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.
Orthobiologics as practiced by an Orthopedic Surgeon

Orthobiologics as practiced by an Orthopedic Surgeon

Autograft is a tissue or organ that is grafted into a new position in or on the body of the individual from whom it was removed; whereas allograft is the transplantation of tissue taken from one individual to another. Bone Marrow Aspirate Concentrate is an autograft while Amniotic Fluid Concentrate is an allograft.  Autograft, at this time serves as the gold standard for almost all situations in which the use of orthobiologics is indicated. Bone Marrow Aspirate Concentrate (BMAC) offers nearly every essential component involved in reversing the damage caused by arthritis including Adult Mesenchymal Stem Cells, Growth Factors, Cytokines, and Vascular Progenitor Cells. Because of the inherent value of Bone Marrow, my first interventional thought is BMAC; in addition it is virtually free of risks and side effects.

The U.S. Food and Drug Administration (FDA) has approved certain growth factors and allied substances for specific indications. Platelet Rich Plasma falls into this category. In addition to BMAC, Autogenous PRP contains many growth factors as well. Stem Cells are at this time, the ideal biological treatment because they recreate the original microenvironment and supply paracrine factors (a type of hormone which binds to receptors in nearby cells influencing their function). Bone Marrow Aspirate contains a variety of cell types such as endothelial progenitor cells (EPCs), osteoprogenitor cells (OPCs), stem cell niche-supporting cells, and cytokines.

You bet this is confusing and not easy to understand. That’s why I try to clarify by writing the Blog. At the same time, it demands that a clinician stays well informed and not depend on the hype of marketing from the start-ups in the field of orthobiologics to influence a potential patient intervention. On Thursday, I travel to Broomfield, Colorado for the first meeting of the Interventional Orthopedics Foundation, the first not for profit dedicated to Regenerative Interventional Orthopedics: The Next Frontier. My presentation will be based on the 24 month outcomes of Bone Marrow Concentrate in knee arthritis. Another issue will be addressed, are there viable stem cells in Amniotic Fluid Concentrate? The Regenexx Advisory Board of which I am a member, will review the challenges presented by the patient with Grade 4 Osteoarthritis for whom until now, we have had little to offer other than referral for a joint replacement. Next week, I will be in a position to upgrade the reader about the present role, if any for mechanically liberated, adipose derived, stem cells as this subject as well will be studied by the advisory panel.

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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

What causes the pain in degenerative arthritis?

An all too common practice today is when the surgeon looks at your X-ray, tells you that you have “Bone on Bone “ and that you need a Total Joint Replacement. There is little discussion of the risks and the potential of an unsatisfactory result. The patient looks for pain relief but doesn’t really appreciate why a joint replacement may be indicated or whether there may be other options for delaying or even avoiding a joint replacement; particularly in Grades two and three osteoarthritis.

During my orthopedic training (readers of this Blog are aware I was a joint replacement surgeon for 37 years before “graduating” into interventional orthopedics) I was made aware that the X-ray evidence of osteoarthritis included joint space narrowing, subchondral sclerosis and osteophyte formation. The lay public refers to these observations as “bone on bone” and spurs. The general connotation is that these findings are consistent with Degenerative Arthritis. The synonym is Hypertrophic Osteoarthritis. The other general category of arthritis is Inflammatory and the most frequent category is Rheumatoid Arthritis. The synonym for Inflammatory Arthritis is Atrophic Arthritis in which there is joint space narrowing with osteoporotic adjacent bone changes (joint space narrowing without spurs or thickening of subchondral bone). There is yet another presentation on X-ray of Degenerative Arthritis that is not inflammatory but shares the atrophic nature of bony change. These occur in patients experiencing systemic osteoporosis who undergo degenerative changes. The interesting observation of the latter category is these subjects don’t hurt until very late into the disease process.

In trying to understand what causes the pain in degenerative arthritis, I haven’t lost sight of the inflammatory mature of the bioimmune process inside the joint but I am recently reminded of the shock absorbing and structural support nature of the bone supporting the cartilage. Is the pain generator the bone or the inflammation within the joint? If there is still a joint space but hypertrophic (sclerotic) subchondral bone, will the subchondroplasty alter the progression of osteoarthritis and delay or postpone a joint replacement? If there is X-ray evidence of “Bone on Bone”, should a bone marrow aspirate concentrate intervention be coupled with the subchondroplasty? If there is atrophic arthritis of a degenerative nature, should treatment be limited to an intraarticular intervention alone? Incidentally, Atrophic Arthritis of a degenerative nature is determined after a C-reactive protein and Erythrocyte Sedimentation Rate serum test excludes inflammatory systemic disease.

What is causing your joint pain and what might be done to delay or perhaps avoid a joint replacement while returning you to a more active life? Call and make an appointment so I may assess you, review images and advance an evidence-based recommendation:

847 390 7666

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Interventional Orthopedic Inclusion and Exclusion Criteria

The Subchondroplasty Procedure

You have presented with a painful joint and imaging is compatible with an arthritic process and/or a bone marrow lesion (contusion/bruise). Bone supports the joint and when damaged either by injury or as part of the arthritic process, contributes to pain and the progression of arthritis. The bone marrow lesion is seen on the MRI while the change of bone, subchondral sclerosis, is seen on the routine X-ray.

Patients with Bone Marrow Lesions are known to have increased pain, less function, faster joint cartilage destruction and reduced benefits from present forms of intervention. By addressing not only the arthritis but the bone surrounding the joint, it is anticipated that the results of intervention for the arthritic or injured joint will be markedly improved.

Subchondroplasty is a minimally invasive procedure targeting and treating subchondral defects that is the altered bone adjacent to and responsible for supporting the joint. During the treatment phase of injecting Bone Marrow Aspirate Concentrate for the arthritic joint, the subchondroplasty adjunct is completed under the fluoroscope. In conjunction with delivering the BMAC into the joint itself, additional Bone Marrow Aspirate Concentrate is placed into the surrounding bone through small drill holes created with a special canula. Up until now, the subchondroplasty drill holes were filled with a synthetic substance manufactured from Calcium Phosphate. The theory was that the Calcium Phosphate granules when placed into the bone defect would eventually be resorbed and replaced by bone. Using Bone Marrow Aspirate Concentrate is a much more physiologic stimulus for effecting bone healing in a much shorter time and by a means that more closely approximates bone healing after injury.

Our goal is to assist the patient in delaying or possibly avoiding a joint replacement through Regenerative Medicine (Cellular Orthopedic) approaches. The Bone Marrow Aspirate Concentrate intervention has proven extremely successful in meeting those goals. The introduction of Subchondroplasty will allow us to offer the possibility of increasing the success rate and the longevity of effect in appropriate settings and in any joint; hip, knee, ankle or shoulder.

 

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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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