Dec 26, 2018
Gone
The FDA has spoken and gone already is the circus of Amniotic Fluid IV, Cord Blood, and Wharton’s Jelly. Below is an example of the headline in a letter from the FDA sent December 20, 2018
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
Genetech, Inc. warned about umbilical cord blood-derived cellular products distributed by Liveyon, LLC. FDA is also sending letters to other firms and providers offering stem cell treatments notifying them of agency’s regenerative medicine policy framework.
Today’s Top Story
FDA Warns Clinics After 12 People Are Hospitalized Following Unapproved Stem Cell Injections
According to The New York Times, 12 people were hospitalized after receiving unapproved stem cell injections marketed by Genetech, Inc. The products were derived from umbilical cord blood and were injected into knees, shoulders, and spines to treat injuries and conditions like arthritis. These patients contracted infections (from E. coliand fecal bacteria) in the bloodstream or joints, and one patient was hospitalized for 58 days. The U.S. Food and Drug Administration (FDA) sent a warning to Genetech for marketing these products without FDA approval and for significant deviations from current good tissue practice and current good manufacturing practice requirements. The agency also said it recently warned 20 clinics that offer unapproved stem cell treatments, although the names of the clinics have not been released.
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Read the FDA statement…
Going
“Federal Trade Commission takes action Stem Cell Clinics making deceptive claims about Amniotic Fluid Products.”
How much longer will we see those seminars ads in our newspapers? At last look, they are still at it; but it is time for the hoax to be closed down.
Coming
In-office Needle Arthroscopy
Knee pain is one of the most common reasons for medical office visits in the United States. Evaluation of the patient begins with a focused history and physical exam. If radiographs are nonrevealing, advanced imaging, such as MRI, often is required to arrive at a diagnosis and develop a treatment plan. Although MRI remains a standard of care in the workup of suspected intra-articular knee injuries, it does have limitations.
A greater number of these injuries may be missed in patients who have previously undergone a knee operation, have metallic implants near the knee joint, or have injuries to multiple structures. In addition, MRI remains limited in its ability to definitively diagnose or quantify cartilage injuries Given these and other limitations, diagnostic arthroscopy remains the gold standard in the diagnosis of intra-articular knee injuries.
Evidence Based Cellular Orthopedics
In November and December, I was the senior author of two major scientific cellular orthopedic outcomes publications that are already impacting the way regenerative medicine is being practiced. Two major regenerative medicine national meetings have added our outcomes findings to their respective agendas.
Scheduled the first half of 2019:
Completion in March of the prospective study on OA treatment with combined intraarticular and intraosseous (subchondroplasty)intervention at the knee.
Creation of a scientific manuscript concerning our 1 to 2-year outcomes in 65 patients who received intraarticular intervention with combined Bone Marrow Concentrate and Growth Factor Concentrate
Review of our Hip outcomes data in patients receiving Bone Marrow Concentrate for Osteoarthritis
Develop the outcomes evaluation abstract in grades 2 and 3 Osteoarthritis of the knee; 117 patients at 1 to 2-years treated with Platelet Rich Plasma derived proteins (Growth Factors).
If you want to learn more about our evidence-based care call (312) 475-1893
You may visit my web site www.sheinkopmd.com
Dec 5, 2018
As interest in biologic therapies for arthritis-a needle, not a knife-continues to expand; patients increasingly are turning to the ads in newspapers or searching the Internet to gather information on this topic. While there is still a lack of scientific consensus on the use of biologics, it is most important for those seeking information not to be misled. My own analysis of resources for patients seeking on line information about biologic therapies for arthritis is that the overall quality is very poor and anything but scientific. Even worse, is a seminar, neither a reliable or credible source of scientific evidence.
Biologic therapies consist of stem cells, platelet rich plasma product and bone marrow aspirate concentrate. New research, I co-authored and that was published last month in The American Journal of Orthopedics: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis, is indicative of the ever-evolving nature of Regenerative Medicine. Biologic therapies and their use in arthritis or musculoskeletal injury in general are an area of vast research and interest within the medical field. Understanding the information online and the misinformation provided at seminars pertaining to biologics allows me to tailor my conversation and address commonly found inaccuracies.
