First, it was a preliminary follow-up, then came a minimum of one to two years. Now it is five years and more with some outcomes at eight years. I am able to provide informed consent to my patients presenting with symptomatic and function limiting major joint arthritis data that a biologic will result in satisfactory pain relief and functional improvement for the majority and avoid a joint replacement in over 65% of those who have undergone a Bone Marrow Concentrate or Adipose-derived Stem Cell application. Here’s a refresher on Biologics that provides additional context.
As patients return for follow-up care of a second or third problematic and activity limiting joint more than five years after the first stem cell or biologic intervention, I am able to gather their outcomes data. That evidence for the most part is subjective reporting by the patient coupled with an orthopedic physical examination; although, on occasion, I am able to document an increase in the cartilage joint space on an X-ray. Nevertheless, beyond clinical question, symptoms have diminished and activity limitations have been altered by the regenerative care I have rendered. That is why the patients are returning.
As I had written in my last blog prior to our family ski adventure in Colorado, I had received biologic injections in my hips and knees, all classified as grade 3 to 4 osteoarthritis on examination and imaging. As well, I had prepared for the eight-day ski trip with a very intensive physical training commitment, six out of every seven days over a prolonged period of time, and the latter efforts are continuing. I am reporting that my wife and I skied five of the eight days allowing the first for altitude acclimation and taking two interval days of rest. While we avoided, when possible, the expert runs of the thrilling days of yesteryear, we were able to ski with our children and grandchildren for an entire week and plan on doing it again next year.
Now the weather is changing and with 50 degrees temperature, my fancy turns to outdoor cycling and fly fishing. Looming in early May is gardening; although this past weekend, we visited our daughter-in-law, son, and 4-month-old grandson in Atlanta, where I spent three, four-hour days helping to prepare their garden for spring planting. And yes, my lifestyle is made possible by proper nutrition, an ongoing physical fitness commitment, and probably most importantly by biologics and stem cells.
If you want to learn more about the Biologic and Stem Cell Care I offer, visit www.sheinkopmd.com or call (847) 390-7666
For the most recent announcements concerning the Personalized Stem Cell Clinical Trial, I will post them on my blog or you may follow the flow at www.PersonalizedStemCells.com.
The cellular, biologic, therapeutic approach using your stem cells may be directed either directly or via the Extracellular Vesicles produced by those stem cells acting via microRNAs. Bone Marrow contains Mesenchymal Stem Cells (MSCs) in addition to Platelets and precursor cells as well as over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs. In addition, there are other exosomes/nanoparticles yet to be identified.
The same is the case with adipose-derived Stem Cells (Stromal Vascular Fraction or SVF). The microRNA is part of the explanation for the therapeutic effect. Exosomes are messengers that carry proteins and nucleic acids that bind like a lock and key to the cell’s RNA, directing its behavior. The net result is less pain, better motion, and improved function with a needle and not a knife.
OK, it is time to see how all of this translates into the clinical setting. Let’s use an example, namely, me. Next Thursday, I travel with my wife, daughter, two sons, and five grandchildren to Vail, Colorado for a week+ of skiing. This will be my 62nd year of skiing; and although I have stopped the helicopter ultimate skiing challenges, in spite of my two arthritic hips and two arthritic knees, here I go again. While our Epic Passes were purchased some months ago and my outer apparel hasn’t changed for some years (I assure you the under ware has been washed since last year) I rent demo skis to get the most out of every run and my eight days of skiing.
Over the past four years, I have allowed myself the luxury of treatment with the same injectable biologics that I offer my patients. For the last three months in anticipation of the ski trip, six days of fitness straining a week has been dedicated to High-Intensity Interval Training (HIIT) on a rowing ergometer alternating with long-distance cycling on an indoor exercise bike. Make no mistake though, it is the use of the cellular biologic approach that allows me to keep going.
When I return, I will review the week that was and support my claims with visuals. In the meantime, whether you want to ski, run, play golf or tennis, bike or fly fish, call my office and schedule a consultation to learn how biologics and cellular medicine can return you to an active lifestyle or keep you going. You may visit my website at www.sheinkopmd.com or call for an office consultation at (847) 390-7666.
Biologics including Adult Mesenchymal Stem Cells (MSCs), Platelet Rich Plasma (PRP), Structural Acellular Collagen Allograft, and Conditioned Media (Autologous Exosomes) are under investigation for regenerative purposes and as a means of postponing, perhaps avoiding a joint replacement for an arthritic joint. The use of autologous therapies has proven safe and effective when the FDA mandates are followed by the credentialed physician. To illustrate the complexity of the emerging discipline of Regenerative Medicine, I will use Platelet Rich Plasma (PRP) as an example.
