“Hello, I thought you would like to know that my stem cell in my left knee has worked. I didn’t expect it to take so long but I have had little to no pain for the past two months. Thank you all again for your care and please advise your patients to be patient! If not for Covid, I would have had knee replacement several months ago. Only good thing about Covid!”
I received this e-mail message of gratitude this morning and I began to think what this patient’s recovery might have been following a Total Knee Replacement (TKR). In the latter scenario, maximum medical improvement is not realized on the average for over six months or longer. Following a Stem Cell procedure, Maximum Medical Improvement may take six months or longer. In the population of patients who undergo a TKR, 40% are left with an incomplete recovery; that is, some pain and a significant permanent loss of motion. In those who opt for the Stem Cell intervention to relieve symptoms of arthritis and improve functional capacity, our data suggest 10% of patients don’t experience satisfaction. Following a failed Total Knee Replacement, outcome, the choices are to accept the permanent alteration of life style or undergo yet a second major surgical procedure; namely, a revision (ouch). Following a Stem cell procedure that doesn’t provide the sought-after outcome, we still offer a needle and not a knife to improve the end results.
Looking back at 2020 and looking forward to 2021, based on observations following our regenerative medicine interventions, I will adjust my post intervention management with a more concentrated Growth Factor/ PRP booster. Our evidence-based results over the past several months using Growth Factors in higher concentrations have been most rewarding. As many readers of this Blog are aware, I am working closely with Personalized Stem Cells, Inc. and the FDA to help launch the next Adipose based Stem Cell Clinical Trial. It is our hope that the Trial will be approved by the end of Q1 or the start of Q2. In the interim, if you are experiencing pain and functional limitation from knee arthritis, consider a Growth Factor /PRP concentrate intervention. While there is an out-of-pocket fee for the treatment to keep you going, ultimately, for those who meet the inclusion criteria for the PSC Clinical Trial, there will be a facility fee but no out of pocket expense for the entire Adipose Based Stem Cell undertaking.
To learn more, follow my website at www.sheinkopmd.com.
To schedule a consultation call (847) 390-7666
Tags: arthritis, arthritis treatment, regenerative medicine, stem cell, stem cell therapy
About 15 years ago, an article was published regarding the use of Platelet Rich Plasma for the treatment of arthritis. Prior to that clinical trial, physicians would use hyaluronic acid (rooster comb) in an attempt to diminish the symptoms from an arthritic joint. The introduction of PRP heralded the beginning of orthopedic, clinical Regenerative Medicine. Our problem then was that no clear-cut definition of Platelet Rich Plasma was advanced; even today, there is a lack of standardization of the many available PRP offerings. That being said, I use the term Proprietary PRP to clarify my compounding of your platelets and plasma in controlling the pain generator in an arthritic joint; namely inflammation. Growth Factor Proteins (too numerous to describe here) contained in platelets and plasma, act as antagonists to the pain generators within the joint. When concentrated and injected into the painful, inflamed joint, symptoms disappear or are minimized and function improves.
Continuing with our webinar, it was the introduction of the Adult Mesenchymal Stem Cell into orthopedic practice 12-years ago, following FDA guidelines for clinical use, that allowed Regenerative Medicine to become a reality. At that time and continuing to the present, the possibility of cartilage regeneration in an arthritic joint can only be realized by a combination of stem cells, platelets and growth factors. The classic source of these joint regenerators is your bone marrow. In order to be FDA compliant, the harvested bone marrow must come from you and be concentrated, not expanded with addition other agents or through culturing.
FDA Approved Cell Based Therapy
Fast forward to 2019 when the first FDA approved Stem Cell Trial using adipose derived Stem Cells made available via Liposuction and processing was initiated by Personalized Stem cell, Inc. I was one of the several investigators involved and we are tabulating and analyzing data which will then hopefully allow us to move forward with the second phase of the Trial. While bone marrow gives us access to tens of thousands of stem cells, adipose tissue (abdominal fat) allows us to recover several millions of stem cells for processing and clinical usage. I will announce on my web site if and when the phase two trial is allowed by the FDA.
In the meantime, my practice based on various orthobiologic offerings to relieve symptoms of arthritis and improve functional capacity continues. While cartilage regeneration isn’t always an option owing to age or co-morbidities, such options including IRAP variations, Exosomes, and Proprietary PRP are available to maintain or restore an active lifestyle.
Finally, in part owing to lack of standardization and in part because of the charlatans and bad actors holding themselves out to be Regenerative Medicine “experts”-one can attend a 72-hour course and then upload a web site claiming expertise-The American Academy of Orthopedic Surgeons has initiated reform of the emerging discipline of regenerative medicine with consumer protection and physician continued education as the primary goal. I am a Board Certified Orthopedic Surgeon, Fellow of the American Academy of Orthopedic Surgeons and Fellow of the American College of Surgeons.
Good riddance to the quacks.
Tags: cell based therapy, cellular therapy, regenerative medicine
“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 (847) 390-7666
Tags: cellular therapy, patient education, publication, regenerative medicine
We certainly are living in changing times and daily uncertainties, but my practice continues. Over the years, I have noted that when there is public angst, I have a bit freer time to review our outcomes. Alfred E. Neuman, the mascot for Mad Magazine during its heyday, had a motto “What, me worry?”; and I try to live by that motto. What I have learned from review of outcomes is that More Is Better; both in the quantity of biologics administered and the number of times repeated over a period of years.
Stem Cells Clinical Trial Update
By the end of July, we will have completed recruiting our Personalized Stem Cells Clinical Trial allotted number of patients. While the Adipose based Stem Cell Trial had started in the fall of 2019, all was put on hold until about a month ago owing to the Pandemic. Our initial observation is that there has been a significant decrease of symptoms and improved function in those who underwent liposuction and the knee intervention prior to the February temporary suspension of the Trial. The hope is that sometime this fall, the PSC Trial will allow recruitment of patients with significant symptoms and limitations generated by bilateral knee osteoarthritic involvement. At the same time, PSC will seek approval from the FDA for permission to expand the number of stem cells available for a patient by culturing.
Regenerative Medicine Update
While all this is taking place, please be reminded that our practice offers several options that have proven successful over time or with repeat procedures. First and foremost is the use of bone marrow derived stem cells, growth factors (cytokines), platelets and precursor cells in the arthritic joint. Many patients have returned both for a repeat intervention after some years or for attention to an additional symptomatic and function limiting joint. The patients, including myself, who have undergone several biologic injections be it proprietary, compounded, platelet rich plasma or the more recently available acellular amniotic fluid, have really benefited from the repeated series.
Last of all, I want to remind the reader that interested patients may access Adipose derived Stem cells outside of the PSC Clinical Trial if interested on a fee for service basis. The advantage of such is that several joints may be treated at the same sitting. In the latter scenario, a mini liposuction is completed and the recovered adipose tissue is prepared for immediate joint intervention via a methodology introduced by Lipogems. The end result of the Lipogems process is micronized adipose tissue; it has become quite popular in several biologic practices around the United States.
If you wish to explore these Regenerative and Orthobiologic options for an arthritic joint or joints, you may visit my web site and access my webinar at www.sheinkopmd.com. Even better would be to seek consultation in my office; you may schedule by calling (847) 390-7666.
Tags: orthobiologics, regenerative medicine, stem cell therapy
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 (847) 390-7666. You may visit my website and watch a webinar at www.sheinkopmd.com
Tags: cellular orthopedics, orthobiologics, regenerative medicine, regenerative orthopedics, TOBI conference