The use of Biologic Therapies is expected to significantly increase in the coming years as our knowledge advances on the use of such. That initiative will be led by well informed, well-educated Board Certified, and Fellowship trained specialists. Unfortunately owing to the relative lack of oversite at present, every type of charlatan, parasite and camp follower can buy an ad for a seminar or produce a web site on the internet. How then should a patient with pain and limited function from arthritis seek to postpone or avoid surgery without becoming a victim of the cord blood or amniotic fluid hoax?
- Your physician must complete a comprehensive medical history, physical examination and review of diagnostic studies.
- Explain the disease process and grade of progression,
- Discuss possible treatment options,
- Present a balanced assessment of the current scientific evidence.
Woe, while writing this Blog, I was just notified about acceptance of yet another scientific article by a peer reviewed medical journal in which I am the senior author: A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis; a Randomized Control Trial with 2 Year Follow-up.
Hopefully some time soon, a Biologic Arthroplasty will be possible; but until then, a Total Joint Replacement is still a necessary option for those not meeting specified inclusion criteria for biologics. To see what treatments may be possible for your arthritic generated pain call (312) 475-1893 to schedule a consultation. Visit my website www.SheinkopMD.com for additional information.
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, ankle pain, arthritic pain, autologous bone marrow concentrate, biologic, biologics, cellular orthopedics, Cord blood, Hip pain, injury, joint pain, knee pain, lipogems, Osteoarthritis, PRP, regenerative medicine, rupture, shoulder pain, sports injury, stem cell, tear, tendinitis
Nov 8, 2018
My goal is to inform each and every patient who presents with a painful joint, the cause of their pain; and based on our scientific and clinical evidence, that intervention which will have the greatest chance of short term and long-term success. While inflammation in the joint is a proximate cause of pain, that pain is not generated by cartilage deterioration as cartilage doesn’t have a nerve supply. While joint pain in part is generated by the synovial tissue lining the arthritic or traumatized joint, the subchondral bone supporting the joint may be even more important when it comes to the pain and limitations resulting from the arthritic affliction.
Bone pathologies resulting from acute or chronic injury presenting as bone marrow lesions associated with insufficiency fractures, persistent bone bruises, osteoarthritis and early stages of avascular necrosis are too often neglected by those holding themselves out to be regenerative medicine specialists. Options for the treatment of these subchondral conditions require a core decompression of the problematic bone and direct application of either bone marrow aspirate or a synthetic orthobiologic. The biologic treatment of bone marrow lesions with these techniques that encourage physiologic bone remodeling and repair when combined with Stem Cell and Protein/Growth Factor concentrates into an arthritic joint offers the best chance for joint preservation and a successful outcome for the patient undergoing a Stem Cell procedure.
Are there Stem Cells in Cord Blood, Wharton’s Jelly or Amniotic Fluid? These three alleged sources of Stem cells are processed when collected. The tissues are then cryopreserved with DMSO or some other cryopreservant. When thawing takes place, the few cells contained do not survive the thawing process. Additionally, DMSO is cytotoxic, a cell killer at room temperature.
As many of my patients are aware, I began my Cellular Orthopedic journey some years ago as an early member of the Regenexx Network. While my personal and practice ethos as the only orthopedic surgeon caused me to leave the network, I still follow the Blog and I find the one posted today most appropriate.
I was on a local radio show this week and a woman called in and claimed that she had been defrauded by a local chiropractic clinic. She paid big bucks for what she was told were “millions of young stem cells” injected intravenous. As I will show you this morning, as a medical expert in this area, I can show you that she is more likely than not the victim of consumer fraud. Let me explain.
The Problem of the Chiro Clinic Bait and Switch
I’ve blogged extensively about how chiropractic, acupuncture, naturopathic, and some physician clinics are defrauding patients by claiming to inject millions of live and young stem cells from amniotic fluid or cord blood (or other products). The problem is that none of these 361 registered tissue products has any significant number of live stem cells.
