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.
The New World of Cell Therapy and Orthobiologics: A Needle and Not a Knife, Part 1

The New World of Cell Therapy and Orthobiologics: A Needle and Not a Knife, Part 1

 My goal is to separate fact from fiction by delivering evidence-based care specifically related to orthobiologics, and contribute to biologics knowledge and application in arthritis and orthopedic conditions. At present, too many patients are navigating the field independently without reliable sources of information resulting all too frequently in substandard care provided by non-orthopedic physicians; thus, experiencing unsatisfactory outcomes. I still am an orthopedic surgeon having evolved into regenerative medicine using stem cells, proprietary platelet rich plasma, growth factors, exosomes and acellular amniotic fluid with a needle and not a knife.

September 29, 2020

“Dr. Mitchell Sheinkop

It was a little over three years ago when we first met. At that time, I could not walk through a Walmart without experiencing significant pain in my left knee. Well, since that time my knee has continued to improve. Fast forward to today, we have just returned from our hiking trip to the southwest national parks (Grand Canyon, Bryce, & Zion). This trip included 7 days of hiking that totaled 60 miles with significant elevation changes (pictures included on enclosed DVD).

Hats off to you and your staff as I could not have been able to do this without you”

The patient who sent me this beautiful expression of appreciation had presented to my office seeking to postpone, perhaps avoid a Total Knee Replacement. He had already been treated for several years by a local physician with physical therapy, non-steroidal anti-inflammatory medication, and injections of cortisone and hyaluronic acid to no avail.  After assessment and review of images, I provided him informed consent regarding the several options available at the time; he elected to undergo a stem cell procedure using Adult Mesenchymal Stem Cells harvested from his bone marrow. Several days prior to the bone aspiration, a Platelet Rich Plasma injection using the patient’s own platelets was completed to initiate healing. Five days later, the bone marrow aspiration was completed in a surgi-center to assure sterility and the concentrated bone marrow containing Stem cells, Platelets, Precursor Cells and Growth Factors were injected into the patient’s left knee under image guidance. About a week later, a concentration of a proprietary Platelet Rich Plasma filtrate was injected into the left knee under image guidance as well. The result is best described the patient himself in the above message quoted above.

What I have described took place three plus years ago. Since then, the biologic options have increased; in part owing to my clinical research and that is what I want to explore with you in this webinar.

Tags: , , ,

Regenerative Medicine Fact Check or Cellular Orthopedic Q&A

Regenerative Medicine Fact Check or Cellular Orthopedic Q&A

Question: 

Dr. Sheinkop, three months ago you did an A2M intervention on a 72- year old athletic man with progressive limitations from an arthritic knee. You reported how he was doing at six weeks, how is he doing at 12 weeks?

Answer: 

Hi. I trust all is well with you. In regards to my progress with A2M I can honestly tell you it has been one of the best procedures I’ve had for my arthritic knee. I’ve been quite active and am experiencing no pain. My arthritic knee is not miraculously healed but I’ve always experienced pain, edema, and discomfort after exercising it. Those symptoms don’t occur since the injections. Perhaps those symptoms were a result of the arthritic proteases that are now subdued.

Question: 

I have received different opinions for PRP injection for arthritis and an entire range of charges. What is the explanation?

Answer: 

There is no uniform definition for Platelet Rich Plasma. In some settings, it may result in a small volume of PRP and plasmas; in others, 60 ccs of blood is recovered via vena puncture with a resultant large concentration of platelet and proteins called growth factors. A patients must be prepared to request explanations from a physician.

Question: 

Are any regenerative medicine procedures covered by Medicare or private insurance?

Answer: 

It seems that Medicare and some private indemnification will preauthorize the use of certain biologics; it is on a case by case basis and varies from insurance company to insurance company.

Question:

Dr Sheinkop, you have previously written in your blog about your arthritic knees and hips. How are you doing and what have you had done?

