Feb 26, 2020
Well not really Stem Cells, but certainly Platelet Rich Plasma and Growth Factor Protein Concentrate. Knowing that the term Stem Cells attracts attention, I used it here so hopefully, you would read this Blog.
On Saturday, February 15, I departed for a week of skiing in Vail, Colorado. In anticipation of the sojourn, in Late December, I underwent an intervention into both of my hips and knees using Platelet Rich plasma derived Proteins termed Growth Factors. My last Blog explored The Recreational Impact of Biologics: Stem cells, Growth Factors and Platelet Rich Plasma. While I dedicate about 5 to 6 hours a week in pursuit of conditioning; two weeks ago, I returned to spin class at the gym after a five-year hiatus substituting the demands of one-hour spin class for the stationary bicycle. While the late December interventions provided pain relief in my hips and knees, I didn’t feel that I would stand up to the demands of Vail, even with my customary rowing ergometer and strength training routines. It took several classes but here I am in Vail returning to the thrilling days of yester-year on spectacular powder and runs.
Returning to the office this morning, it was time to sit down and finish writing this blog. My first act, en route, was to pick up a copy of the February 24, edition of Crain’s Chicago Business, anticipating the appearance of A ROUNDTABLE DISCUSSION ORTHOPEDIC MEDICINE. I had been selected as one of four Orthopedic Surgeons taking part in a question and answer platform. You may find the article quite informative and find it at CHICAGOBUSINESS.COM or find Crain’s Chicago Business wherever you purchase the daily newspaper. One particular question and answer is worth repeating. In response to the question “What new technologies and surgical techniques are you using?”; I responded “Biologics is the new technology that I use with a needle rather than a knife.” A second question and answer are worth repeating. “What insurance issues and concerns are common with orthopedic treatment?” “Recognizing the financial burdens imposed by some of my advanced technology offerings, I’ve created several affordable care alternatives.” Here is the link to the entire article: https://www.chicagobusiness.com/crains-custom-media/roundtable-discussions.
Now comes the readers’ choice. You may read the entire article by buying a newspaper; click the highlighted above; visit my web site at www.sheinkopmd.com or call and schedule a consultation (312) 475-1893.
Download Full Article Here
Tags: biologics, growth factors protein concentrate, regenerative medicine, stem cell intervention
Jan 13, 2020
DEFENSE HEALTH AGENCY 7700 ARLINGTON BOULEVARD, SUITE 5101 FALLS CHURCH, VIRGINIA 22042-5101 MEMORANDUM FOR DEPUTY CHIEF, READINESS AND HEALTH, BUREAU OF MEDICINE AND SURGERY DEPUTY CHIEF OF STAFF G-3/5/7, OFFICE OF THE SURGEON GENERAL DIRECTOR, MEDICAL OPERATIONS AND RESEARCH, OFFICE OF THE SURGEON GENERAL DIRECTOR, NATIONAL CAPITAL REGION MEDICAL
DIRECTORATE SUBJECT: Use of Regenerative Medicine Advanced Therapy (RMAT) Products Not Approved by the Food and Drug Administration (FDA).
Regenerative Medicine Advanced Therapy (RMAT) products not approved by the FDA have the potential to expose patients to unnecessary risk. One such product is injectable micronized dehydrated human amnion/chorion membrane (dHACM) used to treat conditions such as plantar fasciitis, tendonitis or osteoarthritis. Any of these products not approved by the FDA are considered investigational, at present. Therefore, effective immediately, all MHS facilities will stop using injectable RMAT products not approved by the FDA, including dHACM. Once the FDA has approved an RMAT product, further review will occur. The Veteran’s Administration has taken a similar action.
PAUL R. CORDTS, MD Deputy Assistant Director – Medical Affairs Defense Health Agency
At the same time I was made aware of the above Defense Department Memorandum, a patient called my attention to a brochure she had received in the mail on the same day recruiting “victims” to one of several offices in metropolitan Chicago treating patients with the very product that the Defense Health Agency classified as unapproved by the FDA and therefore prohibited for safe use. A day later. I received an e-mail from a health care provider out of state, a non-MD asking me about use of “stem cells and amniotic fluid in my office.”
Are these alleged members of the health care community charlatans, uninformed, or just plain dumb and dumber? “Beware, take care, of the Green-eyed dragon with 13 tails, he’ll feed, with greed”. There is only one FDA approved source of stem cells for arthritis available in the United States and I am pleased to have been designated a Clinical Investigator in the PSC Trial. You may read about it on my website at www.sheinkopmd.com or at www.personalizedstemcells.com . The other potential biologic alternatives that, to the best of my knowledge are approved at this time, involves using your bone marrow as a regenerative option for delivering Adult Mesenchymal Stem Cells, or Platelet Rich Plasma obtained from your circulating blood as resource for Growth Factors.
