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 312-475-1893 for details. Click here to learn more.
Stem Cells and Spinning Classes

Stem Cells and Spinning Classes

Well not really Stem Cells, but certainly Platelet Rich Plasma and Growth Factor Protein Concentrate. Knowing that the term Stem Cells attracts attention, I used it here so hopefully, you would read this Blog.

On Saturday, February 15, I departed for a week of skiing in Vail, Colorado. In anticipation of the sojourn, in Late December, I underwent an intervention into both of my hips and knees using Platelet Rich plasma derived Proteins termed Growth Factors. My last Blog explored The Recreational Impact of Biologics: Stem cells, Growth Factors and Platelet Rich Plasma. While I dedicate about 5 to 6 hours a week in pursuit of conditioning; two weeks ago, I returned to spin class at the gym after a five-year hiatus substituting the demands of one-hour spin class for the stationary bicycle. While the late December interventions provided pain relief in my hips and knees, I didn’t feel that I would stand up to the demands of Vail, even with my customary rowing ergometer and strength training routines. It took several classes but here I am in Vail returning to the thrilling days of yester-year on spectacular powder and runs.

Returning to the office this morning, it was time to sit down and finish writing this blog. My first act, en route, was to pick up a copy of the February 24, edition of Crain’s Chicago Business, anticipating the appearance of A ROUNDTABLE DISCUSSION ORTHOPEDIC MEDICINE. I had been selected as one of four Orthopedic Surgeons taking part in a question and answer platform.  You may find the article quite informative and find it at CHICAGOBUSINESS.COM or find Crain’s Chicago Business wherever you purchase the daily newspaper. One particular question and answer is worth repeating. In response to the question “What new technologies and surgical techniques are you using?”; I responded “Biologics is the new technology that I use with a needle rather than a knife.” A second question and answer are worth repeating. “What insurance issues and concerns are common with orthopedic treatment?” “Recognizing the financial burdens imposed by some of my advanced technology offerings, I’ve created several affordable care alternatives.” Here is the link to the entire article: https://www.chicagobusiness.com/crains-custom-media/roundtable-discussions.

Now comes the readers’ choice. You may read the entire article by buying a newspaper; click the highlighted above; visit my web site at www.sheinkopmd.com or call and schedule a consultation (312) 475-1893.

Download Full Article Here

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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

FDA Warns About Stem Cell Therapies

Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. September,2017

FDA News Release

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy. January, 2019 

New Google policy bars ads for unproven stem cell therapies

Untested, deceptive treatments” can endanger consumers, Internet giant says.” October,2019

Discover the Science and Potential of Exosomes!

Visit the world’s largest exosome production, research and development facility at Kimera Labs, located in Miramar, FL, where world-leading exosome scientists and physicians will present exosomes educational sessions featuring the latest developments in exosome science and clinical research.

In spite of the attempts at consumer and patient protection by the FDA and Google, the bad actors and charlatans are still out there as evidenced by the following e-mail blast I received last week:

How do I explain the continued disregard at attempts by the FDA to protect the patient? The bad actors have been inspired by models of greed and unhinged marketing. But the FDA and potentially the FTC will get to them. The FDA didn’t issue a Public Safety Notice explicitly mentioning exosomes for nothing.  Also, state medical boards are enabled by statements from the FDA that exosomes are experimental drugs, and physicians aren’t supposed to experiment in their patients.

Evidence Based Medicine is the new era of Regenerative Medicine and Cellular Orthopedics

Clinical outcomes and safety of a combined autologous bone marrow concentrate intraossesous and intraarticular injection for knee osteoarthritis at 12 months.  Sheinkop, et al 02/01/2020

A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2-year follow-up. Sheinkop, et al 12/2018

Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees. Sheinkop, et al 11/2018

My Current Clinical Practice

Acellular Growth Factors

Proprietary Platelet Rich Plasma and Fluid Concentrate

This is what I had done at both hips and both knees in December; and I am going skiing in Vail two week from now

Bone marrow Concentrate

Visit www.sheinkopmd.com

Adipose Based Stem Cells

Visit www.personalizedstemcells.com to learn more

To schedule a consultation, call (312) 475-1893. The field of Cellular Orthopedics is dynamic and the associated costs are also changing to increase patient opportunity.

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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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