Apr 2, 2015
Intervertebral disc degeneration is characterized by a gradual loss of cellular function and related breakdown of extracellular matrix. This process leads to a decrease in the mechanical stability of the spine and activation of molecules that trigger painful back and neck symptoms. Implantation of mesenchymal stem cells has been shown to counteract the degenerative process in animal models of disc degeneration and in some initial clinical studies. The regenerative activity of Mesenchymal Stem Cells when injected into the disc results in a reversal of that degenerative disc process. In addition, the injection of MSCs also releases trophic factors that may stimulate the metabolism of disc cells and suppress inflammatory reactions. However, in spite of these promising perspectives, clinical application of MSCs has certain limitations. Potential adverse events such as cell leaking and osteophyte (spur) formation are at present, the limiting factors. I am updating my Blog readers concerning what is on the horizon as every week I receive a question about the subject of the low back and stem cells. Low Back degenerative disease also is something I must consider in each and every patient for whom I perform a Cellular Orthopedic intervention in a hip or knee as there is no question about a Hip-Knee-Spine connection and I must understand its importance when I treat hip and knee pathology. These areas are closely related in function and symptom distribution
The limitation at present of Cellular Orthopedic intervention for intervertebral disc degeneration is the need to further identify potential side effects. While an attractive target for future regenerative strategies, Bone Marrow Aspirate Concentrate/Stem Cell intervention is not ready for prime time. The logical question then is how to cope with the limitations of spinal stenosis and Degenerative Disc and Joint disease of the low back until stem cell care is proven safe and effective? First and foremost comes weight reduction. Next in line is core strengthening in conjunction with stretching. This may be accomplished through Pilates, Tai Chi, Yoga and any other program that follows the principles of strengthening and stretching the core. Incidentally, running and jogging are not injurious to an arthritic spine; just the opposite, both help rehydrate the dried out disc.
To learn more about your personal kinematic Knee-Hip-Low Back continuum, you need an assessment. That’s the only way I can determine the key problem and if one or all need to be addressed.
847 390 7666 to make an appointment
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, Mature Athlete, medicine, Regenerative, Regenexx, stem cells, treatment
Mar 9, 2015
We are always learning from Data and in this Blog, I will let you learn with me. Please note that the results reproduced below are very preliminary and not to confused with the indications or results of our Bone Marrow Aspirate Concentrate/Stem cell interventions and outcomes. Because of the American Academy of Orthopedic withdrawal of support for visco-supplementaion (Hyaluronic Acid)in the arthritic knee, the orthopedic world is seeking something to fill that void, hence the interest in Amniotic Fluid Concentrate. Cortisone injections expanded with local anesthetics has been the mainstay but recent data indicates that local anesthetics kill cartilage and several cortisone injections are equally toxic to cartilage in animal models.
Interim Analysis of Prospective, Multi-Center Outcome Observational Cohort Registry of Amniotic Fluid Treatment for Osteoarthritis of the Knee Douglas Beall, MD,* Sri Nalamachu MD, **
Introduction Osteoarthritis (OA) of the knee is one of the leading causes of functional limitations and poor quality of life. Nonsurgical treatment of OA of knee includes oral medications and injection. Corticosteroid or hyaluronic acid (HA) injections to alleviate pain and/or improve function are common techniques but recently HA effectiveness has been questioned for the treatment of OA of knee in the Medicare population as well as for its overall efficacy. Alternatives are sought to provide pain relief and improve functional outcomes. Allograft amniotic tissues have a long history of clinical use. The use of amniotic fluid in the treatment of knee OA was initially reported by Shimberg who demonstrated that injections of the fluid improved knee function and pain relief without any significant adverse events in 68 patients. Amniotic fluid is a homologue to synovial fluid which acts as a cushion to protect and lubricate the contents in a closed environment. This study measures the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated instruments.
