“Article Title: Clinical outcomes and safety of a combined autologous bone marrow concentrate intraosseous and intraarticular injection for knee osteoarthritis at 12 months
Journal Title: Journal of Regenerative Medicine
Dear Dr. Sheinkop
I am pleased to tell you that your work has now been accepted for publication in Journal of Regenerative Medicine.
It is accepted on 2020-09-14”
100th Publication in an Orthopedic Journal
This will mark the 100th scientific article I have authored or co-authored and has been or will be published in a peer reviewed orthopedic journal. The last three articles have been the result of our outcome efforts in Regenerative Medicine. While I have previously alluded to my having pioneered the integration of patient care with clinical research when I was a joint replacement surgeon, there are few orthopedic surgeons, for that matter clinicians of any kind, who have focused their biologics care and treatment of the musculoskeletal system on evidence based medicine. When you visit an orthopedic surgeon, a patient may feel confident in the surgical recommendations advanced. In the emerging field of Orthobiologics for arthritis and musculoskeletal injury, there is not as of yet, a specialty board certifying the training of the regenerative medicine clinician. The result is the risk to a patient of fraud and abuse by the charlatans, camp followers and bad actors. The best means of patient protection in regenerative medicine is to seek out only those who practice evidence-based medicine.
Returning to the thrilling days of the future, the three-year follow-up of the original patients receiving the combined intraosseous and intraarticular bone marrow concentrate at the arthritic knee will soon be initiated. We need to scientifically document how long the treatment will last. At the same time, we continue outcomes surveillance of those who participated in the pioneering Personalized Stem Cell Clinical Trial. Continuing to work with Personalized Stem Cells, I have established an encrypted communication means with the FDA as we are now moving forward with the planning of the next Adipose derived stem cell trial. You may learn more and see the future at www.PersonalizedStemCells.com.
Studies under consideration for 2020/21
- First clinical trial is for knee osteoarthritis (completed)
- Injection of uncultured cells into two arthritic knees.
- Injection of cultured stem cells into two arthritic knees.
- Multiple clinical trials with one or more injections with uncultured and/or cultured stem cells in knees, hips, shoulders or elbows.
- Treatment of immune mediated conditions as supported by clinical and scientific publications.
*The studies outlined will only be conducted if, or when, FDA approval is obtained for each medical condition, protocol, and cell type.
You may learn more on my web site www.sheinkopmd.com or schedule an appointment by calling (312) 475-1893
Tags: cellular therapy, patient education, publication, regenerative medicine
In my last blog, I used anecdote and two patient experiences to justify my treatment recommendations. This blog will feature a scientific and statistically significant outcomes study that I will be presenting next week at the Orthobiologic Institute Symposium (TOBI) taking place virtually in Las Vegas, Nevada. Since I am the first author of the study, I will claim an author’s license to paraphrase and attempt to simplify.
Cellular Orthopedic Recommendations
Knee osteoarthritis (OA) increasingly is considered to be a whole-joint disease, of which degeneration of the articular cartilage is a critical component of OA pathology, along with alterations to the synovial membrane and changes to the subchondral bone supporting the cartilage. Compounding the treatment of OA is the slow and usually limited recovery of damaged articular cartilage. Conventional therapies, including viscosupplementation, steroids, physical therapy, and non-steroidal anti-inflammatory agents, have shown some benefit in reducing OA-associated knee pain, and improving quality of life/functionality, at least for some period of time, but lack evidence of regenerative or long-lasting benefits. Orthobiologics such as Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) also have been used in treating OA, with variable degrees of success. Although most publications concerning treatment of knee OA use an intraarticular (into the joint) route of injection, there are a few recent publications that have described an intraosseous (into the bone adjacent to the joint) route for injecting an orthobiologic.
The current study was structured to assess the safety and potential therapeutic benefit of treating patients with mild to moderate knee osteoarthritis with a split injection of BMC, such that approximately 80% of the injectate was delivered intraosseous to the tibial plateau, and 20% was delivered intraarticular. Each BMC preparation was analyzed for Total Nucleated Cells (TNC), and culture-based Stem Cells. Clinical outcomes were recorded for the Knee Society Score; Lower Extremity Functional -activity-Scale (LEFS); and Visual Analog Scale-pain- (VAS). We also assessed for correlations with patient factors, including cellularity (Total Nucleated Cells) and Stem Cells) and pre-treatment clinical outcome values.
The results reported in this study demonstrate the safety of intraosseous delivery of BMC to treat mild-moderate knee OA. Equally important, study participants reported a mean change in VAS (pain scale) at the 1-year milestone of -2.6, which is slightly larger than the commonly reported VAS of -2.5, suggesting that the treatment protocol resulted in a meaningful decrease in pain out to 1-year post-treatment. The mean change at 1-year of the LEFS (activity) outcome was +15.8 points, which is 2.3x larger than that commonly for LEFS of 9 points, while marked improvements in KSS-Knee and KSS-Function also were observed.
