Mar 16, 2015
When a patient schedules a Bone Marrow Aspirate Concentrate/Stem cell procedure in our office, part of the recommendations leading up to and following your SD procedure is elimination of Statins for a period before and after the procedure. While Statins are clearly effective in reducing the risk of major atherosclerotic cardiovascular events, and the cardiovascular benefits outweigh the risks of treatment, there is a skeletomuscular price to be paid with the use of Statins. With accumulation of more data and longer term monitoring on the outcomes of Statin prescription, we have learned that adverse events include, most commonly, muscle pain, aching and weakness usually without elevation of muscle enzymes, specifically the CreatineKinase. All Statins can cause myopathy defined here as unexplained muscle pain or weakness. While in rare settings, the myopathy may be accompanied by CPK levels more than 10 times the upper limit of normal, and progression to a serious irreversible form of myopathy, rhabdomyolysis, in most situations, it is muscle pain and weakness without changes in muscle related enzymes. In spite of all of these observations, as of this time there is no scientific explanation in most settings as to why a patient may manifest Statin intolerance.
As far as why Statins are associated with weakness, pain and muscle aches, there is no pharmacologic evidence other than the disappearance of symptoms when the dose is lowered , the proprietary prescription is changed or the pharmacologic is discontinued altogether. The high success rate of the disappearance of symptoms following a period of abstinence and then reintroduction is consistent with nonpharmocological mechanisms for intolerance.
Do Statins adversely affect the muscle cell mitochondria? In a group of obese patients for whom an exercise regimen was incorporated into their weight loss, fitness routine, those on Statins had a more difficult time with a higher expression of diabetes as contrasted with those who had not been prescribed the Statins. I am not an internist; I admit I use Statins as I have a cardiovascular disease family history. They are prescribed by my internist and I don’t challenge his expertise; my recent ultrasound/echocardiogram stress test results confirm his wisdom. Nevertheless, I now have a reasonable explanation for my own transient muscle discomfort and you have a reasonable explanation as to why we recommend the elimination of Statins prior to and following a Regenexx SD Stem Cell procedure for an arthritic joint.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, 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 26, 2015
As we statistically analyze our Outcomes data, in preparation for presentation at 2015 Regenerative Medicine Meetings, it becomes increasingly apparent that Cellular Orthopedics is not a “one and done” event. Neither for that matter is a total joint replacement. While skiing in Vail last week, I was in the company of two Sheinkop patient alumni, one a patient under 40 who had undergone Bone Marrow Concentrate hip intervention for advanced osteoarthritis several years ago and one, a 70 year old who had undergone stem cell intervention for his arthritic knees back in 2012. Yes, I take care of friends and they still are speaking to me. Not only do they communicate but, bike and fish with me as well. In both cases as I followed their initial responses, I convinced them of the value of a second procedure and in both cases, it really worked. The younger Sheinkop alumnus is a boarder, the older, a skier. Nevertheless in both cases, they are still extremely active in spite of advanced arthritis in major joints. Might only one stem cell intervention be necessary if I could treat you earlier in the arthritic process? That’s to be determined by ongoing clinical surveillance. The important issue is that both individuals are examples of the potential of Bone Marrow Aspirate Concentrate. There are many more and in the coming days I will Blog about statistically significant Outcomes as I prepare my speeches and manuscripts. Incidentally, while skiing in Vail last week, I happened to change the channel from a sporting even to the movie, Casablanca. Truly, one of the greatest movies of all time; of the great quotes was Rick Blaine’s “here’s looking at you kid” (Humphrey Bogart). What really caught my attention in addition to Ilsa Lund (Ingrid Bergman) was her quote “Play it once, Sam. For old times’ sake”.
How do the stem cells work? It may not just be the stem cells that make a difference in an arthritic joint. We now know that Bone Marrow contains in addition to stem cells, two other major areas of benefit, Growth Factors and Cytokines. While the Adult Mesenchymal Stem Cell may help regenerate cartilage damaged by injury and arthritis, it is the Growth factors and Cytokines that also play an equally important role in the anti-inflammatory effect and reversal of the arthritic process. What happens when we concentrate and prepare the Bone Marrow and execute the Cellular Orthopedic intervention following the Regenexx algorithm of care is reversal or at least a slowing of the arthritic process, a diminution of pain, an improved functional capacity and a delay, maybe avoidance, of a total joint replacement. While there still may be a need for an occasional Tylenol after a BMAC/Stem Cell intervention, you have a good chance of joining me as an alumnus on the slopes, on the bike, wading up a trout stream, or in a fitness pursuit. As well, we may have to do it again in a year or two; but I have yet to record a complication. “Play it once, Sam. For old times’ sake” or in the stem cell world, play it again Dr. Sheinkop to keep me going.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenexx, Regenexx-SD, stem cells, treatment
Feb 16, 2015
Well OK, maybe a week, unless you work from your home or have a sedentary job; then you may go back to productivity in days. What caused me to call your attention to the minimal inconvenience and the potential major benefit when Bone Marrow Aspirate Concentrate/Stem Cell is selected as the treatment of choice for an arthritic joint as contrasted with a Total Joint replacement is the minimal need to take time off from work. In addition to the superior athletic performance inherent in a stem cell procedure along with the almost complete absence of complication is the fact that you won’t miss days from your job.
