On October 28, 2013, I received IRB approval for a clinical trial with Regenexx Sciences, LLC as the sponsor and me as the Principal Investigator. The study, A Randomized Controlled Trial of Regenexx SD versus Exercise Therapy for Treatment of Knee Osteoarthritis with Historical Comparison to Total Knee Arthroplasty, was undertaken by me because of my recent “graduation” from joint replacement surgery to the new world of interventional orthopedics and because of my 37-year history as a joint replacement pioneer. Earlier this month, I was able to begin forwarding outcomes data to Regenexx in Broomfield, Colorado, for statistical tabulation. The results of this trial will not only impact what and how the Regenexx Network will make interventional recommendations, as the first and most comprehensive study of its kind, it will serve as the basis for comparison of all ongoing and future Regenerative Medicine methodologies for the care and treatment of the arthritic knee.
From Stem cells to Growth factors, the integration of our clinical research and clinical practice is having a major impact within the field of interventional orthopedics. Our results are allowing patients to return to activities they enjoy using a needle instead of a knife. I do not claim to be a cellular biologist but my network now allows me insight into the latest cellular advances. With the incorporation of the Abbott’s Ruby cell counting system into my clinical practice, I now customize the Bone Marrow Concentrate to the individual needs of a patient and thus not only quantitate but qualitate that which I inject into an arthritic joint.
Many Musculoskeletal injuries and certainly arthritis, do not heal with conservative management and historically required surgical intervention. The most contemporary method of effecting healing and regeneration is both Platelet Rich Plasma and Bone Marrow Concentrate. If you take a second look at the title of the clinical trial cited above, you will see the complete title ends with “Historical Comparison to Total Knee Arthroplasty”. The control group for the trial were patients with an arthritic knee in whom I had performed Total Knee Replacements during my surgical years. I am one of the few Orthopedic Surgeons who have experiences both in joint replacement surgery and interventional orthopedics. The majority of stem cell recipients have returned to activities they enjoy; the majority of Total Knee recipients are couch potatoes. When the numbers become available after statistical tabulation, I will post the data on my Blog.
Recently, I became aware of a relatively new web site www.Desirelist.com. The web site allows you to discover, capture and list all you may desire with a high probability of realizing your desires. So, I went on line and listed that which I want for my patients in 2017; namely, Internal Peace in a World at Peace. Where I can make a difference for those limited by arthritis of a major joint , and deliver on your desire for an improved quality of life is through Regenerative Medicine and Interventional Orthopedics.
Happy Chanukah, Merry Christmas and Happy and Healthy New Year
Tags: ACL Injury, arthritis, athletes, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Hip Replacement, Orthopedic Care, stem cells, treatment
This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (847) 390-7666 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy, friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.
As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition. The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.
Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.
There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors. What about adipose derived stem cells and cultured stem cells?
While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.
With all the above written, I am done for today; if you are still unclear or uncertain, call the office for an appointment.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
I haven’t yet heard or read the Thursday Mitt Romney speech as I write this Blog, but as long as the terms Fraud, False Promises, Uninformed, etc. will be headline news this afternoon and all over television tonight, I thought I would expand the theme to which I read and see about misrepresentation when it comes to Cellular Orthopedics. When my computer fired up this morning, one of the first bullets advertised an international stem cell company offering Exosomes if you travel outside of the United States for care. For those of you unfamiliar with the term, Exosomes are extracellular vesicles that have the potential to do good things to your cartilage and soft tissues. As I read the stem cell ad, I noted the following:
“Exosome Injection is a human induced pluripotent stem cell-derived mesenchymal stem cell treatment, which has emerged as a promising supplement to stem cell transplantation therapies. Exosomes derived from mesenchymal stem cells can play an important role in repairing injured tissues. Exosome injection is also utilized as a complement to bone marrow stem cell extractions.”
Thank goodness for the FDA. While the governmental agency has been frequently criticized, the FDA is there to protect us; that’s why you have to travel outside the US for unproven “promising” interventions. To continue the “promising” discussion, the web site promoting Exosomes also invites you to travel outside of the United Sates for Stem Cell assistance with Cancer, Parkinson’s Disease, Alzheimer’s, Cerebral Palsy, etc. 60 Minutes, we need you.
There is a better option to help avoid or postpone a joint replacement, diminish pain, increase motion and improve your functional capacity. At the same time it falls under the standard of practice and thus is FDA compliant; namely the Bone Marrow Aspirate Concentrate/ Stem Cell approach. Not only does Bone Marrow contain Adult Mesenchymal Stem Cells, anti-inflammatory molecules termed, as a group, Cytokines, as well as multiple cellular molecular secretions called Growth Factors; you guessed it, Bone Marrow Concentrate is a great source of those extra cellular vesicles, Exosomes. My Regenexx affiliation and the International Orthopedics Foundation offer quality assurance and safety in an otherwise poorly regulated environment. While the FDA had an April meeting scheduled for testimony and Regenerative Medicine review; that meeting is now set back six months because of a change in leadership at the FDA. Until that delayed meeting, for quality assurance and evidence based cellular orthopedics, seek what is safe, what has been shown to work and forget about “promising supplements.”
