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.
Stems Cells: Promise and Reality

Stems Cells: Promise and Reality

Saturday evening, we returned from four days of fly fishing for Bone Fish, Permit, Jacks, Tarpon and Snook in Punta Allen, Mexico, three hours south of Cancun. The adventure involves standing on the front of a boat for up to six hours a day, with an occasional break. It becomes arduous and exhausting; but exceedingly gratifying and that’s why we do it year after year. Situated in the Mexican State of Quintana Roo in the Si’an Ka’an biosphere, Punta Allen is a perfect base for the type of fishing we love while allowing us to enjoy the Pelicans, Pink Spoonbills, Frigates, mockingbirds, Flamingoes and occasional crocodile, dolphin and manatee. The beaches on the ocean side are pristine so a 5PM swim after fishing allows the knee and hip rehabilitation to continue.

In anticipation of the physical demands, I underwent an autologous concentrated Platelet, Plasma, and Growth Factor Protein knee and hip intervention two weeks prior. My blood was recovered via a standard blood draw, placed in a centrifuge after which it was processed and filtered. The resulting concentrate was then injected under ultrasound guidance into my knees and hips. While my hips were quite uncomfortable for 72 hours following the injections, by time we arrived in Mexico, I had no limitations or symptoms requiring me to alter my activities.

Let me explain why I chose the blood born option in anticipation of my needs rather than that of Bone Marrow Concentrate or participation in the Adipose Fat based Personalize Stem Cell Clinical Trial.  If I were younger, the Bone Marrow Concentrate option makes a lot of sense as we have scientific outcomes data to support said alternative. Seeing how the number of Adult Mesenchymal Stem cells in bone marrow diminish with age, my eyes are set on the PSC Trial. Science tells us that the number of stem cells in adipose tissue do not diminish with age. My particular issue is that both of my knees are affected by advanced Osteoarthritis so I have to wait for FDA approval of the bilateral Personalized Stem cell Trial. Given my excellent response to the Blood derived Platelets, Plasma and Growth Factor Proteins following the injections two years ago, I elected to take advantage of the opportunity to repeat the interventions while waiting for the FDA approval of the PSC Trial allowing both knees to receive millions of stem cells.

To learn more about your treatment options for an osteoarthritic joint, visit my website at www.sheinkopmd.com. You may call to schedule an appointment or consultation, (312) 475-1893.

For those interested, The Personalized Stem Cell trial web site is www.PersonalizedStemCells.Com.

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Advances in Regenerative Medicine Continue

Advances in Regenerative Medicine Continue

The progress in the emerging discipline, Orthobiologics, in part, is the result of the FDA and FTC taking on a stronger oversite role; but additionally, the data I gather contributes to these scientific advances. I will elaborate in this blog.

In order to be FDA compliant, the use of stem cells must be autogenous; that is, the cells must come from you. The orthobiologic industry finally complied so those providers with integrity have made available acellular growth factors. Three weeks ago, I learned that is some cases, Medicare and certain insurance companies will preauthorize said usage. Stay tuned on this one as to whether the product works and whether its use is indeed reimbursed.

Last week, I was made aware that the FDA had served notice to Chara Biologics and Liveyon for marketing biologic products that are unapproved. Stay tuned as more bad actors will be shut down.

https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-risk

Biologic Interventions to Avoid Joint Replacements

This past Friday, I received biologic interventions into my right and left hip and my right and left knee. It worked for me two years ago and I believe the biologics will help postpone, maybe avoid joint replacements while allowing me to keep skiing, fly fishing, cycling, and keeping fit. There were no appreciable amounts of stem cells in that which was processed from my own blood and injected. The anticipation is that the Platelets and Growth Factor Proteins will diminish the pain of arthritis, and assist in restoring full motion to my hips and knees, allowing me to continue my recreational profile.

In the presence of a single arthritic knee joint, I would have enrolled in the FDA approved Personalized  Stem Cell Clinical Trial. You may learn about the Trial at www.Personalizedstemcells.com or on my web site at  www.sheinkopmd.com. In the upcoming months, it is hoped that the FDA will expand approval of the PSC Trial to both knees and eventually, the hips. At this time, there are only two FDA compliant methods of allowing physicians to provide a patient with “stem cells,” one is via your bone marrow and the other via your adipose tissue. In my case, with the several joints involved and given realistic outcome possibilities, I opted for the Growth factor approach. My next step will be the Stem Cell option. 

I will be testing my outcomes of the Biologic interventions next week on a bone fishing trip four-five days in Punta Allen, Mexico. While my schedule is full prior to departure, there are still some office openings available on Tuesday, December 31.  To schedule an appointment at any time call (312) 475-1893

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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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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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Fake news and illegal advertising of stem cell therapies

Fake news and illegal advertising of stem cell therapies

Why Should This  Blog Matter To You?

  • Stem cell treatments are NOT FDA cleared in the United States
  • FDA is scrutinizing physicians and centers that are marketing stem cells

Beware of centers that are offering to:

  • Relieve pain
  • “Regeneration” of tissues
  •  Avoid surgery
  • Treating a variety of inflammatory, degenerative, or autoimmune conditions

Beware of Stem Cells Clinics!

  • Many of these “stem cell clinics” are operated by chiropractors or providers that do NOT have a specialty or advanced training in the musculoskeletal system.
  • They simply do not have the training necessary to perform these injections nor are they licensed to so do.
  • In some cases, surgery is needed. These providers may not evaluate the need for a surgical procedure.

Federal Trade Commission Press Release: https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic

FTC Court Documents: https://www.ftc.gov/enforcement/cases-proceedings/172-3062/regenerative-medical-group-inc

The Complaint filed by the FTC on October 12th states the following:

Defendant Henderson is aware that the vast majority of amniotic clinical studies in the scientific literature has been conducted on animal models. There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases of health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. (p. 4)

The representations set forth in Paragraph 21 […Defendants have represented…that their stem cell therapy: cures [everything]…Is comparable to or superior to conventional medical treatments in curing, mitigating, or treating specific diseases or health conditions including [everything]…] are false or were not substantiated at the time the representations were made. (p. 21)

The FTC essentially has said that there is no clinical basis to claim a therapeutic benefit to treating patients with amniotic stem cells, so the claims and representations by Dr. Henderson constitute deceptive practices and false advertisement.

If you connect the dots, it would suggest that Dr. Henderson engaged in fraud by taking money from patients and treating them with a preparation for which there is no clinically valid proof of therapeutic benefit. Regardless of whether the Department of Justice gets after him for a criminal complaint of fraud or not, I think organizations that offer up a worthless therapy consisting of amniotic stem cells (until proven otherwise with Level 1 studies) could be good targets for class action lawsuits by defrauded patients. The same situation doesn’t apply to PRP and BMC, (what I do) since there is plenty of clinical evidence of therapeutic benefit including my scientific article published in December, 2018.

Sheinkop, et.al Transnational Medicine – published Dec. 13 2018
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis; a randomized control trial with 2 year follow-up.

If you want to complain to the FDA about having received Amniotic Fluid without benefit, use this link:

https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118859.htm

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