Answer:

Last Friday and Sunday, I rode my bike 40 miles each day. When I am not able to cycle, I use my Concept 2 rowing ergometer at a fairly significant pace for 30 minutes or more. I booked my ski trip for Colorado in February and plan to go fly fishing over the upcoming two weekends, the latter may be the most demanding. All this has been made possible by the intervention in my knees and hips with Platelets, growth factors and stem cells.

Question:

Do you have any upcoming clinical trials available for arthritic joints?

Answer:

While the Personalized Stem Cell clinical trial has been completed, PSC has applied to the FDA for an expanded use trial allowing more than one joint to be treated with adipose derived stem cells. I will announce in this Blog when and if, the trial will take place.

To learn more, call (312) 475-1893 and schedule a consultation. You may watch my webinar and view my website at www.sheinkopmd.com. The Personalized Stem Cell website is a valuable resource as well www.Personalizedstemcells.com.

Tags: , , , ,

An Orthobiologic Update

An Orthobiologic Update

The TOBI meeting was held June 12 and 13. Annually, it is the largest gathering of physicians who dedicate their practices to Regenerative Medicine. I have been contributing yearly to the scientific program almost since its inception; and I did so again this year. The evidence I present is based on my having pioneered the integration of clinical practice with outcomes documentation. This year, I focused on the results of an initiative I started four years ago by combining the placement of Bone Marrow Derived Stem Cells and Biologics both into the joint and into the bone adjacent to the joint. In so doing, our team had statistically documented improved outcomes when contrasted to placement of the biologics into the joint alone. 

Orthobiologic Options for Patients

Not every patient with arthritis is a candidate for the approach described in the above paragraph. There are inclusion and exclusion criteria and those can only be assessed at the time of an office visit. For those who are not able to undergo the harvest of either bone marrow derived stem cells or adipose derived stem cells, we have several excellent alternatives to help control the discomfort of osteoarthritis and improve functional capacity. I will devote the remainder of this Blog to explaining two of the alternatives.

The term PRP (Platelet Rich Plasma) has become familiar to the public; but patient beware. The generic product has less than a 50% success rate and only after repeated administration. My proprietary approach, not much more costly than the usual and customary fee schedule for the generic PRP, provides a much greater concentration of biologics including growth factors in addition to six times the concentration of the generic PRP option. It is the intervention that I have personally undergone, and I still consider myself a senior athlete.

The second option is that of a growth factor and anti-inflammatory option; that in many cases, will be covered by Medicare and private indemnification. While our proprietary Platelet Rich Plasma is autologous, that it is prepared from your circulating blood but is available on a self-pay basis; the growth factor/anti-inflammatory option is provided by donors. The processing of the acellular product eliminated the risk of disease transfer and it is an excellent starting point for the use of biologics in the treatment of an arthritic joint.

Help for Patients in Pain

Yesterday, I assessed a 56-year old woman for biologic treatment of her left knee arthritic generated pain and altered functional capacity. Four years ago, she had undergone a right Total Knee Replacement followed 18 months thereafter by a revision procedure. That was followed in a year by yet a third surgical attempt to make the right knee pain free and functional and it is still problematic. The history of a failed knee prosthesis is three surgeries in four years. The natural history of a patient with an arthritic joint who undergoes a biologic intervention is a repeat injection in 18 to 36 months should pain recur.

You may learn more by visiting my web site  www.sheinkopmd.com

You may schedule an office visit by calling (312) 475-1893

 

Tags: , , ,

Scientific Evidence Supporting Cellular Orthopedic Recommendations

Scientific Evidence Supporting Cellular Orthopedic Recommendations

In my last blog, I used anecdote and two patient experiences to justify my treatment recommendations.  This blog will feature a scientific and statistically significant outcomes study that I will be presenting next week at the Orthobiologic Institute Symposium (TOBI) taking place virtually in Las Vegas, Nevada. Since I am the first author of the study, I will claim an author’s license to paraphrase and attempt to simplify.

