Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.

Must yesterday’s joint injury lead to tomorrow’s arthritis?  

My column regarding ACL ruptures appeared last Friday. That afternoon, I received the following inquiry and comment from a reader, regarding the prognosis and possible early preventive interventions for a significant knee injury.

“I am one of relatively few patients who has had the Bone Marrow Concentrate treatment for a fully-torn (not-retracted) ACL tear and to date, I’ve had what I’d consider to be an amazing recovery.  I read your latest blog post and just thought I’d let you know that I’m back to very aggressive skiing (including small but non-trivial jumps).  However, I did want to ask, if you would be willing to comment, if there are actions or periodic diagnostics, you’d recommend to maximize the chances that I’m still happy skiing 10,20,30 years after the injury?  I understand you probably can’t comment but nevertheless wanted to let you know I was also a real-life person who had a significant knee trauma with multiple surgical consults all agreeing it was fully torn and required surgery (to return to high-level skiing) and now have a fairly normal looking ACL in MRI (per independent radiologist) and am back to 100% with activities that require a lot of knee stability.  I did do two rounds of same-day BMA reinjections and a bunch of platelet injections but no surgery.”

The answer is an orthopedic assessment at three-year intervals to look for markers of post traumatic osteoarthritis such as loss of terminal extension and asymmetrical flexion. The MRI is helpful in detecting moderate arthritic changes but the latest development, the needle scope, allows an orthopedic surgeon to directly examine the meniscus and cartilage in an office setting. The concern is post traumatic arthritis, cartilage defects that will progress, and meniscal damage not always seen on the MRI. Here are some thoughts on early intervention with Cellular Orthopedic and Regenerative Medicine options.

A recent Study Compared the Efficiency of Needle Arthroscopy Versus MRI for Meniscal Tears and Cartilage damage. Needle arthroscopy (NA) may be a less costly and more accurate option for diagnosis and treatment of meniscal tears and early onset post traumatic arthritis than MRI, according to a study published in the February issue of Arthroscopy. Researchers collected data on costs for care and accuracy, including procedures for both false-positive and false-negative findings well as private payer reimbursement rates. They compared outcomes using the global knee injury and osteoarthritis outcome score (KOOS). Patients were followed and evaluated over a two-year period. 

There are several restorative options now available when conservative therapies for the treatment of knee degenerative processes, such as non-pharmacological interventions, systemic drug treatment, and intra-articular therapies offer only short-term benefits or fail. Before resorting to surgery; be aware that encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. My clinical published research documents success with using your Bone Marrow Concentrate for joint restoration and combating progression of posttraumatic arthritis. Additionally, I have published an article concerning another source for joint restoration, micro-fractured adipose tissue. The latter has created a huge interest in the context of cartilage regeneration due to its wide availability, ease to harvest and richness in mesenchymal cell elements within the so called stromal vascular fraction. Moreover, MSCs from adipose tissue are characterized by marked anti-inflammatory and regenerative properties, which make them an excellent tool for regenerative medicine purposes.

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ACL injury is a concern in athletes at all levesFrom adolescence to my age

We read about it in the sports pages every day; the player presenting after twisting a knee, feeling a “pop” and going down in a heap. The knee is swollen, the first indication that bleeding has occurred inside the joint. Physical examination of the knee to test the ligaments leads to a suspected tear of the anterior cruciate ligament; the MRI is ordered and confirms the diagnosis.

Because of its poor blood supply and location inside the knee, the ACL has little healing potential. It’s an unfortunate reality, as they are occurring at increasing rates over the past two decades. In part, it’s because more children are playing competitive sports and doing so at a younger age while we seniors are still skiing or playing and competing all year. What are the future implications of a torn ACL? Lindsey Vonn came back after ACL surgery; so did Tiger Woods, Julian Edelman, Tom Brady and Derrick Rose to name a few.  so how bad can it be? The truth is that surgery can restore knee function, but it does little to diminish the risk of arthritis 10 to 15 years down the line or less. Lindsey Vonn announced retirement five years later because of arthritis. Kids who tear their ACL today are often left with 60-year-old knees when they’re 30; and as has been recently stated, Knee Replacement is not necessarily a panacea.

