Aug 30, 2018
Evidence for the efficacy of Platelet Rich Plasma, a blood-derived formulation, and bone marrow derived biologics in osteoarthritis continues to grow in the orthopedic community. On the other hand, as I continually monitor the current landscape of indiscriminate and sometimes inappropriate marketing and use of biologics by the non-orthopedic opportunists, I doubt if the charlatans and camp followers have an overview of what is known about these agents. The increased presence of clinics Is driven by the popularity of PRP and its biologic cousins:
- consumer demand
- aggressive marketing
- a low regulatory bar for many of these regenerative medicine clinics
- the autologous nature that makes many approaches largely safe
- positive data from centers such as ours demonstrating functional and symptom modification
PRP works by activating cellular pathways; more than 3,000 genes are related to these and other pathways, suggesting that PRP probably acts by inducing a transitory inflammatory event, which then triggers tissue regeneration. Bone Marrow Concentrate, does more and addresses the subchondral bone when appropriately injected as well as initiate joint preservation and possible regeneration.
Taking aim
I use a hemoanalyzer to characterize a dose of PRP or Bone Marrow Concentrate allowing me to quantify the composition and biologic activity of these agents. Soon, I will begin pretreatment assessment of the synovial fluid of the arthritic joint so as to best determine who is the optimal candidate for a particular procedure
What do we know?
- Knee osteoarthritis: white blood cell-poor PRP has a positive effect on symptoms, not structure; while Bone marrow Concentrate affects symptoms and structure. I identify what I am putting into the patient. My goal is to have reliable predictors of outcome; that is, do the composition and biologic activity of the material implanted in the patient predict the clinical/imaging outcomes? My PRP contains a high concentration of anti-inflammatory cytokines and anabolic growth factors whereas my use of Bone Marrow Concentrate inside the bone adjacent to the joint in addition to the joint itself is improving the outcomes of the patients I treat.
- To learn more, call my office to schedule an appointment at (312) 475-1893
- You may view my Web site at WWW.Sheinkopmd.com
Tags: anit-inflammatory, biologics, bone marrow, cellular orthopedic, cellular therapy, cytokines, knee osteoarthritis, Orthopedic Surgeon, PRP, regenerative medicine, stem cell
Jun 28, 2018
For those unfamiliar with the designation, it is for the one who makes public pronouncements though I don’t dress elaborately by tradition nor do I carry a handbell saying “Oyez, oyez” (hear ye, hear ye)
“Twenty percent of knee replacement patients are not happy with their total knee replacements.” –Orthopedics, This Week Tuesday, June 12, 2018
“Arthroscopy for knee OA did not reduce or delay the need for a TKA” – Journal Arthroscopy. Sept 23, 9 2017
“Dr. Atul Gawande, a surgeon who was named this week to head the company being formed by Amazon, Berkshire Hathaway and JPMorgan Chase to trim employee healthcare costs, on Thursday cited surgery as the single biggest U.S. healthcare cost and said there are ways to both cut costs and improve patient care” “We need to act through data tracking … to see when treatments are benefiting and when they are not,” Gawande said. – Headline News Now June 25, 2018
There is an appropriate time and place for a joint replacement; a symptom such as pain in the knee should not be the solitary indication. Neither should every patient with a joint complaint be told by a surgeon “you have bone on bone and need a joint replacement”. My office evaluation before I make an evidence-based outcomes recommendation includes a history and physical before I look at the images. Joint range of motion is equally important as is the review of symptoms prior to reviewing your images for determining if I can help you postpone a joint replacement though my menu of Regenerative and joint Restoration alternatives or whether you should proceed to a total joint replacement. Please be reminded that before I evolved into my present approach to musculoskeletal afflictions, I was an orthopedic surgeon at a major medical center where I headed the joint replacement program for many years. Every patient who goes to a physician is not necessarily an automatic candidate for a procedure offered by that physician. Yesterday, I submitted an application for an FDA monitoring of one of our newest offerings and a good deal of the application was not only based on the scientific basis but the inclusion and exclusion criteria.
There is a time and place for doing something or doing nothing. To determine what is in your best interest, call for a consultation (312) 475-1893 or visit one of my two websites; www.sheinkopmd.com or www.Ilcellulartherapy.com
Tags: Arthroscopy, Dr. Atul Gawande, Headline News Now, joint pain, joint replacement, knee arthroscopy, knee pain, knee replacement, knee replacement failure, Orthopedic Surgeon, Orthopedics, Restoration alternatives
Jun 14, 2018
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.
Tags: arthritis, artificial joint, blood plasma, bone marrow, bone marrow lesion, cellular orthopedics, joint pain, joint replacement, knee pain, Med Rebels, Orthopedic Surgeon, Orthopedics, Osteoarthritis, platelet, stem cells, surgery, TOBI
Dec 6, 2017
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
Tags: adipose tissue, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Mesenchymal Stem Cell, Minimal Manipulation and Homologous Use, Orthopedic Care, Orthopedic Surgeon, Platelet Rich Plasma, PRP, regenerative therapies, stem cells
Sep 28, 2017
“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.
Tags: Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Orthopedic Surgeon, Pain Management, regenerative medicine, stem cell treatment
