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.

Vanity, Anecdote and Evidence; how far I will go to present the facts

As regular readers of this Blog are aware and as well, those patients who seek consultation in my office, my cellular orthopedics practice is based on clinical evidence. While the largest marketer of stem cells in the Midwest, bases a recommendation for a product without scientific evidence or even anecdote, my practice is evidence based. While it is true that I can site anecdote after anecdote about a successful outcome, the scientific process requires that I provide statistical support for what I do. The subject of this particular blog is to share with you how far I will go to gather that evidence.

About six months ago, I completed a combined Bone Marrow Concentrate Intra-articular (into the joint) /Subchondroplasty (into the bone) in the right knee of a dairy farmer, in his early 60s, living in Southwest Wisconsin. He was able to follow up at my office in Des Plaines twice following the intervention; but owing to the fall harvest, he had been unable to return for the third follow up in a timely manner. My desire is to assure the success of the procedure, rather than having completed a telephone interview, my wife and I headed out this past weekend to Dodgeville, Wisconsin, where I completed the full evaluation in a booth at the local Culvers.  In addition to the usual historical review of progress, I completed a Physical Examination of the patient including circumferential measurement of the thigh, knee and calf using a tape measure and an assessment of his range of motion using a goniometer for accuracy. I think that the diners at Culvers were just as fascinated at what was taking place in our booth as I was watching the customers in the drive through ordering an early lunch while carrying a recently harvested buck in the back of their pickups. It is deer season in Wisconsin.

Suffice it to say that my patient was thrilled at my willingness to save him a trip to Chicago but he was even happier about the outcome in his arthritic knee. I was thrilled at his response to care. Whereas prior to the right knee intervention, he had constant pain and limitation in function, at six months, the pain and swelling are gone and he has unlimited function be it on stairs, kneeling or climbing in and out of the tractor. What separates me from the madding crowd is the data and evidence for which my recommendations are advanced. Incidentally, two blogs ago, I listed our clinical trials, the basis for our evidence  based practice. Below is the trial in which my Wisconsin patient is enrolled and for which I sought follow up:

  1. Stem Cell Counts and the Outcome of Bone Marrow Concentrate intra-articular and intra-osseous (subchondroplasty) interventions at the knee for grades 2 and 3 OA. (supported in part by Celling). Ongoing

His results are so good that his wife decided to be next in line for her knee that did not respond well to arthroscopic surgery two years ago.

Whether you didn’t respond to surgery or haven’t had surgery, call 312 475 1893 to schedule an appointment or watch my webinar on the website www.ilcellulartherapy.com

This Thanksgiving week, let me give thanks to those who read this Blog

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 Stem cell intervention outcome in a husband and wife

“____ and I are doing well. Mitch administered stem cell therapy on my non-operative hip and things feel great. First time I’ve been pain free in 10 years. Can’t wait for ski season” “Mine are doing great”. This second quote from the mutual friend who is patient getting ready for the ski season who recently underwent a concentrated platelet rich plasma “tune up” in anticipation.

The above quotes are from a husband and wife who underwent stem cell intervention and the second is taken from an e-mail forwarded from the mutual friend who had initially referred the couple to me. Three years ago, the wife had been referred for the limitations in her knee produced by post traumatic arthritic progression. She and her husband were avid ski enthusiasts but the patient could not plan for an upcoming helicopter skiing that winter in western Canada, owing to limitations imposed by arthritis. In the fall of the year, I completed a Bone Marrow Concentrate intervention into her right knee and she returned to Heliskiing. Earlier this summer, the husband elected to undergo a right hip intervention so he might continue at the highest level of recreational skiing. According to his report, there is patient satisfaction from both sides.

Yet, I still strive to improve outcomes and patient satisfaction with the duration of effect. In order to improve results, benefit, and extend the success, I introduced the intraosseous alternative into my treatment protocol when deemed indicated. If the preoperative imaging is compatible with the potential to improve the end result by a subchondroplasty, as I did for a patient this past Wednesday, not only will Bone Marrow Concentrate be injected into the joint, a biologic implant will be injected into the bone adjacent to the joint. The additional procedure adds nothing to the cost of care nor does it require any alteration in the postoperative rehabilitation process. I have requested precertification to determine if indemnification will cover the intraosseous injection of the biologic implant.

On a scientific basis is the fact that it is the subchondral bone that supports the cartilage lining the joint surface. If there is an insufficiency or fragility of subchondral bone, the cartilage will eventually fail. It has been suggested that the pain of arthritis may be the result of alterations in the subchondral bone in addition to inflammation within the joint. Please remember that there are no nerves in cartilage.  