Cellular Orthopedic Recommendations

Knee osteoarthritis (OA) increasingly is considered to be a whole-joint disease, of which degeneration of the articular cartilage is a critical component of OA pathology, along with alterations to the synovial membrane and changes to the subchondral bone supporting the cartilage. Compounding the treatment of OA is the slow and usually limited recovery of damaged articular cartilage. Conventional therapies, including viscosupplementation, steroids, physical therapy, and non-steroidal anti-inflammatory agents, have shown some benefit in reducing OA-associated knee pain, and improving quality of life/functionality, at least for some period of time, but lack evidence of regenerative or long-lasting benefits. Orthobiologics such as Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) also have been used in treating OA, with variable degrees of success. Although most publications concerning treatment of knee OA use an intraarticular (into the joint) route of injection, there are a few recent publications that have described an intraosseous (into the bone adjacent to the joint) route for injecting an orthobiologic.

The current study was structured to assess the safety and potential therapeutic benefit of treating patients with mild to moderate knee osteoarthritis with a split injection of BMC, such that approximately 80% of the injectate was delivered intraosseous to the tibial plateau, and 20% was delivered intraarticular. Each BMC preparation was analyzed for Total Nucleated Cells (TNC), and culture-based Stem Cells.  Clinical outcomes were recorded for the Knee Society Score; Lower Extremity Functional -activity-Scale (LEFS); and Visual Analog Scale-pain- (VAS). We also assessed for correlations with patient factors, including cellularity (Total Nucleated Cells) and Stem Cells) and pre-treatment clinical outcome values.

The results reported in this study demonstrate the safety of intraosseous delivery of BMC to treat mild-moderate knee OA. Equally important, study participants reported a mean change in VAS (pain scale) at the 1-year milestone of -2.6, which is slightly larger than the commonly reported VAS of -2.5, suggesting that the treatment protocol resulted in a meaningful decrease in pain out to 1-year post-treatment. The mean change at 1-year of the LEFS (activity) outcome was +15.8 points, which is 2.3x larger than that commonly for LEFS of 9 points, while marked improvements in KSS-Knee and KSS-Function also were observed.

I understand that which I have attempted to explain may be confusing but the results of this trial should be understood. For clarification, call and schedule a consultation (312) 475-1893. You may visit my website and watch a webinar at www.sheinkopmd.com

Tags: , , , ,

Quarantine and Isolation for Infectious Diseases

Quarantine and Isolation for Infectious Diseases

quarantine-infectious-disease

National Library of Medicine Quarantine signs, for scarlet fever and other diseases, were a familiar sight during the first half of the last century.

Last week, my Blog focused on Social Distancing; not for the Coronavirus but that was how we survived the annual Polio Epidemics prior to Salk and Sabin. On Tuesday night, by chance, Public Television devoted an hour to the subject I had featured in my Blog. I have been trying to explain to my children and grandchildren what we are living through is nothing new, we will get through it.  Since our offices are basically shut down for an unknown period, I started leafing through an old photo album and, was reminded.   

Quarantine and Isolation for Infectious Diseases

When I was in elementary school I had scarlet fever and was confined to my bed for an entire month. A brightly colored quarantine sign was nailed to our apartment on Division and Kedzie in Humboldt Park, Chicago. This would let everyone in the neighborhood know not to go inside until the sign was removed. My brother and father moved in with my mother’s parents on Western and Potomac, while my mother looked after and nursed me. Incidentally, no television in our home so it was mostly keep looking out the window, listening to radio or coloring and connecting dots.  Since there was no Penicillin for childhood diseases, it seemed as if there was always a sign on someone’s house when I was growing up in the 1940s.