Secondary damage may occur in patients who have repeated episodes of instability due to ACL injury. With chronic instability, a large majority of patients will have meniscus damage when reassessed 10 or more years after the initial injury. Similarly, the prevalence of articular cartilage lesions increases in patients who have a 10-year-old ACL deficiency. It is common to see ACL injuries combined with damage to the menisci, articular cartilage, collateral ligaments, joint capsule, or a combination of the above; the “unhappy triad,” especially in football players, soccer players, basketball players and skiers.

Certainly, modern ACL surgery means it’s no longer a career-ender, but recovery ranges still vary widely. In cases of combined injuries, surgical treatment is warranted and generally produces better outcomes. As many as half of meniscus tears may be repairable and may heal better if the repair is done in combination with the ACL reconstruction. Some athletes come back in as little as nine months, while it can take well more than a year for others. Then comes the mental battle, that is the silent war waged after tearing an ACL.  Derrick Rose, we are watching you.

Recent clinical evidence suggests surgery is not your only option; interventional or cellular orthopedics may be a non-surgical alternative that uses your own cells to repair the incompletely damaged ligament. A cellular orthopedic intervention for those who meet the inclusion criteria may substitute for surgery. Those who offer the non-operative option when appropriate, use Bone Marrow or Adipose Tissue harvested from your skeleton or abdomen, process the recovered cells and growth factors with particular attention to FDA compliance, and inject the concentrate into the remaining Anterior Cruciate Ligament cumented incomplete tears with success in returning athletes to a sport.

While intervention and cellular orthopedics may have a role in a torn ACL at times, Joint Restoration, perhaps even Regeneration adjuncts at the time of an ACL repair or for the ensuing arthritis have an absolute evidence-based role. To schedule an appointment call (312) 475-1893.  You may visit my web site at  www.sheinkopmd.com

 

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Joint Rejuvenation and Restoration

Joint Rejuvenation and Restoration

Following injury or wear, limitations need not be limited to professional, college and high school athletes

Last week, my column focused on the post traumatic ravages of the National Football League season; and getting ready for next cycle of body demolition. Those who watched the championship game saw several players assisted off the field following violent trauma. Even the President announced that he would prefer his son not play football. While professional, college and high school competitive sports enjoy high profile, there are the average recreational sports and fitness enthusiasts who progressively experience a diminution of ability to participate in a sought-after activity by virtue of injury or wear and tear; be it basketball, running, cycling, skiing, hockey, fitness endeavors, volleyball, golf, soccer, sailing; so, on and so forth.

As an example, a 67-year-old man presented in my office last week after having read my column, with progressive pain in his left knee and inability to partake in his long-time recreational passion, volleyball. I completed his intake centered on the taking of his medical history, completed an orthopedic physical examination, and ordered X-rays. He brought a recent MRI study to the appointment. The physical therapist who assists me objectively documented his physical findings so we would have pretreatment measurements. Additionally, my therapeutic recommendation is always based on more than an X-Ray and MRI, but also includes the objective and reproducible Range of Joint Motion and assessment of joint stability.

After review of all the above, I administered informed consent for a Bone Marrow Concentrate intervention into his left knee as a means of postponing, perhaps avoiding a Total Knee Replacement and assisting in his return to recreational volleyball. While there are several options for intervention into the arthritic or injured joint including adipose and blood-based alternatives, I recommended Bone Marrow Concentrate for his moderately arthritic knee as a means of providing Concentrated Platelets, Concentrated Growth Factors, anti-inflammatory Cytokines, Adult Mesenchymal Stem Cells, Precursor Cells, Marrow Adipose Tissue, and Hematopoietic Cells, all consistent with FDA compliance requirements. There are mandatory Federal Drug Administration and Federal Trade Commission regulatory standards of compliance in Regenerative Medicine; patients must be cautious when choosing the minimally invasive Cellular Orthopedic option. It takes an office visit, physical assessment and review of images by a board-certified specialist in the regenerative medicine decision making process; not merely attendance at a seminar. Some patients will not meet inclusion criteria, their needs would be better served by accepted surgical norms.