In a recently published scientific article regarding Platelet-Rich Plasma, the author provides a systematic review of preclinical studies and clinical evidence on PRP for joint regeneration concluding that the preclinical literature shows overall support toward this PRP application. An intra-articular injection does not just target cartilage; instead, PRP might influence the entire joint environment according to the study authors Berardo Di Matteo and Elizaveta Kon.
Given the biocompatibility of using the patient’s own proteins, safety is guaranteed. PRP therapies are much more complex than previously thought, and their discovery has opened the door to a vast labyrinth of new questions. The effectors mediating the beneficial effects of PRP have not been identified and platelets contain more than 300 proteins; all this according to the investigator Isabel Andia.
Then there is the question of whether to inject the PRP into the joint (intraarticular-IA), into the bone (intraosseous-IO), or both? In a recent article written by Sanchez, et.al., the PRP is injected into both acting on the cartilage-bone communication as well as inside the joint. It has long been recognized that the subchondral bone plays a role in the progression of Osteoarthritis.
Readers of my Blog should be familiar with subchondroplasty, intraarticular injections of Biologics, and a combination of both. I have written several significant scientific outcomes articles about the various approaches. Returning to my original question, might a non-physician or non-scientist ever understand Biologics and Regenerative Medicine for an arthritic joint? I think not; so, for those with symptoms and limitations generated by an osteoarthritic joint, schedule a consultation by calling (847) 390-7666. You may visit my website at www.sheinkopmd.com.
For those of you afflicted with the symptoms and limitations imposed by osteoarthritis, the question most frequently asked at the time of a consultation: “Will this treatment regenerate my cartilage?” The most commonly affected joint is the knee characterized by progressive destruction of articular cartilage, loss of extracellular matrix, and progressive inflammation. It is the latter that leads to the pain and swelling of the joint. Mesenchymal Stem Cell Therapy (MSC) has been and is being used as a new regenerative treatment for knee osteoarthritis. I use it in my practice by applying bone marrow concentrate to the osteoarthritic joint.
Additionally, between 2019 and 2020, I participated in an FDA Clinical Trial in which adipose-derived stem cells (Stromal Vascular Fraction-SVF) obtained via an abdominal mini-liposuction followed by separation of the SVF from the fat cells, were injected into the arthritic knee joint at several trial centers in the country and followed to monitor outcomes. The sponsor of the SVF trial, Personalized Stem Cells, is soon submitting a request for FDA approval of another major adipose-based stem cell trial for the arthritic knee. You may learn more by visiting www.PersonalizedStemCells.com.
To date, recommended treatment options for the osteoarthritic joint range from non-care to pain control. Now, Cell-based therapy and novel approaches using MSCs or exosomes secreted by MSCs are available through my office.
How do the Stem Cells work?
We now know that MSCs and MSC-exosomes carry out numerous functions in the treatment of Knee Osteoarthritis which include an increase of chondrogenesis, which is a well-orchestrated process mediated by interactions between cellular receptors, growth factors, and surrounding matrix protein. In addition to the next adipose-based stem cell clinical trial, I have been asked to be a co-investigator in an IRB-submitted autologous Exosome trial. More about this latter will be appearing over the next several weeks in my Blog. At the same time, I am participating in an ongoing, IRB-approved observational clinical Trial for those with structural defects in their joints as identified in an MRI. The latter may be covered by third-party indemnification if you meet the inclusion criteria.
Your Guide to Navigating the Journey in Regenerative Medicine
Yes, Regenerative Medicine is an ongoing, complicated journey and at times confusing discipline. What is good for the arthritic knee may also be good for your shoulder and hip. To make sense out of chaos, call my office at (847) 390-7666. You may visit my website at www.sheinkopmd.com.
Good morning, good afternoon or good evening; we wish you a year with minimal symptoms and maximal function. This Blog will focus on year past and the year ahead.
Personalized Stem Cell Clinical Trial
The results of those 36 patients who underwent an adipose derived, stem cell knee intervention during 2019 and 2020 and have been sent to the FDA. The Trial involved seven centers across the country and I was responsible for 16 of the 36 patients enrolled and monitored. Based on the safety and efficacy outcomes of those who participated in the trial, the request for the next more extensive Trial using adipose (fat) derived stem cells following a min-liposuction has been submitted to the FDA. You may follow the beginning of enrollment for the next Stromal Vascular Fraction (adipose derived stem cells as contrasted to those derived from bone marrow) by visiting www.PersonalizedStemCells.com or reading this weekly Blog.
Bone Marrow Derived Stem Cells
The use of Adult Mesenchymal Stem Cells (MSCs) recovered from your bone marrow via needle aspiration is still the basis of Cellular Orthopedics and Regenerative Medicine for symptomatic and function limiting osteoarthritis in the United States as well as ongoing, in our office. By visiting www.sheinkopmd.com you may stay informed as well as learn about advances in technique and the process including the advances in “boosters”.
It is a unique substance found in the wall of the umbilical cord. Contained in Wharton’s jelly is type 1 collagen, a potential source of repair for structural defects in an arthritic joint. As of this present time, the product may only be used as an acellular application with FDA oversight in a clinical trial. To learn more about Clinical Trials of type 1 collagen for arthritic structural defects, call my office and schedule a consultation (847) 390-7666
The Platelets, Growth Factors, and Extra Cellular Vesicles (ECVs) Circulating in your Blood
By using your proteins and molecules obtained from you circulating blood, I am able to provide superior clinical outcomes when compared to hyaluronic acid; that is the gel or cushion so highly visible in the media. Commonly referred to as Platelet Rich Plasma (PRP), there is so much more to the generic term PRP today than when first applied ten years ago in an arthritic setting. The next leap forward in PRP and Extracellular Vesicles will take place on Wednesday when I perform a Bone Marrow Concentrate procedure as a means of introducing stem cells for a patient with an arthritic knee, not interested in a Total Knee Replacement. In addition to the recovery of Adult Mesenchymal Stem cells, Growth factors, Precursor Cells, and Platelets; the Extracellular Vesicles containing messenger RNA will be recovered from the patient’s bone marrow, concentrated and injected into the arthritic knee.
To learn more or schedule a consultation, call (847) 390-7666. My website may be visited at www.sheinkopmd.com.
As we look to the year ahead, I have taken the time to review the outcomes of the several types of Stem Cell, Regenerative, and Biologic interventions for knee arthritis that I completed over the last ten years and the first half of 2021. As an evidence-based practice integrating clinical care with clinical research, I move forward by studying the past in addition to the present and future.
Patient Experience | Evidence-Based Care
In my practice, before undertaking a cellular orthopedic intervention of any kind, an orthopedic history, physical examination, and review of images including X-rays and MRIs are completed. The images are then graded using standard radiologic and orthopedic assessment methodology. Then comes the recommendation for that type of Stem cell, Proprietary Platelet Rich Plasma, or other Biologic/Cellular Orthopedic intervention that might be beneficial. If you have been or when you do become a patient, not only do I evaluate you; an associate performs an objective physical assessment and records those findings in a database. It is via the database monitoring your orthopedic impairments prior to treatment and during return visits over the years that provide me with the evidence as to how to best diminish, hopefully, eliminate your symptoms and improve the functional capacity of the arthritic joint.
It becomes readily apparent that the majority of those who have not enjoyed a satisfactory outcome to a biologic/cellular intervention; there is advanced patellofemoral arthritis in addition to the structural changes affecting the tibial femoral joint compartments. There are three compartments in the knee: 1) the inner or medical tibial-femoral compartment, 2) the lateral or outer tibial-femoral compartment, and 3) the patella-femoral compartment. Patellofemoral arthritis affects the underside of the patella (kneecap) and the channel-like groove in the femur (thighbone) in which the patella rests and glides. Difficulty in kneeling, squatting, climbing, ascending or descending stairs, and getting in and out of a chair are all the result of patellofemoral arthritis.
Given the above, it is mandatory that a skyline or Merchant View be included in the pretreatment radiologic assessment. In designing the treatment protocol for a Stem Cell, Platelet Rich Plasma, collagen application, or other biologic knee intervention; my informed consent for those with advanced patellofemoral arthritis, will now include the need for a repeat injection should a patient not have an initial satisfactory outcome within 12 weeks of the initial treatment.
To schedule a consultation, call (847) 390-7666. You may visit my blog at www.sheinkopmd.com
As far as clinical trials are concerned, the next Personalized Stem Cell trial wherein we use adipose-derived stem cells (Stromal Vascular Fraction-SVF) will be submitted to the FDA for approval in the upcoming weeks. You may follow the timeline at www.PersonalizedStemCells.com. For those with structural joint defects as documented in an MRI, we offer participation in an observational trial at this time if you meet the inclusion criteria.
If you have symptoms and altered function owing to an arthritic joint, give yourself a holiday present by calling (847) 390-7666 to schedule a consultation.