Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.
How Long Will The Bone Marrow Concentrate Benefits Last?

How Long Will The Bone Marrow Concentrate Benefits Last?

On Tuesday, a patient presented with a problematic left knee. She had been walking her dogs when she was attacked by a pit bull. In escaping, her left knee twisted violently, and over the past several weeks, the pain, limp, and swelling have remained. In reviewing her medical records, I was reminded that in 2012, she became the 40th patient I had treated with a Bone Marrow Concentrate for an osteoarthritic knee.

Fast forward to 02/09/2021, until the recent traumatic event, the patient has been symptom-free without limitation of function or lifestyle. When I reviewed the X-ray taken last week and compared the images on file from 2012, there was no appreciable difference in more than nine years. In other words, the Platelets, Adult Mesenchymal Stem Cells, Precursor Cells, and Growth Factors in the Bone Marrow Concentrate successfully eliminated the symptoms and functional limitations secondary to osteoarthritis.

Limited Long-Term Outcomes Using Bone Marrow Concentrate, Until Now

Why this case is of special importance (actually, all patients are) has to do with the relative paucity of long-term outcomes using Bone Marrow Concentrate for osteoarthritis. In 2012, the belief and teaching revolved around the stem cell. More recently, we have recognized that the Growth Factors play an equally important role in the treatment of the arthritic joint, perhaps even more so than stem cells.

My scientific clinical research publications in the discipline of Regenerative Medicine have been based on one to four-year outcomes. This Blog’s subject may represent the longest clinical follow-up of a patient with an arthritic knee that has been treated with Bone Marrow Concentrate. While most patients want to know how quickly following a biologic intervention, they will experience symptom relief and functional improvement, equally or perhaps even more important is the long-term success of the cellular biologic procedure.

Since 2012, I have gathered evidence as to which biologic procedure is best suited for the needs of an arthritic joint. My care is evidence-based. The range of treatment options includes proprietary Platelet Rich Plasma, Bone Marrow Concentrate, Growth Factors, and Adipose-Derived Stem Cells, the latter made possible by my clinical research relationship with Personalized Stem Cells, Inc. While the first PSC FDA approved Clinical Trial for osteoarthritis of the knee has been completed, we hope to receive FDA approval for the next clinical trial.

To learn more about my Biologic Practice using a needle, not a knife for the treatment of arthritis, visit www.SheinkopMD.com. Schedule an appointment by calling (312) 475-1893. You may follow the announcement of the next Personalized Stem Cell FDA approved clinical trial for an arthritic joint at www.PersonalizedStemcells.com.

A Regenerative Medicine Potpourri

A Regenerative Medicine Potpourri

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

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When it comes to a needle and not a knife, why I recommend Bone Marrow Concentrate

The science and art of my biologic initiative to help a patient deal with the symptoms and limitations imposed by osteoarthritis requires the right tools for each situation. Concentrated Bone Marrow Aspirate or Platelet Rich Plasma has emerged as an important biologic tool for me because I have scientific evidence to support what I recommend.

Mesenchymal Stem Cells are undifferentiated cells that influence healing and growth of tissues making up the musculoskeletal system. MSCs are found in bone marrow.

Osteogenic Precursor Cells are derived from MSCs but basically have the potential to produce bone. Hematopoietic Stem cells are precursors to all red blood cells, white blood cells, platelets and other cells influencing bone density. They are found in bone marrow

Platelets are small, colorless bodies found in blood. They contain alpha granules which play a vital role in blood clotting, inflammation and wound healing. They are found in bone marrow.

White Blood Cells (Leukocytes) provide the body with protection against foreign matter. There are several types of white blood cells and they play a role in inflammation and the immune response

I started this Blog with the sentence “The science and art of my biologic initiative.” At times, the art favors the delivery of autologous, Concentrated Growth Factors contained in your blood so as to reverse inflammation. It is inflammation that generates the pain associated with Osteoarthritis.

By centrifuging your Blood and Bone Marrow, I am able to deliver a large number of stem cells, progenitor cells, and growth factors directly to your arthritic bone and joint thus harnessing the body’s biologic potential. I use a proprietary approach having evolved from our research, when possible, introducing concentrated Platelet Rich Plasma before and after the Concentrated Bone Marrow injection or occasionally all together.

