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
Actually, we never closed, but many patients stopped coming for care due to the Covid-19 Pandemic, and the Surgicenter that I depend on temporarily shut down. The good news is that patients are returning and the Surgicenter has reopened allowing me to offer arthritic patients a full menu of services. Most readers of this Blog are aware of our minimally invasive, outpatient procedures for those limited by an arthritic joint and hope to postpone, perhaps to avoid a major surgical procedure. If you have forgotten or are a new patient, I will restate our unique regenerative medicine approaches to a symptomatic joint that limits your function.
Regenerative Medicine Approaches for Treatments
- Proprietary Platelet Rich Plasma (PRP) and Growth Factors. When indicated, the procedure is done in the office using your platelets and plasma
- Acellular Amniotic Fluid. Since this alternative became available without cells, I have embraced it, again when indicate for a patient in lieu of cortisone of hyaluronic acid. The proteins in amniotic fluid may provide four to eight months of pain relief. In many cases, Medicare and private insurance offerings, not all, will cover the cost of care
- Stem Cells and Bone Marrow Concentrate. Actually, it is the Stem Cell in Bone Marrow Concentrate that remains the mainstay of my approach to an arthritic joint for patients who meet the inclusion criteria.
- Adipose Derived Stem Cells. For the past eight months, I have been one of seven centers approved by the FDA for a clinical Trial wherein, stem cells recovered from your adipose tissue via liposuction, are sent to a designated laboratory for manipulation and returned as a drug to treat an arthritic knee. As of next week, we will be recruiting patients again for The Trial as well returning to the Surgicenter for performance of the Liposuction with an advanced methodology.
There are several additional interventions that I perform in the office; but the latter are only intended for short term relief. For the interested patient or the one whose treatment cycle was postponed due to the Pandemic, call (847) 390-7666. You may visit my web site and watch a webinar www.sheinkopmd.com
Be assured that we practice social isolation in the office and waiting room, cleanse offices between patients, and wear Personal Protective Equipment.
Tags: cellular therapy, orthobiologics, regenerative medicine, regenerative orthopedics