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

“Stem cell treatments take root in US”

Headline on page 14 of the Wednesday, May 20, 2015 edition of the Chicago Tribune. The Associated Press journalist, Matthew Perrone then goes on, “But critics point to dangers of a largely unregulated trade.” This is a well written article in which Perrone highlights the charlatans doing the wrong thing, breaking the law, and doing harm. He did his home- work and focuses on the quackery, false claims and almost wholly unregulated mushrooming adipose derived business not unlike what  Pope Brock did in his 2008 novel, Charlatan. Perrone brings into focus the quacks that prey on desperate patients seeking miracles in treating progressive neurologic disorders and the like. As my good friend opined after having read the article, “when ever a new avenue opens, the easy money guys stream in.”Incidentally, the exposure of those who state” if I am breaking the law, how come I haven’t been arrested yet?” isn’t new; 60 Minutes exposed those who seek to enrich themselves no matter the price to society several years ago. Last night, at the Goodman Theater, my wife and I saw Lillian Hellman’s The Little Foxes; very timely. The play takes place circa 1900, in a small Alabama town where the accumulation of wealth by the Hubbard family takes precedence over family, loyalty, decency, honor and morality. Toward the end of the play, the crowning statement in my mind was something to the effect that there are many Hubbard families out there in the mainstream America.

This lack of professional integrity and opportunism is engrained in our society so how do you protect yourself as a patient, be it Bone Marrow Aspirate Concentrate to postpone or avoid a joint replacement or any other area of medical care? The list of reasons to seek out Cellular Orthopedics and Regenerative Medicine is really the lengthy list of contraindications to surgery because of co-morbidities that preclude a total joint replacement surgical procedure. In addition, there are those patients who want to maintain or return to the highest level of recreational endeavor. The answer is quality assurance by your Regenerative Medical specialist assuring you the recommendations and the intervention are evidence based. That evidence comes from ongoing clinical research integrated with clinical care, not just completing a procedure and handing out a bill. You will find that level of evidence based care within the Regenexx Network of physicians located now thoughout the United States. These are not doctors who took a weekend seminar offered by a training company. At Regenexx, we do not treat anything outside the realm of orthopedic diseases. I partake in many week-long courses over the calendar year in which I not only learn but present my data collected on an ongoing basis. Next month, I am off to present my data at TOBI; a four day international program limited to arthritis and sports related injuries. That’s what I do and that’s your assurance that what I do is based on clinical outcomes research and is evidence based.

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On The Horizon of Regenerative Medicine

A Potpourri of Regenerative Medicine Offerings without Scientific Evidence

Prolotherapy

In spite of what you may read and hear about repeated injections of 12 ½ % dextrose into your joint or in the soft tissues surrounding your joint, there is no scientific evidence to support the claims regarding a regenerative influence from Prolotherapy. That is not to say it might or could lessen pain around a joint; but the benefits, if any, are anecdotal in nature and fall under the realm of homeopathy. It belongs under the same classification as Acupuncture; there are followers, anecdote and practitioners but an absence of scientific proof as to how it works. Yet, even with paucity, if not absence of scientific evidence, there is no end to web sites extolling the regenerative nature of Prolotherapy.

From science to tabloid

This week, my office and email were inundated following the headline in the Monday Wall Street Journal concerning a 3D printing of a medial meniscus lattice into which stem cells had been injected. A total of one patient was featured who had an experimental meniscus surgically introduced to replace a previously torn medial meniscus. While in years to come, this may become common place, there are limited indications and many more years of clinical trial ahead before an artificial meniscus becomes a standard of practice. After age 40 or so, meniscal injury as documented on an MRI is more often than not accompanied by arthritis. Post traumatic arthritis and degenerative arthritis are contraindications to meniscal replacement and even are associated with a less than satisfactory outcome to existing arthroscopic interventions. I must remind the reader that degenerative and post traumatic knee arthritis may be reflected on the MRI as an abnormal meniscus but in addition, physical examination is compatible with an altered range of joint motion and mechanical axis deformities.

A Regenerative Medicine Offering with emerging Scientific Evidence

I am finishing up my statistical analysis concerning 170 patients with degenerative and post traumatic knee arthritis who have undergone Bone marrow Aspirate Concentrate/Stem Cell knee care  in preparation for my presentation at the June meeting of The Orthopedic and Biologic  Institute.  After two years of follow-up, there is a statistically significant improvement in diminishing pain, increasing range of motion, enhancing well-being, and facilitating return to or maintenance of a highly active recreational profile. This is scientific evidence and the basis for my Regenerative Medicine approach to helping a patient manage arthritis.

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