Tags: ACL Injury, bone edema, bone lesion, bone marrow, Cartilage, chondromalacia, chronic pain, Cord blood, cryopreserved, Hip, joint pain, joint replacement, Knee, meniscus tear, naturopathic, Osteoarthritis, osteochondral defect, regenerative medicine, shoulder, stem cell, subcondral bone
Jun 22, 2018
My regenerative and restorative Cellular Orthopedics practice is for the most part, evidence based. By that I mean, the outcomes data collected over these past five years regarding the several thousand patients with skeletomuscular afflictions that I have treated with a selection of alternatives using a needle and not a knife is generally based on regenerative and restorative interventions. While not everyone has experienced a dramatic change in symptom relief and functional improvement, many have. The statistical outcomes evidence follows a bell shaped curve with some experiencing immediate improvement as I have in both my hips and knees, while most take several weeks or longer with a continuing improvement up to 18 months post intervention. While it is true that five percent of patients are not satisfied after several years and have gone on to a joint replacement, 95% of my patients are well satisfied and have returned to, or never quit doing what they love.
At the onset of my cellular orthopedic initiative, the interventions were solely based on Platelet Rich Plasma options and Bone Marrow Concentrate; today, our menu of services can be customized so as to meet the needs of all seeking to improve the quality of life and avoid a major surgical procedure. Not only can I concentrate PRP as needed, I can customize the concentration to meet a patient’s particular needs using hemo-analysis. Bone Marrow Concentrate rich in Adult Mesenchymal Stem cells, Platelets, Growth Factors and Precursor Cells is still the foundation of my practice, however for the past year, I am able to offer a Platelet Concentrate derived Growth Factor and Protein Solution option when indicated.
Then there are those whose co-morbidity or prescription medication dependency excludes them from the aforementioned autologous choice of options. As of this upcoming Tuesday, I have acquired an intervention technology that will help patients seeking to a void a total joint replacement who are not candidates for existing regenerative medial offerings. There are many reasons to explain a 5% failure rate including genetic cartilaginous variations, any bell shaped curve will have a small number who don’t pass the final examination. Incidentally, if and when such occurs, I offer another intervention frequently at no charge or certainly at a discounted rate.
Should you want to learn more or schedule a consultation, call
(312) 475-1896. You may visit my web site where you will find the webinar at www.Ilcellulartherapy.com.
Tags: bone marrow, cellular orthopedics, Growth Factors, Hip pain, joint pain, joint replacement, knee pain, Mesenchymal Stem Cell, Osteoarthritis, platelets
May 14, 2018
“Mitch, not sure if you heard, but the FDA via the DOJ has requested injunctions against the mothership clinics of Berman and Lander, as well as the US Stem Cell clinic run by Comella. We can hope that criminal indictments might follow, since they certainly are some of the most flagrant violators of the law in recent med I can think of. The SCIA group can’t be too far behind. It seems that advertising all kinds of cures for everything that ails the patient makes you a higher priority target.” (Personal communication)
I am dedicated to providing patients with the best possible care in regenerative medicine and am pleased to announce that I have adopted a technology platform developed by Greyledge Technologies (Vail, CO). Their technology to generate platelet-rich plasma (PRP) and bone marrow-derived cell concentrate (BMC) is derived from successfully operating a laboratory that is registered with the FDA (listed as a “component preparation and collection facility”, FEI 3008724474), which has cleared two audits with no issues. Based on their platform, I offer my patients customized therapy, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 23 parameters), which I review prior to treatment. This knowledge permits me to make adjustments based on my more than 40 years of experience in orthopedic surgical and now cellular orthopedic practice. No other system or technology gives me this kind of capability to personalize your treatment.
