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 Autobiography of My Knees or What Do Doctors Do?

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.

FDA Approved PSC Stem Cell Clinical Trial for Knee Arthritis

I am pleased to announce that our clinic is being considered for enrollment in the first of its kind stem cell clinical trial for knee arthritis.

Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for treatment of knee arthritis with stem cells from a patients’ own fat.  This is a tremendous honor since there is a limit of ten clinics around the country in the clinical trial.  Our practice and our staff were selected by PSC due to our leadership and experience in treatment of orthopedic conditions, and our experience with regenerative medicine.

The clinical trial includes treatment, follow up, and cell storage for potential use in the future if, or when, additional treatments are allowed by the FDA.  PSC has FDA inspected facilities, approved processing procedures, quality testing procedures, and cell storage and shipping procedures.  More information about the clinical trial can be found HERE.

Our office will be receiving additional information in the near future regarding the details of the clinical trial.

Please contact us at 312-475-1893

Call 312-475-1893 if you are interested in being considered for this study and we will put you on the list for when we are able to start formal study recruitment and screening.

Click here to read the press release.

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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Should All Meniscal Injuries Undergo Operative Treatment ?

Should All Meniscal Injuries Undergo Operative Treatment ?

A patient presents to the office because of pain in the knee with or without a history of injury. An examination is performed followed by an X-Ray. Osteoarthritis may or may not be seen on the X-ray. If there is an altered range of knee motion when compared to the “normal” side, then a preexisting condition is considered. Whether or not the physician considers arthritis, an MRI is requested. The MRI report 48 hours after imaging is consistent with a torn medial meniscus. Should all patients with a torn medial meniscus undergo surgical intervention? If surgery is undertaken, should the procedure be a repair or a partial removal? The management of meniscal injuries must be influenced by the knowledge that meniscal integrity is important in load distribution across the joint. Meniscal injury causes altered joint mechanics and is related to the onset of arthritis.

According to a recently published online article in the British Journal of Sports Medicine, arthroscopic partial meniscectomy (APM) may not be the best option for all patients with knee pain and meniscal tear. Researchers investigated patients with meniscal tears that compared Arthroscopic Partial Meniscectomy to nonsurgical intervention, pharmacological intervention, and no intervention. At six to 12 months, APM patients had a slight improvement in knee pain, knee-specific quality of life, and knee function compared to physiotherapy patients. When excluding osteoarthritis (OA) patients, the aforementioned outcomes exhibited small to moderate improvement. Knee pain, function, and quality of life did not improve for APM patients compared to placebo surgery patients at six to 12 months regardless of OA status.

There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis and who have mechanical or obstructive signs. Arthroscopic partial meniscectomy (APM), a keyhole surgery where loose and fragmented pieces of a torn meniscus is removed, is one of the most common orthopedic procedures performed. Over half of these are performed to treat a meniscus tear in a degenerative knee; however, several recent randomized trials have shown that Arthroscopic Partial Meniscectomy is not superior to conservative treatment or placebo treating meniscus tears associated with a degenerative knee. On the other hand, there is universal agreement that the traumatic meniscus tear, the result of a knee injury in a younger patient with otherwise healthy knee (with no degeneration), should be treated by surgery.

Then what is the downside of meniscal injury and surgery? The medial and lateral meniscus together provide shock absorption, establish a broad base of contact surface and help provide stability to the knee. Those who have undergone total or partial meniscectomy should understand that in five to 15 years, they will develop degenerative arthritis. The long-term outcomes of those whose tears were treated by repair rather than removal has not been established. My Regenerative Medicine practice in part, is the result of those seeking to postpone or avoid a Total Knee Replacement years after a meniscal injury followed by arthroscopic surgery. As long as the arthritis has not progressed to a Grade 4, I am able to assist the patient with joint restoration, at times joint regeneration, it is matter of age and health. While I am able to offer joint restoration, on occasion, joint restoration for those who sustained meniscal and Anterior Cruciate injury in the past, is there anything that could be used as an adjunct at the time of the meniscal injury to promote healing without surgery or postpone, perhaps avoid future postraumatic arthritis?

To learn more. Schedule a consultation (312) 475-1893.You may view my web site at 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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Must yesterday’s joint injury lead to tomorrow’s arthritis?  

My column regarding ACL ruptures appeared last Friday. That afternoon, I received the following inquiry and comment from a reader, regarding the prognosis and possible early preventive interventions for a significant knee injury.

“I am one of relatively few patients who has had the Bone Marrow Concentrate treatment for a fully-torn (not-retracted) ACL tear and to date, I’ve had what I’d consider to be an amazing recovery.  I read your latest blog post and just thought I’d let you know that I’m back to very aggressive skiing (including small but non-trivial jumps).  However, I did want to ask, if you would be willing to comment, if there are actions or periodic diagnostics, you’d recommend to maximize the chances that I’m still happy skiing 10,20,30 years after the injury?  I understand you probably can’t comment but nevertheless wanted to let you know I was also a real-life person who had a significant knee trauma with multiple surgical consults all agreeing it was fully torn and required surgery (to return to high-level skiing) and now have a fairly normal looking ACL in MRI (per independent radiologist) and am back to 100% with activities that require a lot of knee stability.  I did do two rounds of same-day BMA reinjections and a bunch of platelet injections but no surgery.”

The answer is an orthopedic assessment at three-year intervals to look for markers of post traumatic osteoarthritis such as loss of terminal extension and asymmetrical flexion. The MRI is helpful in detecting moderate arthritic changes but the latest development, the needle scope, allows an orthopedic surgeon to directly examine the meniscus and cartilage in an office setting. The concern is post traumatic arthritis, cartilage defects that will progress, and meniscal damage not always seen on the MRI. Here are some thoughts on early intervention with Cellular Orthopedic and Regenerative Medicine options.

A recent Study Compared the Efficiency of Needle Arthroscopy Versus MRI for Meniscal Tears and Cartilage damage. Needle arthroscopy (NA) may be a less costly and more accurate option for diagnosis and treatment of meniscal tears and early onset post traumatic arthritis than MRI, according to a study published in the February issue of Arthroscopy. Researchers collected data on costs for care and accuracy, including procedures for both false-positive and false-negative findings well as private payer reimbursement rates. They compared outcomes using the global knee injury and osteoarthritis outcome score (KOOS). Patients were followed and evaluated over a two-year period. 

There are several restorative options now available when conservative therapies for the treatment of knee degenerative processes, such as non-pharmacological interventions, systemic drug treatment, and intra-articular therapies offer only short-term benefits or fail. Before resorting to surgery; be aware that encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. My clinical published research documents success with using your Bone Marrow Concentrate for joint restoration and combating progression of posttraumatic arthritis. Additionally, I have published an article concerning another source for joint restoration, micro-fractured adipose tissue. The latter has created a huge interest in the context of cartilage regeneration due to its wide availability, ease to harvest and richness in mesenchymal cell elements within the so called stromal vascular fraction. Moreover, MSCs from adipose tissue are characterized by marked anti-inflammatory and regenerative properties, which make them an excellent tool for regenerative medicine purposes.

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