Jan 20, 2017
Last week, a patient who had enrolled in the initial Regenexx Stem Cell Clinical Trial for an arthritic knee visited the office for his five year follow up. He had never paid a nickel out of pocket other than obligatory office co-pays for the intervention. Five years after the administration of concentrated bone marrow, he shared his dissatisfaction with the five-year outcome indicating he had scheduled a total knee replacement because of the ” failure”. The same week, four years after another patient had undergone a bone marrow concentrate intervention for his arthritic hip on a fee for service basis, the patient thanked me for having assisted his return to an active lifestyle. With the return of some symptoms, he asked that I repeat the procedure and help him delay a total hip replacement for another four years, perhaps longer.
What is the benchmark of success when it comes to a cellular orthopedic intervention? On the one hand, five-year postponement and electing to undergo a joint replacement or four years of enabling an active lifestyle and then repeating the intervention. From the humanistic side, the unhappy patient always had a demand and a complaint when seen over the five years while the positive patient always had a smile and a thank you.
Over the several years since beginning my Interventional Orthopedic Practice, I have significantly improved the techniques and technology. In addition, over the last month, I have added the technology enabling customization of the injectate with the addition of the Hemoanalyzer to our algorithm. As in any outcomes analysis, there is the subjective component and the objective component. The ultimate determinant as I see it is the activity profile and scoring.
My Interventional Orthopedic practice is focused on protecting my patients from unproven treatments that may be harmful and unethical, financially exploiting the public; First No Harm. Witness the seductive newspaper ads placed by non-MDs offering stem cells for regeneration using amniotic fluid. I am compliant with federal regulations and the Principal Investigator in a national Amniotic Fluid Clinical Trial. From a scientific perspective, while amniotic fluid may be beneficial for six to 18 months, the proper dosage has yet to be determined and there are insignificant living stem cells in that which is being offered. Also, note that tissue-based stem cell products may not be administered in the absence of an FDA approved indications or approved research protocol.
My Regenerative Medicine, Interventional Orthopedic practice is evidence based and everything that I do is under IRB protocols; that is FDA oversite.
To learn more, you may schedule a consultation by calling 312 475 1896
View my website www.sheinkopmd.com
View my webinar at www.ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, stem cells
Nov 1, 2016
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
Oct 20, 2016
Aging is known to contribute to a multitude of systemic changes including those of the musculoskeletal system leading to decreased health, mobility and function. Most changes in well-being are exacerbated by inactivity. It has been scientifically documented that physical activity and exercise may slow or even reverse these deleterious effects thereby improving health, mobility and function.
In particular, ligaments, tendons and joint capsules become stiffer with age as elastic fibers decrease and cross-links between collagen fibers increase. As connective tissue surrounding the joint changes, so too does the synovial fluid within the joint making movement more difficult. Not only do changes occur within the joint, they also occur in the muscles. The loss of muscle mass and strength also known as sarcopenia, increases with age. Then there is the fatty infiltration of muscle that comes with aging and lack of use.
Recognizing the value of Bone Marrow Concentrate derived Stem Cells, Cytokines and Growth Factors in dealing with his arthritic hip when the alternative was a joint replacement, seven months ago, a 58-year-old man underwent a cellular orthopedic intervention. Over the past many months, the patient committed himself to a minimum of 30 minutes a day, five days a week at moderate intensity aerobic exercise alternating with three days a week at vigorous intensity. In addition, he partook in resistance exercise a minimum of two days a week at a moderate high intensity focusing on 10 exercises at each session targeting most major muscle groups, with 10 to 15 repetitions for each exercise performed thus adding an additional 20 to 30 minutes to the commitment. Then there are the benefits of his additional flexibility and stretching. When this individual came to me at his first visit, his stated goals were to return to a high level of recreational enjoyment with a particular interest in ball room dancing. As of last week, he had reached those goals but he has no intention of failing to comply with his exercise prescription.
The obvious message of my Blog is to let you know I am unable to reach a desired goal without your commitment. I may introduce Stem Cells, Cytokines and Growth Factors into an arthritic joint but to reach your desired goal or delay or perhaps avoid a joint replacement, those many changes that occur with aging can be slowed and even reversed by a combination of cellular orthopedics and exercise.
If you want to learn about the evidence, schedule an appointment 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Growth Factors, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, regenerative medicine, Regenexx, stem cells, treatment
Sep 27, 2016
I challenge the reader with this question because it becomes apparent, even the majority of the medical community can’t provide an accurate answer. There are all kinds of claims and statements running rampant; so today, I will try to make some order out of chaos. Let me begin with the patient who repeats what they have been told by their orthopedic surgeon, stem cells don’t work. My response, “for what?” Oh yes they do if you understand where, when, how and why?
Bone marrow has several categories of molecules, cells and vesicles; anti-inflammatory cytokines, adult mesenchymal stem cells and growth factors. The cytokines are a group of molecules that address the inflammation associated with osteoarthritis and thereby relieve pain. The stem cells orchestrate regeneration of cartilage and the joint; while growth factors actually alter the bio-immune process of osteoarthritis. Working together, bone marrow content, when concentrated, has the ability to relieve pain, improve motion, restore function, slow or halt the progression of arthritis and possibly regenerate the joint.
