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.

Cartilage repair revisited

Articulate cartilage has little to no capacity to undergo spontaneous repair because it has no blood supply nor is it able to regenerate across a physical gap. In order to restore cartilage in a skeletally mature patient, there is a need for outside help. In some settings, osteochondral transfer (bone with cartilage) may be harvested from elsewhere in a damaged joint and repositioned or relocated in that joint. In other settings, fresh cadaveric tissue (allograft) may be used. More recently, attempts have been directed at “engineering” cartilage. For engineering to take place, there are three requirements. First must come a matrix scaffold necessary to support tissue formation. Second are cells such as mesenchymal stem cells either from bone marrow or synovial membrane lining the joint. Third comes signaling molecules (cytokines) and growth factors. Platelet Rich Plasma is a source of signaling molecules. While Bone Marrow Concentrate doesn’t meet every need for tissue engineering, to the best of my knowledge at this time, there is nothing superior for a long term successful outcome either as an adjunct to a surgical procedure for a small defect or as a primary intervention for an arthritic joint.
There are several ways to measure success after an attempt at cartilage repair. For a contained or global defect, MRI is the primary outcome measure; whereas for osteoarthritis, the Outcome objective metrics I use have proven statistically significant and reproducible. I write this Blog in between presentations by the faculty at American Academy of Orthopedic Surgery Program: Articular Cartilage Restoration-The Modern Frontier. I came here to learn and learn I did about surgical procedures for contained injury. When it comes to osteoarthritis, I learned little but contributed much. No, I am not being egotistical, I am reporting what transpired at the meeting and what is transpiring in my practice. Of interest is the universal agreement by those treating the global defect with surgery and those of us who treat osteoarthritis with stem cells; including the supporting bone ( bone marrow edema)in the therapeutic algorithm via subchodndroplasty is paramount.
“He, who has data, need not shout”

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Health Care-Practice Guidelines and Grades of Recommendation must be based on Levels of Evidence and not anecdote or personal; that’s why I recommend what I do

Patients should participate in strengthening, low-impact aerobic exercises, and neuromuscular education; and engage in physical activity.

Rationale:

This recommendation is rated strong because of seven high-strength studies of which five showed beneficial outcomes. The exercise interventions were predominantly conducted under supervision, most often by a physical therapist.

I recommend weight loss for patients with symptomatic osteoarthritis of the knee and a BMI = 25.

Rationale:

Physical Function shows important improvement in outcomes for this patient population. Function also shows statistical improvement that is clinically significant. Diet and exercise combined achieves the best results.

I do not recommend using acupuncture in patients with symptomatic osteoarthritis of the knee

Rationale:

In Studies that comparing acupuncture to groups receiving non-intervention sham, usual care, or education, the majority, show no clinically significant improvement. While there is a lack of efficacy, there is no potential harm.

I am unable to recommend for or against the use of physical agents (including electrotherapeutic modalities) in patients with symptomatic osteoarthritis of the knee.

Rationale:

Due to the overall scientifically inconsistent findings for various physical agents and electrotherapeutic modalities, I am unable to make a recommendation for or against their use in patients with symptomatic osteoarthritis of the knee. To better understand the role of pulses in the management of arthritis, I am waiting for FDA approval to launch a clinical trial using a pulsed brace after a bone marrow concentrate/stem cell procedure.

I am unable to recommend for or against manual therapy in patients with symptomatic osteoarthritis of the knee.

Rationale:

Due to the lack of studies examining most manual therapy techniques, I am unable to opine. No studies evaluating joint mobilization, joint manipulation, chiropractic therapy, patellar mobilization, or myofascial release were found of scientific merit.

I cannot recommend using glucosamine and chondroitin for patients based on science; yet I personally use them

Rationale:

At this time, both glucosamine and chondroitin sulfate have been extensively studied. There is essentially no evidence that minimum clinically important outcomes have been achieved compared to placebo. There is no evidence of potential harm. The same may be said of the  neutraceuticals methylsulfonylmethane, omega-3, gelatin, vitamin D, dimethylsulfoxide, antioxidants, and coenzyme Q10. 01

I will not use needle lavage for patients with symptomatic osteoarthritis of the knee.

Rationale:

The published evidence shows little or no benefit from needle lavage in the treatment of osteoarthritis of the knee.

I am able to recommend growth factors and stem cells derived from Bone Marrow Aspirate in conjunction with platelet rich plasma for patients with symptomatic osteoarthritis of the knee.

Rationale:

I have an ever-increasing Data-Base of Outcome measurements to support my recommendations with Levels of Evidence at 1B and 3 with a Grade D governmental guideline Grading (the highest). You may learn more at the National Guideline Clearinghouse (http://www.guidelines.gov) or make an appointment at 847 390 7666

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Why the need for restoration of articular cartilage

Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy,  friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.

