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.
Two Stem Cell Announcements

Two Stem Cell Announcements

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Cellular Orthopedics and Biologics, a Regenerative Medicine Medical Practice directed by Mitchell B Sheinkop, MD, that specializes in evidence-based care and the development of advanced patient therapies, announces it has entered into a Clinical Study with Celling Biosciences to jointly explore Bone Marrow Concentrate products.

Under the agreement, Mitchell B. Sheinkop, MD, will collaborate on the study of existing therapies as well as the development of new therapies that can potentially transform the treatment of musculoskeletal disease including acute injuries and chronic disease in joints.

This collaboration will leverage Cellular Orthopedics and Biologics’ extensive expertise in clinical research and patient care, as well as Celling Biosciences cutting-edge technology and innovative therapies. This partnership will allow accelerated development of new regenerative medicine products for my patients more efficiently and at a Lower cost.

A New Chapter of Innovation | Interventional Regenerative Orthobiologics

“Our team is dedicated to developing safe and effective therapies that can improve patient outcomes and quality of life. We believe that this collaboration will enable us to enhance our product development process through an even more rigorous data-driven approach,” says Dr. Sheinkop. The collaboration represents an exciting new chapter in the development of regenerative medicine products and has the potential to revolutionize the field of interventional regenerative orthobiologics.

Clinical Study – Osteoarthritis | Micro-fractured Fat

In addition to the aforementioned, I am also announcing that I have established a Clinical Study coordinated initiative with JoinTechLabs allowing for yet a second Regenerative Medicine option in which your fat is put to work. The micro-fractured fat obtained by a mini-liposuction in the office expands my scope of services so I can meet the needs of almost all patients with symptomatic and function-limiting Osteoarthritis.

About Mitchell B Sheinkop MD – a leader in orthobiologics. The practice is dedicated to the science and research of innovative biologic medicine and its potential while supplying patients with the best products and education available to improve their quality of life. Learn more about The Cellular Orthopedics and Biologics menu of options including platelet-rich plasma, bone marrow concentration, and protein concentration filters www.sheinkopmd.com or call and schedule a consultation (312) 475-1893.

A pause for Biologics; but I am back

A pause for Biologics; but I am back

It has been many years since I took personal time off to change offices and receive a “tune up” for my arthritic joint right hip. I am back. This past Wednesday, I completed three concentrated bone marrow procedures in my new settings under local anesthesia in our specially designed treatment room. Because the patients are participating in a Clinical Study, when combined with the elimination of the surgi-center dependency, the cost of Regenerative care for an arthritic joint is far less when compared to previous fee schedules. The same holds true for next Wednesday when the emphasis will be on Micro-fractured Fat following a mini-liposuction for those whose needs are best served by the latter methodology. Those patients who meet the micro-fractured adipose tissue inclusion criteria will also be entered into our Outcomes protocol and thus enjoy a cost reduction. Keeping in mind that my practice is evidence-based with treatment decisions made using scientific methodology and not an advertisement and a testimonial by a paid spokesperson; it requires an office assessment and review of images to enable me to make a definitive recommendation. We also use the full scope of Platelet Rich Plasma (PRP) alternatives and other Biologics when deemed appropriate.

For those who have stored adipose tissue from the first FDA-approved Stem Cell Clinical Trial, I am afraid we have to wait for a ruling on The FDA’s contesting of the California Appellate Court 2022 opinions. In the latter, Stem Cell culturing and usage was ruled part of the practice of medicine but then the FDA challenged the decision so we have to wait for the legal process to run its course. By the same token, for those interested in the second Personalized Stem Cell Clinical trial, the application is in progress; as of yesterday, PSC indicated a decision by the FDA should be forthcoming in 2023. Please understand that I share your frustration as my adipose tissue is waiting in the PSC deep freeze until the FDA to allows my arthritic knees to be addressed.

As I see it, the best option for a patient with symptomatic and functional limitations from an arthritic joint would be to call (312) 475-1893 and schedule an examination, review of images, and consultation. The ethos of my practice is informed consent. As of Thursday, March 16, 2023 patients will have a choice of locations including the 618 W Fulton Chicago office and the Glenview office, 2200 Waukegan Rd.

