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.

The Ultimate Performance Success Following a Cellular Orthopedic Procedure

Every year at this time, we each recall and celebrate several significant events of historic, cultural and spiritual importance. No matter what your roots or upbringing or present belief, these past eight days usually involve a gathering of friends and family to jointly read and remember that which happened long ago and still impacts us today. Whether done in a house of worship or in the home, somehow, we ask similar questions and teach our children and grandchildren that which befell us in ancient days. To underscore those similarities, some years ago, when my son had his Bar Mitzvah at the Western Wall, a Franciscan Monk who I had come to know invited us the next day to a Pre-Easter service at the Church of the Holy Sepulchre. Other than The Gregorian chants and the frankincense, the superstructure of the 90-minute service was quite familiar.

I use this yearly celebration to reflect and meditate; it also initiates the spring cleaning ritual in our house. Having grown up in Humboldt Park and later Albany Park to parents who left Europe in time, Passover meant it was time to clean and wash the kitchen cabinets, recycle, and dispose of certain foods. On Division Street, we lived near my orthodox grandparents; in Albany Park, they lived with us, so the everyday plates and silverware were taken to the basement and exchanged for special settings reserved for this time of year.

Certainly, times have changed and we have assimilated; but my wife still prepares the appropriate meals for the week and makes sure the house is immaculate. Then the family and company visits end and we are challenged by the need to address the residual back scuffs on our wood kitchen floor; lots of them and pronounced. Here is where the ultimate test of the cellular orthopedic intervention to my own hips and knees, now almost four months ago comes into play.

With the coverage varying between the Masters, Cubs, and Sox games in the background, we genuflexed, spread the Murphy Oil Soap and started rubbing away with microfiber wipes. This exercise lasted about two hours, admittedly with several breaks. Nevertheless, we accomplished our mission and I got up unassisted to head to the health club for my strength training respite.

This morning, Section one of the Chicago Tribune carried three full pages, in color, competing ads concerning Regenerative Medicine; none giving much information about science or outcomes but certainly employing one-time prominent athletes as spoke persons. Is it worth a free lunch to become a marketing dupe? As readers of my Blog know, I myself had Cellular Orthopedic intervention to my knees at the end of 2017 and to my hips at the start of 2018. This morning I scheduled two ski trips in 2019 to Vail; on Saturday morning, I am headed to Southwest Wisconsin for a long weekend to bike and fly fish; and I am on standby at any time to genuflex and spread that murphy oil soap.

So as advertised on Friday night Cable, you may receive a $250 gift certificate for attending a Stem Cell Seminar, or you may get examined and receive counsel from this orthopedic surgeon focusing on Cellular orthopedics. For the latter call 312 475 1893 to schedule an appointment, one on one. You may access my web site and watch the webinar at www.Ilcellulartherapy.com

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News from the International Orthopedics Foundation Annual Meeting

News from the International Orthopedics Foundation Annual Meeting

I am sitting at my computer this morning writing the weekly Blog posting and not attending the IOF meeting taking place today in Broomfield, Colorado; yet I am reporting about the meeting. Instead of attending, I am preparing for a week-long ski adventure with my family next week in Vail, Colorado while trying to catch up in my practice. How is it than possible that I know what is taking place at the meeting? Listed below are five of the 10 ongoing or completed cellular orthopedic clinical trials in which I am a principal investigator or co-researcher. The preliminary and final data resulting from these clinical research initiatives is the outcomes foundation for what is being presented at the IOF podium today and tomorrow.

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

2) Outcomes of Bone Marrow Concentrate (stem cell, platelet and growth factor) Intervention at the Knee for Grades 2 and 3 OA in 50 patients at 2 to 4 years. (supported in part by Regenexx)

3) Outcomes of Intra-articular Bone Marrow Concentrate versus those of combined Intraarticular and Intraosseous interventions for grades 2 and 3 OA at the knee at one year. (self-funded). Ongoing

4) How does the PRP and Mononucleated cell count affect the outcome of a BMC intervention for grades 2 and 3 Knee OA? (a joint project with Greyledge) Ongoing

5) Safety and Efficacy of Percutaneous Injection of Micro-Fractured Adipose Tissue for grade 4 Osteoarthritic Knees, minimum follow-up of 18 months in 30 patients (supported in part by Lipogems)

I had to prioritize; and since most of the arthritis data being presented is all or in part mine, I already know the subject matter. By staying home, I also found the opportunity to browse “stem cell” websites as suggested by ads in today’s newspapers or introduced by email blasts this week.  Wow, a patient acting more like a consumer is really at risk for succumbing to Regenerative Medicine “false news”.

