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.

Screening and Enrollment Begins- FDA Approved Clinical Trial for Knee Arthritis

I am pleased to announce that our clinic is now approved and credentialed for the first of its kind stem cell clinical trial for knee arthritis. For those who are suffering from knee arthritis pain in a single knee, this is a unique opportunity to explore stem cell treatment in an FDA approved research study. This is a tremendous honor since there is a limit of ten clinics around the country in the clinical trial. Our practice and our professional staff were selected by Personalized Stem Cells due to our leadership and experience in the treatment of orthopedic conditions, and our experience with regenerative medicine.

Details:

Personalized Stem Cells, Inc. (PSC) has received approval from the FDA for conducting a clinical trial for the treatment of knee arthritis with stem cells from a patients’ own fat. 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.

Enrollment:

Call 312-475-1893 if you are interested in being considered for this study and would like to discuss initial screening for your condition to determine if you meet the criteria for this study.

A Cellular Orthopedic Update

Between vacations, holidays, developing an algorithm for a new clinical trial, while at the same time credentialing for the FDA Personalized Stem Cell Clinical Trial, I ran out of time so I haven’t been blogging as usual. All this while, I continue to practice Regenerative Medicine.

As we approach 2020, the discipline of Regenerative Medicine will change as the cells and options available will be classified as drugs. What will hopefully take place is a restoration of the public trust in Regenerative Medicine given the harm done by those promoting birth product as a source of stem cells.

When a patient would attend an advertised seminar, pay a relatively large amount of money without an examination or review of images only to receive dead cells, those of us practicing evidence based Cellular Orthopedics were faulted along with the Charlatans and Camp Followers even though we weren’t part of the scam. In 2020, point of service care will be overseen by federal regulations with reclassification of autologous tissue and cells injectables as drugs so that IRB oversight and FDA clearance will be necessary to maintain a practice.

My particular role will be as a clinical investigator in the Personalized Stem Cell Clinical Trial for which our credentialing will have been completed on Thursday. It will have been the most highly regulated process in the world of Regenerative Medicine ever undertaken and I am thrilled to be part of it. At the same time, I am partaking in the design of another trial for a different regenerative approach directed to those who do not meet the inclusion criteria for the Personalized Stem Cell Trial. We have completed safety and efficacy preliminary follow-up on 20 patients who received the alternative option which is a pain blocker and anti-inflammatory but does not have regenerative potential.

To learn about the Personalized Stem Cell approach, visit PersonalizedStemcells.com. To see your options if you don’t meet the inclusion criteria for PSC, follow this Blog.

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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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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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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