Unadulterated Corruption in Regenerative Medicine

Unadulterated Corruption in Regenerative Medicine

Marketing and Reach can be bought; experience cannot. What prompted me to address the fake news concerning Regenerative Medicine is the lasted media blitz repeated in print, on the radio, and on TV by the current opportunists with the standard unsubstantiated testimonials by influencers who are paid to play. While History Repeats Itself may be a song released in March of 1966 and recorded by Cab Calloway, the phrase actually has been credited in different forms to George Santayana, Winston Churchill, and Mark Twain. The general idea of history repeating itself, however, is of much more ancient origin. When it comes to Regenerative Medicine, beware and take care; only a few years ago we were bombarded by charlatans, now in prison, marketing amniotic fluid as a source of stem cells for all comers with arthritis. No need for a physical examination or a pretreatment X-ray, just show up for a seminar, free lunch, and write a check.

A Climb of Clinical Mastery & Human Connection Over Many Years

While marketing and reach can be bought, knowledge and experience come with time and within the context of evidence-based practice. The science and art of medicine is the ability to provide the right solution for each individual patient. This happens over the course of a journey… a climb of clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation:

1) Micro-fractured Adipose Tissue
2) Bone Marrow Aspiration Concentrate
3) Platelet Rich Plasma
4) Plasma Rich Growth Factors
5) Master Protease Inhibitor
6) Subchondroplasty

You may visit my website at www.sheinkopmd.com. Better yet, schedule a consultation by calling (312) 475-1893. While our Chicago office is now 618 West Fulton, in Mid-March, our Glenview office will be up and running. What may be of particular interest to some are our research studies concerning Bone Marrow Aspirate and Micro-Fractured Adipose Tissue. While not Clinical Trials, as safety and efficacy have already been established for Bone Marrow Concentrate and Micro-Fractured Adipose Tissue, hence FDA compliant, the long-term Outcomes of these applications have yet to be determined. Additionally, rather than a hit-or-miss technique, my studies will attempt to standardize the nature of the injectate through advanced scientific analysis. For those willing to participate in the studies, there is a significant discount for the standard out-of-pocket cost of Regenerative Medical procedures. For answers to all your questions or to schedule a consultation call (312) 475-1893.

When Choosing Regenerative Medicine Options, Ask for the Outcomes Data

When Choosing Regenerative Medicine Options, Ask for the Outcomes Data

Most of you are probably old enough to remember Sargent Joe Friday on the radio and then the TV detective series, Dragnet. His calling card: “just tell me the facts”. Over the past several weeks, I have been confronted with a significant healthcare issue as so many men are after age 55. My specialist provider sent me for test after test and then finally scheduled me for his treatment choice for my situation. I did keep the initial appointment with the next subspecialist who then mapped out a treatment protocol that was to start in 72 hours. I started having reservations about the proposed and scheduled treatment protocol; and, decided to seek a second opinion. This past Monday, at the second opinion, I was given the facts and outcome data concerning several treatment options for my situation based on scientific evidence. The informed consent process resulted in my choosing a different treatment protocol than that which had originally been mandated.

I write about this to encourage the reader to ask for evidence-based outcomes data in the Regenerative Medicine decision-making process whether it be which physician or what treatment. There are choices to be made when a patient with a painful joint and limited function opts for a Regenerative Medicine “stem cell” intervention. The American Academy of Orthopedic Surgeons has undertaken a Biologics Initiative to deliver accurate, evidence-based information. This is with my own outcomes research, the latter has resulted in scientific publications providing leadership and guidance to the emerging Regenerative Medicine subspecialty. Thus, I am able to assure my patients that all recommended care is based on outcomes data; and they will not fall victim to fake news or media hype from the newest opportunists in the marketplace.

What are your alternatives in Regenerative Medicine/Stem Cell care for an arthritic, symptomatic, function-limiting joint? They fall under the following categories:
1) Platelet Rich Plasma
2) Bone Marrow Concentrate
3) Adipose Tissue

Within the aforementioned categories, there are many subgroups, approaches, and kits available for processing the preparation to be injected. I am aware that there are other alternatives advertised for use in Cellular Orthopedics, in general, they are not FDA-compliant at this time.

When all is said and done, when choosing a Regenerative Medicine Option, which alternative is best?

Call (312) 475-1893 to schedule a consultation after which I will be best able to make a recommendation. You may visit my website at www.sheinkopmd.com.