Summary of methods This is a protocol-driven, single arm post-market Registry reviewed and approved by the Western Institutional Review Board (Olympia, WA). Patients with Kellgren Lawrence Grade 1-3 OA via radiologic examination were eligible for enrollment. Excluded patients were < 35 years, had BMI > 45 or had received Hyaluronic Acid injections in the previous six months, or steroid or PRP injection in the last three months. There were no threshold pain inclusion or exclusion criteria. Eligible patients were injected with 4cc of minimally processed amniotic fluid (AmnioClear LCT; Liventa Bioscience, West Conshohocken, PA) into the affected knee. Primary efficacy endpoints are VAS scores and WOMAC overall and Pain, Stiffness and Difficulty (function) subscore scales, measured during office visits at baseline and at 30, 90 and 180 days. Enrollees also filled out weekly Pain Diaries to report WOMAC Pain subscore (5 questions) at weeks 1-4 post-treatment. Results To date over 420 of an anticipated 470 Registry enrollees have been treated. This is an interim analysis of the first 181 patients to attain 30 day follow up and the first 51 to attain 90 day follow up visits, with 15 of 23 investigational sites reporting. WOMAC Pain subscore average improvement over baseline was 62.1 percent (150.9 mm) and 62.3 percent (151.2 mm), respectively at 30 days and at 90 days. VAS average improvement over baseline was 58.9 percent (37.7mm) and 62.5 percent (40 mm) at 30 and 90 days, respectively. All other WOMAC scores showed similar improvement.
OMEGA Statistics, Murieta, CA On average, patient outcomes improved significantly compared to basel
Tags: Amniotic, arthritis, athletes, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenexx, stem cells, treatment, Ultrasound Guided Injection
Feb 9, 2015
As we worked away in our Chicago offices last week, a group of five skiers were Helicopter skiing along the Columbian River basin in British Columbia. What is so special is that each of the five is over age 65 and three of them are able to ski because of the care received in my office. 15 years ago, while I was still a joint replacement surgeon, one of the five underwent a uni-compartmental knee replacement. About six years later, because of progression of the arthritis in the remaining compartments of his knee, I converted the “UNI” to a Mobile Bearing Knee Prosthesis. Fast forward to 2012 when I began Bone Marrow Aspirate Concentrate/ Stem Cell interventions for an arthritic joint to postpone or prevent a joint replacement. The patient for whom I performed those surgical reconstructions presented with end stage arthritis and thus would not have been a candidate for a Cellular Orthopedic Regenerative procedure. The other two skiers ascending the slopes via helicopter in search of fresh limitless powder have undergone Bone Marrow Aspirate Concentrate / Stem cell procedures over the last 24 months and there they are enjoying an ultimate skiing experience as “master “ skiers. As a point of reference for my notion of the continuum of care for the scope of cellular orthopedics, one of those two has undergone the procedure several times. The first year, it was for the left knee. The second round was for the right knee and this year, a “refresher” for both knees. While actually thinking about this Blog, I received the following ALERT real time from the lodge –I just received word from the five skiers that there is a blizzard so the helicopter couldn’t fly this morning but the group hopes to get out this afternoon.
If I have piqued your interest, read more about skiing here: Knee Stem cells in Chicago and Heliskiing-Regenexx. Not only is the article of interest, you get to see what I looked like in 2012 in my retro ski outfit.
The January 13, 2015, article Stem Cell ACL: Cutting Edge Knee Repair Sans Surgery appearing in www.onthesnow.com is also informative and it features one of my five alumni.
