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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.
Interventional Orthopedic Inclusion and Exclusion Criteria

Interventional Orthopedic Inclusion and Exclusion Criteria

Why our Regenerative Medicine/Interventional Orthopedic clinical practice is where you should consult before undergoing a Cellular Medicine intervention:

I am an orthopedic surgeon, Professor Emeritus at Rush, who for 37 years, performed Joint Replacement Surgery for arthritis before “graduating” into Cellular Orthopedics. Basically, I exchanged my knife for a needle. As a Fellow of the American Academy of Orthopedic Surgeons, I am required to partake in the Mandatory Disclosure Policy requiring me to update disclosures and potential conflicts of interest at least semiannually (April and October). All AAOS members involved as continued medical education faculty and authors, orthopedic volunteers in organizational governance, clinical practice guidelines, appropriate use criteria, and performance measures development, and editors-in-chief and members of editorial boards are required to complete disclosure in the AAOS Orthopedic Disclosure Program. My membership and active participation in the American Academy of Orthopedic Surgeons, my Fellowship in the American College of Surgeons, and my membership in the American Medical Association is your quality assurance that I subscribe to evidence based clinical practice guidelines. As such, it is my responsibility to offer Regenerative Medicine interventions to only those who meet Inclusion Criteria and educate patients who I can’t help about joint replacement alternatives. Furthermore, I also am bound by professional ethics not to add unproven treatments to my range of services.

Inclusion criteria are based on a medical history and physical examination, first and foremost and secondarily, after a look at an X-ray or MRI. Conversely, we employ a relatively strict list of exclusion criteria for those patients who just won’t benefit from Cellular Orthopedic interventions. Admittedly, while our practice is based on the scientific evidence, from time to time there are new treatment options. Unlike many who offer stem cell treatments, when a new regenerative option is brought to my attention, if I feel that it falls within FDA approved guidelines, I will investigate, apply for an IRB centered scrutiny and provide exhaustive informed consent to a patient. Your quality assurance of my standards of practice should also be reinforced by my participation as a member of the Regenexx Network and my involvement in the recently formed Regenexx Board of Advisors. In addition, I have made a commitment to my patients that I would become familiar with any new clinical trial initiatives and participate if I feel there is a role for such in my practice.

Over the next several weeks, I will share with you my review of new Regenerative Offerings, especially for those who might otherwise not meet our Regenexx inclusion criteria.

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Interventional Orthopedic Inclusion and Exclusion Criteria

What’s Available for Treating Degenerative Arthritis through Interventional Orthopedics

As I have previously indicated in my Blog, the world of Cellular Orthopedics is growing at an exponential pace. Evidence Based Medicine supports weight reduction, physical therapy, anti-inflammatories, analgesics, and cortisone injections for symptomatic relief. Evidence Based Medicine no longer supports the use of Hyaluronic Acid injections (visco-supplementation). Historically, the next step is a joint replacement when the aforementioned conservative measures no longer have an effect. When I initiated my practice of Interventional Orthopedics as part of the Regenexx Network, their patient satisfaction surveys supported the use of Bone Marrow Aspirate Concentrate interventions for osteoarthritic joints. Since my entry into the sub-discipline of Regenerative Medicine, we have gathered data on every patient seeking consultation and care and, have expanded the Outcomes measurement intake to include objective data points in addition to those of a subjective nature. Along the way, we have gained a better understanding as to how a patient might better respond to Interventional orthopedic options. The evidence is growing.

Just as my practice has grown and the Regenexx Outcomes Data base has grown, so too have the Interventional Orthopedic treatment alternatives increased. Now there is Amniotic Fluid Concentrates available to replace Hyaluronic Acid as a six to 12 month anti-inflammatory. As of July of this year, two companies have introduced Adipose derived stem cell alternatives claiming a mechanical means of emulsifying fat and eliminating the need for the enzyme collagenase; the latter not approved by the FDA when it comes to the musculoskeletal system. As of this time, there is no scientific evidence to support the claims of success in arthritis with both Amniotic Fluid Concentrate and Adipose Derived Stem Cells. Those studies will take several years before there is clinical evidence to support said use in arthritis.