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
My last Blog brought you greetings and discussed some of the issues reviewed at the first meeting of the Interventional Orthopedic Foundation. This not for profit foundation was founded to help facilitate the transfer of scientific regenerative medicine developments into clinical practice. One challenge is how to improve the outcomes of what is now the gold standard of Interventional Orthopedics, Bone Marrow Aspirate Concentrate in managing arthritis of major joints. We seek to see longer effect and better results. While there are all kinds of claims being made for amniotic fluid concentrate and adipose (fat) derived stem cells, as of now, there is no data to support said claims.
I have played a large role in documenting the success of Bone Marrow Concentrate intervention for arthritis. Now I want to see if I can improve those results. At the Interventional Orthopedic Foundation meeting, various means of improving outcomes were discussed including, hyperbaric oxygen, ultrasound, lasers, ultraviolet light and finally, electro-stimulation. I was reminded of a study in which I was involved five years ago using an electronic pulse joined to a knee brace to try to regenerate cartilage. The study was based on animal models who when subjected to an electronic pulse grew cartilage. It occurred to me that the answer to improving the quantity and the quality of a Bone Marrow Aspirate Concentrate/ Stem cell intervention for an arthritic knee might be the pulsed brace. If every patient who undergoes a stem cell intervention for arthritis is prescribed a brace post treatment, since we know that the pulse is safe and potentially helpful, why not add the pulse to the post intervention protocol. To that end, I am happy to announce the introduction of this methodology to our post intervention protocol via a clinical trial starting in December
We will follow each patient for up to a year with our standard clinical objective and subjective means and periodic X-Rays with no added fiscal burden to the patient. The results of this study will then be presented to the 2016 meeting of the Interventional Orthopedic Foundation as I continue to integrate patient care with research. There is no question that patients who wore the brace and used the pulse for arthritis without stem cell intervention in the past were improved; imagine the potential leap forward by adding the pulse to the brace after a Bone marrow Aspirate Concentrate/ Stem Cell intervention.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenerative Pain Center, Regenexx, Regenexx-SD, stem cells, treatment
In spite of what a patient may be told by the physician and what salesmen tell the doctors, research by the Interventional Orthopedics Foundation laboratories found no viable stem cells in Amniotic Fluid Concentrate once shock thawed. While there may have been living stem cells in amniotic fluid when harvested, part of the commercial preparation and storage requires freezing. Once shipped for clinical use, the preparation is quickly thawed (shock thawing) as required for injection. While a slow thaw over 24 to 48 hours will preserve stem cells, shock thawing kills cells although the hyaluronic acid content and the Cytokine/Growth Factor content is maintained. The net conclusion is that Amniotic Fluid Concentrate may be beneficial as a symptom altering intervention but with no regenerative potential.
Analysis of the available enzymatic means of liberating stem cells from fat is a violation of FDA restrictions. The Interventional Orthopedics Foundation has been aware of the increasing claims that adipose derived stem cells are superior to Bone Marrow Aspirate Concentrate derived stem cells in various orthopedic conditions. As such, the Foundation studied the law and the proprietary claims. The conclusions reached are that there is no scientific data or publications to support the claims of superior outcomes of fat over bone marrow and the use of the enzyme, collagenase to liberate the stem cell from the adipose tissue is violation of FDA guidelines. By the same token, the introduction of a mechanical means to liberate biologically active molecules from fat may fall within FDA guidelines but the impact in arthritis has yet to be clinically documented.
No consensus has yet been reached regarding the substitution of Amniotic Fluid Concentrate for hyaluronic acid in relieving the symptoms of degenerative arthritis. The necessary clinical evidence to support a change in skeletal muscular practice guidelines is still being collected. As of January 1, 2016, I will be participating in that latter initiative in my interventional orthopedic practice. The Interventional Orthopedics Foundation also recognizes the absence of a scientific based means of helping a patient delay or even avoid a joint replacement for advanced arthritis. What we are able to do now and for which we have supporting data is to successfully intervene in Grades two and three osteoarthritis. Beginning in December, I will be initiating a clinical trial that is designed to meet the challenge in advanced arthritis but we will not have statistical evidence of a successful outcome for some time.
If you want more information regarding proven methods using Interventional Orthopedics for delaying or even avoiding a joint replacement in Grades 2 and 3 arthritis or what may be possible for advanced osteoarthritis to avoid a joint replacement, schedule your consultation at 847 390 7666. For those patients who have been told they have too serious a co-morbidity to allow for a joint replacement, let us try to help you as well using needle instead of a scalpel.
Tags: Amniotic, arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, technology, treatment