I understand that which I have attempted to explain may be confusing but the results of this trial should be understood. For clarification, call and schedule a consultation (312) 475-1893. You may visit my website and watch a webinar at www.sheinkopmd.com
Tags: cellular orthopedics, orthobiologics, regenerative medicine, regenerative orthopedics, TOBI conference
Well not really Stem Cells, but certainly Platelet Rich Plasma and Growth Factor Protein Concentrate. Knowing that the term Stem Cells attracts attention, I used it here so hopefully, you would read this Blog.
On Saturday, February 15, I departed for a week of skiing in Vail, Colorado. In anticipation of the sojourn, in Late December, I underwent an intervention into both of my hips and knees using Platelet Rich plasma derived Proteins termed Growth Factors. My last Blog explored The Recreational Impact of Biologics: Stem cells, Growth Factors and Platelet Rich Plasma. While I dedicate about 5 to 6 hours a week in pursuit of conditioning; two weeks ago, I returned to spin class at the gym after a five-year hiatus substituting the demands of one-hour spin class for the stationary bicycle. While the late December interventions provided pain relief in my hips and knees, I didn’t feel that I would stand up to the demands of Vail, even with my customary rowing ergometer and strength training routines. It took several classes but here I am in Vail returning to the thrilling days of yester-year on spectacular powder and runs.
Returning to the office this morning, it was time to sit down and finish writing this blog. My first act, en route, was to pick up a copy of the February 24, edition of Crain’s Chicago Business, anticipating the appearance of A ROUNDTABLE DISCUSSION ORTHOPEDIC MEDICINE. I had been selected as one of four Orthopedic Surgeons taking part in a question and answer platform. You may find the article quite informative and find it at CHICAGOBUSINESS.COM or find Crain’s Chicago Business wherever you purchase the daily newspaper. One particular question and answer is worth repeating. In response to the question “What new technologies and surgical techniques are you using?”; I responded “Biologics is the new technology that I use with a needle rather than a knife.” A second question and answer are worth repeating. “What insurance issues and concerns are common with orthopedic treatment?” “Recognizing the financial burdens imposed by some of my advanced technology offerings, I’ve created several affordable care alternatives.” Here is the link to the entire article: https://www.chicagobusiness.com/crains-custom-media/roundtable-discussions.
Now comes the readers’ choice. You may read the entire article by buying a newspaper; click the highlighted above; visit my web site at www.sheinkopmd.com or call and schedule a consultation (312) 475-1893.
Download Full Article Here
Tags: biologics, growth factors protein concentrate, regenerative medicine, stem cell intervention
FDA Warns About Stem Cell Therapies
Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. September,2017
FDA News Release
FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy. January, 2019
New Google policy bars ads for unproven stem cell therapies
“Untested, deceptive treatments” can endanger consumers, Internet giant says.” October,2019
Discover the Science and Potential of Exosomes!
Visit the world’s largest exosome production, research and development facility at Kimera Labs, located in Miramar, FL, where world-leading exosome scientists and physicians will present exosomes educational sessions featuring the latest developments in exosome science and clinical research.
In spite of the attempts at consumer and patient protection by the FDA and Google, the bad actors and charlatans are still out there as evidenced by the following e-mail blast I received last week:
How do I explain the continued disregard at attempts by the FDA to protect the patient? The bad actors have been inspired by models of greed and unhinged marketing. But the FDA and potentially the FTC will get to them. The FDA didn’t issue a Public Safety Notice explicitly mentioning exosomes for nothing. Also, state medical boards are enabled by statements from the FDA that exosomes are experimental drugs, and physicians aren’t supposed to experiment in their patients.
Evidence Based Medicine is the new era of Regenerative Medicine and Cellular Orthopedics
Clinical outcomes and safety of a combined autologous bone marrow concentrate intraossesous and intraarticular injection for knee osteoarthritis at 12 months. Sheinkop, et al 02/01/2020
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2-year follow-up. Sheinkop, et al 12/2018
Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees. Sheinkop, et al 11/2018
My Current Clinical Practice
Acellular Growth Factors
Proprietary Platelet Rich Plasma and Fluid Concentrate
This is what I had done at both hips and both knees in December; and I am going skiing in Vail two week from now
Bone marrow Concentrate
Adipose Based Stem Cells
Visit www.personalizedstemcells.com to learn more
To schedule a consultation, call (312) 475-1893. The field of Cellular Orthopedics is dynamic and the associated costs are also changing to increase patient opportunity.
Tags: cellular orthopedics, FDA, FDA-approved stem cell therapie, regenerative medicine
I make this orthopedic recommendation as emeritus professor of orthopedic surgery at a major medical center where I was director of the joint replacement program and where I performed close to 20,000 knee and hip replacements. First and foremost, try to postpone a joint replacement for as long as possible. A failed joint replacement will reassign you to a couch potato category.
