May 20, 2020
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 (312) 475-1893. 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
Feb 5, 2020
FDA Warns About Stem Cell Therapies
Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. September,2017
FDA News Release
FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy. January, 2019
New Google policy bars ads for unproven stem cell therapies
“Untested, deceptive treatments” can endanger consumers, Internet giant says.” October,2019
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Discover the Science and Potential of Exosomes!
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Visit the world’s largest exosome production, research and development facility at Kimera Labs, located in Miramar, FL, where world-leading exosome scientists and physicians will present exosomes educational sessions featuring the latest developments in exosome science and clinical research.
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In spite of the attempts at consumer and patient protection by the FDA and Google, the bad actors and charlatans are still out there as evidenced by the following e-mail blast I received last week:
How do I explain the continued disregard at attempts by the FDA to protect the patient? The bad actors have been inspired by models of greed and unhinged marketing. But the FDA and potentially the FTC will get to them. The FDA didn’t issue a Public Safety Notice explicitly mentioning exosomes for nothing. Also, state medical boards are enabled by statements from the FDA that exosomes are experimental drugs, and physicians aren’t supposed to experiment in their patients.
Evidence Based Medicine is the new era of Regenerative Medicine and Cellular Orthopedics
Clinical outcomes and safety of a combined autologous bone marrow concentrate intraossesous and intraarticular injection for knee osteoarthritis at 12 months. Sheinkop, et al 02/01/2020
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2-year follow-up. Sheinkop, et al 12/2018
Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees. Sheinkop, et al 11/2018
My Current Clinical Practice
Acellular Growth Factors
Proprietary Platelet Rich Plasma and Fluid Concentrate
This is what I had done at both hips and both knees in December; and I am going skiing in Vail two week from now
Bone marrow Concentrate
Visit www.sheinkopmd.com
Adipose Based Stem Cells
Visit www.personalizedstemcells.com to learn more
To schedule a consultation, call (312) 475-1893. The field of Cellular Orthopedics is dynamic and the associated costs are also changing to increase patient opportunity.
Tags: cellular orthopedics, FDA, FDA-approved stem cell therapie, regenerative medicine
Jan 28, 2020
I have been invited to participate in a Crain’s Chicago Business Orthopedic Roundtable discussion scheduled to appear in Crain’s on 02/24/2020. My focus will be on Orthobiologics and Cellular orthopedics. As readers of this blog are aware, I personally underwent orthobiologic interventions into my hips and knees in December. This past weekend, I trekked and trudged through 8 inches of snow to reach some of my favorite trout creeks in Southwest Wisconsin’s Driftless Area. While the fishing was slow to say the least and my fingers were frozen, my hips and knees did great.
Does Bone Marrow Concentrate really work?
From The Am J Sports Med. 2019 Oct;47(12):2881-2887. doi: 10.1177/0363546519867933. Epub 2019 Aug 21
Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow-Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee.
Abstract
BACKGROUND:
The use of bone marrow-derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up.
PURPOSE/HYPOTHESIS:
The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up.
STUDY DESIGN:
Cohort study; Level of evidence, 2.
METHODS:
Seventy-two patients who underwent either ACI or BMSC implantation-matched in terms of age and lesion site- were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation.
RESULTS:
There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period.
CONCLUSION:
BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.
An Update about our FDA-Approved Personalized Stem Cell Clinical Trial.
Some changes are taking place in the trial to allow an accelerated recruitment on the one hand; but an overall decrease in the number of subjects who will be allowed to participate. If you are interested, please call about changes in the inclusion criteria and costs: (312) 475 1893
Tags: Bone Marrow Concentrate, how does stem cell therapy work, stem cell therapy, what is bone marrow concentrate, what is regenerative medicine
Nov 8, 2019
When I entered the early years of Regenerative Medicine about 10 years ago, the approach was initially based on what was termed PRP (Platelet Rich Plasma). Shortly thereafter, BMC (Bone Marrow Concentrate) became dominant while PRP was redefined; and to this day, there is no universal definition of PRP. In my practice, when I provide informed consent to a patient, I offer standard PRP, concentrated PRP and proprietary PRP. While the terms standard and concentrated are self-explanatory, proprietary is a preparation process that not only provides concentrated platelets, it includes the growth factors Interleukin-1Receptor Antagonist Protein (IRAP), Alpha-2 Macroglobulin (A2M), Tumor Necrosis Factor Blocker (TNF-alpha), and many more.
Unfortunately, over the past decade, the use of the term Stem Cell has become commonplace and many so-called stem cell providers and options have been and are being marketed. I have said it before and I will say it again, until August of 2019, the only FDA compliant means of providing a patient with living stem cells for the treatment of an arthritic joint was via concentrated bone marrow. The use of any and all other methodologies is not FDA and FTC compliant; the claims for birth tissue as an approved source of viable cells is erroneous. To learn more, please visit my blog archives.
A reasonable question then is what happened in August of 2019? It is the month wherein Personalized Stem Cells were approved by the FDA for a Clinical Trial. It is the first time that a patient may gain access to pure stem cells for the treatment of an arthritic joint. Heretofore, Bone Marrow Concentrate allowed for the delivery of 10 to 20 thousand Adult Mesenchymal Stem Cells to an arthritic joint. With the FDA approval of the PSC process, I can now provide 10 to 20 million Adult Mesenchymal Stem Cells to the arthritic joint. All this information is further explained on my website sheinkopmd.com.