In spite of the misinformation found in the marketplace, the Amniotic Fluid Products do not provide a living source of Mesenchymal Stem Cells. They do contain various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1) and may have some value.

As I have indicated, Regenerative Medicine and Cellular Orthopedics is both an art and a science. This morning, I am working on the science as a co-author on the outcomes of the subchondroplasty manuscript. To learn more, visit my website at www.sheinkopmd.com.

You may schedule and an appointment or consultation by calling (312) 475-1893.

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Masterful Care of The Aging Athlete

I consider myself an aging athlete who still skis, cycles, dedicates five days a week to fitness, plans to soon plant a garden, and walks up a spring creek with a fly rod. When my arthritic hips and knees began to limit my recreational profile several years ago, I chose the regenerative medicine option rather than joint replacements. Having performed joint replacements for 37 years and studied the benefits and limitations of such, I elected to postpone, perhaps avoid major surgery with the inherent risks and limitations. First it was Platelet rich plasma, next came PRP with Growth factor Proteins; and next came stem cells. At the get go, I did not expect to regenerate cartilage; but I did hope to restore joint function, minimize pain, and maintain the highest possible activity potential. Even with Grade 4 osteoarthritis of my major joints, I can report that I skied for a week in Vail this past February as I did a year ago, recently spent three days wading though spring creeks in Southwestern Wisconsin with a fly rod in pursuit of trout, and cycled 30 miles last Saturday. I am not alone as my biking, skiing and cycling buddy with similar knee issues returned last week from his yearly helicopter skiing adventure. I have been managing his knee arthritic issues with regenerative medicine interventions for over five years.

Then there are the athletes in their 50s. Certainly, the option is there for a joint replacement for a grade three arthritic joint but what If? What if there is a complication, an adverse event, a failure to regain motion, or residual pain? The fall back potion after a failed joint replacement is another joint replacement and the outcomes of revision surgery are frequently not satisfactory. Several weeks ago, I described the recreational pursuits of a 58-year-old volleyball enthusiast who had initially considered a joint replacement when 15 years after an arthroscopic partial meniscectomy, the predictable post traumatic arthritis had forced him to suspend his activities. He chose a regenerative medicine stem cell option; and eight weeks thereafter, he is back to playing volleyball three times a week. While on occasion, a booster follow-up injection is needed; we are in the process of developing a manuscript for scientific publication focusing on the successful outcomes of 20 patients followed for one to two years after a combined injection of bone marrow concentrate containing stem cells into the knee and the bone adjacent to the knee. These are recreational athletes between ages 45 and 60 who won’t quit.

On May 4, I am one of three invited faculty to present at The Regenerative Medicine Training Institute (RMTI). On June 7 and 8, I have been asked to participate in the Workshop and Lab Faculty at the largest Regenerative Medicine program in North America (TOBI). Owing to our integration of patient care with scientific outcomes monitoring, we have been able and continue to provide masterful and evidence-based care to aging athletes. To continue to remain in the forefront of Regenerative Medicine, I dedicate a good deal of time reviewing the future while monitoring the outcomes of patient care. Several new treatment options are soon to be launched including expanding my scope of care to those with inflammatory arthritis.

To learn more, call for a consultation (312) 475-1893. You may visit my website: www.sheinkopmd.com

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“There is no such thing as a free lunch”

“There is no such thing as a free lunch”

I will let the scientific facts speak for themselves. Keep this in mind the next time you see the advertisement from the Stem Cell hustlers of America. There is no such thing as a free lunch.

From: The American Journal of Sports Medicine

Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells with Bone Marrow Comparison

Alberto J. Panero, DO*, Alan M. Hirahara, MD, FRCSC, Wyatt J. Andersen, ATC,
First Published 7, 2019 Research Article https://doi.org/10.1177/0363546519829034

Abstract
Background:
In vivo amniotic fluid is known to contain a population of mesenchymal stem cells (MSCs) and growth factors and has been shown to assist in healing when used as an adjunct in procedures across multiple medical specialties. It is unclear whether amniotic fluid products (AFPs) contain MSCs and, if so, whether the cells remain viable after processing.
Purpose: To determine whether MSCs, growth factors, and hyaluronan are present in commercially available Amniotic Fluid Products.

