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.

When it comes to a needle and not a knife, why I recommend Bone Marrow Concentrate

The science and art of my biologic initiative to help a patient deal with the symptoms and limitations imposed by osteoarthritis requires the right tools for each situation. Concentrated Bone Marrow Aspirate or Platelet Rich Plasma has emerged as an important biologic tool for me because I have scientific evidence to support what I recommend.

Mesenchymal Stem Cells are undifferentiated cells that influence healing and growth of tissues making up the musculoskeletal system. MSCs are found in bone marrow.

Osteogenic Precursor Cells are derived from MSCs but basically have the potential to produce bone. Hematopoietic Stem cells are precursors to all red blood cells, white blood cells, platelets and other cells influencing bone density. They are found in bone marrow

Platelets are small, colorless bodies found in blood. They contain alpha granules which play a vital role in blood clotting, inflammation and wound healing. They are found in bone marrow.

White Blood Cells (Leukocytes) provide the body with protection against foreign matter. There are several types of white blood cells and they play a role in inflammation and the immune response

I started this Blog with the sentence “The science and art of my biologic initiative.” At times, the art favors the delivery of autologous, Concentrated Growth Factors contained in your blood so as to reverse inflammation. It is inflammation that generates the pain associated with Osteoarthritis.

By centrifuging your Blood and Bone Marrow, I am able to deliver a large number of stem cells, progenitor cells, and growth factors directly to your arthritic bone and joint thus harnessing the body’s biologic potential. I use a proprietary approach having evolved from our research, when possible, introducing concentrated Platelet Rich Plasma before and after the Concentrated Bone Marrow injection or occasionally all together.

In spite of the misinformation found in the marketplace, the Amniotic Fluid Products do not provide a living source of Mesenchymal Stem Cells. They do contain various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1) and may have some value.

As I have indicated, Regenerative Medicine and Cellular Orthopedics is both an art and a science. This morning, I am working on the science as a co-author on the outcomes of the subchondroplasty manuscript. To learn more, visit my website at www.sheinkopmd.com.

You may schedule and an appointment or consultation by calling (312) 475-1893.

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Masterful Care of The Aging Athlete

I consider myself an aging athlete who still skis, cycles, dedicates five days a week to fitness, plans to soon plant a garden, and walks up a spring creek with a fly rod. When my arthritic hips and knees began to limit my recreational profile several years ago, I chose the regenerative medicine option rather than joint replacements. Having performed joint replacements for 37 years and studied the benefits and limitations of such, I elected to postpone, perhaps avoid major surgery with the inherent risks and limitations. First it was Platelet rich plasma, next came PRP with Growth factor Proteins; and next came stem cells. At the get go, I did not expect to regenerate cartilage; but I did hope to restore joint function, minimize pain, and maintain the highest possible activity potential. Even with Grade 4 osteoarthritis of my major joints, I can report that I skied for a week in Vail this past February as I did a year ago, recently spent three days wading though spring creeks in Southwestern Wisconsin with a fly rod in pursuit of trout, and cycled 30 miles last Saturday. I am not alone as my biking, skiing and cycling buddy with similar knee issues returned last week from his yearly helicopter skiing adventure. I have been managing his knee arthritic issues with regenerative medicine interventions for over five years.

Then there are the athletes in their 50s. Certainly, the option is there for a joint replacement for a grade three arthritic joint but what If? What if there is a complication, an adverse event, a failure to regain motion, or residual pain? The fall back potion after a failed joint replacement is another joint replacement and the outcomes of revision surgery are frequently not satisfactory. Several weeks ago, I described the recreational pursuits of a 58-year-old volleyball enthusiast who had initially considered a joint replacement when 15 years after an arthroscopic partial meniscectomy, the predictable post traumatic arthritis had forced him to suspend his activities. He chose a regenerative medicine stem cell option; and eight weeks thereafter, he is back to playing volleyball three times a week. While on occasion, a booster follow-up injection is needed; we are in the process of developing a manuscript for scientific publication focusing on the successful outcomes of 20 patients followed for one to two years after a combined injection of bone marrow concentrate containing stem cells into the knee and the bone adjacent to the knee. These are recreational athletes between ages 45 and 60 who won’t quit.

