The number of options for regenerative medicine continues to multiply in metropolitan Chicago so the patient seeking the best alternative must remain ever vigilant. A two-day course basically allows anyone with a medical license to become an immediate “expert”. Incidentally, several of these national course directors recently lost their medical licenses and are waiting to learn if the next step will be prison. Another course director was exposed as not having a medical license. One on the other hand, may always travel off shore for a two-day meeting to allow for the building of a web site offering regenerative medicine options.
What differentiates my approach to Cellular Orthopedics is the fact that I am one of the first and few orthopedic surgeons who has dedicated a practice to regenerative medicine. Second of all, I now have over five years of clinical experience assisting patients impacted by arthritis with postponing and at times, avoiding a joint replacement. Most important is our integration of clinical outcomes with a constant upgrading and improvement in clinical results. That data collection methodology is what led to the invitation for me to introduce Cellular Orthopedics to the September, 2017, meeting of the Russian Orthopedic Association in St Petersburg attended by 1500 orthopedic surgeons from Russia, Ukraine, and surrounding countries in Eastern and Central Europe and Asia. Our outcomes data has additionally provided the material enabling two major regenerative medicine scientific manuscripts to be submitted to peer reviewed orthopedic journals.
While a patient may find many regenerative providers on the web or in the media, there is no one in the field of Cellular Orthopedics who provides our expertise and experienced decision making from evidenced based stem cell outcomes. As in everything in life, we strive to do better. The next step is an upgrade in our qualitating that which is being injected into an arthritic joint so as to allow customization. I am happy to announce that a newly upgraded and expanded laboratory will enable me to offer the latest advances in the field of Cellular Orthopedics and envision the future.
If you are experiencing pain and limitation in function from osteoarthritis, call and schedule a consultation 312 475 1893 or watch my webinar on the website Ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, stem cell treatment
The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells.
Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.
“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”
The clinic is one of many around the country that claim to use stem cells derived from a person’s own fat to treat a variety of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says. The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration. Stem-cell researchers praised the FDA’s actions.
“This is spectacular,” says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. “This is the right thing to do.”
Daley praised the FDA’s promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on “snake-oil salesmen” marketing unproven treatments.
Stem-cell research is “a major revolution in medicine. It’s bound to ultimately deliver cures,” Daley says. “But it’s so early in the field,” he adds. “Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven’t been proven to work and may be unsafe. “Others agreed “I see this is a major, positive step by the FDA,” says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell “treatments” that may not be real treatments,” Knoepfler says.
“Don’t stop now”. Say I. This Blog has been asking for FDA intervention in those settings where Amniotic Fluid is being marketed as a source of stem cell regeneration for over a year. There is only one way to be safe and not sorry:
You may access my web site Ilcellulartherapy.com and watch my webinar Or call for an appointment — 847-390-7666
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Growth Factors, Orthopedics, Osteoarthritis, Pain Management, Regenerative, stem cell treatment, stem cells, treatment
It was difficult for me to sit and listen to so many “show and tell” presentations not supported by scientifically overseen outcomes data. Too much anecdote about unproven methodologies; many not compliant with FDA guidance. Basically, it was frequently repeated false news. I was taken aback by what so called physicians are injecting into the joints of their patients. Florida seems to lead the way in the cook book approach to arthritis followed closely by California. Illinois is guilty as well but not the medical community. Despite my negativity about the absence of science, this gathering certainly did not begin to approach the science and integrity of presentation found in the discipline of orthopedic surgery; of particular interest to me was the universal agreement that there is no regenerative potential in Amniotic Fluid Concentrate. A matter of fact, there was not one outcomes paper presented concerning amniotic fluid. It becomes ever so important that a patient choose an experienced, scientifically oriented, regenerative medicine specialist when seeking a non-surgical option for an arthritic knee, hip, ankle or shoulder. The patient must bear in mind that the specialist’s goal is to improve function, diminish pain and postpone, possibly avoid a joint replacement for an arthritic joint. When the arthritis has reached end stage, there are those who should have a joint replacement; only a specialist is equipped to properly advise a patient.
In the orthopedic world, scientific papers are not considered to have significance unless the outcome results have been followed for a minimum of two years and more. Furthermore, the articles in order to be considered authoritative must have statistical significance. It seems that the charlatans and camp followers are offering patients an intervention that is neither FDA compliant nor for which there is scientific outcomes data. The one exception to all the fake news was the presentation by Dr. David Karli of Greyledge Orthobiologics who introduced The Method of Ratios for Assessing PRP and BMC Theraeutic Potential. This novel approach to quantitating and qualitating the injectate I am sure will soon become a standard of care for cellular orthopedics so I will quickly introduce into my practice. The Method of Ratios will allow the clinician to better understand what will be injected into a joint.
