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
Patients receiving either Hyaluronic Acid (HA- Synvisc, Supartz, Euflexxa) or Platelet Rich Plasma (PRP) injections will experience modest-term pain relief according to an article appearing in Orthopedics Today, August, 2017. In the study reviewed, Ultrasound Guided injections were given weekly for three weeks and patient-reported outcome measures (PROMS) were recorded for up to one year. “Both the PRP and HA groups demonstrated an improvement in PROMS at 24 weeks that declined to near baseline levels at one year” according to the article. “Patients with lower grade Osteoarthritis and lower weight responded more favorably to intra-articular injections”. The effect of both Hyaluronic Acid and Platelet Rich Plasma appeared to be modest and temporary.
Why I chose this topic this week for my Blog has to do with my preparation for the upcoming talks I am invited to give September 21st and 22nd in St. Petersburg, Russia at the meeting of 1200 orthopedic surgeons from Russia, Ukraine and neighboring countries both in Europe and Asia. As I indicated last week, this will be the first time a non-operative intervention of a cellular orthopedic, regenerative nature, as I practice, will have been introduced into this region of the world. While Hyaluronic Acid and Platelet Rich Plasma may offer short term pain diminution for individuals limited in function by the symptoms of Osteoarthritis, it becomes clear by scrutinizing my data base that not only does concentrated bone marrow afford long term relief, the Mesenchymal Stem Cells and Growth Factors found in bone marrow when concentrated participate in regenerative possibility thereby delaying and perhaps even avoiding a joint replacement. My presentations will be evidence based without the false news and unsupported marketing claims ever present in the media.
What we have learned about Amniotic Fluid (AF) from my role as principal investigator in several multisite studies is that AF does have concentrated Hyaluronic Acid and therein may offer six to 12 months decrease in symptoms and increase in function, the effect is limited in duration; and with no viable stem cells in Amniotic Fluid Concentrate, there is no regenerative potential. Owing to the absence of inherent absence of stem cells and hence regenerative potential, I will not include amniotic fluid in my presentations.
As a scientific invitee, my responsibility is to introduce that for which we have scientific support and clinical evidence. If you want to gain a better understanding of Regenerative Medicine and Cellular Orthopedic and learn how you may postpone or perhaps avoid a joint replacement for the symptoms and limitations imposed by osteoarthritis, make an appointment, visit my web site and watch my webinar.
Tags: arthritis, hyaluronic acid, Interventional Orthopedics, Knee Pain Relief, Orthopedics, Osteoarthritis, PRP, Regenerative, stem cells
Last week, we traveled to Israel to celebrate the wedding of our youngest son. Israel became the destination for the event as Eric and Judith had met there while his music business was subcontracting to Coke and Judith led the International Marketing initiatives for Coke. The event took place on July 5th, at an organic farm in the outskirts of Jerusalem. In such a majestic and historical setting prior to and after the ceremony, there took place several organized tours including one of Jerusalem, another at the Dead Sea and for several, a trip to Petra. It was a relatively small group of the attendees; one in particular, a very close and long-time friend has been the subject of my Blog in years past as I described his return to skiing, biking and fly fishing following a Bone Marrow Concentrate/Growth Factor Concentrate/Stem Cell concentrate intervention. Prior to those procedures, he had been forced to give up his athletic passions for several years because of the limitations imposed by arthritis of both knees.
Above is his activity score from Monday, July 3, when Bob and his wife toured Jerusalem’s Old City including a hike on the ramparts of the wall surrounding the Christian Quarter, the stop and prayer at the Temple Mount and a shopping spree at the Arab Suk (bazaar).
What Bob represents is the potential for continued improvement over several years following a regenerative intervention, a process of which I am continually reminded as time passes and I have a longer follow up of my patients. Our mission and ethos is to help patients with arthritic joints enjoy an active life style and postpone, perhaps avoid joint replacements when arthritic impairment ensues. The documentation from the patient above is one of improving outcome as time passes. While his is an anecdote, our data base increasingly reflects similar happenings for the majority of our patients.
There are now many providers for those with arthritic impairment seeking improved function and less symptoms; and who are not candidates for a joint replacement or who do not want to undergo the major surgical undertaking. In your choice of an Interventional Cellular specialist, inquire about her or his long-term outcomes; not just “will I get a free lunch if I attend a seminar?”
To learn more, call for a consultation 847 390 7666
You may watch my webinar and learn more by visiting my website at Ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, joint replacement, Knee Pain Relief, Orthopedic Surgeon, Regenerative, stem cells
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
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