Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-475-1893 for details. Click here to learn more.
How Might Activity Bolster Cartilage

How Might Activity Bolster Cartilage

Can Activity Bolster Cartilage?

It may even delay arthritis and influence cartilage healing. Could running actually be good for your knees, hips, and back? Cartilage, which doesn’t have a blood supply of its own, is generally thought to not have the ability to repair itself once damaged. Yet, in real life, while some some runners will develop knee arthritis, as a cohort, runners are statistically less likely to experience arthritis of the knee, hip or back than non-runners. In recent studies, animals that ran had thicker, healthier cartilage than those that were sedentary, suggesting that the active animals’ cartilage had changed in response to running. Perhaps in humans, cartilage in runners likewise might adapt to repetitive loading cycles. Taking it a step further, you might presume that the cartilage will grow thicker and remodel just as muscle does when we exercise.

Looking at the possible pathways that cartilage uses to remodel and heal in adults with activity, might the explanation be biologics found in your bone marrow, adipose tissue, and plasma? Assume that you have addressed your joint and back pain with the usual and customary measures of Non-Steroidal Anti-inflammatory Medications; weight reduction; Physical Therapy; as well as braces, orthotics and supports; and you still are experiencing symptoms and functional impairment. Next you have tried injections with hyaluronic acid or cortisone with diminishing return; in the latter case with potential damage to your cartilage. The underlying source for joint and back pain are molecules resulting from inflammation in those joints. These molecules are enzymatic proteins that generate pain and destroy the cartilage cells and tissues in the joint or disc space. 

Activities That Can Help

Our bodies do produce defense mechanisms against destructive enzymes; but in order to be effective, these proteins and molecules must get into the joint or disc space in high concentrations. Cyclic loading by activities such as running or cycling is a mechanical mechanism by which your body’s growth factors, stem cells and the like are able to effect cartilage in a joint or intervertebral disc; think of it as a sponge like action of absorption. Another means of delivering the Growth Factor Protein and Stem Cell is via injection following my harvesting your platelets, plasma, circulating blood, adipose tissue or bone marrow; concentrating and filtering; and then injection into the arthritic joint or failing intervertebral disc. The injection of biologics may provide the necessary concentration of molecules to bind and remove destructive enzymes from you joints as well as initiate a healing process.

To learn more about Orthobiologics, visit my website at www.sheinkopmd.com.  You may schedule an appointment by calling (847) 390-7666

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Current Evidence Based Orthobiologics and Stem Cell Care for The Musculoskeletal System

Current Evidence Based Orthobiologics and Stem Cell Care for The Musculoskeletal System

Tono-Bungay by H.G. Wells, tells the story of a miraculous cure-all, Tono-Bungay, that is in fact nothing other than a pleasant-tasting liquid with no positive effects. Nonetheless, when the young George Ponderevo is employed by his uncle Edward to help market this ineffective medicine, he finds his life overwhelmed by its sudden success. Soon, the worthless substance is turned into a formidable fortune.

H.G. Wells first published the book in 1909, but he may well have been describing the relatively unregulated market place for the charlatans and camp followers promoting Regenerative Medicine and Stem Cells in 2020. As an orthopedic surgeon with an ethos of helping arthritic patients postpone, perhaps avoid a major joint replacement, I am happy to share the October 14, 2020, press release post:  “The American Academy of Orthopaedic Surgeons (AAOS) continues to demonstrate its commitment to advancing the quality of musculoskeletal care in a fully transparent and scientific way. Debuting today as a new member benefit, the AAOS Biologics Dashboard is a dynamic online tool designed to help orthopaedic surgeons navigate the FDA approval status of biologic-based interventions. The development of the AAOS Biologics Dashboard is just one of several efforts within the Academy’s Biologics Initiative that offers evidence-based guidance to the musculoskeletal health community.”

Orthobiologics for the Musculoskeletal System

Orthobiologics is an evolving frontier. As new therapies, such as regenerative medicine therapies and stem-cell injections, become increasingly popular due to their potential to regenerate tissue and enhance bone healing and reduce pain, the AAOS continues to recognize a need for reliable and credible sources, of evidence-based therapies. These new tools further validate my ongoing commitment in separating science from anecdote with the goal of helping my patients receive the highest quality of evidence-based care.