To learn more or to schedule a consultation, call (312) 475-1893
Tags: clinical trials, FDA approved stem cell research, regenerative medicine, stem cell research
Jan 3, 2020
The complexities inherent in biologics, cellular therapies, and stem cells as therapeutic entities are being been addressed at a number of levels. Thoughtful editorials, consensus statements, and even actions by state licensing boards, the FDA and the FTC for unprofessional conduct are starting to “drain the swamp.”
A large part of this growing industry consists of off-label uses; many in Regenerative Medicine seem to practice without FDA compliance. There are some indications where biologics and cellular therapies show genuine promise such as osteoarthritis, and my ongoing clinical research is conformational. Still owing to the bad actors, charlatans, and camp followers, substantive questions remain, including some basic concerns about safety, efficacy, cell sourcing and delivery, host response, and mechanism of action. There is only one way to approach this problem, and that is research with FDA governance (Personalizedstemcells.com).
In general, people thrive on novelty. We look for the latest and newest forms of treatment, hoping that the just-released remedy with the special formula will be the one to cure our problems and ease our pains. We do this as patients, and we do it as physicians. My major concern is that anyone licensed by the Department of Education and Registration may attend a weekend course, upload a web site, and begin fleecing an unsuspecting public.
Musculoskeletal disease and the resulting pain and loss of function are an invitation to the charlatans and camp followers: 20% of the population experiences arthritis and other serious musculoskeletal diseases. it’s not surprising that patients (and providers) will look anywhere for relief, and the bad actors will take advantage of an opportunity.
In the past, this approach has not worked well for many patients. The list of failed treatments for common musculoskeletal diseases is a long and sad one, from nutraceuticals to chelation therapy, and diets from alfalfa to zinc. At times, orthopaedic surgeons have not been careful stewards of clinical evidence—we continue to use viscosupplementation, despite the paucity of good evidence and we continue to use arthroscopic knee surgery in patients who should not have it. It would be nice, after all this, to get it right vis-à-vis stem cells and related treatments.
It appears that government sanctions, editorial sermons, and statements from specialty groups have not arrested the many dubious practice patterns we’ve all seen and too many patients experience. Witness the Amniotic Fluid debacle in Illinois last year perpetrated by the Bad Actors wherein patients were paying astonishing amounts of money (and taking yet-unquantified risk) for treatments that were of no benefit. The Amniotic Fluid marketed at seminars had and has no viable stem cells or biologics and cell therapies for regeneration of musculoskeletal tissues. The same holds true for Cord Blood and Wharton’s Jelly as evidenced by the epidemic of infections experienced in 2018 and 2019.
In this new decade, be informed, protect yourself, and seek out Board Certified Specialists in Regenerative Medicine if you want to postpone, perhaps avoid a joint replacement; or if you want to maintain or return to a fully active lifestyle. To schedule an appointment, call (312) 4745-1893. You may learn more at www.sheinkopmd.com.
Tags: biologics, cellular therapy, clinical trials, opinion on stem cell threeapy, stem cell therapy
Jul 24, 2019
I am pleased to announce that our clinic is being considered for enrollment in the first of its kind stem cell clinical trial for knee arthritis.
Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for treatment of knee arthritis with stem cells from a patients’ own fat. This is a tremendous honor since there is a limit of ten clinics around the country in the clinical trial. Our practice and our staff were selected by PSC due to our leadership and experience in treatment of orthopedic conditions, and our experience with regenerative medicine.
The clinical trial includes treatment, follow up, and cell storage for potential use in the future if, or when, additional treatments are allowed by the FDA. PSC has FDA inspected facilities, approved processing procedures, quality testing procedures, and cell storage and shipping procedures. More information about the clinical trial can be found HERE.
Our office will be receiving additional information in the near future regarding the details of the clinical trial.
Please contact us at 312-475-1893
Call 312-475-1893 if you are interested in being considered for this study and we will put you on the list for when we are able to start formal study recruitment and screening.
Click here to read the press release.
Jun 18, 2019
Continued hawking by commercial interests to an apparently uncritical group of healthcare providers and the willingness of patients to accept scientifically unfounded statements has made the utterance “I had stem cells” increasingly commonplace. I can not begin to tell you how much time I dedicate to explaining and debunking the myth that a patient can receive a “stem cell” injection at this time.
