Nov 5, 2015
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
Oct 29, 2015
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
Oct 8, 2015
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.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, joint replacement, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, treatment
Aug 13, 2015
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.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Pain Management, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection
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
