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.

“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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Exciting Cellular Orthopedic Debates

Exciting Cellular Orthopedic Debates

Well, it is really an internal debate as to whether I should have a concentrated platelet rich plasma procedure or a bone marrow concentrate procedure as I get ready for the upcoming ski season. While it is true that I exercise five to six days a week rotating between outdoor cycling, strength training and rowing, the demands of skiing on the knees are such that I need to rethink my approach. I share this personal flow of conscience to provide guidance and council for readers of this blog. As for so many of us senior recreational participants, each activity has unique demands so we must anticipate each activity from a separate approach. While generalized fitness improves the quality of life and even well-being, maybe even prolonging life, if you want to ski with arthritic knees, now is the time to plan ahead.

Let me share with you my plan based on an observation of the outcomes in over 1500 patients in whom I have intervened with Cellular Orthopedic alternatives over the past five years. In the next several weeks, I will undergo a concentrated PRP intervention ultrasound guided into both of my knees. I will be using the upgraded methodologies for preparation of injectate and customize the PRP with our soon to be activated cell counter. This will provide me with a 20x dosage over that which has been available up until the present; and yes, I too have to pay for the methodology. I will then wait until mid-December, and if I am not satisfied, I will undergo a Bone Marrow Cell Concentrate procedure for both of my knees.

Below are two reasons received in the last 48 hours as to why I believe Cellular Orthopedic is exciting:

“My uber-condensed version, though, is that on almost all days in the last 8 months, I’ve had virtually no knee pain with daily activity. That’s a massive improvement from even the 12-month follow-up visit. I first started to suspect things were improving at about 10 months post-op. At 12 months, I was hopeful but still skeptical. At 14 months things, rapidly improved and have mainly remained there ever since. So, on the whole, I’m vastly improved. I suppose any number of factors could have contributed to that improvement, but Regenexx certainly seems to have helped tremendously.”

“Attended the company golf outing this past weekend. Last year I was concerned so I took an Advil before we started and ended up taking another halfway through the 18 holes. The last four holes I didn’t even leave the cart (to sore/tight to get in and out).

This year I fully intended to bring the Advil again but forgot it. Turned out I did not need it. Finished the 18 holes like nothing. Felt fine after and the next day.

Believe we can consider this a win!!!!”

Do you want to enjoy relief from arthritic symptoms and limitations?

Call 312 475 1893 to schedule a visit or visit my website to watch my 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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“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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“FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments”

Advancing the Discipline of Cellular Orthopedics

Most readers know that I “graduated” from joint replacement surgery into an emerging field of Regenerative Medicine about five years ago. Prior to that time, I had dedicated 37 years to Reconstructive Orthopedic Surgery and played an active role in a joint replacement practice combining research with education as I improved the quality of life for my patients. By the end of my surgical career, I had authored more than 90 scientific papers in the field of hip and knee replacement as well serving in the leadership of the joint replacement program at a major medical center in Chicago.

That was “back in the day” of joint replacement surgery; but rather than live in the past, I have elected to partake in the present and advance Cellular Orthopedics into the future. I now have the largest and most comprehensive clinical outcomes data base in the United States concerning Bone Marrow Concentrate, Mechanical preparation of Adipose Graft, and Amniotic Fluid injection used in the treatment of knee arthritis. This information has allowed me, up until now, to make a scientifically based recommendation as to the best regenerative option for dealing with an arthritic joint.

In my initiative to advance the discipline of Cellular Orthopedics, the next innovation will be to offer a prior analysis of the stem cell content for the patient seeking the regenerative option as a means of postponing or avoiding a joint replacement. Should a patient present with osteoarthritis seeking to determine if she, he or hir will benefit from Adult Mesenchymal Stem Cells and Growth Factors, I am able to offer the equivalent of a bone marrow biopsy and determine the amount of viable cellular orthopedic content available in that individual’s bone marrow. My recommendations then would be based on actual number of cells and not on age related or disease influenced averages or estimates. Predictability of an individual’s outcome in determining whether to proceed with the regenerative intervention would be customized and not generalized. Where this scientific leap forward would be of particular interest includes patients over age 70, those who have received immune altering systemic management for a co-morbidity or for patients whose medication requirements up until now would have eliminated them from a regenerative consideration.

To learn more schedule an appointment 847 390 7666

You may access my web site and watch my Webinar at www.Ilcellulartherapy.com

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