The FDA again held a meeting to address issues pertaining to Regenerative Medicine. At the conclusion of the meeting, an updated set of guidelines was developed for patient protection in the use of stem cells, growth factors, and platelet rich plasma. While still being interpreted by the Regenerative Medicine community, what becomes clear is the call for better self-regulation. It is not ethical or acceptable for anyone holding themselves out to be practicing cellular medicine to hold a seminar, recruit a patient, inject some substance into a joint and request payment. Equally important are the credentials of that practitioner.
For the past four and a half years, I have followed the outcomes of all my patients using the same subjective and objective parameters in my practice of Interventional Orthopedics that I used to follow the results during my joint replacement career. Over that 37-year span, because of my data collection initiative, many new generations of Hip and Knee Prostheses were introduced into adult reconstructive orthopedic surgery. Statistical analysis of data allows for progress in care and development of new product. Today, I still gather outcomes data for each patient. That initiative has led to refinement and advances in the emerging subspecialty of Regenerative Medicine; both in my own practice and around the globe.
Anticipating the future, I am headed off this upcoming weekend to join a small group of those looking to the future in advancing the practice of cellular medicine. Up until now, our data collection and Outcomes registry was clinical in nature; in a short time, that data will also include cellular data. This latter is the next way to refine the practice of regenerative medicine.
By having tighter control over the composition of autologous PRP and BMC preparations for use in my practice of regenerative medicine, through comprehensive analysis of autologous patient samples, I will have a chance to see what levels of important constituents like Stem Cells, Growth Factors, Platelets, RBCs, WBCs, and so on are present in the preparation.
How might I take advantage of the data? The most obvious use would be for me to record values of your sample analysis in a spreadsheet and enter in demographic and clinical outcomes data. I will continue to enter your results of outcomes assessments obtained during follow-up visits that I routinely use to monitor your recovery. By applying this strategy to all patients I treat, an internal database will inform me about optimization strategies for treating my patients, allowing me to modify and customize the make-up of that which will be injected. Why go to the trouble, you might be asking yourself? Having a detailed knowledge of what I am injecting into my patient puts me in a position to refine my practice of regenerative medicine. And that is a good thing, since you the patient ultimately will benefit from my optimizing the use of autologous materials like PRP and BMC.
To schedule your appointment call 312 475 1893
Tags: arthritis, BMC, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, knee replacement, Osteoarthritis, Pain Management, Platelet Rich Plasma, platelets, PRP, regenerative medicine, stem cells, Ultrasound Guided Injection
In the late summer of 2015, I was featured on a Fox cable news segment featuring a patient on whom I had performed a Bone Marrow Aspirate Concentrate –Stem Cell intervention coupled with a subchondroplasty procedure. The patient had experienced a poor result from a right Total Knee Replacement years earlier and was seeking a means of improving function and minimizing her left knee pain resulting from arthritis. Cartilage does not have a nerve supply so scientists and clinicians have long sought a clear understanding of the pain generator in osteoarthritis. While there still is not a clear-cut consensus, many clinicians are looking at the bone marrow lesions seen on an MRI when taken of an arthritic joint as the possible cause of pain associated with arthritis.
In the case of my patient, the combined BMAC-Stem Cell procedure coupled with the subchondroplasty had resulted in a very satisfactory outcome and such maintains at this time to the best of my knowledge. What was unique about my patient was the use of Bone Marrow Concentrate-Stem Cells to serve as the catalyst to effect healing of the bone marrow lesions. Up until that time, surgeons were using a synthetic calcium phosphate material to fill the defects above and below a joint surface with a mandatory three months of protected weight bearing and six months of altered physical activity. The introduction of Bone Marrow Concentrate with Stem cells required 48 hours of crutch support and six weeks of restricted physical activity.
My patient who received media attention served to foster a debate in the medical device industry as to the superior methodology serving as an adjunct to a subchondroplasty. First came the initial trial using a subchondroplasty procedure and synthetic filler with the inherent need for prolonged altered function and assisted ambulation. Now there are several clinical trials in development pertaining to an arthritic joint and the minimally invasive, percutaneous subchondroplasty comparing the synthetic filler to the Bone Marrow Aspirate Concentrate-stem cell adjunct; with the latter used both inside the joint and in the adjacent subchondral bone.