Study Design:
Descriptive laboratory study.

Methods:
Seven commercial companies that provide amniotic fluid were invited to participate in the study; 3 companies (the manufacturers of PalinGen, FloGraft, and Genesis AFPs) agreed to participate and donated AFPs for analysis. The AFPs were evaluated for the presence of MSCs, various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1), and hyaluronan by enzyme-linked immunosorbent assay and culture of fibroblast colony-forming units. These products were compared with unprocessed amniotic fluid and 2 separate samples of MSCs derived from human bone marrow aspirates. All groups used the same culture medium and expansion techniques. Identical testing and analysis procedures were used for all samples.

Results:
MSCs could not be identified in the commercial AFPs or the unprocessed amniotic fluid. MSCs could be cultured from the bone marrow aspirates. Nucleated cells were found in 2 products (PalinGen and FloGraft), but most of these cells were dead. The few living cells did not exhibit established characteristics of MSCs. Growth factors and hyaluronan were present in all groups at varying levels.

Conclusion:
The Amniotic Fluid Products studied should not be considered “stem cell” therapies, and researchers should use caution when evaluating commercial claims that products contain stem cells. Given their growth factor content, however, AFPs may still represent a promising tool for orthopaedic treatment.

Clinical Relevance:
Amniotic fluid has been proposed as an allogenic means for introducing MSCs. This study was unable to confirm that commercial AFPs contain MSCs.

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Opening Day Coming Soon! For Major League Baseball on March 28; for Golf, Even Sooner

The basic principles behind the golf swing and the swing at home plate are not that much different. While the preferences may vary, when you break down the mechanics, there is similarity. Certainly there are differences between laying down a bunt and a 230-yard drive off the first Tee. The same differences are in play when putting is contrasted to the swing driving a 385-foot home run out of the park. In the several scenarios, the swing should look like one smooth, continuous motion that culminates with you holding a nicely balanced finish as the ball sails through the air. Within that motion however, is a series of techniques that each must be executed properly in order to produce the desired outcome.

Concentrating on golf swing mechanics, there is the Takeaway, Back swing, Transition, Impact, and Follow through. Continuing to explore the swing mechanics, backward movement of the shoulders and arms is followed by backward rotation of the spine, cocking of the hips, cocking of the wrists, timing, rotation of the pelvis, forward rotation of the spine, pushing and pulling of the arms and shoulders, guiding action and follow through.

Even if the physics behind my explanation is not perfect, the point here is that any pain and altered motion caused by injury or arthritis will affect your game. If you haven’t been able to play since last fall, now is the time to head out to the gym to catch up on strength training, stretching, with emphasis on spinal and pelvic rotation. Then there are the golf simulators and indoor driving ranges in and around Chicago. 

If you experience pain in your muscles and joints along with limited motion, recent legislative changes in Illinois allow you direct access to the physical therapist. If after several sessions with the physical therapist, you haven’t realized the improvement you seek, it is time for an evaluation by an orthopedic surgeon. She or he, perhaps me, will complete a medical history and physical examination and review X-ray and MRIs of the effected anatomy. The end result of that intake may be a prescription for further PT, a prescription of pharmacologic management or in my case, a Regenerative Medicine/ Stem Cell procedure; that is a needle and not a knife.  

I have documented in several recent scientific publications that Regenerative Medicine using either Bone Marrow Concentrate or Micro-fragmented Adipose tissue recovered by Liposuction will allow you to play 18 holes of golf this upcoming season. At times concentrated and then processed Platelets offer an opportunity for a patient afflicted with arthritis or limited by bodily injury to return to an active lifestyle and enjoy a full schedule of outdoor recreational pursuits. Please make note that my regenerative menu of services is based on your own cells and proteins that have been proven to work and meet FDA and FTC guidelines.

The weather forecast is improving and the sun was out today; the opening of both the baseball and golf season is only a about a week or so away.  I say “Play ball.” 

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