What was to have initially taken place this month, basically a purge of the products not FDA approved in the marketplace, has been delayed until May of 2021. In my practice, I can assure my patient that all care will anticipate the FDA rules and be compliant with the FDA regulatory apparatus by prior screening on the new AAOS Biologics Dashboard. Although there is no board certification for a regenerative medicine or stem cell physician, look for the letters FAAOS after the M.D., as they describe membership in the American Academy of Orthopedic Surgeons and is your protection and quality assurance if you chose to undergo a stem cell or cellular orthopedic procedure.

To schedule a consultation, call (847) 390-7666. My web site is accessed via www.sheinkopmd.com

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The New World of Cell Based Therapy and Orthobiologics

The New World of Cell Based Therapy and Orthobiologics

About 15 years ago, an article was published regarding the use of Platelet Rich Plasma for the treatment of arthritis. Prior to that clinical trial, physicians would use hyaluronic acid (rooster comb) in an attempt to diminish the symptoms from an arthritic joint. The introduction of PRP heralded the beginning of orthopedic, clinical Regenerative Medicine. Our problem then was that no clear-cut definition of Platelet Rich Plasma was advanced; even today, there is a lack of standardization of the many available PRP offerings. That being said, I use the term Proprietary PRP to clarify my compounding of your platelets and plasma in controlling the pain generator in an arthritic joint; namely inflammation. Growth Factor Proteins (too numerous to describe here) contained in platelets and plasma, act as antagonists to the pain generators within the joint. When concentrated and injected into the painful, inflamed joint, symptoms disappear or are minimized and function improves.

Continuing with our webinar, it was the introduction of the Adult Mesenchymal Stem Cell into orthopedic practice 12-years ago, following FDA guidelines for clinical use, that allowed Regenerative Medicine to become a reality. At that time and continuing to the present, the possibility of cartilage regeneration in an arthritic joint can only be realized by a combination of stem cells, platelets and growth factors. The classic source of these joint regenerators is your bone marrow. In order to be FDA compliant, the harvested bone marrow must come from you and be concentrated, not expanded with addition other agents or through culturing.

FDA Approved Cell Based Therapy

Fast forward to 2019 when the first FDA approved Stem Cell Trial using adipose derived Stem Cells made available via Liposuction and processing was initiated by Personalized Stem cell, Inc. I was one of the several investigators involved and we are tabulating and analyzing data which will then hopefully allow us to move forward with the second phase of the Trial. While bone marrow gives us access to tens of thousands of stem cells, adipose tissue (abdominal fat) allows us to recover several millions of stem cells for processing and clinical usage. I will announce on my web site if and when the phase two trial is allowed by the FDA.

In the meantime, my practice based on various orthobiologic offerings to relieve symptoms of arthritis and improve functional capacity continues. While cartilage regeneration isn’t always an option owing to age or co-morbidities, such options including IRAP variations, Exosomes, and Proprietary PRP are available to maintain or restore an active lifestyle.

Finally, in part owing to lack of standardization and in part because of the charlatans and bad actors holding themselves out to be Regenerative Medicine “experts”-one can attend a 72-hour course and then upload a web site claiming expertise-The American Academy of Orthopedic Surgeons has initiated reform of the emerging discipline of regenerative medicine with consumer protection and physician continued education as the primary goal.  I am a Board Certified Orthopedic Surgeon, Fellow of the American Academy of Orthopedic Surgeons and Fellow of the American College of Surgeons.

Good riddance to the quacks.

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Mesenchymal Stem Cell Treatment Update for Arthritis

Mesenchymal Stem Cell Treatment Update for Arthritis

There are two clinical, readily available sources of adult mesenchymal stem cells, to the cellular orthopedist; the musculoskeletal building cells that have the potential to stop the progression of arthritis. These cells may reverse the damage, regenerate cartilage, and eliminate the pain generator, inflammation. MSCs work in conjunction with platelets and proteins called Growth Factors.

In my clinical evidence-based setting, we have explored and continue to investigate the several possible approaches to treating the arthritic joint with either your adult mesenchymal stem cells, your platelets and /or your growth factors either separately or in combination with each other. I have previously authored or co-authored the results of the clinical outcomes of using adipose derived approaches to arthritis and bone marrow concentrate containing stem cells in restoring the arthritic joint to well-being. My most recent scientific publication is based on using concentrated bone marrow both in the joint and in the subchondral bone adjacent to the joint as there is increasing evidence regarding the role of the subchondral bone in the causation of arthritis.

