For one, to the best of my knowledge, he doesn’t ski but I did earn a letter as a member of the Roosevelt High, basketball team. No, the common ground is the fact that we both have undergone a similar intervention for osteoarthritis of the knee. Six years or so before Bryant’s retirement, he traveled to Dusseldorf, Germany to undergo an orthobiologic intervention for an arthritic knee that was threatening to prematurely end his playing career. That orthobiologic intervention was unavailable at the time in the United States; but professional athletes were traveling to Dusseldorf to help prolong their careers. I closely followed the outcomes and was amazed to see Kobe Bryant’s return to professional basketball following his procedure for five more years, given he had stage four Osteoarthritis of his knee. His knee X-Ray was available on the internet. At the same time, I postponed my surgical procedures knowing that both of my knees and both of my hips were problematic, waiting for access to a treatment similar to that which the professional athletes were having in Europe. Last September, as an invited speaker at the Russian Orthopedic Society annual meeting, I was able to gain access to the treatment regimen very much available by now in Western Europe and Great Britain. My hope was to partake in a family ski vacation from February 17 to 24. On December 27, I underwent biologic intervention into both of my knees; and on January 11, both of my hips.
On Saturday, I returned from a ski week in Vail, including my wife, three children, one daughter-in-law and five grandchildren. Two other spouses don’t ski. I skied six consecutive days with my wife, children and at times, grandchildren. It was an opportunity for returning to the thrilling days of yesteryear as far as skiing was concerned, made possible by Orthobiologics. Imagine, three months ago I was experiencing painful limitations in both hips and in both knees; now I am planning a return four-day skiing visit at the end of March to catch the spring powder. I don’t know if I can help you ski; but I can help you overcome limitations imposed by arthritic joints.
Citing Oliver Wendel Holmes; “We do not quit playing because we grow old; we grow old because we quit playing”.
To learn more visit: www.ilcellulartherapy.com or call for an appointment 312 475 1893
Tags: arthritis, biologic intervention, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip pain, Interventional Orthopedics, knee pain, Knee Pain Relief, Kobe Bryant, Orthopedics, Osteoarthritis
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.
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 (847) 390-7666
Tags: autologous proten, bone marrow, C-SCP, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, FDA, Growth Factors, Interventional Orthopedics, joint replacement, Knee Pain Relief, Osteoarthritis, Platelet Rich Plasma, Subchondroplasty
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 (847) 390-7666.
Tags: anti-inflammatory, arthritis, Autologous Protein Concentrate, cytokines, Growth Factors, Hip Replacement, horse, injection, Interventional Orthopedics, joint replacement, Knee Pain Relief, Osteoarthritis, Pain Management, regenerative medicine, rheumatoid arthritis, treatment, treatment of equine lameness
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.
Tags: arthritis, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Mesenchymal Stem Cell, regenerative medicine, stem cells
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