What we have learned and is supported by clinical evidence is how to better plan and prepare for a Bone Marrow Aspirate Concentrate intervention. First a clinician must rule out referral of pain from other sources; this is accomplished by a thorough history and physical examination. The status of a meniscus, labrum, and the articular cartilage must be taken into account. Mechanical malalignment –a bowed leg or knock knee-must be ascertained and excesses corrected. Ligamentous deficiencies will contribute to the end result and must be corrected before any Intervention of an orthopedic nature.

I have provided a lot for a reader to digest. If you want clarification or to learn if you are a candidate for INTERVENTIONAL ORTHOPEDIC to postpone or eliminate a joint replacement for osteoarthritis, call for an appointment:.

847 390 7666

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Interventional Orthopedic Inclusion and Exclusion Criteria

Osteoarthritis, Total Joint Replacement and Biologic Arthroplasty

In the past several years, the major joint replacement manufacturers have dedicated increasing resources to the field of OrthoBiologics with the belief that joint replacements for arthritis, as we know them today, will no longer control market share. In anticipation of this introduction of scientific advances for the care and treatment of arthritis, I “graduated” from joint replacement to Regenerative Medicine (Cellular Orthopedics ) three years ago. I exchanged an incision and scalpel for a trochar and syringe in offering pain relief, improved function, alteration of the natural history of arthritis progression, and perhaps regeneration of cartilage for the usual and customary prosthetic joint.

The poster child for the field of Regenerative Medicine has been Kolbe Bryant of the Los Angeles Lakers who when faced with career ending arthritic issues of his knee traveled to Germany for what at that time was unavailable in the United States. He has extended his career with a biologic intervention whereas a joint replacement would have necessitated retirement. Today in the United Sates, Bone Marrow Aspirate Concentrate containing Mesenchymal Stem Cells, Cytokines and Growth Factors is the basis for intervention whereas at the startup, three years ago, it was Platelet Rich Plasma. The next generation of OrthoBiologics is now in development and I am happy to announce that I will be playing a major role in the future of Regenerative Medicine as I am now helping design and introduce several clinical trials. On Friday night, August 21, Fox News Chicago will air the story of one of my patients and why, after an unsatisfactory outcome of a total knee replacement on the right, she chose the Orthobiologic option on the left. In that story, you will learn how and why I added Subchondroplasty as an adjunct to improve the outcome.

At Regenexx, we are continuing to stay ahead of the maddening crowds with research and development. I have been asked to join the Regenexx advisory panel and contribute based on my experience first as a Joint Replacement surgeon and for the past three years as an Interventional Orthopedist integrating patient care with research and education. If you want to benefit from the present, make an appointment; if you want to know about the future, stay tuned.

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Interventional Orthopedic Inclusion and Exclusion Criteria

Changing Interpretations in Regenerative Medicine

As I have written in this Blog, the explanation of how a Stem Cell orchestrates change is dynamic with a shift in scientific thinking from the stem cell as a progenitor to the stem cell acting as a Bio-immune moderator and as a Medicinal Drug Store affecting lots of other cells. So too is there an evolution in the role of Amniotic Fluid Concentrate and that of Adipose Derived Stem Cells.

I will start with Amniotic Fluid Concentrate (AFC). In the beginning, the AFC was introduced in the marketplace as a source of viable stem cells to be positioned as an alternative to Bone Marrow Aspirate Concentrate. That introduction of Amniotic Fluid Concentrate followed success in healing chronic wounds associated with Diabetes and vascular insufficiency. The producers and manufacturers of AFC recognized an opportunity to introduce their product as an alternative for treating arthritis. At first, the commercial approach was to market the concentrate as a source of viable stem cells. Within six months though, reason prevailed and the Amniotic Fluid Concentrate was repositioned in the marketplace as an alternative to Visco-supplementation; a joint gel so to speak with longer term and a higher percent success rate than that with Hyaluronic Acid options.