I was reminded of the minimal and short term impact on your life when choosing Bone Marrow Aspirate Concentrate /Stem cells for an arthritic joint this past Friday when a busy Podiatrist sought consultation because of an arthritic knee. She had experienced progressive impairment from advancing arthritis of her knee and three months ago had undergone a Cellular Orthopedic intervention for that arthritic knee. A week later she was on her way to Europe for a long anticipated vacation. She came to the office looking for a long term plan of action as the patient realized as a mature adult, Cellular Orthopedics is a continuum of care and not a onetime experience. That continuum is something I will focus on next time; but for now, let’s focus on the “No Time Off” theme. Inherent in a Total Joint Replacement is obligatory six to 12 week convalescence; that may become a six-month ordeal if a complication such as an infection is experienced. The patient about whom I am writing made it clear that she did not wish to take time away from her profession nor did she wish to risk complication, hence she was planning six or 12 month boosters to keep her working and active. Incidentally, please don’t forget that a total joint replacement may not be a onetime surgical event either. They wear, they fail, they get infected and need to be revised. That revision never is a happy event nor does the outcome come close to the results following an uncomplicated first procedure.
When comparing the potential benefits of a Bone Marrow Aspirate Concentrate/Stem Cell procedure for an arthritic joint to the lost productivity, financial obligation in the new world of high deductibles, and risks of a total joint replacement, the balance sheet speaks for itself. Speaking of balance sheets, I am off to Vail this week for a ski week with family and friends. On Monday, the 23rd, I will be visiting Regenexx to review our Outcomes Data and set forward several interventional protocols. While I seem to Blog mostly about stem cells and arthritis, there is unlimited possibility in the world of Sports Medicine for you to avoid surgery should trauma put you on “Injury Reserve” Check out Sports Illustrated and Stem Cells- that is for injury, not bathing suits.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Hip, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Regenerative, Regenexx, stem cells, treatment
Feb 2, 2015
The world of Regenerative Orthopedics began in the United States with the publication of a scientific article reporting the results of platelet rich plasma in the treatment of knee arthritis. That took place about six years ago. No one really understood at the time of the publication why something so important in the clotting cascade of the human body would be beneficial in the treatment of an arthritic joint.
The next step in improving results of Platelet Rich Plasma injections for an arthritic joint was the understanding that whereas one injection would help, three injections over a three month period would improve outcomes. Scientists began further efforts at understanding why the platelet, so critical in the clotting cascade, would be beneficial in treating arthritis, and soon a better understanding of how platelets function came to be appreciated.
Platelets are the primary source of bioactive tissue growth factors. When concentrated they are potent. When activated, they release their growth factors and cytokines in clinically active quantities. Regenexx has developed a formula for superior concentrations and immediate activation. Whereas most Platelet Rich Plasma is created at bedside, we create ours in a laboratory with maximum concentration and prompt activation. Our research supports better stem cell growth following the Regenexx SCP procedure. Although the Regenexx Stem Cell Plasma formula is part of the Bone Marrow Aspirate Concentrate algorithm, we now are able to offer it when indicated as an independent intervention when Bone Marrow Concentrate is not possible. In addition, it is a wonderful “booster” when anticipated milestones with Bone Marrow Aspirate Concentrate are not met. Let me cite two patient examples.
Two years ago, an 83 year old man was selling his condo in Palm Springs because his arthritic knee would no longer tolerate a round of golf and his co-morbidity posed a very high risk for a joint replacement. He sought consultation and I recommended a Regenexx SCP intervention. Three weeks after the procedure, he took his condo off the market and returned to Palm Springs for the winter migration from Chicago. I spoke with him via phone in August and he had purchased his tickets for the return migration to the desert this winter.
36 weeks ago, I performed a Bone Marrow Aspirate Concentrate/Stem Cell intervention into the right hip of a 29 year old man with early onset degenerative arthritis. At six weeks, he was 25% symptomatically improved. At 12 weeks, he was 50% improved. At 18 weeks, he was still 50% improved so I administered a C-SCP booster. At 36 weeks he is 80% improved and thrilled. Cellular Orthopedics requires a continuum of monitoring and possibly more than one intervention.
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Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, PRP, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
