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 27, 2016
I recently received the yearly publication from the Orthopedic and Rheumatology Institute of the Cleveland Clinic; the latter recognized as one of the 10 most prestigious orthopedic centers in the nation. Every year the publication, a marketing exercise by the Cleveland Clinic, focuses on certain subspecialty areas within the discipline of the care and treatment of the musculoskeletal system. The obvious purpose of such a yearly event is to recruit referrals from practicing orthopedic surgeons and rheumatologists as well as the medical community in general.
This year the focus was on Adult Total Hip Arthroplasty for Osteoarthritis and Adult Unilateral Total Knee Arthroplasty for Osteoarthritis. I will summarize the results; let’s start with the hip:
“Hip-Related Pain 1 Year After Surgery: “on average, 92% of patients reported clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain).”
“On average, 90% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function).”
The knee doesn’t fare as well:
“On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain).”
“On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function).”
The data was derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed.
In my practice, every patient who undergoes a Bone Marrow Concentrate intervention is entered into an outcomes data base with both subjective and objective data points measured. It is quite comprehensive and numbers over 500 patients extending over a span now of 4 and ½ years. While the Cleveland Clinic report is based on subjective parameters and ours on both subjective and objective scores, I am able to extract subjective measures alone. I am pleased to report that in the case of the hip and the knee, our outcomes with a needle are equal to or better than those of the major surgery with a scalpel. Then factor in the prompt rehabilitation of a stem cell procedure compared with the prolonged rehabilitation inherent in a joint replacement. Lastly, consider the relative absence of complications of a stem cell intervention compared to the morbidity and mortality of a joint replacement.
Perhaps of greater significance to the stated advantage of a Bone Marrow Concentrate procedure for Osteoarthritis is the fact that no bridges are burned. If the patient is not satisfied at one year or five, a stem cell procedure may be repeated with a needle. If the arthritis progresses to an advanced stage, the fall back option is a joint replacement. The only choice following an unsatisfactory joint replacement is to accept the surgically induced impairment or undergo a risky revision surgery with a high likelihood of a complication or less than satisfactory outcome. Call 312 475 1893 to schedule an appointment today.
For more information watch my Regenerative Medicine Webinar Video
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, knee replacement, Orthopedic Care, Orthopedics
Aug 12, 2016
“Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and osteoarthritis results in better functional outcomes than physical therapy alone is uncertain.”
The above article appeared in the May, 2013 edition of the New England Journal of Medicine but is still a subject matter of great debate in the orthopedic community. The major reason for the continued debate has to do with arthritis and the nature of the meniscal tear. In the study cited, 351 symptomatic patients 45 years or older with a meniscal tear and evidence of mild to moderate osteoarthritis were followed for up to 12 months using the same outcomes measurement modalities that I use in my Regenerative Medicine practice. The end result indicated no difference in outcomes for those who underwent arthroscopy and physical therapy as compared to those who underwent physical therapy alone.
In analyzing the study, there is no emphasis placed on the nature of the clinical tear or whether the osteoarthritis affects the entire joint or only a single compartment. What allows me to opine on the subject is my 40-year experience in treating the same type of patients prior to my having graduated to Cellular Orthopedics. During my surgical career, I used arthroscopic surgery when indicated and joint replacement, both total and partial when the latter were deemed appropriate. Now I use stem cells derived from bone marrow in almost every setting as there is evidence that the regenerative potential inherent in bone marrow concentrate will significantly impact the outcomes of patients with a degenerative meniscal tear with associated degenerative arthritis.
Be aware that the vast majority of patients over age 45 will show meniscal changes on an MRI. Also be aware that the vast majority of those meniscal changes will be accompanied by arthritic changes in the articular cartilage of the knee. The only absolute indication for arthroscopic intervention is the mechanical symptom such as “clunking”, locking or giving way. Otherwise, it is the judgement of the orthopedic surgeon that will lead to the definitive recommendation. Therein is the problem as the reconstructive orthopedic surgeon will tend to make one type of recommendation while the sports medicine oriented arthroscopist will tend to be surgically oriented.
If any cohort of patients with osteoarthritis and a degenerative meniscal tear is followed for five to ten years, progressive arthritic changes will be documented via a history and physical as well as via imaging studies. There is only one way to date to potentially alter this natural history and that is by intervening with stem cells and putting their regenerative potential into effect. If not addressed early on, those knee joint changes will result in an eventual grade four osteoarthritic degeneration and an indication for a knee replacement be it partial or total.