When the patient last Friday repeated that her orthopedic surgeon had told her stem cells don’t work, my response was he is right, there is no chance of regenerating cartilage in a 78 year old woman. Yet the procedure would still be worthwhile as a long term pain reliever and the potential to improve function and postpone, or even avoid, a joint replacement. While regeneration of cartilage is realistic under age 50, pain relief, improved function and better motion is probable at any age for those who chose to undergo a Bone Marrow Concentrate procedure for grades 2 and 3 osteoarthritis.
Three weeks ago, I completed a procedure on a 93 year old man who hadn’t been able to get out of his wheelchair since April. Last week, his wife reported he was walking down the block with the aid of the walker. Three years ago, I completed a bone marrow concentrate stem cell procedure on a 39 year old marathon runner who had stopped competing six months earlier because of knee pain from early onset degenerative arthritis. As of last month, he had competed in 17 marathons since his intervention.
So, if you want to run, walk, bike, ski, and live pain free, call for a consultation.
312-475-1893
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, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Sep 20, 2016
Last week, a patient called and cancelled her scheduled Bone Marrow Concentrate Regenexx SD Stem cell procedure declaring that she had found a less expensive provider for stem cells. I wished her well and devoted some time to trying to better understand the price range posted on the internet for the Regenexx SD procedure. While I couldn’t really get a grasp on the geographic differences in costs, I did realize the chaos and confusion potential of trying to compare apples and oranges. The Regenexx SD Stem cell procedure is the gold standard in the emerging world of Cellular Orthopedics (Regenerative Medicine). There is a seven year outcomes data base supporting the safety and efficacy of the Regenexx methodology. We have been monitoring the successful outcomes of our procedures for a longer time and with the most detailed, reproducible criteria in the field. If you look at non Regenexx websites, you frequently find our outcomes data reproduced (many times without permission).
The Regenexx mission statement is to get the patient back to things he or she loves faster and without surgery. The actual preparation for the procedure, the harvesting and processing of the bone marrow and the follow up management is proprietary in nature; that’s why price shopping doesn’t work. If it isn’t a Regenexx SD procedure, it is a generic knockoff and you will really minimize the chance of success. There are several Regenerative Medicine practices outside of Regenexx in the Midwest; yesterday, a patient called to schedule a Regenexx SD procedure after having gone elsewhere for less cost and experienced the anticipated unsatisfactory outcome.
This is not cookie cutter technology. The harvesting of the bone marrow cannot be from a single site or you risk a marked diminution in the number of adult mesenchymal stem cells harvested. The amount of bone marrow harvested must meet the quantitative requirements for maximum benefit. The simple recovery of 10 ccs of bone marrow is doomed to fail yet the latter is frequent in some settings so as to minimize charges. Then there is the proprietary system of concentrating and processing only available through Regenexx. Last of all, the counting of cells is not a futile exercise as suggested by the “knock off” clinics. We are able to sense success in numbers.
To determine if you are a candidate for stem cell management of your arthritis, you need to make an appointment. A telephone interview doesn’t do it nor does my looking at your images. The determinant is based on my intake and my experience. There are patients whose needs are better served by a joint replacement. If you do meet the inclusion criteria for management for your arthritis with stem cells, there is no better alternative than the Regenexx SD intervention
312 475 1893 to schedule an appointment.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
Sep 12, 2016
First of all, let me expand on the concept of Regenerative Medicine at times also understood as Cellular Orthopedics or Stem Cell therapy. Cells with stem cell properties are present in bone marrow, the peripheral circulatory system, adipose tissue, synovial tissue, muscle tissue, and tendon. At this time, the FDA allows point-of-care bone marrow aspirate intervention for arthritis. From a clinical standpoint, the stem cell concentrate of bone marrow aspirate is technique-dependent and I have found it to be an ever increasingly important factor of therapeutic benefit. When it comes to Adipose-Derived Stem cells, use of these products places risk upon the clinician and the patient because they do not meet the criteria of homologous use and are not autologous. Enter the latest interest in amniotic fluid concentrate with all the marketing hype. As of this time, to the best of my knowledge, there is no clinical outcomes science to justify such use. I should know as I am the Principal Investigator in the largest Clinical Trial involving amniotic fluid for arthritis ever undertaken.
Next, the reader should understand that Osteoarthritis is graded, not all OA is the same. To qualify for a Regenerative Medicine procedure, the degree of arthritis must not exceed grade three based on Imaging and Physical Examination. The standard grading system is termed the Kellgren-Lawrence Scale in which the X-ray image is scored. The physical examination is also taken into account to confirm that the extent of degenerative deformity has not exceeded inclusion criteria.
Now let me explain how Stem Cell intervention is accomplished in my setting, who may benefit, and when Regenerative Medicine is not a reasonable option. Actually if you watch my Webinar,
https://sheinkopmd.com/webinar/
you will better understand.
What are a patient’s options when a first intervention isn’t long lasting? Assume if you will that you have not realized the outcome that would be satisfying to you and rewarding to your interventional orthopedic specialist; there are two options:
Repeat Stem Cell Procedure
I have had at least ten patients in my practice who ultimately reached their goals after a repeat Bone marrow stem cell intervention
Joint Replacement
While it is a procedure that we seek to postpone, perhaps even avoid with a Regenerative Medicine intervention, stem cell procedures do not burn bridges
After watching my webinar, to learn more or schedule an appointment call 312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, treatment