As The Stem Cell World Turns

As The Stem Cell World Turns

From Bob Harman, CEO, Personalized Stem Cells:

“In November of last year, I sent a letter to all of you about the Cell Surgical Network (“Berman”) FDA case ruling by Judge Bernal and how this created a unique opportunity to for us to create a pay-for-service business and work with physicians like yourselves to offer treatments to patients of their own cultured cells outside of a traditional clinical study. Since that time, FDA has filed an appeal. Although we believe this process could lead to a broader opportunity, at this present time we believe it prudent not to rely on this ruling for broader use outside of the Central District of the 9th Circuit.
We continue to move forward with our plans to develop a platform for pay-for-service therapy. The most protected method is the Federal Right-to-Try program, implemented as the law of the land in 2017. This program is Federally mandated and runs parallel and separate from all FDA programs and jurisdiction. We will be sending you more detailed information on patient qualification and application for treatment in the coming weeks. We believe this to be a great opportunity to provide needed cell therapy to your patients, including those with cells already stored.

In parallel, we are submitting additional supplements to the FDA to allow us to proceed into cultured cell formal clinical trials. Our filing will be completed in Q1 and we anticipate being able to proceed into a randomized trial in Q2 in knee OA. Following their review and acceptance (30-60 days) of the updates, we will re-initiate the pay-for-service therapy option via the Federal Right-to-Try law and also will initiate the new clinical study.

We know that this delays the ability to get treatments for patients in need, but once the above is completed, we will have a solid platform of continued clinical studies and ability to treat patients in a fee-for-service manner. We continue to believe strongly in both opportunities for treating patients with their own cultured stem cells. We promise to keep you updated and we remain committed to being the best provider of stem cell services.”

For those who do not wish to postpone care for their arthritic joints; who do not meet the inclusion criteria when and if the FDA approves the cultured cell option; or who do not want to partake in a randomized Trial; we have the FDA-cleared Micro-fractured Fat Graft Study. Participants in the Micro-Fractured Adipose Study, wherein the adipose tissue (abdominal fat) is recovered by mini-liposuction as in the Stem Cell Trial for which we are waiting for approval, may do so at a significant discount from the prevailing out-of-pocket costs.

To learn more about how we may help you in the present and in the future, call (312) 475-1893 to schedule an office visit. Visit my website at www.sheinkopmd.com

Regenerative Medicine: The Past, Present and Future

Regenerative Medicine: The Past, Present and Future

A disclaimer at the get-go. The title of this Blog was influenced by my repeat viewing the other night, when I became tired of news and sports, of the Good, the Bad, and the Ugly, about 40-odd years after my first watch. The penetrating music was never forgotten.

The Past

Yesterday was my initial office session in the new 618 West Fulton Street office. The first patient was a middle-aged police officer who I had initially treated for a fracture dislocation of his right hip in 1991, after having been involved in a vehicular collision. Please be reminded that at the time, I was a Professor of Orthopedics at a major academic medical center in Chicago, dedicated to joint replacement and reconstructive surgery of the hip and the knee. His treatment required an open reduction and internal fixation of a fracture/dislocation of the right femoral head. He had kept his medical records of the time; and so, when pain and restricted function at the hip were progressing, the still-active police officer decided to seek me out.

The Present

A full orthopedic assessment of the patient, with particular emphasis on his right hip, was followed by X-rays. Once I viewed the image, while l honestly didn’t remember the patient by name, I quickly recalled his case as the surgical intervention took place very early in the morning and required special instrumentation in order to maximize the end result. The Osteochondral Fracture of the femoral head at the time had healed, and I recognized the two retained mini-screws used for fracture fixation at the time. More important was the absence of avascular necrosis; that is loss of blood supply to the femoral head from the traumatic dislocation and the surgical reconstruction. Most important was the fact that the surgical reconstruction had resulted in 30-plus years of an unlimited quality of life and no restriction in his physical demands as a police officer.

The Future

Given the physical examination compatible with a minimal loss of hip motion, and an X-ray indicative of early onset, grade 3 osteoarthritis; I recommended a Bone Marrow Concentrate procedure for the right hip. In our evidence-based Regenerative Medicine and Cellular Orthopedic Practice, we have the statistics to support the recommendation enabling the application of the Adult Mesenchymal Stem Cells, Platelets, Growth Factors, and Precursor Cells to diminish or eliminate pain from the inflammation generated by osteoarthritis while at the same time influencing the progression of arthritic changes. The end result will postpone and, hopefully, assist the patient in avoiding a hip replacement while still in his mid-50s.

To learn more about how we may help you in the present and in the future, call (312) 475-1893 to schedule an office visit. Visit my website at www.sheinkopmd.com

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