Mar 28, 2019
Opening day of the baseball season is today, Thursday, March 28. I noted this morning on the sports pages how many players will not be available for the start of the race owing to injuries sustained in Spring training. In the basketball coverage, from the get go of March Madness to now, most teams have been playing at times without a star owing to injury. Then there are the final weeks of hockey, will Chicago make the playoffs? Certainly, injury could play a major role. Next in line are the joggers, cyclists, tennis players, so on and so forth who will soon be unable to meet their recreational goals owing to tendon, muscle and ligament injury. With spring comes strains and sprains.
The term strain applies to the over stretching or tearing of muscles and tendons; while a sprain is the overstretching or tearing of a ligament. The most common location for a muscle strain is the hamstring; while the most common location for a sprain is at the ankle joint. Stretching muscle and tendon groups is the best prevention for strain. At this time of the year, especially for the weekend warriors, stretching strengthening and hydration are paramount for minimizing injury.
In spite of the best of fitness preparation and compliance, you feel that stabbing pain in your calf, in the back of the thigh, in your low back in the area of the shoulder. You may choose to take advantage of direct access to the physical therapist. Should you have a greater concern regarding the nature and severity of an injury, call for an orthopedic assessment. After a physical examination, the X-ray, Ultrasound or MRI may be ordered for a most accurate diagnosis or to grade the severity of injury. If and when, physical therapy, anti-inflammatories, or a cortisone injection do not provide relatively short-term relief, it may be time to consider a regenerative medicine intervention. For sports injuries, Platelet Rich Plasma is increasingly proving effective in promoting healing, minimizing impairment, and allowing for the quickest return to highest levels of performance. The major determinant of success is the quality of the PRP as measured by either ratios of protein, platelet and cellular content; or by the actual platelet content of the plasma itself.
While in some clinics, Platelet Rich Plasma is produced by a blood draw and centrifuging, there is no standardization or quality control. In my practice, we create a known and standardized PRP. At the beginning, a finger stick is leads to a platelet count of the patient’s circulating blood. Next, the number is entered into a computer algorithm taking into account the proprietary kit being used as well as the ultimate platelet concentration and plasma volume following the centrifuging process. A repeat platelet count is done prior to injection making sure that desired numbers have been reached. if not, we are able to adjust numbers and concentration to the sought-after target. In this way we can customize the platelet Rich Plasma for each patient’s needs. Once prepared, an ultrasound unit is employed to assist targeting and making sure the PRP is injected into the desired location; that is the site of injury. The procedure is standardized in our office but customized for the shoulder, elbow, hamstring or calf. On occasion, the process may have to be repeated in three to six weeks for maximum benefit. Don’t let an injury ruin your season; if usual and customary is not effective, call for an appointment.
For more information, visit https://sheinkopmd.com or call (312) 475-1893 to schedule a consultation.
Tags: ACL, ACL Injury, anterior cruciate, arthritic knee, arthritis, Autologous Protein Concentrate, baseball, BMC, board-certified, Bone Marrow Concentrate, bone marrow edema, cells, cellular orthopedic, cellular orthopedics, FDA, football, golf, Growth Factors, hematopoietic cell, injection, Interleukin 1 Receptor Antagonist Protein, IRAP, joint health, joint pain, lipogems, Mesenchymal Stem Cell, micro-fragmented adipose, muscle injury, muscle strain, OA, Orthopedic Surgeon, Osteoarthritis, pain, Physical Therapy, Platelet Rich Plasma, platelets, PRP, regenerative medicine, repair, Rotator cuff tear, soccer, sports injuries, sports medicine, stem cells, strain, suntimes, tear, training, volleyball
Mar 7, 2019
“Why bother with the truth when you can make it all up”
David Baldacci
“As practicing physicians, scientists, and regulatory experts we have increasingly observed aggressive advertising and sales tactics being used by alternative health clinics (chiropractors, naturopaths, and acupuncturists) as well as physicians and mid-level providers to market “stem cell” treatments derived from birth tissues. One example is full-page print ads in major newspapers used to recruit elderly patients and others desperate for effective treatments to seminars where prospective patients are informed that they can be injected with millions of live and functional stem cells to relieve their symptoms. The products used are derived from birth tissues such as umbilical cord blood and/or Wharton’s Jelly or amniotic fluid/membrane. Many patients spend thousands of dollars on these therapies to treat orthopedic problems and/or a myriad of other incurable diseases. The seminars typically state that there are robust clinical data supporting the safety and efficacy of these products, regardless of the condition or pathology being treated, when no such clinical evidence exists. In addition, some manufacturers of birth tissues claim that their products contain live and functional stem cells, while other manufacturers do not make these same claims. Claims of live cells are not compliant with FDA regulations, which require this type of donor tissue to be non-viable.