As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition.  The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing  its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.

Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.

There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors.  What about adipose derived stem cells and cultured stem cells?

While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.

With all the above written, I am  done for today; if you are still unclear or uncertain, call the office for an appointment.

847 390 7666

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Continuing Cartilage Restoration Education

Physicians should be in a constant state of education to keep their skills and knowledge at the forefront so that their patients get the best care possible. At the same time, I personally have devoted over 40 years to integrating patient care with research and education be it directed to joint replacement, and for the past four years, to postponing and at times, avoiding joint replacement. As the vast majority of health professionals, I strive on a daily basis to meet the need of my patients. Each and every patient for whom I provide care is entered into a HIPAA compliant outcomes database. From time to time, results are extracted from that data-base and presented at Cellular Orthopedic meetings. Soon we will be submitting the outcomes of several clinical trials for statistical analysis and publication. Almost every therapeutic intervention I recommend is based on science and statistically significant outcomes; rarely on anecdote.

The emerging field of regenerative medicine aims to deal with arthritis and cartilage injury by providing the required elements (cells, inductive molecules, and local environment) to promote true joint and cartilage regeneration. Cellular Regenerative Medicine is rapidly evolving and changing on an almost weekly basis. This is both good news and bad news as there are those who would try to prosper through marketing rather than science. Witness the invitation I received last week to travel to the Bahamas for stem cell care based on anecdote; or the advertisement for the “opportunity” to attend a weekend course to teach me how to use adipose tissue for every malady in the human body. How is it possible to track outcomes from medical tourism or to teach adipose related cellular orthopedic intervention when the latter is not FDA approved?

To assure you that I remain in the forefront of Cellular Orthopedics, from March 31-April 2, 2016, I will be participating in a Continuing Educational course, Articular Cartilage Restoration: The Modern Frontier, sponsored by the American Academy of Orthopedic Surgeons. This is a premier skills course that provides hands-on exposure and practice for the most updated techniques in cartilage restoration while allowing for a contemporary overview of established and new procedures to treat the entire knee joint for cartilage damage ranging from focal defects to arthritis.

Although I no longer am involved with orthopedic resident education, as Professor Emeritus at Rush, I have taken the Interventional Orthopedics Foundation pledge to continue to integrate my clinical interventions with outcomes surveillance. Several scientific presentations at the early March meeting of the American Academy of Orthopedic Surgeons resulted because of my ongoing initiatives. I am the orthopedic surgeon who four years ago, exchanged a scalpel for a stem cell.

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On Published Regenerative Medicine Articles in Scientific Journals

In a commercial advertisement appearing on page 3 of the Monday, March 14, 2016 Chicago Tribune, a claim by the Osteo Relief Institute bases, in part, the validity of a “cutting-edge” treatment-Viscosupplementation intervention-on an article published in the Journal of Managed Care Pharmacy. Having published over 100 scientific papers in peer reviewed journals and never having heard of the Journal of Managed Care Pharmacy; I looked up the Journal to learn it is an advertising vehicle for the pharmaceutical industry.

From the American Academy of Orthopedic Surgeons: “AAOS Evidence-Based Clinical Practice Guidelines are based on a systematic literature review of published studies. Multidisciplinary guideline development groups construct Evidence-Based Clinical recommendations.” “Although some patients report relief of arthritis symptoms with viscosupplementation, the procedure has never been shown to reverse the arthritic process or re-grow cartilage”. The AAOS no longer supports the use of Viscosupplementation in the treatment of arthritis.

What we do with your stem cells at Regenexx is not only address symptoms of arthritis; based on our clinical trials, data base, and scientific publication documentation, is to improve function while addressing the progression of arthritis at a molecular and bio-immune level. Stem cells, in addition to the cytokines and growth factors in Bone Marrow Concentrate, have the potential to regenerate cartilage. Because of the lack of proven success over 20 years as determined by meta-analysis of the scientific literature concerning viscosupplemenation, the Regenexx network is moving away from offering Hyaluronic acid (Gels) and slowly the insurance industry is dropping coverage as well.

There is no question that the Osteo Relief Institute marketing campaign is attractive to a patient but what about a scientific foundation?  Don’t get me wrong, I too can succumb to well done advertising. The Most Interesting Man in the World ad campaign caused me to switch to Dos Equis beer. Your arthritic related limitation is a totally different matter and your choice of treatment should not be influenced by an advertising campaign. Seek out that which is evidence based and available through board certified physicians and surgeons.

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