, regenerative medicine
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