To date, two research investigations have been conducted which document the content of commercially available amniotic and cord blood products sold by FDA-registered manufacturers (those regulated solely under section 361 of the Public Health Service (PHS) Act). We are aware of additional investigations that are in progress. Both Berger, et al. and Becktell from the Fortier laboratory at Cornell University, found that these amniotic and cord blood products did not contain live or functional stem cells. In addition, both research groups found that many of the growth factor levels in these products were significantly lower than those found in common autologous orthobiologic products like platelet-rich plasma. Fortier et al. did report that these products do contain proteins like lumican and cytokines, which may positively impact orthopedic injuries, but concluded that more research is needed before any claims can be made. While there are early clinical data on stem cells that are isolated from fresh birth tissues and culture expanded, these studies used treatments which are not analogous to the commercially available, cryopreserved, FDA registered birth tissue products. In addition, it should be noted that while the clinical evidence in this area is evolving and one day may support the clinical efficacy of cryopreserved birth tissues for some orthopedic applications, no such evidence exists at this time. In particular, we are aware of FDA approved clinical trials that use these tissues for diseases such as knee osteoarthritis, which are ongoing.
Consensus Statement: The aggressive marketing approach currently used by practitioners and clinics regarding various birth tissue products as safe and effective “stem cell therapy” is not supported by the existing scientific literature.”
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, Cornell University, cryopreserved, FDA, Federal Trade Commission, Food and Drug Administration, FTC, joint pain, joint regeneration, joint replacement, Osteoarthritis, Public Health Service, Regenerative, research, stem cell, stem cell seminar, stem cell shot, surgery, umbilical cord blood, umbilical cord stem cells, Wharton’s Jelly
Feb 4, 2019
On Monday, the annual migration for attempts at the physical Restoration and Regeneration of the NFL players injured bodies began. While in the past, the losers would chant “wait ‘til next year”; very soon, the NFL winners and losers alike will take flight to Orthopedic Surgeons around the USA and world, on occasion, some will even find their way to my office, seeking both operative and non-operative repair of the injuries incurred over the last eight months. What I will offer is Regenerative and Restorative initiatives using either the patient’s bone marrow, circulating blood or body fat. While I use a needle and not a knife in my practice, at times it takes arthroscopy and open surgical procedures to assist the athlete in returning to play or extending a career. The fall NFL 2019 schedule is already on line; there is a sense of urgency. These attempts at restoring and regenerating anatomic and physical well-being are not limited to the professional football player. To the best of my recollection, it was Tiger Woods in 2008, who brought regenerative medicine to the attention of the American public. When in 2011, Kobe Bryant traveled to Dusseldorf, Germany for a highly publicized orthobiologic treatment of his arthritic knee, returning to play for another six seasons, he was soon after followed by the professional golfer Fred Couples, baseball player Alex Rodriguez, and NFL star Payton Manning. All returned to their respective sport and extended playing careers; many more have followed. Now Cellular Orthopedics, Regenerative Medicine and Joint Restoration are available around our country as well as at my office for professional, college, high school, amateur athletes and fitness enthusiasts of any age.
Orthobiologics and Cellular Orthopedics are a dynamic approach to body injury and arthritis using the individual’s own (autologous) platelets, molecules and proteins circulating in the blood (Cytokines and Growth factors), adipose tissue, or bone marrow to effect healing and eliminate pain. At this time, it is FDA Compliant to use such in the care and treatment of injury and arthritis as long as that which is to be used has been harvested from the patient herself or himself, not cultured or expanded, and not treated with additional agents. The successes are no longer merely anecdotal; there is an ever-increasing body of scientific evidence to validate the emerging discipline of Cellular Orthopedics. For instance, in my office, I integrate patient care with documenting outcomes and that has led to several recent scientific publications contributing to an evidence-based orthobiologics practice. You may find those publications and more at my web site www.sheinkopmd.com. To schedule a consultation call (312) 475-1893.