Stem Cells are found in almost every organ and tissue in the body but to be FDA compliant, those stem cells can not be separated from your Bone Marrow, Adipose Tissue or Circulating Blood and used in a clinical setting for an arthritic condition. As you might have read in my blog last week, a clinical trial is waiting to be approved that might make it possible to offer millions of stem cells for the care and treatment of arthritis but approval has not yet been granted by governmental regulatory bodies. As such, the use of Biologics continues to be based on concentrated Autologous Bone Marrow Aspirate, Micro-Fractured Adipose Tissue or the recovery and concentration and separation by filtration of Growth Factor Proteins from your circulating blood.
I have published major scientific studies based on the clinical outcomes of both Bone Marrow Concentrate and Micro-Fractured Adipose Tissue for the treatment of the arthritic knee. I am one of the few clinicians who has studied the effects of Bone Marrow Concentrate in Grades 2 and 3 Osteoarthritis of the knee and Micro-Fractured Adipose Tissue for Grades 3 and 4 Osteoarthritis of the knee. A third scientific trial, this one reporting the results of using Bone Marrow Concentrate in the bone supporting the arthritic knee joint (subchondroplasty) is in progress; while the preliminary ground work for a fourth publication reviewing outcomes of growth factors for arthritic joints who do not meet the inclusion criteria for other biologics is being developed.
In response to your belief that you had a stem cell injection; my response, “no you didn’t.” In most settings, it was a Platelet Rich Plasma injection; and that discussion will have to wait for another Blog as PRP warrants a separate discussion.
To schedule a consultation, call (312) 475-1893. You may visit my web site at sheinkopmd.com
May 15, 2019
The New York Times: 2019/05/13 “Stem cell Treatments Flourish with Little Evidence That They Work”
Several years ago, I asked a question of a cellular biologist as to how is Bone Marrow Concentrate effective if the number of adult mesenchymal stem cells diminish as we age? His response: “Bone Marrow contains lots of things including stem cells and proteins called cytokines or growth factors. It may be that the growth factors are most important in joint restoration and blocking pain.”
Let’s take for example, inflammatory arthritis such as Rheumatoid and Psoriatic arthritis. The common denominator is a pro-inflammatory cytokine called Tissue Necrosis Factor found in the body’s immune system. The growth factor, TNF-alpha blocker is now used to control the inflammation and alter the body’s immune response to the proinflammatory protein. As a result of TNF-alpha blockers, Phil Mickelson is a very competitive golf professional, (You have seen him as a spokes person for Psoriatic Arthritis treatment with Humira). Since the introduction of TNF alpha blockers in Scandinavia five years ago, there has been a 40% reduction in Total Knee Replacements for inflammatory arthritis. When Kobe Bryant traveled to Dusseldorf, Germany almost nine years ago, he received treatment for a very arthritic knee with Interleukin -1 Receptor Antagonist Protein, along with other blockers. Shortly thereafter, he returned to play another five years in the NBA. The IRAP that Bryant received was and is an anti-inflammatory, a growth factor blocker, a cytokine.
As I agree in part with the criticism in the New York Times concerning Stem Cells, those who read this Blog will recall that I don’t “sell” stem cells. Bone Marrow is used in part because of the fact that it contains stem cells; but more importantly as we age, Bone Marrow contains Growth Factors, the anti-inflammatory protein Cytokines that restore a joint by minimizing pain and improving function. Over the last eight years, we have accumulated the evidence that Bone Marrow Concentrate works for arthritis via stem cells, growth factors, or all of the above. Recently we have taken a major step forward by filtering high concentrations of Growth Factors from the Platelet Poor Plasma, previously discarded, that remained after we centrifuge the bone marrow and add the filtrate to that which is injected into the painful joint. Stem Cells maybe, highly concentrated Growth Factors that act to block pain and improve function, for certain.
You may learn more by visiting my web site at www.sheinkopmd.com or call for a consultation (847)390-7666
Tags: ACL, ACL Injury, anterior cruciate, arthritic knee, arthritis, Autologous Protein Concentrate, BMC, board-certified, Bone Marrow Concentrate, bone marrow edema, cells, cellular orthopedic, cellular orthopedics, FDA, Growth Factors, hematopoietic cell, inflammatory arthritis, injection, Interleukin 1 Receptor Antagonist Protein, IRAP, joint health, joint pain, knee replacement, Kobe Bryant, meniscal injury, meniscectomy, Mesenchymal Stem Cell, micro-fragmented adipose, muscle injury, muscle strain, nterleukin -1 Receptor Antagonist Protein, OA, Orthopedic Surgeon, Osteoarthritis, pain, Physical Therapy, Platelet Rich Plasma, platelets, pro-inflammatory cytokine, PRP, Psoriatic Arthritis, regenerative medicine, repair, Rotator cuff tear, sports injuries, sports medicine, stem cells, strain, tear, Tissue Necrosis Factor, TNF alpha blocker, torn medial meniscus, training