At age 67, there is little chance at Cartilage Regeneration for my patient, but there is a high probability of Joint Restoration; that is increased motion, diminution of pain and the return of ability, in this patient’s case to play volleyball. He will wear an off-loader brace for six weeks, partake in physical therapy and then gradually return to his Chicago Park District three games a week routine. The patient will have reached his competitive goals through care based on the scientific evidence and outcomes documentation. As long as I introduced the subject of competitive goals, off I go to ski in Colorado next week; about a year after having undergone Cellular Orthopedic interventions to both of my arthritic hips and both of my arthritic knees. Without the biologics, not only would I be unable to ski, I would be ready for two knee replacements and two hip replacements. I should have listened to my mother and stuck to the piano and violin.

To learn more about continuing to reach your competitive goals, visit my web site www.sheinkopmd.com or call and schedule a consultation 312-475-1893).

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Fake news and illegal advertising of stem cell therapies

Fake news and illegal advertising of stem cell therapies

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

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Regenerative Medicine in 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

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The Right Cellular Orthopedic Procedure for You

The truth about reparative medicine in orthopaedics and why it matters to you is that in the USA, millions of people suffer from orthopedic conditions and are looking for options to major surgery. At the same time, there is a segment of the population that can’t safely undergo a major joint replacement procedure. Then there are those who are highly active and are looking to keep up with their sporting activities and an unlimited life style. The older generation is living longer and very active. The younger generation is also participating in sports and playing for a longer period. The wear and tear in joints cause pain and ultimately may cause or aggravate an arthritic process. There is an option to surgery and a means of postponing, perhaps avoiding a Total Joint Replacement. While Cellular Orthopaedics (Regenerative Medicine), offers a reparative technology, it is important to recognize that all therapies in the marketplace are not equal. There are many different types of tissues: fat, bone marrow, amniotic fluid, placental tissue, cord blood, Wharton’s Jelly, and circulating blood marketed for intervention but only concentrate from your own bone marrow, concentrate and filtered platelet product from your own blood, and now micro-fractured fat from your own adipose tissue meet FDA compliance requirements.

Over the past ten years, advances in reparative medicine have resulted from science and research behind the different options. You may read about my role at www.sheinkopmd.com/published-research-articles/ to learn more. I was one of the first orthopaedic surgeons to study the effects of Micro-fractured Fat (Lipogems) in patients with Grade 4 Osteoarthritis of the knee who were en route to a Total Knee Replacement. Now that the FDA has granted clearance, many physicians are showing up with claims of offering adipose stem cells. While fat has reparative qualities and can help promote a healing environment, it is not a resource for cartilage regeneration.

As always though in the current health marketing environment, a patient must guard against misrepresentation of product, effect and outcomes. The article I published in November of 2018, is the only scholarly article of which I am aware that has true clinical adipose outcomes data. https://www.amjorthopedics.com/article/safety-and-efficacy-percutaneous-injection-lipogems-micro-fractured-adipose-tissue. Those clinics offering a type of fat technology that is processed using enzymes and manipulates the cells are doing so by failing to abide by FDA Guidance. Additionally, some providers are offering “Stem Cell Treatments” at very high costs and thus mislead the public along with the parasites, camp followers and charlatans promoting amniotic fluid, cord blood and Wharton’s jelly. Our goal is to provide the right treatment options for a patient with solutions that have strong scientific evidence behind the technology and are cleared by the FDA. I am happy to be a leader in the Evidence Based initiative.

To schedule a consultation call (312) 475-1893          You may visit my web site at www.sheinkopmd.com

 

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