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 24, 2019
Why Should This Blog Matter To You?
- Stem cell treatments are NOT FDA cleared in the United States
- FDA is scrutinizing physicians and centers that are marketing stem cells
Beware of centers that are offering to:
- Relieve pain
- “Regeneration” of tissues
- Avoid surgery
- Treating a variety of inflammatory, degenerative, or autoimmune conditions
Beware of Stem Cells Clinics!
- Many of these “stem cell clinics” are operated by chiropractors or providers that do NOT have a specialty or advanced training in the musculoskeletal system.
- They simply do not have the training necessary to perform these injections nor are they licensed to so do.
- In some cases, surgery is needed. These providers may not evaluate the need for a surgical procedure.
Federal Trade Commission Press Release: https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic
FTC Court Documents: https://www.ftc.gov/enforcement/cases-proceedings/172-3062/regenerative-medical-group-inc
The Complaint filed by the FTC on October 12th states the following:
Defendant Henderson is aware that the vast majority of amniotic clinical studies in the scientific literature has been conducted on animal models. There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases of health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. (p. 4)
The representations set forth in Paragraph 21 […Defendants have represented…that their stem cell therapy: cures [everything]…Is comparable to or superior to conventional medical treatments in curing, mitigating, or treating specific diseases or health conditions including [everything]…] are false or were not substantiated at the time the representations were made. (p. 21)
The FTC essentially has said that there is no clinical basis to claim a therapeutic benefit to treating patients with amniotic stem cells, so the claims and representations by Dr. Henderson constitute deceptive practices and false advertisement.
If you connect the dots, it would suggest that Dr. Henderson engaged in fraud by taking money from patients and treating them with a preparation for which there is no clinically valid proof of therapeutic benefit. Regardless of whether the Department of Justice gets after him for a criminal complaint of fraud or not, I think organizations that offer up a worthless therapy consisting of amniotic stem cells (until proven otherwise with Level 1 studies) could be good targets for class action lawsuits by defrauded patients. The same situation doesn’t apply to PRP and BMC, (what I do) since there is plenty of clinical evidence of therapeutic benefit including my scientific article published in December, 2018.
Sheinkop, et.al Transnational Medicine – published Dec. 13 2018
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.
If you want to complain to the FDA about having received Amniotic Fluid without benefit, use this link:
https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118859.htm
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, FDA, joint pain, joint regeneration, joint replacement, Osteoarthritis, Regenerative, research, stem cell, surgery
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
Jan 10, 2019
Nonobstructive meniscal tears
There is increasing evidence to suggest that patients with meniscal tears at the knee that do not cause “clunking”, giving way, or locking; hence nonobstructive, may benefit from Cellular Orthopedic intervention coupled with physical therapy. Previous studies involving patients over 45 years of age comparing arthroscopy with physical therapy for nonobstructive meniscal tears as seen on an MRI justify an initial conservative approach; but patient satisfaction may require 24 months to achieve. For those patients who undergo arthroscopic surgery, there is a significant increased risk of repeat knee surgery. In our practice, those patients electing to use the Physical Therapy option without surgery but with a Cellular Orthopedic intervention minimized the length of time needed to return to full activity.
Number of stem cells in amniotic fluid
The functionality of stem cells in amniotic fluid as sold today is a myth. Research shows that 250cc of fresh C-section delivered amniotic fluid, when introduced immediately into culture, only yields 40 stem cells. This means there are 0.16 stem cells per 1 cc of full-term amniotic fluid. Scientific literature referred to by the amniotic fluid marketing forces is based on amniotic fluid collected early in pregnancy.
Acetabular Labral Tear
A hip (acetabular) labral tear is damage to cartilage and tissue in the hip socket. In some cases, it causes no symptoms. In others it causes pain in the groin. Just because a tear is seen in the hip labrum on an MRI, it does not mean the tear is necessarily the cause of the pain. Before initiating treatment, the orthopedic surgeon must exclude that an underlying arthritic condition within the hip is not the real pain generator. More recently recognized is predisposition for a tear in those with abnormal acetabular architecture.
On biologics for knee osteoarthritis
Orthobiologics may become a mainstream treatment for knee osteoarthritis. While Platelet-rich plasma and hyaluronic acid injections are the most established biologics-based treatments for knee osteoarthritis so far, it’s not too early to make confident use of stem cells. At the same time, I must continually warn patients to be particularly careful about claims for these substances. All recommendations for intervention must be FDA compliant and evidence based. (To learn about my contributions to the cellular orthopedic scientific evidence, visit www.sheinkopmd.com. Under the information bullet on the top, you will find published articles)
Eventually, I believe the science and FDA will triumph over quackery and orthobiologics will become an essential part of every knee surgeon’s armamentarium. Available orthobiologics, include:
- Hyaluronic acid
- Platelet-rich plasma
- Cytokine modulation
- Stem Cells
- Exosomes
- Adipose tissue
To learn more or to schedule an evidence based consultation, call (312) 475-1893
Tags: adipose tissue, amniotic fluid, biologics, bone marrow, cytokine modulation, Exosomes, fat, hyaluronic, joint, labral tear, Micro-Fractured Adipose, orthobiologics, Osteoarthritis, pain, Platelet Rich Plasma, PRP, renovation, stem cell, torn meniscus
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
