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.

On Cartilage Regeneration

Since we practice in an emerging discipline of Regenerative Medicine, how is regeneration determined? Cartilage repair should be evaluated with use of a scoring system that considers the volume of the defect that becomes filled with repair tissue, the integration of repair tissue with adjacent cartilage, and the macroscopic appearance and biomechanical properties of the repair site. The macroscopic assessment is particularly important in evaluating cartilage repair because it provides information about the quality of the full repair site compared to the incidental histological assessment which only evaluates a biopsy of the repair site.

If the aforementioned answer to my introductory question may seem scientifically oriented, that is purposeful on my part; because only those able to explain Regenerative Medicine on a clinical, technical and scientific basis should be caring for your arthritic joint.  

While an arthroscopic evaluation provides the best opportunity for a determination of joint regeneration 18 months or greater following a Bone Marrow or Platelet Rich Plasma or other cellular orthopedic intervention for arthritis, an invasive surgical evaluation is not realistic. For a quantitative MRI to assist in the assessment requires availability of a specialized imaging center and there are just too many variables to allow for dependable quantitation; expense is prohibitive. The most dependable and reproduceable means of measuring the arthritic or injured joint response to a cellular orthopedic intervention is a history and physical examination, the latter completed with a tape measure and goniometer as well as an activity assessment. By comparing a baseline measurement prior to an intervention and at serial intervals following the procedure, one may determine if regeneration is indeed taking place and thus establish clinical practice guidelines and determine Evidence Based Quality and Value.

Now for the real question, does cartilage regeneration need to take place on a macroscopic level for cellular orthopedics to succeed? New therapies such as bone marrow derived stem cells, growth factors and cytokines; platelet-rich plasma (PRP); and IRAP (interleukin-1 receptor antagonist protein) first and foremost address the bio-immune basis of degenerative arthritis. By controlling the pain and eliminating inflammation; stopping the progression (at least slowing) of Osteoarthritis; reversing scarring, thus improving motion and function; and lastly, possibly regenerating cartilage for those in whom regeneration is possible. From the editors of the Encyclopedia Britannica: “Interleukin (IL), any of a group of naturally occurring proteins that mediate communication between cells. Interleukins regulate cell growth, differentiation, and motility. They are particularly important in stimulating immune responses, such as inflammation.”

Should our future blogs and discussions address not cartilage regeneration but rather reversing the proinflammatory cytokine production from the synovial lining of the inflamed knee? One such possible pharmacological treatment of OA is anticytokine therapy. Interleukin-1 (IL-1), as a main inflammatory and catabolic cytokine in the pathophysiology of OA, represents one of the possible treatment targets.  Koby Bryant was one of the first highly visible professional athletes who travelled to Germany over eight years ago for Interleukin-1 Receptor Antagonist Protein intervention for an arthritic knee. Many, have followed including golfer Fred Couples for his problematic back.

If this Blog has introduced new considerations and questions, then let me clarify. Call 312 475 1893 to schedule an appointment. You may watch my webinar at www.Ilcellulartherapy.com

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Continuing update regarding FDA oversite of regenerative medicine

After my last blog was posted, a patient sent me a brochure she had received while attending a Regenerative Medicine Seminar focusing on how “stem cell therapy could change your life”. Within the brochure was a full page dedicated to how amniotic fluid stem cell therapy could treat ALS, Autoimmune Disease, Avascular Necrosis, Cartilage Damage, Rheumatoid Arthritis, Traumatic Brain Injury, to name just a few of the 30 listed conditions. The marketing hype went on to indicate “_________  is building the largest network of FDA compliant stem cell centers in the US.”

Last week I emphasized that in order to FDA compliant, Regenerative Medicine must follow several regulatory requirements:

  • Minimal Manipulation of the cells or tissue bearing the cells
  • Autologous source and homologous application

Minimal manipulation of cells means that they can not be cultured nor can tissues be treated with enzymes to release the stem cells. One such example is a prohibition on fat being subjected to the enzyme collagenase. In simple terms, it is contrary to FDA regulations to perform a liposuction, treat the recovered fat with an enzyme, and inject the cells into a joint or other skeletomuscular structure. As of this writing, I am still seeking clarification on using a mechanical means to emulsify the fat and use the end product in the musculoskeletal system.

