Oct 22, 2015
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.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, PRP, Regenerative, Regenexx, stem cells, technology, treatment
Oct 1, 2015
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
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
Jul 30, 2015
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
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Regenexx, stem cells, treatment
Jun 11, 2015
Cellular Orthopedics for the Musculoskeletal injury and Degenerative Arthritis
What is the problem?
Trauma and Osteoarthritis are part of the cycle of life. Muscle, ligament and tendon injuries frequently occur during sports related activities or accidents; degenerative arthritis may be post traumatic by many years or occur as part of the aging process
What treatments are available?
As of today, it includes Platelet Rich Plasma (PRP) following several protocols and Bone Marrow Aspirate Concentrate (BMAC) rich in stem cells, growth factors and anti-inflammatories called Cytokines. As of next week, all may change as the Orthobiologic update taking place in Las Vegas over the weekend will potentially introduce an entire new menu of therapeutic intervention alternatives for musculoskeletal injury and disease.
What is Platelet Rich Plasma?
Platelets are part of your circulating blood producing growth factors that assist in repair and regeneration of tissue. When a high concentration of platelets are created via the centrifuge, healing may progress more quickly and pain may be reduced
What is Bone Marrow Aspirate Concentrate?
Taken form the back of your pelvis, aspirated bone marrow may be concentrated and prepared allowing for pain relief, improved function, a more rewarding quality of life, and possibly influence the Bio-immune response of degenerative arthritis
What is Amniotic Fluid Concentrate?
The source is the pregnant woman coming to term and delivering via Cesarean section. The recovered amniotic fluid is processed, concentrated, and now available as an alternative to Visco-supplemenation with hyaluronic acid. It is a new option and data concerning the length of pain relief is still being determined.
Do these Regenerative Medicine alternatives work?
When properly applied the answer is yes. What we don’t know is for how long? The effect of Platelet Rich Plasma in injury is intended to speed up the repair process. In the case of Amniotic Fluid, the outcomes are still being studied without a known end point. I have been involved in studying the clinical outcomes of Bone Marrow Aspirate Concentrate intervention for osteoarthritis. The paper I will be presenting this weekend confirms satisfactory results up to two years. The data collection continues.
Is there a downside side to Regenerative Medicine and Cellular Orthopedics?
In my experience the answer is yes and no. Yes because there is no indemnification for the new world of regenerative medicine; care is an out of pocket self pay undertaking because the field is new and five year outcomes data still not available. On the other hand, at three years, I have seen no adverse events and the vast majority have responded well with improved function and quality of life. Out of over 600 knees and over 100 hips, to the best of my knowledge, seven have gone on to a total joint replacement.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, C-SCP, Clinical Studies, Concentrated Stem Cell Plasma, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
May 28, 2015
Osteoarthritis of the knee is one of the leading causes of functional limitation and progressive deterioration in the quality of life. Nonsurgical treatment of the osteoarthritic knee has been the usual and customary weight reduction directive, recommendation for physical therapy, prescription for non-steroidal anti-inflammatories, followed by injections with corticosteroids and hyaluronic acid. The goal is to reduce pain and improve function but the classical non operative approach is not universally successful or long lasting. Alternatives are continually sought to provide pain relief and improve functional outcomes.
Recently, there has been a major initiative to introduce Amniotic Fluid in the treatment of the osteoarthritic knee. Allograft (from a third party) amniotic tissues have a long history of clinical use having been first reported in 1938. It is thought to be a homologue to synovial fluid, acting as a cushion to protect and lubricate in the closed environment of the knee. A recent study measured the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated outcomes measurement tools. In the registry review, early outcomes suggest that the use of processed amniotic fluid allograft may offer a safe and effective treatment for OA of the knee for 90 days. The suggestion is that this treatment may be more durable than single corticosteroid injections and perhaps hyaluronic acid treatments. The study providing the background for this blog is still in progress. Of interest is the fact that no claim is made in the article supported by the pharmaceutical company that amniotic fluid is chondrogenic or contains stem cells. The latter is an extremely important consideration; beware of those who promote amniotic fluid on their web sites as providing viable stem cell content. As of this time, while amniotic fluid may contain cytokines (anti-inflammatories) and growth factors, it is only to be considered in the same category and comparable, perhaps longer lasting than a corticosteroid injection or a hyaluronic acid intervention.
The standard of Regenerative Medicine and Cellular Orthopedics remains Bone Marrow Aspirate Concentrate as the best source of anti-inflammatory cytokines, growth factors and only FDA approved source of viable adult mesenchymal stem cells. In spite of the FDA approval mandate, as recent as this morning, I received an invitation to attend a course that would teach me how to use adipose derived stem cells in my practice. Let me emphasize two points, Amniotic Fluid does not have viable stem cells until proven otherwise and adipose derived stem cells are illegal for use in the musculoskeletal system. That being said, even if adipose derived stem cells were FDA approved and thus available; bone marrow aspirate concentrate provides the Cytokines and the growth factors not found in fat while bone marrow aspirate concentrate provides stem cells not found in processed amniotic fluid.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, FDA, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenexx, stem cells, Synvisc, treatment