If you want to learn more about the difference between the stem cell purveyors and a legitimate, FDA compliant, evidence based, cellular orthopedics initiative, call to schedule a consultation or to get a second opinion.

You may schedule a visit at (312) 475-1893

You may access my website and watch a webinar at   www.ilcellulartherapy.com

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

On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be governed by homologous use. As I interpret the guidelines there are winners and losers:

Winners
Physicians who use compliant regenerative therapies:

  • Amniotic fluid without stem cells
  • Blood-derived preparations (e.g., PRP, PPP)
  • Bone marrow aspirate

Losers
Physicians who use non-compliant regenerative therapies:

  • Adipose tissue-derived materials obtained by enzymatic digestion
  • Amniotic fluid with cells Cord blood derived materials (non-autologous treatments)
  • Stem Cell Clinics that advertise about using amniotic fluid as a source of stem cells and regenerative therapy along with those clinics that treat everything from alopecia to ALS to arthritis

You might ask how is that different from the current situation? First of all, the FDA Commissioner has stated in press releases that the FDA is going to go after bad actors. The Cures Act provided for increased funding to the FDA, which we suspect the Commissioner will use in part to go after the bad actors. Also, the FDA wrote in their Guidance on Minimal Manipulation and Homologous Use that “healthcare providers” need to pay attention. We have never seen them explicitly refer to the doctors and clinics providing regenerative medicine. Finally, the FDA indicated that there would be a transition period (3 years) during which manufacturers would need to enter the RMAT program to get their non-compliant products properly approved; or else. And the reason that there could be teeth in the “or else” is that the FDA will get lots of fees from all of the non-compliant products entering the RMAT program.
Last of all, what the FDA did not address as part of consumer protection; but what I incorporate in my daily practice is evidence based intervention.

Now that you are better informed and have an idea as to the laws governing our regenerative medicine marketplace, stay away from the Charlatans and Camp Followers. Then take the next step and ask your physician for the Outcomes Evidence on which a regenerative intervention for your arthritic joint is based before undergoing a procedure. To better understand that evidence call for (312) 475 1893 to set up a consultation

You may watch my webinar by accessing my web site www.ilcellulartherapy.com.

* Minimal Manipulation and Homologous Use

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My Algorithm If Stem Cell Intervention Doesn’t Last or Doesn’t Work

I am being forthright; based on my review of data, while 80% or more of my patients continue to enjoy
satisfactory outcomes at four years or more following a stem cell intervention, there are those whose
symptoms and functional limitations recur. Please be aware that when I undertake the care and
treatment of a patient with a symptomatic and function limiting joint, it is with the notion of
regeneration and long-term benefit. It doesn’t always happen; there are may possible explanations.
Most important though is the need to identify possible causes of potential failure at the beginning, and
that is why we have recommendations before and after a procedure as to how to manage alcohol, diet,
supplements and a rehabilitation protocol. We also review your past medical history to identify any
possible indication that your stem cells have been adversely affected by co-morbidity or prior
treatments.

Assume if you will that you adhered to the initial pre-and post-intervention protocol but now returned
to my office months or years later with recurring symptoms. First and foremost is an updated medical
history and physical examination. That is followed by repeat images including X-rays and an MRI.
Mechanical progression of joint injury may result from aggravation of the preexisting damage by
subsequent trauma. Then there is the reality of identifying new processes within or adjacent to the joint.
This morning, I returned the phone call of a southwest Wisconsin dairy farmer; not the same patient I
wrote about last week. He has been a patient for over four years with a full restoration of work related
activities and recreational pursuits following several regenerative interventional options. After three
hours of basketball, three weeks ago, his knee pain returned. I called him back while he was milking his
cows and it was the first time I have been “mooed” at over a cell phone. I requested that the patient
update his X-rays, MRIs and then allow me to reevaluate him. A repeat stem cell intervention with a
more advanced technology, a subchondroplasty in addition to the stem cell intervention of his joint?
The recommendations will be based on an updated evaluation. In my practice of cellular orthopedics, it
isn’t one and done. Additionally, some of the more advanced techniques are being covered in part by
health care insurance

If you want to learn more, call for an appointment (312)475 1893
You may access my web site at www.Ilcellulartherapy.com and watch my webinar

After I completed writing this Blog, I opened the Bone and Joint Newsletter.
Lead article: Study Suggests Knee Replacement Be Reserved for Those More Severely Affected by Osteoarthritis. A recent analysis found that the current practice of TKR as performed in the USA had minimal effects on quality of life and quality adjusted life years

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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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“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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