There is a way of still being an athlete and significantly reducing your risk of injury, take up esports. Marquette University is adding varsity esports, a competitive video gaming team in the fall of 2019. The team will have tryouts, coaches and regular practices just like any intercollegiate sport
Tags: arthritis, athletes, autologous, avascular necrosis, bone marrow, cellular orthopedics, cytokines, esports, Growth Factors, injury, joint pain, joint replacement, joint restoration, knee pain, meniscus tear, MSC, OA, orthobiologic, Orthopedic Surgeon, Osteoarthritis, Pain Management, pain reduction, patyon manning, platelets, PRP, sports injury, sports medicine, stem cells, superbowl, surgery, tiger woods, torn labrum
Jan 16, 2019
I swear to tell the truth, the whole truth, so help me G_d. Injured cartilage in a skeletally mature adult typically doesn’t heal on its own; surgical techniques are needed in an attempt to repair and replace cartilage. These latter procedures are appropriate for specific cartilage injury, rather than the widespread cartilage changes found in the osteoarthritic joint. That is not to say that someday soon, we may have the ability to regenerate cartilage. Research is ongoing in regenerative medicine with continual progress as evidenced by preliminary success in spinal cord injured patients:
StemCyte gets FDA green light to continue studying spinal cord injury treatment stem cells.
Now for the bad news. In spite of false news generated by the charlatans, parasites, camp followers and hucksters in their Regenerative Medicine seminars, print media and television adds; there is no scientific evidence to support their claims of cartilage regeneration, hair restoration, cure of erectile dysfunction, so on and so forth.
Stem cell fraud? Couple says therapy gave them ‘false hope’
“Unfortunately, what I had hoped to be a hard-hitting expose turned into limp-noodle babbling. Another missed opportunity.” Continuing the commentary about regenerative medicine clinic charlatans and fraud started by NBC, when a patient showed me a brochure from yet another group that holds itself out to treat every abnormal medical condition from A to Z with “Stem Cells”, I suggested that he request data regarding their successes. Please bear in mind the self- contradicting adage that Always and Never statements are always false and never true. They are frequently used by people who suffer from personality disorders. On Friday he sent me the response to his inquiry regarding outcomes at a one of the national stem cell clinics.
“success rates per our clinical research network are VERY encouraging: Orthopedic: knee 83%, hip 80%, back (cervical, thoracic, lumbar, sacral 80% ave., ED 77%, Cataracts 100%” Remember what I just wrote about Always and Never?
The good news though is that there is emerging scientific evidence to justify Joint Restoration with a cellular orthopedic procedure. While an image of an arthritic joint allows for identification of cartilage and meniscal changes, that same image will frequently be consistent with bone marrow edema, and thickening of the bone adjacent to a joint (subchondral sclerosis) as well as loose bodies within the joint. As cartilage does not have a nerve supply, the pain generation in Osteoarthritis more probable than not is the result of inflammation of the synovial joint lining and the subchondral bone. While there is no scientific means of re-growing cartilage after age 40 at this time-defects may be filled by surgery-orthopedic surgeons focusing on Cellular Orthopedics have developed methods to restore the joint function by blocking the pain generators, restoring healthy subchondral bone, and reversing bone marrow edema.
To schedule an Evidence Based Consultation, call (312) 475-1893
You may read my Blog and explore my published research articles on the website www.sheinkopmd.com
Tags: arthritis, bone marrow edema, cartilage regeneration, cellular orthopedic, Hip pain, inflammation, joint health, joint pain, knee pain, medicine, meniscus tear, Osteoarthritis, restoration, soft tissue repair, stem cell, stem cell injection, subchondral bone
Dec 13, 2018
You may recall from my last several Blogs that The American Journal of Orthopedics published my paper in November: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis. While surfing the internet this morning, I noted that many physicians are labeling the procedure a source of stem cells; it is not.
Lipogems is now U.S. Food and Drug Administration (FDA) approved for use in Orthopedics. The proprietary name is applied to a Micro-fragmented Adipose Tissue Transplant System that was the technology I introduced and monitored in a scientific clinical trial dating back three years leading to the publication. Federal regulators have now cleared the way for the device and technology that uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process. Lipogems is attractive to orthopedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopedics. Unfortunately, clinics and physicians are erroneously, describing the procedure as a source of stem cells; I will emphasize again it is not. Even the Lipogems company uses term reparative and not regenerative.
The Power of Fat
When I grew up, my grandmother and mother fed me chicken soup for whatever ailed me. Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Micro fragmented adipose tissue may be an option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”
To schedule an evidence-based consultation for your arthritic joint, call (312) 475-1893.