Are your arthritic joint changes affecting both the cartilage and the supporting bone? Is the actual source of your joint pain, the supporting bone or bone marrow lesions adjacent to the hip, knee, ankle or shoulder? It would require a complete examination and review of X-rays and an MRI for me to answer the question and advance the most appropriate therapeutic recommendation. Could it be that the failure of a regenerative intervention wasn’t a failure of the stem cells but rather a failure to address the real pain generator, subchondral bone?
Call for an assessment 312 475 1893 and I will try to answer that question.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection
Hamstring muscle injuries — such as a “pulled hamstring” — occur frequently in athletes. They are especially common in athletes who participate in sports that require sprinting, such as track, soccer, and basketball. A pulled hamstring or strain is an injury to one or more of the muscles at the back of the thigh. Most hamstring injuries respond well to simple, nonsurgical treatments. In this Blog however, I am not focusing on “athletes”, I am raising concern about an epidemic of significant hamstring injuries, as I see it, in middle aged fitness enthusiasts who are seeking consultation in my office.
The hamstring muscles run down the back of the thigh. There are three hamstring muscles:
- Biceps femoris
They start at the bottom of the pelvis at a place called the ischial tuberosity. They cross the knee joint and end at the lower leg. Hamstring muscle fibers join with the tough, connective tissue of the hamstring tendons near the points where the tendons attach to bones. The hamstring muscle group helps you extend your leg straight back and bend your knee.
A hamstring strain can be a pull, a partial tear, or a complete tear. Muscle strains are graded according to their severity. A grade 1 strain is mild and usually heals readily; a grade 3 strain is a complete tear of the muscle that may take months to heal. Most hamstring injuries occur in the thick, central part of the muscle or where the muscle fibers join tendon fibers. In the most severe hamstring injuries, the tendon tears completely away from the bone. It may even pull a piece of bone away with it. This is called an avulsion injury.
Muscle overload is the main cause of hamstring muscle strain. This can happen when the muscle is stretched beyond its capacity or challenged with a sudden load. Hamstring muscle strains often occur when the muscle lengthens as it contracts, or shortens. Although it sounds contradictory, this happens when you extend a muscle while it is weighted, or loaded. This is called an “eccentric contraction.” Restated, several contributory factors have been proposed as being related to injury of the hamstring musculo-tendinous unit. They include: poor flexibility, inadequate muscle strength and/or endurance, dyssynergic muscle contraction during running, insufficient warm-up and stretching prior to exercise, awkward running style, and a return to activity before complete rehabilitation following injury. I am currently investigating Platelet-rich plasma (PRP) for its effectiveness in speeding the healing of hamstring muscle injuries. PRP is a preparation developed from your own blood. It contains a high concentration of proteins called growth factors that are very important in the healing of injuries. For the avulsion, Bone Marrow Concentrate may obviate the need for surgery. For more information call for a consultation 847 390 7666
Tags: athletes, Benefits and Risk, Interventional Orthopedics, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Platelet Rich Plasma, PRP, Regenerative, treatment, Ultrasound Guided Injection
The December 2015, Journal of the American Academy of Orthopedic Surgery, featured a Review Article titled Establishing Realistic Patient Expectations Following Total Knee Arthroplasty. The abstract begins with the following sentence “nearly 20% of patients are dissatisfied following well-performed total knee arthroplasty with good functional outcomes.” It continues, “surgeons must understand the drivers of dissatisfaction to minimize the number of unhappy patients following surgery.” There are several studies that have shown unfulfilled expectations are a principal source of patient dissatisfaction following a joint replacement including a failure to relieve pain, improve walking ability, return a patient to sports, and improve psychological well-being. In my previous career as a joint replacement surgeon, it became all too apparent that patients were overly optimistic with regard to expected outcomes following surgery. Published data on clinical and functional outcomes following joint replacement show that persistent symptoms such as pain, stiffness, and failure to return to preoperative levels of function, are common and normal. I thought I should repeat realistic expectations after a Bone Marrow Aspirate/Stem Cell intervention for an arthritic joint based on my data over three and a half years of said procedures for arthritis allowing you to decide which is the next best procedure for you.