Reader be aware, Cellular Orthopedic benefits are not only realized by heli-skiers. What happened next to those skiers was that the rains came and that resulted in a premature ending of their Canadian Mountain Heli-skiing adventure. Now for the happy outcome, the group went back home and this week, each member is preparing for a repeat ultimate skiing endeavor by returning to training on their road bicycles in this balmy weather.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Jan 12, 2015
That quote comes from University of Chicago Economist and Nobel Laureate, Gary Becker, who died in 2014. Central to his work was the concept that economics can help explain behavior. As seems to be happening more and more, this Blog will expand on the evidence concerning Bone Marrow Aspirate Concentrate/Stem cell outcomes for intervention in the arthritic joint. The Data and my experience clearly document success at all stages of arthritis in a major joint for some period of time. What I am unable to conclude is in whom we are actually regenerating cartilage or in whom we are seeing pain relief and improved functional capacity owing to concentrated Growth Factors and Cytokines. Whereas my initial interventions two and a half years ago were limited to a “younger” arthritic demographic, the successes resulted in my expanding the inclusion criteria last year without age exclusion as I observed Outcomes success in those approaching 80 years of age. What I don’t know yet is in whom the improvements are related to the stem cells in the Bone Marrow Aspirate Concentrate or whether to the Growth Factors influencing your own stem cells or the Cytokines acting as anti-inflammatories, accompanying the stem cells in the Bone Marrow Aspirate Concentrate. What the evidence does indicate is that the older the patient or the more advanced the arthritis at the time of BMAC intervention, the better the outcome with a second or even third procedure. What I don’t know yet is a predictor of the survivorship of an outcome. I do know that the best chances of long-term benefits are in those with less than Grade 4 arthritis. For those who experience something less than hoped either in the initial result or extent of benefit, let’s explore the economics.
Just as our health care indemnification is undergoing change, so is my understanding of the scope of services that may be beneficial in this evolving discipline of Cellular Orthopedics. The good news is that unlike the insurance world where less health care coverage seems to be associated with greater cost for indemnification to the patient, I have identified a means of decreasing the economic burden to a patient for a repeat Bone Marrow Aspirate Concentrate/Stem cell intervention or related Regenerative Medicine injection, if a single procedure doesn’t provide the degree of relief or survivorship of outcome desired. It may well be that Cellular Orthopedics involves a range of approaches and not a single intervention. My office will work with you to provide you a scope of Evidence Based Care with an economic approach that allows the patient to avoid or at least delay a joint replacement.
Tags: arthritis, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Hip, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedics, Osteoarthritis, Pain Management, Regenexx, Regenexx-SD, stem cells, treatment
Jan 5, 2015
This time of year always brings with retrospection, reviews and prophecy, no matter what area of interest. As my area of professional concern is arthritis and assisting a patient avoid or at least delay a joint replacement, I thought it would be helpful to look at what Outcomes we recorded in our Data Base. Unlike the majority of Regenerative “experts” marketing themselves on the internet, I don’t cite the results of others or make unsupported claims, I document what I learn from having treated patients with Bone Marrow Aspirate Concentrate over two and a half years. Imagine if you would the complexity of having integrated patient care with clinical research using all the parameters I applied to development of new generations of total hip and total knee prosthetics during my almost 40 year joint replacement career. That’s why there are few if any involved in musculoskeletal care via Regenerative Medicine who are able to provide a patient the comprehensive experience I offer.
As of this morning, we have registered over 525 patients in our comprehensive Data Base with measurement pre and post Bone Marrow Aspirate Concentrate/Stem Cell intervention in 125 hips and almost 400 knees. Of the hips, three have gone on to a joint replacement; of the knees, two have gone on to a total knee replacement to the best of my knowledge. What I have defined from my experience is who will benefit from a BMAC intervention and who should undergo a joint replacement. Note the absence of reference to adipose derived stem cells. The explanation is simple; the FDA views such as a drug and hence does not approve the use of fat in the management of arthritis. I am also beginning to get a better understanding about how long the benefits of the intervention will maintain and how to best manage and extend those benefits. In the joint replacement world, the benchmark parameter is survivorship, how long until the prosthesis fails? In the stem cell world, I am interested in observing and prolonging the pain relief and functional improvement after the Bone Marrow Aspirate Concentrate Stem Cell procedure.
Evidence Based Medicine and Best Practices require maintenance of an outcomes data base; not an injection without ongoing follow-up. As I perused the internet this morning, other than Regenexx, I find a paucity of clinical data and a predominance of unsupported claims. In my lifetime of joint replacement surgery, there were many others performing large numbers of procedures around the country. We would meet periodically and present our own scientific outcomes and the evidence and learn from each other, all leading to the best possible clinical practices of total joint replacements. When it comes to the seductive claims from Stem Cell clinics found all over the Web, my challenge this year: Show Me Your Evidence
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Mature Athlete, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Pain Management, Regenexx, Regenexx-SD, stem cells, treatment