The appropriate method of advising an arthritic patient as to whether surgery may be postponed or even avoided begins with a specialty consultation including a comprehensive intake, a physical examination including functional testing, and review of images. Only those with specialty training, board certification and experience both in surgery and in regenerative medicine are able to properly advise the patient. I will again underscore the importance of choosing the Cellular Orthopedic expert and not determining what may be best for you by surfing the cloud.
If you want to become better informed, browse my website www.sheinkopmd.com.
You may watch my webinar at www.ilcellulartherapy.com or call to schedule a consultation (847) 390-7666.
Tags: Amniotic, amniotic fluid, arthritis, BMC Theraeutic Potential, bone marrow, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Dr. David Karli, Greyledge, Interventional Orthopedics, Knee Pain Relief, OrthoBiologic Institute, Platelet Rich Plasma, Regenerative, stem cells
It is now over four years since I began the most comprehensive outcomes clinical trial ever undertaken in which Bone Marrow Concentrate was used to reduce pain, improve function, increase activities and alter the progression of osteoarthritis in a knee joint. At the start, it was generally believed that the adult mesenchymal stem cells would reproduce themselves and emerge as cartilage therein regenerating the joint. Continued scientific investigation has taught us that the adult mesenchymal stem cell acts as the conductor of a complex bio-immune process in conjunction with growth factors. One such growth factor is an endogenous polypeptide molecule, Transforming Growth Factor -Beta (TGF-ẞ). There are many other growth factors derived from the Bone Marrow Concentrate that play a role but that discussion is beyond the scope of this Blog. Additionally, be aware that Platelet-derived growth factor attracts mesenchymal stem cells and can stimulate proteoglycan production and chondrocyte proliferation. Incidentally, should you decide to seek consultation with one of the plethora of so called regenerative medical specialists populating the internet and advertising in the media, before you go, print my blog and ask them relevant questions pertaining to the science. You make be surprised to learn you as a potential regenerative consumer know more about the subject than the highly visible marketing provider.
Getting back to the clinical trial, the recruiting process of 50 patients ended two years ago and now we have two to four year of outcomes data to statistically analyze; that scientific process will be completed next week and presented at the Orthobiologic Institute meeting taking place in Las Vegas, June 8 to 10. For the first time, real outcomes data having been analyzed using the same criteria I used in my 37- year career as a joint replacement surgeon and head of a joint replacement program at a major medical center in Chicago will be presented to the regenerative medicine community. Unfortunately, I am unable to control the charlatans and camp followers who will attend the meeting and even try to use my data for their marketing. I choose to share my data as a challenge to those who seek to market and advertise stem cells for every malady known to mankind.
If you want to become better informed, you may access my website www.sheinkopmd.com.
You may watch my webinar www.ilcellulartherapy.com or call to schedule a consultation 312 475 1893.
Tags: bone marrow, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Mesenchymal Stem Cell, proteoglycan, stem cells, Transforming Growth Factor -Beta
Last week, my associate attended a continued medical education course held in a venue near the Wisconsin-Illinois border; a site frequently used by the Stem Cell Institute of America to host amniotic fluid marketing seminars. My colleague overheard a conversation between several physical therapists touting the success of amniotic fluid in regenerating cartilage on their patients, “you can see the increased joint space on the x-ray when we see the patient in follow-up”. I have addressed the issue of the absence of viable stem cells in amniotic fluid ad-nauseam (borrowing a recently expressed symptom from the Director of the FBI) but I am continually amazed at how false news when repeated takes on a fantasy of its own. Additionally, my patients frequently ask to repeat the imaging so they might see if the cartilage is growing.
Much of the current research effort pertaining to cartilage is experimental and has to do with the MRI techniques known as T2 mapping and delayed gadolinium enhanced MRI of cartilage (dGEMRIC). In addition to MRI techniques, optical coherence tomography (OCT) may allow arthroscopic evaluation of cartilage by performing microscopic cross-sectional imaging of articular cartilage. In the final analysis, the only present clinical cost effective, non-invasive means of quantitating and qualitating the patient response to an intervention are exactly the parameters I measure in my office; the only comprehensive methodology of its kind in the clinical field of Regenerative Medicine.
When a patient asks me how do I know whether an intervention is a success, I don’t point to an increased joint space on the X-ray as it is not there to be seen. I review patient specific outcomes including pain scores, activity scores, subjective input, and objective measurements and compare the pre-intervention findings with the latest scoring.
In the interval between starting to write this Blog and now, I received an unsolicited update from a patient who had attended the Stem Cell Institute of America seminar. He had asked so many questions during the seminar, the chiropractors running the seminar gave him the PalinGen Flow brochure (their source of amniotic fluid) as my patient had challenged their evidence beyond the speakers’ ability to respond. My patient, who eventually underwent a bone marrow concentrate intervention with my assistance, read the document and learned that PalinGen Flow makes no mention of stem cell content in their literature.
To schedule an appointment call (847) 390-7666
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com
Tags: arthritis, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, joint replacement, Mesenchymal Stem Cell, Regenerative, regenerative medicine, stem cell treatment