Three years ago, the notion of Adipose Derived Stem Cells (ADSC) was rarely researched or commented on as an option for arthritis since the FDA had made it clear that in order to not be classified as a Pharmaceutical, an orthobiologic could not be manipulated or expanded. Until recently, in order to liberate the stem cell from adipose tissue and make the cells biologically available, the product of lipo-aspiration would have to be treated with an enzyme, collagenase for four hours. This would violate the FDA mandate of no manipulation and the four hour rule for reintroduction into the body. Over the last several months, at least two companies from Europe have introduced a mechanical means of allegedly liberating Mesenchymal Stem Cells from Lipo-Aspirate and thereby making it readily available and FDA compliant. How the FDA ultimately interprets mechanical emulsification cannot be predicted. Additionally, how MSCs from adipose tissue clinically perform when compared to MSCs derived from Bone Marrow Aspirate will be a matter of great debate. This alternative could be directed to those too far advanced to benefit from Bone Marrow Aspirate Concentrate.

What is subchondroplasty?  For another Blog.

My office has been asked to play a role in clinical investigation of the several alternatives I have reviewed in this Blog. Protocols are under development and await IRB approval. To learn more about the present and future of the non –operative care of arthritis at any stage, make an appointment

847 390 7666

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Interventional Orthopedic Inclusion and Exclusion Criteria

In Regenerative Medicine, the Sooner, the Better

Cartilage is known to be damaged by Interleukin-1B (IL-1B), a cell signaling protein responsible for blood-induced cartilage damage. When there is trauma to a joint and a hematoma ensues, the faster the hematoma is evacuated, the less damage to cartilage long term. The blood in the joint now provides an explanation as to why some years after an injury, a patient will present with an osteoarthritic joint. An example is the tear of the Anterior Cruciate Ligament. Findings in the research laboratory also indicate that the faster the blood is removed from the injured joint, the less damage to the cartilage. To emphasize the harm from IL-B1, we are experiencing increased number of patients with a history of an ACL tear who are in need of intervention for post traumatic arthritis at younger ages than in the past even when the ACL has been successfully repaired.

Turning our attention to fractures within the joint, it is important for orthopedic surgeons to realize the impact of blood on cartilage. There is an upregulation of cartilage-degrading enzymes suggesting that the indications for surgical repair of an intra-articular fracture should be expanded and the surgery considered urgent and not delayed. There is an additional adjunct that should be introduced into the algorithm of care of the joint injury and resulting hematoma; namely, Bone Marrow Aspirate Concentrate. Interleukin-1B Receptor Antagonist Protein serves as a dose- and time-dependent protection from blood-induced damage. The higher the concentration and the earlier the introduction, the less cartilage damage sustained. When Bone Marrow is aspirated, recovered with the Mesenchymal Stem Cells (MSCs) are those cells in the bone marrow that produce Interleukin-1 Receptor Antagonist Proteins (IRAP). When the aspirate is concentrated, included in the centrifugate along with the MSCs is a therapeutic quantity of IRAP and that means stopping the degradation of cartilage by the harmful blood born Il-1B.

So what is my take home message? The swollen joint after trauma needs to be aspirated as quickly as possible to remove blood. The intra-articular injury to a joint must be addressed either by surgery or non-operative means on an urgent basis; intervention should not be considered elective. Bone Marrow Aspirate Concentrate should be increasingly used as an adjunct in the care of a joint injury. Should you experience that joint injury, discuss using Bone Marrow Aspirate Concentrate as an adjunct. If your orthopedic surgeon is unfamiliar, once the damage is acutely addressed, call us to see if there is a place for Cellular Orthopedics as a means of improving your long term outcome.

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