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:
Physicians who use compliant regenerative therapies:
- Amniotic fluid without stem cells
- Blood-derived preparations (e.g., PRP, PPP)
- Bone marrow aspirate
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
I have always wanted to incorporate a holistic component into my practice, but, hesitated because of a commitment to patients that I would limit my professional pursuits to allopathic medicine; that is evidence based cellular orthopedics. Given the increasing body of information that healthy pursuits, a fitness focused life style, and yes, supplements, may indeed impact an individual’s activity status, well-being and even longevity; I have decided to network with Nutrition Connection Balance, an individualized nutrition, supplementation and counseling practice that has the potential to optimize your stem cell health, quality and yield.
Now for my confession, I have been using nutritional supplements and pursuing a fitness based lifestyle since entering orthopedic practice some -?–?– years ago. While my genetics stacked the deck against me, the environment in which I have immersed myself has rewarded me with well-being and good health while allowing me to still partake in those recreational undertakings I enjoy at a fairly competitive level. On top of the latter, my professional pursuits keep me at the forefront of the evolving specialty of regenerative medicine. Following my presentations earlier this month to 1500 surgeons attending the Russian Orthopedic Association annual meeting in St Petersburg, Russia, I was contacted by a ballerina, a member of the Bolshoi Ballet based in Moscow. She has a knee condition keeping her from dancing and has been told the only remedy would be a stem cell intervention. Today, I received her images and will reach out later today to The Chicago based to Russian Radio 1240am to help interpret the instructions for the download of the Zip File.
Meanwhile, I digress so let’s return to Medical Nutrition Therapy. The understanding I developed with Nutrition Connection Balance is that the consult may be initiated via phone or in-office. BY calling (847) 985 1200, you will be introduced to the practices of Valerie Early RD, LDN, RPHT and Lauren Chavez RD, LDN. While the standard of web site practice seems to offer nutraceuticals for sale by physicians, chiropractors and other camp followers holding themselves out to be regenerative medicine practitioners and capable of delivering stem cells form frozen and processed amniotic fluid, I have nothing to gain financially from my endorsement other than a healthier candidate with a better chance of a successful outcome following a stem cell intervention.
If you are limited in lifestyle by arthritic or injury generated painful joints or limited function, call for a consultation 312 475 1893 or view my webinar at www.ilcelulartherapy.com. If you want to learn more about Nutrition and Supplements, call Nutrition Connection Balance 847 985 1200
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, Orthopedic Care, regenerative medicine, stem cells
On August 3rd, I wrote a Blog titled” Advancing the Discipline of Cellular Orthopedics”. As readers of my weekly Blog as swell as present and former patients are aware, I have long focused my clinical practice first in joint replacement and now in Cellular Orthopedics, on the integration of patient care and research. When I traded the scalpel for a needle five years ago, I introduced that data collection and research methodology developed during my joint replacement career into the emerging discipline of Regenerative Medicine. Several months ago, I made a major decision to place increasing emphasis on that integration of patient care with research rather than continue to pursue the business model methodology. First the bad news, the diminution of marketing exposure inherent in my decision has temporarily resulted in a drop off in the number of procedures being performed. On the other hand, the international recognition of my efforts has culminated in an invitation to introduce the subspecialty of Cellular Orthopedics at the annual meeting of the Russian/ Ukrainian Orthopedic Association being held in St Petersburg, Russia, September 21st to 23rd. This meeting will be attended by over 1200 orthopedic surgeons from the region and it will be the first-time participants will have been introduced to non-operative alternatives for assisting a patient limited by arthritis of a major joint.
Sponsored by Zimmer-Biomet, Corporation, the largest prosthetic reconstructive company in the world, politics are set aside and the well-being of the human being becomes the only consideration. I am organizing my several presentations following the same educational principles I adhered to when I lectured in St Petersburg, Moscow and Vladivostok in 2004, 2005, and 2006. Then I shared my knowledge of joint replacement surgery and taught how I did things at Rush. Now I will share what I have learned in helping patients postpone, perhaps even avoid a joint replacement presenting at a workshop and then sharing my scientific outcomes data.
It is a personally rewarding opportunity for me as it is an international recognition of my initiatives and lends credence to my decision to have separated myself from the business model pursuit. Imagine my personal satisfaction to be returning by invitation to the birthplaces of my mother and father 85 years after they had been forced to leave? I am experiencing the ultimate reward from my profession.
If you want to personally gain from my Cellular Orthopedic experiences and knowledge, schedule an appointment buy calling 312-475-1893 or view my website and webinars www.ilcellulartherapy.com.
Tags: Bone Marrow Concentrate, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Mesenchymal Stem Cell, Orthopedic Care, regenerative medicine, Russian/ Ukrainian Orthopedic Association, stem cell treatment, Zimmer-Biomet
Also known as degenerative joint disease, osteoarthritis is the most common joint disorder, and continues to be the leading cause of impaired quality of life in the United Sates. While OA is defined as the progressive loss of cartilage structure and function; that definition has most recently been expanded to include changes to bone, tissues within and around the joint and changes in alignment.