The two patients seeking consultation last week are both in their early 50s and like to ski; while one still enjoys soccer and tennis on weekends, the other plays weekend basketball and goes to a fitness facility during the week. In both cases, at the beginning of the week, they limp with painful and stiff joints. In the latter of these patients, I had previously completed a concentrated bone marrow/stem cell intervention into the left hip and left knee. In the other, the patient has had the joint fluid drained from his knee on several occasions in conjunction with a cortisone injection and a cartilage defect in his recent MRI.
While we all know of joint replacement success stories, there is a 70% chance of the need for a second operation to repair that failed joint in a lifetime when that replacement was introduced in a middle-aged recreational athlete. In fact, there may be a need for still a third revision in a life time; and the outcome of revision surgery does not approach that of a first-time success. For the 30% who do not enjoy a successful outcome with continued pain and loss of motion, your athletic days are over.
A reasonable question that follows is whether there are successful surgical cartilage restoration procedures that will maintain or restore function for more than two years? At this point in time, in spite of anecdotal, sensational claims, there is no outcome evidence that surgical attempts at joint restoration will stand up to use and abuse for more than 24 months.
My Orthopedic Recommendation
What is the alternative for the two middle aged athletes? In making my recommendations, I took into consideration that which is FDA approved, the biologic option for which we have four to five years of statistically significant outcomes data, and that approach for which there is finally partial or total insurance coverage. In the first scenario, I recommended a repeat Stem Cell intervention into the hip as our evidence clearly supports the greater success with lasting benefit of a second Stem Cell procedure. For the knee, I administered informed consent for the FDA approved Personalized Stem Cells clinical trial. Visit WWW.PersonalizedStemCells.com. For the second patient, I suggested a concentrated, customized, Platelet and Growth Factor intervention to reverse the inflammation and thereby eliminate his pain and swelling. In the long term, the FDA PSC Trial would be the probable solution as well.
To learn more or schedule a consultation, call (312) 475-1893. You may visit my web site at www.sheinkopmd.com.
Tags: athletic middle-aged men, biologic options for male athletes, orthopedic recommendation, patient education, treatments for middle-aged men
The complexities inherent in biologics, cellular therapies, and stem cells as therapeutic entities are being been addressed at a number of levels. Thoughtful editorials, consensus statements, and even actions by state licensing boards, the FDA and the FTC for unprofessional conduct are starting to “drain the swamp.”
A large part of this growing industry consists of off-label uses; many in Regenerative Medicine seem to practice without FDA compliance. There are some indications where biologics and cellular therapies show genuine promise such as osteoarthritis, and my ongoing clinical research is conformational. Still owing to the bad actors, charlatans, and camp followers, substantive questions remain, including some basic concerns about safety, efficacy, cell sourcing and delivery, host response, and mechanism of action. There is only one way to approach this problem, and that is research with FDA governance (Personalizedstemcells.com).
In general, people thrive on novelty. We look for the latest and newest forms of treatment, hoping that the just-released remedy with the special formula will be the one to cure our problems and ease our pains. We do this as patients, and we do it as physicians. My major concern is that anyone licensed by the Department of Education and Registration may attend a weekend course, upload a web site, and begin fleecing an unsuspecting public.
Musculoskeletal disease and the resulting pain and loss of function are an invitation to the charlatans and camp followers: 20% of the population experiences arthritis and other serious musculoskeletal diseases. it’s not surprising that patients (and providers) will look anywhere for relief, and the bad actors will take advantage of an opportunity.
In the past, this approach has not worked well for many patients. The list of failed treatments for common musculoskeletal diseases is a long and sad one, from nutraceuticals to chelation therapy, and diets from alfalfa to zinc. At times, orthopaedic surgeons have not been careful stewards of clinical evidence—we continue to use viscosupplementation, despite the paucity of good evidence and we continue to use arthroscopic knee surgery in patients who should not have it. It would be nice, after all this, to get it right vis-à-vis stem cells and related treatments.
It appears that government sanctions, editorial sermons, and statements from specialty groups have not arrested the many dubious practice patterns we’ve all seen and too many patients experience. Witness the Amniotic Fluid debacle in Illinois last year perpetrated by the Bad Actors wherein patients were paying astonishing amounts of money (and taking yet-unquantified risk) for treatments that were of no benefit. The Amniotic Fluid marketed at seminars had and has no viable stem cells or biologics and cell therapies for regeneration of musculoskeletal tissues. The same holds true for Cord Blood and Wharton’s Jelly as evidenced by the epidemic of infections experienced in 2018 and 2019.
In this new decade, be informed, protect yourself, and seek out Board Certified Specialists in Regenerative Medicine if you want to postpone, perhaps avoid a joint replacement; or if you want to maintain or return to a fully active lifestyle. To schedule an appointment, call (312) 4745-1893. You may learn more at www.sheinkopmd.com.
Tags: biologics, cellular therapy, clinical trials, opinion on stem cell threeapy, stem cell therapy