Special Announcement - Now Enrolling for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-767-5761 for details. Click here to learn more.
Attention ‘Stem Cell Charlatans and Birth Tissue Bad Actors/Camp Followers’: The End Is Coming

Attention ‘Stem Cell Charlatans and Birth Tissue Bad Actors/Camp Followers’: The End Is Coming

DEFENSE HEALTH AGENCY 7700 ARLINGTON BOULEVARD, SUITE 5101 FALLS CHURCH, VIRGINIA 22042-5101 MEMORANDUM FOR DEPUTY CHIEF, READINESS AND HEALTH, BUREAU OF MEDICINE AND SURGERY DEPUTY CHIEF OF STAFF G-3/5/7, OFFICE OF THE SURGEON GENERAL DIRECTOR, MEDICAL OPERATIONS AND RESEARCH, OFFICE OF THE SURGEON GENERAL DIRECTOR, NATIONAL CAPITAL REGION MEDICAL

DIRECTORATE SUBJECT: Use of Regenerative Medicine Advanced Therapy (RMAT) Products Not Approved by the Food and Drug Administration (FDA).

Regenerative Medicine Advanced Therapy (RMAT) products not approved by the FDA have the potential to expose patients to unnecessary risk. One such product is injectable micronized dehydrated human amnion/chorion membrane (dHACM) used to treat conditions such as plantar fasciitis, tendonitis or osteoarthritis. Any of these products not approved by the FDA are considered investigational, at present. Therefore, effective immediately, all MHS facilities will stop using injectable RMAT products not approved by the FDA, including dHACM. Once the FDA has approved an RMAT product, further review will occur. The Veteran’s Administration has taken a similar action.

PAUL R. CORDTS, MD Deputy Assistant Director – Medical Affairs Defense Health Agency

At the same time I was made aware of the above Defense Department Memorandum, a patient called  my attention to a brochure she had received in the mail on the same day recruiting “victims” to one of several offices in metropolitan Chicago treating patients with the very product  that the Defense Health Agency classified as unapproved by the FDA and therefore prohibited for safe use. A day later. I received an e-mail from a health care provider out of state, a non-MD asking me about use of “stem cells and amniotic fluid in my office.”

Are these alleged members of the health care community charlatans, uninformed, or just plain dumb and dumber?  “Beware, take care, of the Green-eyed dragon with 13 tails, he’ll feed, with greed”. There is only one FDA approved source of stem cells for arthritis available in the United States and I am pleased to have been designated a Clinical Investigator in the PSC Trial. You may read about it on my website at www.sheinkopmd.com or at  www.personalizedstemcells.com . The other potential biologic alternatives that, to the best of my knowledge are approved at this time, involves using your bone marrow as a regenerative option for delivering Adult Mesenchymal Stem Cells, or Platelet Rich Plasma obtained from your circulating blood as resource for Growth Factors. 

To learn more or to schedule a consultation, call (312) 475-1893

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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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Is it the stem cells or the growth factors?

The New York Times: 2019/05/13 “Stem cell Treatments Flourish with Little Evidence That They Work”

Several years ago, I asked a question of a cellular biologist as to how is Bone Marrow Concentrate effective if the number of adult mesenchymal stem cells diminish as we age? His response: “Bone Marrow contains lots of things including stem cells and proteins called cytokines or growth factors. It may be that the growth factors are most important in joint restoration and blocking pain.”

Let’s take for example, inflammatory arthritis such as Rheumatoid and Psoriatic arthritis. The common denominator is a pro-inflammatory cytokine called Tissue Necrosis Factor found in the body’s immune system.  The growth factor, TNF-alpha blocker is now used to control the inflammation and alter the body’s immune response to the proinflammatory protein. As a result of TNF-alpha blockers, Phil Mickelson is a very competitive golf professional, (You have seen him as a spokes person for Psoriatic Arthritis treatment with Humira). Since the introduction of TNF alpha blockers in Scandinavia five years ago, there has been a 40% reduction in Total Knee Replacements for inflammatory arthritis. When Kobe Bryant traveled to Dusseldorf, Germany almost nine years ago, he received treatment for a very arthritic knee with Interleukin -1 Receptor Antagonist Protein, along with other blockers. Shortly thereafter, he returned to play another five years in the NBA. The IRAP that Bryant received was and is an anti-inflammatory, a growth factor blocker, a cytokine.

As I agree in part with the  criticism in the New York Times concerning Stem Cells, those who read this Blog will recall that I don’t “sell” stem cells. Bone Marrow is used in part because of the fact that it contains stem cells; but more importantly as we age, Bone Marrow contains Growth Factors, the anti-inflammatory protein Cytokines that restore a joint by minimizing pain and improving function. Over the last eight years, we have accumulated the evidence that Bone Marrow Concentrate works for arthritis via stem cells, growth factors, or all of the above. Recently we have taken a major step forward by filtering high concentrations of Growth Factors from the Platelet Poor Plasma, previously discarded, that remained after we centrifuge the bone marrow and add the filtrate to that which is injected into the painful joint. Stem Cells maybe, highly concentrated Growth Factors that act to block pain and improve function, for certain.

You may learn more by visiting my web site at www.sheinkopmd.com  or call for a consultation (847)390-7666

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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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