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.

Regenerative Medicine-Are You a Candidate?

Over five years ago, I exchanged a scalpel for a needle and thus entered a developing discipline of cellular orthopedics. My goal was to assist patients with joint afflictions and orthopedic conditions delay, perhaps avoid a surgical procedure by capturing their body’s restorative or regenerative potential and applying evidence-based techniques.

To meet these goals, I introduced the same integration of clinical care with patient outcomes that I had pioneered over a 37-year Joint Replacement career at a major academic orthopedic center in Chicago where I retired as director of the Joint replacement Program. A data base was established and the outcomes of every patient who has undergone a Cellular Orthopedic procedure has been entered into that Data Base regulated by IRB over-site.

Now I am ready to begin sharing the outcomes we have gathered with statistically documented evidence concerning who is a candidate for Cellular Orthopedics, what is the best customized approach for a particular regenerative or restorative procedure and when to advise a patient that surgery might be a better option.

This past weekend, I had a poster exhibit on display at the TOBI meeting in Las Vegas in which I reported preliminary outcomes of a combined Intraarticular and Intraosseous (subchondroplasty) Bone Marrow Concentrate intervention for grades 2 and 3 Osteoarthritis at the knee. I am now working on four presentations as an invited guest speaker at the October meeting of Med Rebels, a well-attended regenerative medicine conference for continuing education credits concerning patient outcomes for different aspects of Cellular Orthopedic recorded in my data base.

What we have learned in these past five years plus is that everyone doesn’t respond to regenerative medicine interventions. You may best gain in-site as to why by reading a blog that I wrote exploring reasons for lack of successes: When Bone Marrow Concentrate Intervention Fails. On the other hand, in part due to the evidence I have gained as well as continuing technological advances, I have a better idea as to who is a candidate for regenerative medicine.

To learn if you are a candidate, schedule a consultation at (312) 475-1893. You may access my web site where you will find my webinar www.Ilcellulartherapy.com.

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A Regenerative and Restoration Milestone

A Regenerative and Restoration Milestone

It happens every year since the day I was born, there is a birthday celebration in my home and it happens again this week. Sure, I have a little more graying of my hair; but fortunately, I have my hair. I also have an activity level that would not have been possible, given the arthritis in my knees and hips, unless I had undergone restorative and regenerative intervention taking advantage of Bone Marrow Concentrate and Platelet Rich Plasma Offerings as I write about in these blogs. 

To give you some insight of what is possible no matter your age and before you become a couch potato owing to pain and functional limits imposed by arthritis, let me describe what I have planned for the Memorial Day weekend. You might recall that I was experiencing progressive functional limitation until a regenerative procedure was completed on my knees, December, 27, 2017 followed by a similar procedure in my hips on January 11, 2018. On this upcoming Thursday, I will begin planting a relatively large vegetable garden in the mid-day when we arrive in Southwest Wisconsin followed by a late afternoon 30-mile bike ride. First, we stop at the Amish Greenhouse in our neck of the woods to collect the vegetables and Herbs. On Friday the cycling and planting will continue; Saturday will be a half day of fly fishing followed by more planting and then another 30-mile bike ride. Sunday will be a repeat of Saturday after the evening outdoor barbecue. Monday morning is another half day of fly fishing, then planting of the herb plot after which we return to Chicago and office patients on Tuesday.

I felt your pain until I took advantage of the possibility for functional restoration and joint regeneration that I offer my patients. No more kvetching from me. The way I want to live is the way I practice.  I am not ready to slow down even though birthdays are being celebrated each year; and I don’t have to alter my way of life; having enjoyed symptom relief and functional restoration via Bone Marrow Concentrate and Platelet Rich Plasma offerings.

To learn about how you might continue to enjoy or perhaps return to an active, symptom free lifestyle, call (312) 475-1893 To schedule an appointment. You may visit my blog at HTTP://www.ILcellulartherapy.com where you may watch the webinar

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FDA Compliant Therapies

For those who may have missed it, I was featured Monday night in a Fox 32 news report presented by Fox News investigative reporter Sylvia Perez.

http://www.fox32chicago.com/health/customers-warn-that-doctors-are-scamming-patients-with-fake-stem-cell-claims

Regular readers of my Blog are aware of the opinions I have frequently expressed regarding the charlatans and camp followers that have taken advantage of the regenerative medicine marketplace promising to cure arthritis, Alzheimer’s, Alopecia, ALS, Autism, and every malady known to mankind finally ending at the letter Z. They don’t exclude spinal cord injury, residuals of stroke nor ED while they are at it. The message regarding what stem cells can do is found in newspaper ads, television commercials and radio spots, the latter in the Chicago listening area by a well-known sports announcer. Either attend a seminar or make an appointment for treatment; they will cure your disease, eliminate pain and do away with your suffering. “Call now to schedule an appointment”.