On May 4, I am one of three invited faculty to present at The Regenerative Medicine Training Institute (RMTI). On June 7 and 8, I have been asked to participate in the Workshop and Lab Faculty at the largest Regenerative Medicine program in North America (TOBI). Owing to our integration of patient care with scientific outcomes monitoring, we have been able and continue to provide masterful and evidence-based care to aging athletes. To continue to remain in the forefront of Regenerative Medicine, I dedicate a good deal of time reviewing the future while monitoring the outcomes of patient care. Several new treatment options are soon to be launched including expanding my scope of care to those with inflammatory arthritis.

To learn more, call for a consultation (312) 475-1893. You may visit my website: www.sheinkopmd.com

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Should All Meniscal Injuries Undergo Operative Treatment ?

Should All Meniscal Injuries Undergo Operative Treatment ?

A patient presents to the office because of pain in the knee with or without a history of injury. An examination is performed followed by an X-Ray. Osteoarthritis may or may not be seen on the X-ray. If there is an altered range of knee motion when compared to the “normal” side, then a preexisting condition is considered. Whether or not the physician considers arthritis, an MRI is requested. The MRI report 48 hours after imaging is consistent with a torn medial meniscus. Should all patients with a torn medial meniscus undergo surgical intervention? If surgery is undertaken, should the procedure be a repair or a partial removal? The management of meniscal injuries must be influenced by the knowledge that meniscal integrity is important in load distribution across the joint. Meniscal injury causes altered joint mechanics and is related to the onset of arthritis.

According to a recently published online article in the British Journal of Sports Medicine, arthroscopic partial meniscectomy (APM) may not be the best option for all patients with knee pain and meniscal tear. Researchers investigated patients with meniscal tears that compared Arthroscopic Partial Meniscectomy to nonsurgical intervention, pharmacological intervention, and no intervention. At six to 12 months, APM patients had a slight improvement in knee pain, knee-specific quality of life, and knee function compared to physiotherapy patients. When excluding osteoarthritis (OA) patients, the aforementioned outcomes exhibited small to moderate improvement. Knee pain, function, and quality of life did not improve for APM patients compared to placebo surgery patients at six to 12 months regardless of OA status.

There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis and who have mechanical or obstructive signs. Arthroscopic partial meniscectomy (APM), a keyhole surgery where loose and fragmented pieces of a torn meniscus is removed, is one of the most common orthopedic procedures performed. Over half of these are performed to treat a meniscus tear in a degenerative knee; however, several recent randomized trials have shown that Arthroscopic Partial Meniscectomy is not superior to conservative treatment or placebo treating meniscus tears associated with a degenerative knee. On the other hand, there is universal agreement that the traumatic meniscus tear, the result of a knee injury in a younger patient with otherwise healthy knee (with no degeneration), should be treated by surgery.

Then what is the downside of meniscal injury and surgery? The medial and lateral meniscus together provide shock absorption, establish a broad base of contact surface and help provide stability to the knee. Those who have undergone total or partial meniscectomy should understand that in five to 15 years, they will develop degenerative arthritis. The long-term outcomes of those whose tears were treated by repair rather than removal has not been established. My Regenerative Medicine practice in part, is the result of those seeking to postpone or avoid a Total Knee Replacement years after a meniscal injury followed by arthroscopic surgery. As long as the arthritis has not progressed to a Grade 4, I am able to assist the patient with joint restoration, at times joint regeneration, it is matter of age and health. While I am able to offer joint restoration, on occasion, joint restoration for those who sustained meniscal and Anterior Cruciate injury in the past, is there anything that could be used as an adjunct at the time of the meniscal injury to promote healing without surgery or postpone, perhaps avoid future postraumatic arthritis?

To learn more. Schedule a consultation (312) 475-1893.You may view my web site at www.sheinkopmd.com.

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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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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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