To learn more, come in for a consultation 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip Replacement, joint replacement, Knee, Knee Pain Relief, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, stem cells, treatment
Aug 4, 2016
There are now available six month follow up Outcomes Data regarding 20 patients who underwent a fat graft harvest, micro-fracture of the fat graft and intervention in an arthritic knee, the latter so severe that the original recommendation to the patient had been a Total Knee Replacement. 85% of this group are very satisfied at this time with the post intervention pain relief and functional improvement. One patient did elect to undergo a Total Knee Replacement eight weeks after the initial intervention. While six-month Data is very preliminary and doesn’t lend itself to a scientific journal publication, I am told the results will become the subject matter of a White Paper, an authoritative report, while the outcomes of the 20 patients will continue to be monitored.
As I have previously reported, I personally am taking a Principal Investigator role in a Clinical Trial centered on the most contemporary ortho-biologic methodology for processing Amniotic Fluid Concentrate. What piqued my interest is the continued marketing placements in our media: ”Stem Cell therapy is an exciting new therapy option that treats arthritis”. “Free Educational Seminar”. “Stem cell regeneration utilizes amniotic stem cells”. I am reminded of the prank I used as a child on my playmates “Pete and Repeat were sitting in a boat, Pete fell out, who was left?” As I have written on my Blog multiple times, there are no viable stem cells in amniotic fluid once processed, irradiated, frozen and fast thawed. That is not to say that AFC may not act as an anti-inflammatory eventually replacing visco-supplementation in attempting to improve the well-being of patients affected by arthritis; but it has no regenerative potential. My interest in leading a Multi-Center Clinical Trial -no out of pocket expense for those who meet the inclusion criteria-is to learn appropriate dosage and duration of effect if any. Subchondroplasty continues to be a subject of increasing interest in the orthobiologic world. I will be serving as a Principal Investigator in a stem cell based subchondroplasty clinical trial as soon as there is IRB approval toward the end of August. I hope to determine if a combined intraarticular and extra-articular Bone Marrow Concentrate approach will result in superior outcomes when contrasted to the standard intraarticular approach.
Be advised and reminded the Regenerative Medicine discipline is evolving and the over seer is the FDA. Make sure that should you decide to pay unreasonable amounts for unproven therapies, those marketing such are doing so under an IRB regulatory methodology. To learn more, schedule an appointment:
312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
Jun 20, 2016
This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (312) 475-1893 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
Feb 8, 2016
Every week, I receive updates via brochures and journals concerning the clinical and basic science orthopedic research being done around the country at the various university medical centers. I like to read them to understand how Cellular Orthopedics is emerging and is being accepted in academic institutions. When I retired from Rush and joint replacement surgery five years ago, my colleagues had a very jaundiced view of my new endeavors telling me and then my patients that Regenerative Medicine was unproven, was ten years away, and was not a reasonable alternative to a joint replacement. It is with great pleasure that I am able to announce the American Academy of Orthopedic Surgery Surgical Skills update will include a three day course next month on Articular Cartilage Restoration: The Modern Frontier, as a continuing educational initiative. The title of one particular lecture really caught my attention Move-Over PRP/Viscosupplementation: Stem cells are in and why.
Taking it a step further, the latest bulletin from Jefferson Medical College’s department of orthopedic surgery reviews the basic science being done in the Laboratory of Theresa Freeman, PhD, Associate Professor of Orthopedic Surgery. “The development of Osteoarthritis can often be attributed to a trauma that occurs in youth, which begins the slow degeneration of cartilage. By reducing cartilage damage immediately after an injury, the development of osteoarthritis can be dramatically slowed.”
I have been making the case for an affirmative stem cell intervention every time an anterior cruciate surgical repair takes place or for that matter, when an individual undergoes an arthroscopic procedure. Two weeks ago, I completed a Bone Marrow Aspirate Concentrate Stem cell procedure three weeks after a young middle aged man had undergone micro fracture for a cartilage defect on the weight bearing part of his femur at the knee. On Friday, I scheduled a 72 year old gentleman for a stem cell procedure ten days after he had undergone arthroscopic surgery for a degenerative tear of his medial meniscus during the course of which degenerative changes were documented in the weight bearing zone at the inner compartment of his knee.
A webinar is scheduled by the American Academy of Orthopedic Surgeons next month in order to introduce its orthopedic membership to what may be possible through Cellular Orthopedics. I have already advised you about the Continuing Education Course next month on Articular Restoration. The orthopedic academy membership is only now being introduced to what I have been practicing for almost four years. There are now close to 750 patients in my data base who have undergone Cellular Orthopedic procedures for arthritic joints to relieve pain, increase function and avoid, certainly postpone a joint replacement. On Saturday, I am headed out to Colorado to ski with family for a week. For readers of my blog, you may recall I have undergone a regenerative procedure for my left knee. While I am realistic and I don’t dwell on being who I used to be, I believe anything is possible at any age. If you want to continue or possibly return to skiing, biking, hiking, climbing, fly fishing, skating, fitness, etc, and the limitation is arthritis, schedule a consultation
847 390 7666
Tags: ACL Injury, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