To determine if you are a candidate for postponing or avoiding a Joint replacement for the pain and limited function attributable to arthritis and what treatment alternative will result in the most satisfactory and longest lasting end result, call for a consultation

Call (312)475 -893 or visit my web site and watch the webinar:  www.ilcellulartherapy.com

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Ongoing happenings in Stem Cell Care of Arthritis

The number of options for regenerative medicine continues to multiply in metropolitan Chicago so the patient seeking the best alternative must remain ever vigilant. A two-day course basically allows anyone with a medical license to become an immediate “expert”. Incidentally, several of these national course directors recently lost their medical licenses and are waiting to learn if the next step will be prison. Another course director was exposed as not having a medical license. One on the other hand, may always travel off shore for a two-day meeting to allow for the building of a web site offering regenerative medicine options.

What differentiates my approach to Cellular Orthopedics is the fact that I am one of the first and few orthopedic surgeons who has dedicated a practice to regenerative medicine. Second of all, I now have over five years of clinical experience assisting patients impacted by arthritis with postponing and at times, avoiding a joint replacement. Most important is our integration of clinical outcomes with a constant upgrading and improvement in clinical results. That data collection methodology is what led to the invitation for me to introduce Cellular Orthopedics to the September, 2017, meeting of the Russian Orthopedic Association in St Petersburg attended by 1500 orthopedic surgeons from Russia, Ukraine, and surrounding countries in Eastern and Central Europe and Asia. Our outcomes data has additionally provided the material enabling two major regenerative medicine scientific manuscripts to be submitted to peer reviewed orthopedic journals.

While a patient may find many regenerative providers on the web or in the media, there is no one in the field of Cellular Orthopedics who provides our expertise and experienced decision making from evidenced based stem cell outcomes. As in everything in life, we strive to do better. The next step is an upgrade in our qualitating that which is being injected into an arthritic joint so as to allow customization. I am happy to announce that a newly upgraded and expanded laboratory will enable me to offer the latest advances in the field of Cellular Orthopedics and envision the future.

If you are experiencing pain and limitation in function from osteoarthritis, call and schedule a consultation   312 475 1893 or watch my webinar on the website  Ilcellulartherapy.com

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Back from St Petersburg, Russia where I educated the Orthopedic   Surgeons from Russia, Ukraine and more

Back from St Petersburg, Russia where I educated the Orthopedic   Surgeons from Russia, Ukraine and more

“I already started getting numerous enquirers regarding your research and practical application of SCP using bone marrow material. People are asking how can they learn more, maybe pay a visit and observe the procedure with their own eyes. Quick and massive feedback, unprecedented.” This from the sponsor of the meeting of the Russian Orthopedic Society meeting in St Petersburg, September 21 to 23 where I had been an invited speaker to introduce Regenerative Orthopedics and Orthobiologics to an audience previously unaware of developments evolving in the United States wherein a patient symptomatic or otherwise affected by osteoarthritis might postpone or avoid a joint replacement with a needle rather than a knife.

What first struck me on our return from the airport on Monday afternoon while driving down the Kennedy was the unending display of outdoor advertising that really obstructs the view of the beautiful skyline of downtown Chicago. My wife and I had just enjoyed unobstructed beauty for five days in St Petersburg. While a case can be made for freedom of speech, I could rapidly adjust to less visual pollution in our City. Next came the pollution of Regenerative Medicine ads appearing in the newspaper when we arrived home and started catching up on the news. I had devoted four weeks developing my evidence based and outcomes supported, scientific presentations prior to departing on September 19 for the St Petersburg meeting, only to return to claims by local health care professionals without scientific authenticity and without evidence based support. While I was speaking at an international clinical conference to orthopedic surgeons; and the media hype appearing in Chicago and suburban newspapers was direct to the public marketing be it in an ad format or Health and Fitness section of a suburban newspaper, professionals have a moral, ethical and professional obligation to present materials based on evidence and science.   

Perhaps my criticism is the result of a view of health care from the unique perspective of an Orthopedic Surgeon integrating science and outcomes surveillance with clinical care in his practice. These are the reasons why I was invited to introduce evidence based cellular orthopedics to the international orthopedic community. If you want to take advantage of that knowledge and experience for the care and treatment of your arthritic joint, watch my webinar and visit the website www.ilcellulartherapy.com or call for a consultation 312 475 1893.

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“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”

The clinic is one of many around the country that claim to use stem cells derived from a person’s own fat to treat a variety of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says. The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration. Stem-cell researchers praised the FDA’s actions.

“This is spectacular,” says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. “This is the right thing to do.”

Daley praised the FDA’s promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on “snake-oil salesmen” marketing unproven treatments.

Stem-cell research is “a major revolution in medicine. It’s bound to ultimately deliver cures,” Daley says. “But it’s so early in the field,” he adds. “Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven’t been proven to work and may be unsafe. “Others agreed “I see this is a major, positive step by the FDA,” says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell “treatments” that may not be real treatments,” Knoepfler says.

“Don’t stop now”. Say I. This Blog has been asking for FDA intervention in those settings where Amniotic Fluid is being marketed as a source of stem cell regeneration for over a year. There is only one way to be safe and not sorry:

You may access my web site   Ilcellulartherapy.com and watch my webinar Or call for an appointment   — 312-475-1893

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