While the Coronavirus may grab more headlines today, in addition to Polio, the best known and most dreaded illness was streptococcal infection leading to  scarlet fever and Rheumatic Heart Disease. Simply hearing the name of these diseases, and knowing that they were present in the community, was enough to strike fear into the hearts of those living in the post war United States and Europe. These diseases, even when not deadly, caused large amounts of suffering to those infected. In the worst cases, all of a family’s children were killed in a matter of a week or two. Indeed, up until early in the 20th century, scarlet fever was a common condition among children. The disease was so common that it was a central part of the popular children’s tale, The Velveteen Rabbit, written by Margery Williams in 1922.

Below are several abstracts from the Journal of The American Medical Association:

Article

June 11, 1938

SCARLET FEVER QUARANTINE

JAMA. 1938;110(24):2012. doi:10.1001/jama.1938.02790240036015

Article

March 8, 1947

PENICILLIN FOR SCARLET FEVER

ARCHIBALD L. HOYNE, M.D.ROWINE HAYES BROWN, M.D.

Author Affiliations

JAMA. 1947;133(10):661-663. doi:10.1001/jama.1947.02880100005002

The Quarantine, Isolation and Social Distancing worked for me then when penicillin was not yet readily available and Polio vaccine was still in the future. Now we not only have vaccines and antibiotics, we have stem cells.

In my case in the 1940s, I survived but my next complication of preantibiotic Scarlet Fever after the Quarantine were four weeks in the hospital with acute Glomerular Nephritis, a rare complication called Bright’s Disease. I survived that Isolation too and here we are ???? years later, in spite of all.

  I will look forward to consulting with you for your arthritic problems in the not too distant future.  Call (312) 475-1893 to schedule an appointment

Tags: , , , , , ,

My Orthopedic Recommendation for Two Recreational Middle-Aged Athletes

My Orthopedic Recommendation for Two Recreational Middle-Aged Athletes

I make this orthopedic recommendation as emeritus professor of orthopedic surgery at a major medical center where I was director of the joint replacement program and where I performed close to 20,000 knee and hip replacements. First and foremost, try to postpone a joint replacement for as long as possible. A failed joint replacement will reassign you to a couch potato category.

The two patients seeking consultation last week are both in their early 50s and like to ski; while one still enjoys soccer and tennis on weekends, the other plays weekend basketball and goes to a fitness facility during the week. In both cases, at the beginning of the week, they limp with painful and stiff joints. In the latter of these patients, I had previously completed a concentrated bone marrow/stem cell intervention into the left hip and left knee. In the other, the patient has had the joint fluid drained from his knee on several occasions in conjunction with a cortisone injection and a cartilage defect in his recent MRI.

While we all know of joint replacement success stories, there is a 70% chance of the need for a second operation to repair that failed joint in a lifetime when that replacement was introduced in a middle-aged recreational athlete. In fact, there may be a need for still a third revision in a life time; and the outcome of revision surgery does not approach that of a first-time success. For the 30% who do not enjoy a successful outcome with continued pain and loss of motion, your athletic days are over.

A reasonable question that follows is whether there are successful surgical cartilage restoration procedures that will maintain or restore function for more than two years? At this point in time, in spite of anecdotal, sensational claims, there is no outcome evidence that surgical attempts at joint restoration will stand up to use and abuse for more than 24 months.

My Orthopedic Recommendation

What is the alternative for the two middle aged athletes? In making my recommendations, I took into consideration that which is FDA approved, the biologic option for which we have four to five years of statistically significant outcomes data, and that approach for which there is finally partial or total insurance coverage. In the first scenario, I recommended a repeat Stem Cell intervention into the hip as our evidence clearly supports the greater success with lasting benefit of a second Stem Cell procedure. For the knee, I administered informed consent for the FDA approved Personalized Stem Cells clinical trial. Visit WWW.PersonalizedStemCells.com. For the second patient, I suggested a concentrated, customized, Platelet and Growth Factor intervention to reverse the inflammation and thereby eliminate his pain and swelling. In the long term, the FDA PSC Trial would be the probable solution as well.

To learn more or schedule a consultation, call (312) 475-1893. You may visit my web site at www.sheinkopmd.com.

Tags: , , , ,

Pin It on Pinterest