As a result of the technology I have adopted, my office has been able to create a scientific outcomes data base using the same parameters in cellular orthopedics as when I was the director at one of the five largest joint replacement programs in the country. At that time, I pioneered the integration of patient are with research and education. The latter allowed me to rise to the position of full professor; having publish over 75 scientific articles in the field of hip and knee joint replacement. I am happy to update you with the fact that I am at it again. On June 10, my paper concerning the preliminary outcomes of combined intraarticular and intraosseous stem cell intervention for knee arthritis will be presented in Las Vegas at of The Orthopedic and Biologic Institute (TOBI) annual meeting. The manuscript concerning Autologous Bone Marrow Concentrate and Platelet Product for Symptomatic Knee Arthritis: A Randomized Controlled Trial, Minimum 2 Year Follow-Up was submitted to a major orthopedic journal and is one of three papers I have been invited to deliver from the scientific podium of The Medrebels, October 26 to 28 meeting in Austin, Texas.
If you want to avail yourself of the best opportunity to postpone, perhaps avoid a joint replacement for arthritis while enjoying pain relief and restoration of an active life style, chose science over advertised anecdote. Call (312) 475-1893 to schedule an appointment. You may access my website and watch the webinar at www.Ilcellulartherapy.com.
Tags: APGC injection, arthritis, BMC injection, Bone Marrow Concentrate, bone on bone, Greyledge, Growth Factor Concentrate, Hip pain, intraarticular, intraosseous, joint pain, knee pain, Medrebels, Osteoarthritis, PRP, stem cell intervention, TOBI
Mar 13, 2018
I write this Blog as an Orthopedic Surgeon following the 2018 annual meeting of the American Academy of Orthopedic Surgeons, just concluded in New Orleans. The topic matter is of sufficient concern that Use and Abuse of Biologics became an agenda focus receiving several hours of attention.
Clinical use of biologics to treat all health problems has greatly outpaced the evidence. Every office day, patients bring advertisements about Stem Cells appearing in the print media. The enticing cure all claims and testimonials are quite seductive. Concerns over misinformation from direct-to-consumer marketing of unproven treatments have led to recent calls to action from government and scientific agencies, including the National Academy of Sciences and the American Association for the Advancement of Science.
These calls to action are of special relevance to orthopedics because a recent study showed that more than 85 percent of 351 businesses, which represent 570 clinics across the country, were marketing “stem cell” treatments for musculoskeletal problems. Analyses of these treatments show a diversity of offerings with most clinics using preparations that do not contain clinically significant numbers of stem cells. Widespread use of these cash-for-service, unproven, and poorly described treatments raise concerns for public health and safety.
The Academy collaborated with the National Institutes of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) and held a think tank symposium on “Optimizing Clinical Use of Biologics in Orthopedic Surgery” on Feb. 15–17. 2018, at Stanford University to accomplish the following objectives:
- establish a clear, collective impact agenda for the clinical evaluation, use, and, optimization of biologics in orthopedics
- develop a guidance document on clinically meaningful endpoints and outcome metrics for the evaluation of biologics for common orthopedic problems
The symposium addressed key issues including poor definition of treatments and mechanisms of action; lack of standardized data and outcomes collection and reporting in existing clinical studies; and minimal evidence to support the myriad of ailments treated with these products. Leaders from clinical medicine, research, and government, as well as young investigators selected through a competitive process, participated in the event.
I am happy to be one of the first orthopedic surgeons in the Midwest limiting my practice to cellular orthopedics. Additionally, based on my model of having integrated patient care with outcomes surveillance as a joint replacement surgeon, anticipating and contributing to the new world of evidence-based regenerative medicine, I already have in place a cooperative venture allowing me to measure the platelets, growth factors and now stem cells that have been injected into a joint or the bone adjacent to that joint. I don’t know of any other practice or center that can make this claim. My team has entered into discussions to designate our model as the foundation for the future methodology of clinical evaluation, use and optimization of biologics in orthopedics.
As a patient, you have a choice to make: either respond to a marketing scheme or be educated and seek evidence before undergoing a “stem cell” procedure.
To schedule an appointment call 312 312 475 1893
Visit my web site and watch the webinar www.ilcellulartherapy.com
Tags: biologic intervention, cellular orthopedics, National Institutes of Arthritis