Autologous is defined by Merriam-Webster as “involving one individual as both donor and recipient”. It then follows that it is contrary to FDA regulations to use the stem cells in amniotic fluid when recovered by amniocentesis in the musculoskeletal system of a different individual. Add to the latter, the fact that there are no living stem cells in amniotic fluid once sterilized, frozen or lyophilized for preservation and fast thawed for intervention.

Next, I will address homologous as “having the same relation, relative position, or structure” according to the Oxford dictionary. From the FDA oversite standpoint, you can’t put stem cells from amniotic fluid into a joint nor can you introduce fat into a joint. For those patients with arthritis and related orthopedic conditions, beware of the scammers, charlatans and camp followers. As well, for those with degenerative diseases other than orthopedic, be forewarned. There are scoundrels out there very willing to fleece you and take advantage of desperation. For those looking to address non-orthopedic degenerative conditions such as ALS, Autoimmune Disease, Congestive Heart Failure, Multiple Sclerosis, etc., clinical trials are taking place at major medical centers. You may learn about the various trials at NIH.Gov. The FDA warned the non-compliant clinics that they have three years so cheaters will continue to cheat.

From the skeletomuscular and arthritic standpoint, there are clinical specialists available to address your arthritic and other orthopedic problems using FDA compliant Platelet and Bone Marrow derived options just as credentialed as all the other specialties in medicine and surgery. As an orthopedic surgeon, I for one have the scientific outcomes data to support my cellular orthopedic initiatives.  To learn more about evidence based cellular orthopedics call 312 475 1893 to schedule a consultation.

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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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What I was reminded about in preparing for my St. Petersburg lectures

What I copied and pasted above are three slides from my upcoming presentations to the 1200 Orthopedic Surgeon attendees at the combined meeting of the Russian Orthopedic Society to be held September 23 and 24 in St Petersburg, Russia. The members will travel from Ukraine, all of Russia including Vladivostok and Siberia, Norway, Estonia, Latvia, Lithuania, Poland, Belarus, Georgia, Azerbaijan, Kazakhstan, and who knows. The mission is orthopedic education and not politics so there are no boarders. As I have previously written, between 2001 and 2007, I had been an invited lecturer and visiting surgeon in more than 37 countries including those listed above. At that time, I was invited to teach hip and knee replacement for arthritis; now I am invited to teach about biologic and regenerative medical means of postponing, perhaps avoidance of a joint replacement for arthritis.

In preparing instructional courses, I continue to expand my knowledge base out of necessity. It is the best continued educational endeavor possible and yet there are no continued medical educational credits for me. In the three slides copied from my talks and pasted above, you will note the code of FDA regulations. No matter our political disagreements, most of the world looks to our FDA for guidance. PRP and Bone Marrow Concentrate are approved while Amniotic Fluid with stem cells is not. Let me now ask the reader a question. How is it possible to advertise “Regenerative Therapy” if Amniotic Fluid actually has living stem cells and such is the case when harvested by amniocentesis when the Federal Code of Regulations prohibits said use as it is drug? If on the other hand, as science indicates, the stem cells in amniotic fluid when fast thawed for injection are killed, how can there be a regenerative possibility in that injectate? Bone Marrow Concentrate has a ten-year clinical scientific basis, I have been clinically documenting outcomes for five.

My next Blog will update you with my experience at the Russian Orthopedic Society meeting, when I return on September 25. If you want an update on how Cellular Orthopedics may help you lessen the pain from osteoarthritis and related joint disease as well as increase your function, call 312-475-1893 to schedule an appointment or watch my webinar: https://sheinkopmd.com/learn-how-regenerative-medicine-may-help-you/

Hyaluronic Acid, Platelet Rich Plasma and Bone Marrow Concentrate

Hyaluronic Acid, Platelet Rich Plasma and Bone Marrow Concentrate

Patients receiving either Hyaluronic Acid (HA- Synvisc, Supartz, Euflexxa) or Platelet Rich Plasma (PRP) injections will experience modest-term pain relief according to an article appearing in Orthopedics Today, August, 2017. In the study reviewed, Ultrasound Guided injections were given weekly for three weeks and patient-reported outcome measures (PROMS) were recorded for up to one year. “Both the PRP and HA groups demonstrated an improvement in PROMS at 24 weeks that declined to near baseline levels at one year” according to the article. “Patients with lower grade Osteoarthritis and lower weight responded more favorably to intra-articular injections”. The effect of both Hyaluronic Acid and Platelet Rich Plasma appeared to be modest and temporary.