While trauma, disease, infection, genetics, gout, and neuropathy may lead to secondary osteoarthritis, primary OA is the result of a degeneration that occurs with normal use. This wear and tear of the joint becomes more prevalent with advancing age.
Changes to Cartilage
The progressive loss of cartilage is a process that involves three overlapping stages: cartilage matrix (surroundings) damage, cartilage chondrocyte (cell) response to tissue damage, and decline of chondrocyte synthetic response (ability to maintain its environment)
Changes to Bone
As cartilage degenerates, there is increased exposure of the bone supporting the joint (subchondral bone). With time, the subchondral bone becomes dense (sclerosis) with cyst formation. Cartilage does not regenerate on its own starting about age 40. With time the aborted reparative process may result in osteophyte formation (spurs).
Changes to Periarticular Soft Tissues (in and around the joint)
Synovitis develops (inflammation of the joint lining) because of the release of inflammatory factors by the chondrocytes. A vicious cycle continues with further break down of cartilage followed by thickening of the joint capsule and shortening leading to loss of motion. Muscle undergoes atrophy (shrinkage and weakening) with the relative inactivity of the joint because of pain leading to instability
Changes to Alignment
Abnormal hip-knee-ankle alignment can accelerate structural changes; varus malalignment (bowed leg) increases medial compartment (inner side of the knee) disease fourfold, and valgus (knock knee) malalignment increases lateral (outer) disease twofold. Whether malalignment is associated with development of osteoarthritis or if malalignment is a result of OA is still a subject of debate. However, it has been demonstrated that malalignment can affect more than cartilage because malalignment predis- poses the patient to bone marrow lesions (nonhealing stress fractures).
Treatment of Osteoarthritis
Life style modification, rehabilitation (physical therapy), complementary and alternative therapy, pain relievers, intraarticular injections (cortisone, hyaluronic acid gels), arthroscopic and joint replacement surgery, and now, regenerative intervention.
Regenerative Intervention (an injection, not an incision)
Cellular intervention is what I do. Biologic solutions through cartilage regeneration is the goal of my practice. My stem cell source is the patient’s own bone marrow. Equally important are growth factors; the latter found in bone marrow and in platelets.
To learn more, visit my web site www.sheinkopmd.com
You may watch my webinar www.ilcellulartherapy.com
Then schedule an appointment 312 475 1893
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Knee Pain Relief, Orthopedic Care, Osteoarthritis, regenerative medicine
Blog: “Please explain Interventional Orthopedics?”
Dr Sheinkop: “Five years ago, after 37 years of performing hip and knee replacements at a major medical center in Chicago, where I served as director of the Joint Replacement program, I exchanged the scalpel for a needle. Having achieved my surgical goals, I elected to help pioneer the emerging subspecialty of interventional orthopedics, introducing clinical research so that regenerative medicine in the musculoskeletal system would be evidence based. Instead of a long incision, lengthy rehabilitation, potential major complications, and potential infection, I use bone marrow and growth factor concentrate through a needle to help a patient reduce or eliminate pain from an arthritic joint, improve motion and increase functional capacity.”
Blog: “Why did you take this route?”
Dr Sheinkop: “My clinical joint replacement research initiatives, wherein every patient on whom I had operated was closely monitored and followed, made me realize that patients under 60 were too prone to early revision surgery; that is a repeat replacement in a relatively short time. I became aware of the potential of the stem cells and growth factors in bone marrow concentrate to assist a patient with grades two and three arthritis of a major joint in postponing, perhaps avoiding a major joint replacement. As well, for older patients with grade four osteoarthritis who have too many co-morbidities and aren’t safe surgical risks, Bone Marrow Concentrate is a reasonable option.
Blog: “What evidence have you accumulated?”
Dr Sheinkop: “80% of our patients are very satisfied after four years. At the knee, only 7 % have gone on to have a joint replacement. At the hip, that number is about the same. I now have about four percent of patients who have undergone or are scheduled to undergo a repeat Bone Marrow Concentrate procedure after three to four years. Equally important is the comparison of activities after a Bone Marrow/ Growth Factor intervention versus a Total Joint Replacement. I have arthritic knees, grade three. I underwent an intervention on my left side 18 months ago. Last weekend, I went fly fishing for two days in Southwest Wisconsin walking along the creeks, at times in the spring creeks. This week, I am going skiing in Vail with my family. None of this would be possible with a joint replacement.”
Blog: “This is fascinating information; so much so that I want to continue this interview into next week. I want to ask you in particular about the acetabular labrum which seems to be receiving all kinds or attention, arthroscopic knee meniscectomy in the presence of arthritis, non-surgical alternatives for a torn ACL, and subchondroplasty”
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Orthopedic Care, Regenerative