You may learn more about the Personalized Stem Cell Clinical Trial at personalizedstemcells.com For those patients who do not meet the inclusion criteria for the stem cell methodology for the Trial or who aren’t candidates for bone Marrow Concentrate, do as I have done; consider the Proprietary Platelet Rich Plasma/ Growth Factor option. I realize that this Blog has a lot to consider so let me clarify during an office consultation call (312) 475-1893 to schedule an appointment.
Oct 14, 2019
Let’s start with a definition. Orthobiologics is that subdivision of Regenerative Medicine wherein cells from your circulating blood, adipose tissue or bone marrow (autologous) are recovered, processed and reintroduced to that part of your musculoskeletal system generating symptoms and limitations. Unless the biologic is used as an adjunct at a surgical procedure, a needle is the standard of practice rather than a knife.
The FDA and FTC have established principles governing Regenerative Medicine; and finally, those rules and regulations are being enforced to eliminate the charlatans, the camp followers and uninformed physicians. It is a slow enforcement process that really won’t have a significant impact until September of 2020; until then patient beware. Birth tissues such as cord blood, amniotic fluid and placental tissues have no viable stem cells once processed, preserved and reconstituted for injection. That’s a scientific fact readily repeated in the medical literature; which leaves us with three sources of living cells: blood, bone marrow, and fat (adipose tissue) for the care and treatment of an arthritic or inflamed joint.
Platelet Rich Plasma (PRP), initially was the result of recovering several vials of your blood and placing them in a centrifuge. The resultant buffy coat, found in between the plasma on the top and the combined red and white cells on the bottom, was now recovered and injected into the problematic joint. Eventually, it was realized that the plasma was rich in proteins termed growth factors and the growth factors had unlimited benefit in eliminating the inflammation, that is the pain generator of arthritis. Now we use a combination of platelets and filtered plasma rich in growth factors for an arthritic joint
Adipose tissue is abundant in the body’s midsection; and that fat is a rich source of stem cells. The problem has been that the process required to liberate those stem cells from the fat cells (adipocytes) was not FDA compliant; that is not until Personalized Stem Cells received FDA approval this past summer to begin a trial for an arthritic knee. You may read more about the PSC Trial in my past blogs archived on my web site or by accessing PersonalizedStemcells.com
As you will learn from investigating the FDA approved PSC Clinical Trial, many patients won’t meet the inclusion criteria for participation in the trial. There are alternatives and that’s the place for Bone Marrow Concentrate. I have been using BMC for over eight years with reproduceable and good to excellent results in the majority of patients. My practice is evidence based and I co-authored the evidence to support the use of bone marrow concentrate in a medical journal in December of 2018. That evidence is now the basis for the use of BMC in arthritis all over the United Sates.
To learn more about any of the subject matter found in this blog, call (312) 475-1893 to schedule an appointment unless you are calling about the FDA approved PSC Trail. Then call (312) 475-1893
You may visit my web site at sheinkopmd.com
Sep 27, 2019
Now you know it, I have degenerative arthritis of both knees. It has affected me for more than ten years. In 2017 because of progressive symptoms and limitation, I had thought that I would need to give up skiing, cycling and fly fishing. At the time, imaging was compatible with grade 4 OA at the patellofemoral part of the joint; but grade 2 to 3, between tibia and femur. My decision in late December of 2017 was a proprietary Platelet Rich Plasma filtered concentrate into both knees and it worked (growth factors). I skied, cycled and walked up spring creeks in Southwest Wisconsin all of 2018 and most of 2019 but now limited discomfort is recurring and my gait is changing. While as most persons over 65, there is some degree of wear and tear in the low back contributing to my discomfort after prolonged standing; the pain generator is inflammation from osteoarthritis of my knees. The question for me now is whether to repeat the procedure of 2017 that was successful in relieving pain and improving function by concentrating platelets and filtering the growth factor proteins in my plasma?
Fast forward to the end of this year or the beginning of 2020. The Personalized Stem Cell FDA application for The Clinical Trial using Adipose Derived Stem Cells to treat knee OA, Grade 2 to 4 has been approved as of late July of this year. As you may have learned, ours is the first center in the Country to have been trained and credentialed to recruit and perform the procedure (www.sheinkopmd.com and www.personalizedstemcells.com); several patients are now scheduled for the procedure and four more scheduled for the prescreening process. My personal issue is that I have OA affecting both knees. PSC has indicated it will be applying for FDA approval to treat patients with bilateral knee osteoarthritis sometime after mid-November. In order to assure my preparedness to ski in January and February of 2020 with full recovery and rehabilitation, I will need to have instituted treatment by December 1. As well, while the Wisconsin trout fishing season ends on October 15, it reopens about January 6. For those not familiar, the hiking, climbing, crawling and unstable walking in or along a spring creek can be as demanding as skiing down a mogul run on the ski slopes out West.
Here is my plan based on my stem cell experience, biologic familiarity, and privilege of having been selected as a Center of Excellence for the Personalized Stem Cell FDA approved Clinical Trial. If the FDA approves the PSC bilateral application by mid-November, I will opt for the latter. On the other hand, if my self-imposed recreational time table is in doubt of being kept, I will repeat the IRAP (PRP growth factor) interventions and then opt to proceed with the PSC undertaking when possible. To learn more about the Personalized Stem Cell Trial, call (847) 370-4523, To schedule an office visit, call (312) 475-1893
Good running, cycling, skiing, walking, golfing, boating, fly fishing, curling, bowling etc., etc., etc.