You may access my website at www.sheinkopmd.com
If you schedule before the end of the year, I will share my wife’s chicken soup recipe on request
Tags: arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, knee pain, lipogems, Micro-fragmented Adipose Tissue Transplant, Osteoarthritis, stem cells
Nov 29, 2018
My Blog has frequently addressed the false ads claiming Amniotic Fluid, Chord Blood, Wharton’s Jelly and the like contain living stem cells emphasizing that the processes of preservation and sterilization followed by freezing kills off any living cells. Sylvia Perez first addressed the issue on Fox News’ Conversation in Health, January 29, 2018 and Pam Zekman posted her investigative report on WBBM-TV, the week before Thanksgiving. Yet patients continue falling for the hoax.
In contrast, let’s address the positive, cellular orthopedics; the ongoing practice of evidence- based medicine. Below are two statistically significant scientific studies that play a role in helping determine the best possible outcomes to a regenerative intervention
November 21, 2018
Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Osteoarthritis
New research published by TOBI Faculty suggests autologous, micro-fractured, minimally manipulated adipose tissue may represent a nonsurgical treatment option for knee osteoarthritis patients seeking alternatives to total knee replacement.
Congratulations Jay Panchal, MD, Gerard Malanga, MD, Mitchell Sheinkop, MD on this new publication in The American Journal of Orthopedics.
Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees
To download or read the publication: https://www.amjorthopedics.com/article/safety-and-efficacy-percutaneous-injection-lipogems-micro-fractured-adipose-tissue
Treatment of Knee Osteoarthritis with Autologous Bone Marrow Concentrate and Cytokine Concentrate – A Prospective Clinical Case Series Study
Abstract submitted to the Orthopedic Research Society Annual Meeting, 2019
Mitchell B. Sheinkop1 , Marry Langhenry2 , Jizong Gao3 1. Orthopedic Surgery, Rush University, Chicago, IL.2. Cellular Orthopedics, Chicago, IL 3. Celling Biosciences, Austin, Texas.
INTRODUCTION: Osteoarthritis (OA) is an organ disease that affects most structures of the joints including cartilage, synovium and subchondral bone. The pathophysiology of knee osteoarthritis can be broken down into pathoanatomy, cell biology, and genetics. Although fibrillation of articular cartilage is regarded as the primary changes and potential cause of clinical symptoms, the synovium and capsule undergo progressively inflammatory changes and secrete proteolytic enzymes that may contribute to the progression of OA. Meanwhile, the subchondral bone tissue develops lytic lesions with edema, sclerosis, and cyst formation. Therefore, it has been recommended that the treatment of OA should be a comprehensive approach to create a homeostatic environment to facilitate the OA treatment with a long-lasting outcome. Bone marrow contains mesenchymal stem cells (MSCs). Different cytokines such as alpha 2-macroglobulin (A2M) (Wang et al) and growth factors have been identified in the blood and bone marrow aspirate. Either bone marrow concentrate (BMC) or MSCs have been injected into the knee joint to treat OA with promising clinical outcomes. Hernigou et al reported that injection of BMC into the subchondral bone area was able to delay or eliminate the need for total knee arthroplasty (TKA) and clinical outcome was comparable to TKA in the contralateral knee. Cytokines and growth factors in the blood or bone marrow aspirate were concentrated by filtering method to prepare autologous therapeutic biologics. In the current study, a consecutive series of patients with moderate to severe OA were treated by intra-articular and intra-subchondral bone injection of BMC and autologous concentrated cytokines/growth factors. The quantity of representative cytokines and growth factors in the concentrate were also measured. Patients were evaluated for the improvement of systems and knee functions by following up to 6 months after injection. METHODS: This prospective case series study was approved by the Institutional Review Board.
To learn more or to schedule an evidence-based consultation call (312) 475-1893
You may visit my web site and read my blogs at www.sheinkopmd.com
Regenerative Medicine is an option for those with arthritis but don’t be fleeced by the hucksters and camp followers.
Tags: autologous bone marrow concentrate, biologics, BMC, cellular orthopedics, cytokine concentrate, Growth Factors, knee pain, lipogems, Micro-Fractured Adipose, MSC, OA, Orthopedic Surgeon, Osteoarthritis, PRP, regenerative medicine, stem cells, suchondral, TOBI