“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
Stem Cells and Back Pain?
I estimate that more than 60% of patients seeking regenerative medical options for an arthritic joint have a major co-morbidity; namely, degenerative disc and joint disease of the low back. The backache complaint is so frequent that I only wish I could recommend stem cell intervention into the degenerative disc or degenerative facet joint at L3-L4, L4-L5, and L5-S1. Yet, the evidence-based statistical data for safety and efficacy is not quite sufficient to allow me to begin a stem cell initiative concerning the low back. Is there an alternative for those experiencing daily back pain; something to make a symptomatic patient functional?
A Virtual Way to Combat Back Pain
During our forced shelter-in-place over the past many weeks, my wife, Sharon, has not been able to visit Body and Brain Yoga or enjoy a weekly appointment for a 55-minute Pilates session. Her low back started to become a recurrent source of concern, symptoms, and limitations until she came across DesirelistTV. #AtHomeTogether, the website features MOVE with us, DINE with us, and Let Us Entertain you; segments led by professionals and all professional content is for free. Try it at www.desirelist.com/TV ; the “coaches”, instructors, and professionals change daily, as does the subject matter. This is where I joined master mixologists to learn how to make the perfect Margaritas for Cinco De Mayo.
Ah, but I have digressed from the low back. By “attending” the virtual yoga, tai chi, core strengthening and stretching classes four to five days a week, Sharon no longer has a back symptom; she has regained all of her function and then some. In the meantime, my office schedule is starting to fill up, the Surgi-Center that I depend on will reopen for me on May 13, and I will be returning to our Personalized Stem Cell Clinical Trial next week as well. All patients may be certain that our offices, Surgi-Center and staff will be using every available precaution and more when we assess and treat our patients. What is your ultimate assurance that we are taking every know precaution to protect patients? It is quite straight forward: neither Mary, Kelly, nor I want to be infected with COVID-19.
On Tuesday, we evaluated and treated 14 patients including interventions in six with orthobiologic products. Wednesday, we treated both knees of a patient with a proprietary Platelet Rich Plasma/growth factor autogenous biologic. Today, Thursday, four patients are scheduled. Next week, we will return to working at the Surgi-Center following all protective guidelines and then some.
To catch up or keep up, visit my website at www.sheinkopmd.com as well as www.PersonalizedStemCells.com. You may learn about stem cells and COVID-19.
To schedule a consultation, call (847) 390-7666.
Caution: Beware of illegal and illegitimate stem cell clinics.
Tags: back pain, can stem cells be used for back pain?, regenerative medicine, stem cell therapy for back pain, stem cells and your back