Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-475-1893 for details. Click here to learn more.
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

Tags: , , , ,

My Opinion Regarding the Current Use of Biologics and Cellular Therapies

My Opinion Regarding the Current Use of Biologics and Cellular Therapies

The complexities inherent in biologics, cellular therapies, and stem cells as therapeutic entities are being been addressed at a number of levels. Thoughtful editorials, consensus statements, and even actions by state licensing boards, the FDA and the FTC for unprofessional conduct are starting to “drain the swamp.”

A large part of this growing industry consists of off-label uses; many in Regenerative Medicine seem to practice without FDA compliance. There are some indications where biologics and cellular therapies show genuine promise such as osteoarthritis, and my ongoing clinical research is conformational. Still owing to the bad actors, charlatans, and camp followers, substantive questions remain, including some basic concerns about safety, efficacy, cell sourcing and delivery, host response, and mechanism of action. There is only one way to approach this problem, and that is research with FDA governance (Personalizedstemcells.com).

In general, people thrive on novelty. We look for the latest and newest forms of treatment, hoping that the just-released remedy with the special formula will be the one to cure our problems and ease our pains. We do this as patients, and we do it as physicians. My major concern is that anyone licensed by the Department of Education and Registration may attend a weekend course, upload a web site, and begin fleecing an unsuspecting public.

Musculoskeletal disease and the resulting pain and loss of function are an invitation to the charlatans and camp followers: 20% of the population experiences arthritis and other serious musculoskeletal diseases. it’s not surprising that patients (and providers) will look anywhere for relief, and the bad actors will take advantage of an opportunity.

In the past, this approach has not worked well for many patients. The list of failed treatments for common musculoskeletal diseases is a long and sad one, from nutraceuticals to chelation therapy, and diets from alfalfa to zinc. At times, orthopaedic surgeons have not been careful stewards of clinical evidence—we continue to use viscosupplementation, despite the paucity of good evidence and we continue to use arthroscopic knee surgery in patients who should not have it. It would be nice, after all this, to get it right vis-à-vis stem cells and related treatments.

It appears that government sanctions, editorial sermons, and statements from specialty groups have not arrested the many dubious practice patterns we’ve all seen and too many patients experience. Witness the Amniotic Fluid debacle in Illinois last year perpetrated by the Bad Actors wherein patients were paying astonishing amounts of money (and taking yet-unquantified risk) for treatments that were of no benefit. The Amniotic Fluid marketed at seminars had and has no viable stem cells or biologics and cell therapies for regeneration of musculoskeletal tissues. The same holds true for Cord Blood and Wharton’s Jelly as evidenced by the epidemic of infections experienced in 2018 and 2019.

In this new decade, be informed, protect yourself, and seek out Board Certified Specialists in Regenerative Medicine if you want to postpone, perhaps avoid a joint replacement; or if you want to maintain or return to a fully active lifestyle. To schedule an appointment, call (312) 4745-1893. You may learn more at www.sheinkopmd.com.

Tags: , , , ,

“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.

Tags: , , , , , , , , , , , , ,

Birds do it, bees do it, even Jack Nicklaus does it; I am talking about stem cells

In the ongoing initiative to remain in the forefront of cellular orthopedic offerings for arthritis, “a needle, not a knife”, it was time to advance my skills when dealing with low back pain. About 70% of my patients, in addition to major joint disease, present with degenerative disc and facet joint generated symptoms. At times, it is difficult to determine as to whether hip and knees symptoms come from those joints or are referred from the low back so off I went for Continuing Education. Arriving in San Jose on Thursday, mid- day, and activating my cell phone to see how the world might have changed over the past 4 1/2 hours during my flight, I found an e-mail from my daughter, a physical therapist:

Jack Nicklaus reveals his secret, experimental stem cell therapy in CNN interview
“I’m not a doctor, but I think that stem cell is going to change…the direction of orthopedics, totally,” Nicklaus said, remarking the procedure has given him the opportunity to keep teeing it up. “As long as my stem cells allow me…Golf is a game of a lifetime, I hope to play for my lifetime”. –Joel Beall

How about that one for timing; thank you CNN. Now we may add to the list of celebrities who have undergone regenerative medicine interventions but golfing great Jack Nicklaus deserves special attention. Unlike the star athletes who continually undergo stem cell and PRP interventions so as to compete such as Fred Couples, Steph Curry and an ever- increasing list; Nicklaus underwent a restorative procedure to his back so he could just enjoy a painless round of golf. It is Sunday and I am headed home. Now I am better prepared to help you restore your active lifestyle and overcome limitations imposed by osteoarthritis in a major joint or the low back.

The algorithm of care requires an office assessment and review of images including X-rays, MRIs and at times, a CT scan. Whether further preliminary study is needed will be subsequently determined; and I emphasize, the process may not be “one and done”. After age 45, it more often than not restoration, not regeneration, so maintenance may periodically be needed. Last of all, the improvement following any regenerative or restorative intervention may take 6 to 12 weeks at a minimum.

The next step is your phone call to schedule a consultation. (847) 390-7666
You may view my web site and watch the webinar at www.Ilcellulartherapy.com

A website update to include the low back is forthcoming

Tags: , , , , , , ,

It’s been a busy week for our Cellular Orthopedic practice

On Wednesday, I completed several bone marrow concentrate procedures for patients with arthritic knees. You will recall that Concentrated Bone Marrow contains living Adult Mesenchymal Stem Cells, Growth Factors, Platelets, Exosomes, Precursor Cells and more allowing for pain relief, improved function and possible regeneration in those afflicted by arthritis. In the afternoon, four patients underwent Autologous Platelet and Growth Factor interventions; two in the hip and two in their knees. An example of the outcome, now four months following intervention in my own knees and hips, I spent last weekend hiking along several spring creeks, fly fishing in Southwest Wisconsin in the morning and planting over 150 Lilly bulbs in the afternoon. Admittedly, I slept well on Saturday and Sunday night but visited the health club on these past Tuesday and Wednesday evenings for my fitness routines.

On Monday, we finalized and edited a manuscript reporting the results of 56 patients with arthritic knees, followed for 2 to 4 years having received Bone Marrow Concentrate. Using the same outcome metrics and statistical tabulation methods I had employed as a joint replacement surgeon, this study is one of the most significant trials ever completed and to be published in Cellular Orthopedics. Our study not only will help determine the indications for a “stem cell” procedure, but also assist in determining how long the benefits will last, and provide a road map for when adjunct or repeat interventions are indicated. Now the physician will be better prepared to help a patient decide between a Total Joint Replacement and a Cellular Orthopedic intervention on an evidence based knowledge.

I am writing this Blog while flying to San Jose, California where I am partaking in advanced training that will allow me to expand my regenerative medicine practice to the low back. Again and again, patients ask as to what I might offer to address low back pain and disc disease now that I have successfully intervened in an arthritic hip or knee. Indications and techniques for addressing the lumbar spine will make up the curriculum enabling me to add discogenic and degenerative arthritic conditions of the low back to my scope of regenerative care by mid May.

To the patient who called, “I heard through the grapevine that it doesn’t work”, you may avoid falling victim to the Fake Stem Cell claims in newspaper ads or via celebrity testimonials; those in amniotic fluid are dead on arrival to you. Seek scientific evidence at (847) 390-7666 or learn more on my web site where you may watch my webinar www.Ilcellulartherapy.com.

Tags: , , , , , , , , , , , , , , , , ,

Pin It on Pinterest