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.
On The Horizon of Regenerative Medicine

On The Horizon of Regenerative Medicine

There has been a major change in thinking about how a Mesenchymal Stem Cell functions as I have touched on in recent blogs. The focus of research has been on their potential to differentiate into multiple tissues such as cartilage and bone. This has led to a vast body of work dedicated to the potential of the MSC for tissue engineering or regenerative medicine in musculoskeletal applications. More recently, the emphasis has changed from the Mesenchymal Stem Cell’s functional differentiation to a greater emphasis on a secretor of molecules. As recent as three years ago it was thought that the MSC when concentrated and placed into a joint would survive and become a dynamic part of that tissue. The survival of implanted cells is now viewed with increasing doubt but we continue to observe major benefits to the arthritic joint from intervention with Bone Marrow Concentrate. It is becoming clearer that the real function of the MSC is to regulate the immune system and to secrete molecules that direct the behavior of the resident cells. In this role, the Mesenchymal Stem Cell serves as a conductor, a medicinal stem cell effectively acting like a growth factor factory or drug store.

It is what the cells secrete rather than the cell actually morphing into cartilage in an arthritic joint. When Bone Marrow Aspirate is concentrated, the implanted cells produce several soluble mediators that initiate or enhance the healing process. The exact growth factors and cytokines being expressed by the cells still haven’t been defined.

Let’s explore how this coincides with the Regenexx SD algorithm. We anticipated the future when we introduced the Same Day Bone Marrow Aspirate Concentrate program three years ago. It is well accepted that an acute inflammation is needed to initiate a healing response; hence the first step in the Regenexx-SD program. The Bone Marrow Aspirate Concentrate intervention that follows then intervenes so the acute inflammation doesn’t become chronic by secreting anti-inflammatory factors. Next the healing process begins with immune modulation and cytokines explaining the mechanism of relatively immediate pain relief reported by most patients. Lastly, the follow-up injection of activated Concentrated Platelet Rich Plasma modifies the cellular behavior enhancing the secretory profile of the Mesenchymal Stem Cells. When all is said and done, the vast majority of patients presenting with grades 2 and 3 osteoarthritis are enjoying pain relief and restoration of function more than two years after an intervention. What will follow next is a new approach for those with stage four osteoarthritis who have been told they need a Total Joint Replacement.

Stay Tuned.

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On The Horizon of Regenerative Medicine

Orthopedic Surgery through a Syringe

That’s the headlines in several orthopedic articles recently appearing in scientific journals and that’s what is predicted for the future. I have been using that syringe in lieu of a scalpel for three years. Four years ago, it was a four-inch incision for a knee and a ten-inch incision for a hip. A revision required more than double that length with major muscle disruption of life and a marginally successful outcome.

Let’s return to the alternative for a joint replacement in an arthritic joint, Bone Marrow Aspirate Concentrate. This past weekend, I presented the 12 to 24 month outcomes of Bone Marrow Aspirate Concentrate for knee arthritis in 172 patients I have treated, at the Orthopedic and Biological Institute 5th annual meeting held in Las Vegas. More than 500 physicians from around the world attended it. The paper was very well received as indicated by a continual flow of e-mail commentary, and will influence how the attendees approach osteoarthritis in their respective patient populations in the immediate future. While I educated the audience, I also learned something from several French and Spanish Orthopedists speaking at the meeting. In addition to treating the arthritic joint, three studies were delivered in which the bone immediately adjacent to the arthritic joint was injected with stem cells in addition to placing BMAC in the joint itself. Called a subchondroplasty, it adds little extra to the procedure and to date, seems to have significantly improved results. As of July 1, the modified approach will be included in my treatment protocol for the osteoarthritic knee when I deem appropriate. It takes a team and a lot of time and effort to complete these outcome studies. That’s why most clinicians don’t partake. At most, some do it by telephone or forms to be completed by the patient and mailed in. That’s not the way of a joint replacement surgeon. Our outcome scoring is objective and includes hard end points such as reproducible measurements. My having incorporated clinical research into my patient care efforts has resulted in a continual improvement with better and longer lasting outcomes in my management alternatives for arthritis. I have the data to prove it.

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On The Horizon of Regenerative Medicine

Plain Language Summary of Regenerative Medicine

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.

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On The Horizon of Regenerative Medicine

Continuing Stem Cell and Regenerative Medicine Education for the Patient

Education seems to be on the mind of a growing list of presidential hopefuls so I decided to focus on the continuing educational theme. Today, you can complete a college degree and even grad school on line; this week. I am offering a tuition free short course in cellular orthopedics.

To protect the viability of stem cells and maximize their ability to restore well being to an arthritic joint, clinical studies over the last decade have clearly shown that direct injection is the preferred method to transplant cells. Those same clinical studies have documented that these stem and progenitor cells contained in bone marrow have immense potential to improve tissue and organ function. The key is to keep them viable after harvesting as laboratories and my studies have correlated symptomatic relief with higher cell counts and higher viability. Regenexx has contributed to what it takes to maximize stem cell viability; namely, avoidance of smoking, certain categories of pharmaceuticals such as statins, minimal alcohol consumption, and exercise with healthy eating. To summarize, stem cells cannot be transported from state to state, city to city, or even from facility to facility. Now you understand the Regenexx directive regarding what to do and what to consume prior to and for six weeks following a Bone Marrow Aspirate Concentrate intervention. See the Regenexx Web Site for more information at:  www.Regenexx.com

As I have written in my blog many times, top researchers are increasingly concluding that “stem cells” are not the main event but rather part of a multi-dimensional therapeutic solution. Osteoarthritis is caused by any number of triggers including trauma, disease, aging cartilage programmed to die (apoptosis), mechanical forces and congenital predilection to name a few. Your joints’ enemies are called metalloproteinases (MMPs) and aggrecanases which don’t only just degrade the cartilage; they also contribute to a toxic joint environment. Stem cells have been shown not only to restore damaged cartilage, but to inhibit inflammation; they are one component though of a more complex treatment approach with Bone Marrow Aspirate Concentrate.  To summarize, while adipose tissue may contain stem cells (Stromal Vascular Fractions), fat doesn’t come close to comparing with the the Growth factors and Cytokines to neutralize the MMPs and the aggrecanases when compared to Bone Marrow Aspirate Concentrate.

The major scientific work we depend on for basic science guidance comes from Mark F. Pittenger, Ph.D. Simply put, Dr. Pittenger said that Mesenchymal Stem Cells reduce inflammation and lay the foundation for tissue regeneration and repair. Since his landmark publication, we have learned that there is more in the Bone Marrow Aspirate Concentrate than mesenchymal stem cells that may alter the bio-immune response of arthritis. To summarize, there is science and there are false claims by charlatans and those with proprietary interests and hidden agendas. We need to do more scientific studies and that’s why I have integrated patient care with clinical research; a cellular orthopedic practice based on Outcomes and not undocumented claims.

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On The Horizon of Regenerative Medicine

The Case for Amniotic Fluid Treatment in Osteoarthritis of the Knee

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.

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