First and foremost, the fall back position of an unsatisfactory Bone Marrow Aspirate/Stem Cell intervention at any joint is a repeat procedure for which we have supporting data that a second intervention actually does better than a first. Compare the latter to the rescue of a failed or unsatisfactory joint replacement, a complex major surgical procedure called a revision. The outcome of a repeat Bone Marrow Aspirate/Stem Cell intervention is a better result. Compare that to the outcome of a revision hip or knee replacement; namely, a better X-ray, Even though we have experiencing higher than average temperatures in the Midwest for now, my thoughts turn to skiing. My patients, who have undergone a stem cell procedure with arthritic hips and knees are either on the slopes or headed that way. While after a hip replacement, I will admit that some patients return to the slopes, almost none do so after a total knee prosthesis. After a revision hip or knee, forget it and plan for a cane.
While the world of joint replacement surgery is really not changing, what has been still is; I am able to get you on the slopes or at least relieve your pain with a needle and not a knife without burning any bridges. Joint replacements have a place for advanced arthritis; although Cellular Orthopedics may even now help grade four osteoarthritis. To learn more about realistic expectations and avoid disappointment following a total joint replacement, call for an appointment 847 390 7666
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment, Ultrasound Guided Injection
An all too common practice today is when the surgeon looks at your X-ray, tells you that you have “Bone on Bone “ and that you need a Total Joint Replacement. There is little discussion of the risks and the potential of an unsatisfactory result. The patient looks for pain relief but doesn’t really appreciate why a joint replacement may be indicated or whether there may be other options for delaying or even avoiding a joint replacement; particularly in Grades two and three osteoarthritis.
During my orthopedic training (readers of this Blog are aware I was a joint replacement surgeon for 37 years before “graduating” into interventional orthopedics) I was made aware that the X-ray evidence of osteoarthritis included joint space narrowing, subchondral sclerosis and osteophyte formation. The lay public refers to these observations as “bone on bone” and spurs. The general connotation is that these findings are consistent with Degenerative Arthritis. The synonym is Hypertrophic Osteoarthritis. The other general category of arthritis is Inflammatory and the most frequent category is Rheumatoid Arthritis. The synonym for Inflammatory Arthritis is Atrophic Arthritis in which there is joint space narrowing with osteoporotic adjacent bone changes (joint space narrowing without spurs or thickening of subchondral bone). There is yet another presentation on X-ray of Degenerative Arthritis that is not inflammatory but shares the atrophic nature of bony change. These occur in patients experiencing systemic osteoporosis who undergo degenerative changes. The interesting observation of the latter category is these subjects don’t hurt until very late into the disease process.
In trying to understand what causes the pain in degenerative arthritis, I haven’t lost sight of the inflammatory mature of the bioimmune process inside the joint but I am recently reminded of the shock absorbing and structural support nature of the bone supporting the cartilage. Is the pain generator the bone or the inflammation within the joint? If there is still a joint space but hypertrophic (sclerotic) subchondral bone, will the subchondroplasty alter the progression of osteoarthritis and delay or postpone a joint replacement? If there is X-ray evidence of “Bone on Bone”, should a bone marrow aspirate concentrate intervention be coupled with the subchondroplasty? If there is atrophic arthritis of a degenerative nature, should treatment be limited to an intraarticular intervention alone? Incidentally, Atrophic Arthritis of a degenerative nature is determined after a C-reactive protein and Erythrocyte Sedimentation Rate serum test excludes inflammatory systemic disease.
What is causing your joint pain and what might be done to delay or perhaps avoid a joint replacement while returning you to a more active life? Call and make an appointment so I may assess you, review images and advance an evidence-based recommendation:
847 390 7666
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection