The why behind different charges for regenerative medicine procedures

Last week, I assessed three different patients for Cellular Orthopedic joint restoration; and each patient asked about the reason behind my fee schedules? One patient had told me of a friend who had attended a seminar by the Stem Cell Institutes of America and who was quoted a fee somewhat lower than my charges. As I have previously emphasized, the Stem cell Institutes of America use Amniotic Fluid that is concentrated and once processed and thawed, has no viable stem cells or regenerative potential. There may be proteins that survive but basically, a patient receives an injection of hyaluronic acid that cushions the joint for up to six months at best and for which there is no supportive outcomes data.

The second patient had been quoted a fee for cord blood. The latter is provided in frozen form and much of the value is lost during the thawing process. While significantly less costly than a bone marrow concentrate and growth factor concentrate intervention, there is no outcomes data to support usage. The FDA has warned against the use of “stem Cells” derived from anyone or anything other than your own (autologous). So if amniotic fluid and cord blood did deliver viable stem cells, their use would be contrary to FDA guidelines; but let’s move on since neither has living cells when thawed.

Then there are the adipose derived globules, notice I didn’t use the term stem cells. Fat globules are prepared after liposuction and the fat is mechanically broken down but the stem cells aren’t released. In order to release stem cells from the fat, the tissue has to be treated with collagenase. The FDA prohibits use of collagenase in fat unless it is for a cosmetic indication.

My knowledge base is the result of first having completed three clinical trials using Amniotic Fluid for arthritis and in each trial, the outcomes were not satisfactory after six months. I next traveled to Southern California to investigate cord blood. I was skeptical at best but tried the product in three knees, all with very unsatisfactory results. Two years ago, I completed a clinical trial on a mechanically derived adipose based product; the manuscript for that study was accepted by highly regarded orthopedic journal and will be published later this year.

When all is said and done, you may save money with the bottom feeders who advertise and market without data or outcomes to support their claims or you can avail yourself of my knowledge, expertise and statically proven outcomes. To schedule a consultation, call 847 390 7666. You may visit my web site at WWW.SheinkopMD.com

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Autologous Bone Marrow Concentrate for Osteoarthritic Knee

Autologous Bone Marrow Concentrate for Osteoarthritic Knee

The argument frequently advanced by orthopedic surgeons in response to a patient’s inquiry concerning stem cells for arthritis is that it is too early, there is not enough research, It is better to have a major surgical procedure. For those of you who have read my blog or have sought orthopedic consultation in my office, I have emphasized that my recommendations are evidence based. Each patient, for whom I have completed a cellular orthopedic intervention for arthritis, has been entered into a registry or clinical outcomes data base, IRB approved. Just as I pioneered the integration of clinical care with clinical research over 37 years as a joint replacement surgeon, so too do I now partake in the growth and development of the clinical pathways for regenerative medicine.

Last month, I exhibited a poster at a large regenerative medicine meeting wherein I shared my preliminary outcomes and thus educated other professionals using Intraarticular and Subchondral Bone Injection of Autologous Bone Marrow Concentrate and General Fluid Concentrate for Osteoarthritic Knees-A Prospective Clinical Study. Osteoarthritis is an organ disease that affects most structures of joints including cartilage, synovium and subchondral bone. Pathology in subchondral bone contributes to the initiation, progression and pain of Osteoarthritis. In previous European studies, the injection of autologous bone marrow concentrates into bone supporting the joint significantly relieved pain and improved function of the affected knee. The preliminary outcomes in the study that I presented via a poster exhibit, investigated the effectiveness of injections of Bone Marrow Concentrate with General Fluid Concentrate (Growth factors), into both the knee joint and the subchondral bone. The study recorded all the standard Endpoints I had previously used in joint replacement clinical outcomes trials.

Bone Marrow was collected from the pelvis and a filtration system allowed for concentration of Mesenchymal Stem Cells, Platelets, Precursor Cells and Growth factors such as A2M, IRAP, EGF, PDGF, TNF-B blocker, etc. After preparation, a mixture of Bone Marrow Concentrate and Growth factor Concentrate was injected into the bone (subchondral) and into the joint.

In the study, all patient injections went well and there were no complications. The Preliminary Results documented diminished pain and improved function. We concluded that injection of Bone Marrow Concentrate and Growth factor Concentrate into both the subchondral bone area and joint cavity significantly improved function of the affected knee joints and significantly reduced joint pain. While there are many stem cell providers to be found because of their marketing, choose the center of excellence in Cellular Orthopedics that is evidence based.

Call to schedule a scientific based consultation from an orthopedic surgeon 1 (847) 390-7666.

You may access my web site at www.SheinkopMD.com.

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Looking back to see the future of Cellular Orthopedics

My regenerative and restorative Cellular Orthopedics practice is for the most part, evidence based. By that I mean, the outcomes data collected over these past five years regarding the several thousand patients with skeletomuscular afflictions that I have treated with a selection of alternatives using a needle and not a knife is generally based on regenerative and restorative interventions. While not everyone has experienced a dramatic change in symptom relief and functional improvement, many have. The statistical outcomes evidence follows a bell shaped curve with some experiencing immediate improvement as I have in both my hips and knees, while most take several weeks or longer with a continuing improvement up to 18 months post intervention. While it is true that five percent of patients are not satisfied after several years and have gone on to a joint replacement, 95% of my patients are well satisfied and have returned to, or never quit doing what they love.

At the onset of my cellular orthopedic initiative, the interventions were solely based on Platelet Rich Plasma options and Bone Marrow Concentrate; today, our menu of services can be customized so as to meet the needs of all seeking to improve the quality of life and avoid a major surgical procedure. Not only can I concentrate PRP as needed, I can customize the concentration to meet a patient’s particular needs using hemo-analysis. Bone Marrow Concentrate rich in Adult Mesenchymal Stem cells, Platelets, Growth Factors and Precursor Cells is still the foundation of my practice, however for the past year, I am able to offer a Platelet Concentrate derived Growth Factor and Protein Solution option when indicated.

Then there are those whose co-morbidity or prescription medication dependency excludes them from the aforementioned autologous choice of options. As of this upcoming Tuesday, I have acquired an intervention technology that will help patients seeking to a void a total joint replacement who are not candidates for existing regenerative medial offerings. There are many reasons to explain a 5% failure rate including genetic cartilaginous variations, any bell shaped curve will have a small number who don’t pass the final examination. Incidentally, if and when such occurs, I offer another intervention frequently at no charge or certainly at a discounted rate.

Should you want to learn more or schedule a consultation, call
(312) 475-1896. You may visit my web site where you will find the webinar at www.Ilcellulartherapy.com.

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Regenerative Medicine-Are You a Candidate?

Over five years ago, I exchanged a scalpel for a needle and thus entered a developing discipline of cellular orthopedics. My goal was to assist patients with joint afflictions and orthopedic conditions delay, perhaps avoid a surgical procedure by capturing their body’s restorative or regenerative potential and applying evidence-based techniques.

To meet these goals, I introduced the same integration of clinical care with patient outcomes that I had pioneered over a 37-year Joint Replacement career at a major academic orthopedic center in Chicago where I retired as director of the Joint replacement Program. A data base was established and the outcomes of every patient who has undergone a Cellular Orthopedic procedure has been entered into that Data Base regulated by IRB over-site.

Now I am ready to begin sharing the outcomes we have gathered with statistically documented evidence concerning who is a candidate for Cellular Orthopedics, what is the best customized approach for a particular regenerative or restorative procedure and when to advise a patient that surgery might be a better option.

This past weekend, I had a poster exhibit on display at the TOBI meeting in Las Vegas in which I reported preliminary outcomes of a combined Intraarticular and Intraosseous (subchondroplasty) Bone Marrow Concentrate intervention for grades 2 and 3 Osteoarthritis at the knee. I am now working on four presentations as an invited guest speaker at the October meeting of Med Rebels, a well-attended regenerative medicine conference for continuing education credits concerning patient outcomes for different aspects of Cellular Orthopedic recorded in my data base.

What we have learned in these past five years plus is that everyone doesn’t respond to regenerative medicine interventions. You may best gain in-site as to why by reading a blog that I wrote exploring reasons for lack of successes: When Bone Marrow Concentrate Intervention Fails. On the other hand, in part due to the evidence I have gained as well as continuing technological advances, I have a better idea as to who is a candidate for regenerative medicine.

To learn if you are a candidate, schedule a consultation at (847) 390-7666. You may access my web site where you will find my webinar www.Ilcellulartherapy.com.

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A Regenerative and Restoration Milestone

A Regenerative and Restoration Milestone

It happens every year since the day I was born, there is a birthday celebration in my home and it happens again this week. Sure, I have a little more graying of my hair; but fortunately, I have my hair. I also have an activity level that would not have been possible, given the arthritis in my knees and hips, unless I had undergone restorative and regenerative intervention taking advantage of Bone Marrow Concentrate and Platelet Rich Plasma Offerings as I write about in these blogs. 

To give you some insight of what is possible no matter your age and before you become a couch potato owing to pain and functional limits imposed by arthritis, let me describe what I have planned for the Memorial Day weekend. You might recall that I was experiencing progressive functional limitation until a regenerative procedure was completed on my knees, December, 27, 2017 followed by a similar procedure in my hips on January 11, 2018. On this upcoming Thursday, I will begin planting a relatively large vegetable garden in the mid-day when we arrive in Southwest Wisconsin followed by a late afternoon 30-mile bike ride. First, we stop at the Amish Greenhouse in our neck of the woods to collect the vegetables and Herbs. On Friday the cycling and planting will continue; Saturday will be a half day of fly fishing followed by more planting and then another 30-mile bike ride. Sunday will be a repeat of Saturday after the evening outdoor barbecue. Monday morning is another half day of fly fishing, then planting of the herb plot after which we return to Chicago and office patients on Tuesday.

I felt your pain until I took advantage of the possibility for functional restoration and joint regeneration that I offer my patients. No more kvetching from me. The way I want to live is the way I practice.  I am not ready to slow down even though birthdays are being celebrated each year; and I don’t have to alter my way of life; having enjoyed symptom relief and functional restoration via Bone Marrow Concentrate and Platelet Rich Plasma offerings.

To learn about how you might continue to enjoy or perhaps return to an active, symptom free lifestyle, call (847) 390-7666 To schedule an appointment. You may visit my blog at HTTP://www.ILcellulartherapy.com where you may watch the webinar

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The U.S. FDA regulation of cell therapies finally is enforced

“Mitch, not sure if you heard, but the FDA via the DOJ has requested injunctions against the mothership clinics of Berman and Lander, as well as the US Stem Cell clinic run by Comella. We can hope that criminal indictments might follow, since they certainly are some of the most flagrant violators of the law in recent med I can think of. The SCIA group can’t be too far behind. It seems that advertising all kinds of cures for everything that ails the patient makes you a higher priority target.” (Personal communication)

I am dedicated to providing patients with the best possible care in regenerative medicine and am pleased to announce that I have adopted a technology platform developed by Greyledge Technologies (Vail, CO). Their technology to generate platelet-rich plasma (PRP) and bone marrow-derived cell concentrate (BMC) is derived from successfully operating a laboratory that is registered with the FDA (listed as a “component preparation and collection facility”, FEI 3008724474), which has cleared two audits with no issues. Based on their platform, I offer my patients customized therapy, since each preparation is analyzed for platelets, red blood cells and white blood cells (among 23 parameters), which I review prior to treatment. This knowledge permits me to make adjustments based on my more than 40 years of experience in orthopedic surgical and now cellular orthopedic practice. No other system or technology gives me this kind of capability to personalize your treatment.

As a result of the technology I have adopted, my office has been able to create a scientific outcomes data base using the same parameters in cellular orthopedics as when I was the director at one of the five largest joint replacement programs in the country. At that time, I pioneered the integration of patient are with research and education. The latter allowed me to rise to the position of full professor; having publish over 75 scientific articles in the field of hip and knee joint replacement. I am happy to update you with the fact that I am at it again. On June 10, my paper concerning the preliminary outcomes of combined intraarticular and intraosseous stem cell intervention for knee arthritis will be presented in Las Vegas at of The Orthopedic and Biologic Institute (TOBI) annual meeting. The manuscript concerning Autologous Bone Marrow Concentrate and Platelet Product for Symptomatic Knee Arthritis: A Randomized Controlled Trial, Minimum 2 Year Follow-Up was submitted to a major orthopedic journal and is one of three papers I have been invited to deliver from the scientific podium of The Medrebels, October 26 to 28 meeting in Austin, Texas.

If you want to avail yourself of the best opportunity to postpone, perhaps avoid a joint replacement for arthritis while enjoying pain relief and restoration of an active life style, chose science over advertised anecdote. Call (847) 390-7666 to schedule an appointment. You may access my website and watch the webinar at www.Ilcellulartherapy.com.

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