Why I chose this topic this week for my Blog has to do with my preparation for the upcoming talks I am invited to give September 21st and 22nd in St. Petersburg, Russia at the meeting of 1200 orthopedic surgeons from Russia, Ukraine and neighboring countries both in Europe and Asia. As I indicated last week, this will be the first time a non-operative intervention of a cellular orthopedic, regenerative nature, as I practice, will have been introduced into this region of the world. While Hyaluronic Acid and Platelet Rich Plasma may offer short term pain diminution for individuals limited in function by the symptoms of Osteoarthritis, it becomes clear by scrutinizing my data base that not only does concentrated bone marrow afford long term relief, the Mesenchymal Stem Cells and Growth Factors found in bone marrow when concentrated participate in regenerative possibility thereby delaying and perhaps even avoiding a joint replacement. My presentations will be evidence based without the false news and unsupported marketing claims ever present in the media.

What we have learned about Amniotic Fluid (AF) from my role as principal investigator in several multisite studies is that AF does have concentrated Hyaluronic Acid and therein may offer six to 12 months decrease in symptoms and increase in function, the effect is limited in duration; and with no viable stem cells in Amniotic Fluid Concentrate, there is no regenerative potential. Owing to the absence of inherent absence of stem cells and hence regenerative potential, I will not include amniotic fluid in my presentations.

As a scientific invitee, my responsibility is to introduce that for which we have scientific support and clinical evidence. If you want to gain a better understanding of Regenerative Medicine and Cellular Orthopedic and learn how you may postpone or perhaps avoid a joint replacement for the symptoms and limitations imposed by osteoarthritis, make an appointment, visit my web site and watch my webinar.

312-475-1893

www.sheinkopmd.com

www.ilcellulartherapy.com

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Postpone, perhaps avoid joint replacements

Postpone, perhaps avoid joint replacements

Last week, we traveled to Israel to celebrate the wedding of our youngest son. Israel became the destination for the event as Eric and Judith had met there while his music business was subcontracting to Coke and Judith led the International Marketing initiatives for Coke. The event took place on July 5th, at an organic farm in the outskirts of Jerusalem. In such a majestic and historical setting prior to and after the ceremony, there took place several organized tours including one of Jerusalem, another at the Dead Sea and for several, a trip to Petra. It was a relatively small group of the attendees; one in particular, a very close and long-time friend has been the subject of my Blog in years past as I described his return to skiing, biking and fly fishing following a Bone Marrow Concentrate/Growth Factor Concentrate/Stem Cell concentrate intervention. Prior to those procedures, he had been forced to give up his athletic passions for several years because of the limitations imposed by arthritis of both knees.

Above is his activity score from Monday, July 3, when Bob and his wife toured Jerusalem’s Old City including a hike on the ramparts of the wall surrounding the Christian Quarter, the stop and prayer at the Temple Mount and a shopping spree at the Arab Suk (bazaar).

What Bob represents is the potential for continued improvement over several years following a regenerative intervention, a process of which I am continually reminded as time passes and I have a longer follow up of my patients. Our mission and ethos is to help patients with arthritic joints enjoy an active life style and postpone, perhaps avoid joint replacements when arthritic impairment ensues. The documentation from the patient above is one of improving outcome as time passes. While his is an anecdote, our data base increasingly reflects similar happenings for the majority of our patients.

There are now many providers for those with arthritic impairment seeking improved function and less symptoms; and who are not candidates for a joint replacement or who do not want to undergo the major surgical undertaking. In your choice of an Interventional Cellular specialist, inquire about her or his long-term outcomes; not just “will I get a free lunch if I attend a seminar?”

To learn more, call for a consultation 847 390 7666

You may watch my webinar and learn more by visiting my website at Ilcellulartherapy.com  

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