For a free lunch and without an evaluation or examination, you can undergo an amniotic fluid intervention that is “regenerative” as it is claimed, at a cost in the neighborhood of $5,000. I have been involved in amniotic fluid clinical trials for four years underwritten by the largest provider of amniotic fluid in the nation; and our first statement to participants in these clinical trials, without charge for the injectate, is that there are no living stem cells in the amniotic fluid once processed, sterilized, frozen and fast thawed for usage. Hold on, there is more. On September 16, 2017 the FDA published mandatory guidelines: any and all regenerative agents must be autologous and homologous. In plain speak the injectate must come from the same patient and be used as nature intended. Stem cells from donor sources are not compliant.

Featured in the Fox News special report are two patients. One had undergone a complete medical history, physical examination and skeletomuscular evaluation prior to his Cellular Orthopedic intervention enjoying a marvelous outcome; the other, an amniotic fluid injection into his knee without any prior evaluation or preparation and an awful end result. You may watch the actual report by clicking on that underscored above.

One of the standard of practice methodologies in which we take great pride and which I believe separates us from the madding crowd of regenerative medicine camp followers and charlatans; is our evidence based cellular orthopedic approach.  In preparation for a scientific podium presentation in two weeks, we are collating our outcomes data at one year for patients who underwent a combined intraarticular (into the knee) and intraosseous (into the subchondral bone) autologous bone marrow and growth factor intervention for osteoarthritis grades two and three. At six weeks, we recorded a 22% improvement in pain relief; 42% at six months, and 89% at 12 months. In future blogs, I will breakdown the outcomes data further and expand on our documented outcomes based on our several cellular orthopedic options.

To learn more, you may review my web site and watch my webinar at www.ILcellulartherapy.com

You may schedule a consultation by calling (312) 475-1893

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A Regenerative and Restoration Milestone

Update on the Cellular Orthopedic intervention to my knees

If you read my blog posting last week, you would have learned that I personally underwent a cellular orthopedic intervention to both of my knees on Wednesday, 12/27. The symptoms attributable to my own osteoarthritis had progressed to a degree that I was becoming limited in my recreational profile. While there indeed was a response to anti-inflammatory medications, every time I am reminded of the potential complications of NSAIDS, I become medication adverse. This led to the injection into both of my knees of an Autologous Protein Concentrate (APC) with the hope of treating my pain and slowing the progression of cartilage degradation and destruction of my knees.

The process used was a cell-concentration system which concentrated my own anti-inflammatory cytokines and anabolic growth factors. Pioneered in Europe, an ever-increasing number of professional athletes have been prolonging their careers by accessing this treatment. I have waited over five years for the Autologous Protein Concentrate methodology to become available in the United States; three weeks ago, I was granted access. To date, my pain secondary to knee osteoarthritis is not only reduced but gone; I can only hope it stays that way. My function is significantly improved as evidenced by an ability to have pursued my fly fishing passion chasing bone fish with my wife, daughter-in-law and son for three days in Ascension Bay, Mexico, over the New Year weekend.  For those unfamiliar, bone fishing requires a continued down and up to a platform on the front of a three-man boat with prolonged standing while balancing. At times, I climbed out of the boat and waded through the flats for 30 to 45-minute intervals until it was time to change locations. Since returning home on January 1, I have been able to return to my fitness profile without restriction previously afforded by my Osteoarthritis generated symptoms and limitations.

As in any and all treatments, a patient must be given informed consent and be warned both of the benefits and risks; so, I will let you in on an adverse event in my early outcome. Owing to the increased activity attributable to the diminution of my pain and increased functional capacity resulting from my initial response to the Autologous Protein Concentrate intervention, instead of climbing down from the fly fishing platform in the front of our boat when it was time to trade places with my wife, I jumped down. In so doing, I kicked the rod holding rack and fractured the fifth toe on my left foot, the pinky toe. Though a bit of a nuisance, it is not too great a price to pay for the relief and improved function of my knees.

To learn more, call my office and schedule an appointment; as I haven’t yet updated my web site with an explanation of the Autologous Protein Concentrate intra-articular injection for treatment of knee osteoarthritis (312) 475-1893.

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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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