Mesenchymal Stem Cell Treatment Clinical Trial Update

This past Thursday night, the several of us involved in the first FDA approved, recently completed, Clinical Stem Cell Trial (Personalizedstemcells.com.), reviewed the preliminary responses in 38 enrolled patients. First and foremost, we recorded no serious adverse events; no complications from the drug injected after liposuction and preparation. Several minor complaints were observed as part of the liposuction process. Of the 38 patients, the vast majority are enjoying a positive response in the treated arthritic joint. The FDA has required our monitoring the patients for a year; however, our next milestone follow-up will be at day 84 from the time of the joint injection.

Based on what we have learned to date about the safety and efficacy of adipose derived stem cells in the treatment of the arthritic knee, our investigators under the auspices of PersonalizedStemCells.com will be applying for a second phase clinical trial at the knee; but additionally, safety and efficacy for the hip and for several joints at the same time. I will announce the start of trial enrollment when approved in this blog and on my website, www.sheinkopmd.com.

These new clinical trials probably will not be open to enrollment until December or perhaps the first quarter of 2021. For those patients who are seeking relief now without jeopardizing participation in the clinical trial, call (847) 390-7666. I offer a full menu of biologic interventions for the arthritic joint including concentrated bone marrow, Proprietary Platelet Rich Plasma (PRP), Growth Factors and other Orthobiologics and determine which is the best option at the time of the office visit

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100th Publication on Evidence Based Regenerative Medicine and Cellular Orthopedics

100th Publication on Evidence Based Regenerative Medicine and Cellular Orthopedics

“Article Title: Clinical outcomes and safety of a combined autologous bone marrow concentrate intraosseous and intraarticular injection for knee osteoarthritis at 12 months

Journal Title: Journal of Regenerative Medicine

Dear Dr. Sheinkop

I am pleased to tell you that your work has now been accepted for publication in Journal of Regenerative Medicine.

It is accepted on 2020-09-14”

100th Publication in an Orthopedic Journal

This will mark the 100th scientific article I have authored or co-authored and has been or will be published in a peer reviewed orthopedic journal. The last three articles have been the result of our outcome efforts in Regenerative Medicine. While I have previously alluded to my having pioneered the integration of patient care with clinical research when I was a joint replacement surgeon, there are few orthopedic surgeons, for that matter clinicians of any kind, who have focused their biologics care and treatment of the musculoskeletal system on evidence based medicine. When you visit an orthopedic surgeon, a patient may feel confident in the surgical recommendations advanced. In the emerging field of Orthobiologics for arthritis and musculoskeletal injury, there is not as of yet, a specialty board certifying the training of the regenerative medicine clinician. The result is the risk to a patient of fraud and abuse by the charlatans, camp followers and bad actors. The best means of patient protection in regenerative medicine is to seek out only those who practice evidence-based medicine.

Returning to the thrilling days of the future, the three-year follow-up of the original patients receiving the combined intraosseous and intraarticular bone marrow concentrate at the arthritic knee will soon be initiated. We need to scientifically document how long the treatment will last. At the same time, we continue outcomes surveillance of those who participated in the pioneering Personalized Stem Cell Clinical Trial. Continuing to work with Personalized Stem Cells, I have established an encrypted communication means with the FDA as we are now moving forward with the planning of the next Adipose derived stem cell trial. You may learn more and see the future at www.PersonalizedStemCells.com.

Studies under consideration for 2020/21

  • First clinical trial is for knee osteoarthritis (completed)
  • Injection of uncultured cells into two arthritic knees.
  • Injection of cultured stem cells into two arthritic knees.
  • Multiple clinical trials with one or more injections with uncultured and/or cultured stem cells in knees, hips, shoulders or elbows.
  • Treatment of immune mediated conditions as supported by clinical and scientific publications.

*The studies outlined will only be conducted if, or when, FDA approval is obtained for each medical condition, protocol, and cell type.

You may learn more on my web site www.sheinkopmd.com or schedule an appointment by calling (847) 390-7666

 

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