Feb 2, 2018
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
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
Jan 5, 2018
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.
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
Nov 29, 2017
I am being forthright; based on my review of data, while 80% or more of my patients continue to enjoy
satisfactory outcomes at four years or more following a stem cell intervention, there are those whose
symptoms and functional limitations recur. Please be aware that when I undertake the care and
treatment of a patient with a symptomatic and function limiting joint, it is with the notion of
regeneration and long-term benefit. It doesn’t always happen; there are may possible explanations.
Most important though is the need to identify possible causes of potential failure at the beginning, and
that is why we have recommendations before and after a procedure as to how to manage alcohol, diet,
supplements and a rehabilitation protocol. We also review your past medical history to identify any
possible indication that your stem cells have been adversely affected by co-morbidity or prior
treatments.
Assume if you will that you adhered to the initial pre-and post-intervention protocol but now returned
to my office months or years later with recurring symptoms. First and foremost is an updated medical
history and physical examination. That is followed by repeat images including X-rays and an MRI.
Mechanical progression of joint injury may result from aggravation of the preexisting damage by
subsequent trauma. Then there is the reality of identifying new processes within or adjacent to the joint.
This morning, I returned the phone call of a southwest Wisconsin dairy farmer; not the same patient I
wrote about last week. He has been a patient for over four years with a full restoration of work related
activities and recreational pursuits following several regenerative interventional options. After three
hours of basketball, three weeks ago, his knee pain returned. I called him back while he was milking his
cows and it was the first time I have been “mooed” at over a cell phone. I requested that the patient
update his X-rays, MRIs and then allow me to reevaluate him. A repeat stem cell intervention with a
more advanced technology, a subchondroplasty in addition to the stem cell intervention of his joint?
The recommendations will be based on an updated evaluation. In my practice of cellular orthopedics, it
isn’t one and done. Additionally, some of the more advanced techniques are being covered in part by
health care insurance
If you want to learn more, call for an appointment (312)475 1893
You may access my web site at www.Ilcellulartherapy.com and watch my webinar
After I completed writing this Blog, I opened the Bone and Joint Newsletter.
Lead article: Study Suggests Knee Replacement Be Reserved for Those More Severely Affected by Osteoarthritis. A recent analysis found that the current practice of TKR as performed in the USA had minimal effects on quality of life and quality adjusted life years
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mesenchymal Stem Cell, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, regenerative medicine, stem cell treatment
Aug 31, 2017
The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells.
Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.
“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb said in a statement Monday. The FDA has taken action against clinics in California and Florida. The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”
The clinic is one of many around the country that claim to use stem cells derived from a person’s own fat to treat a variety of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says. The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration. Stem-cell researchers praised the FDA’s actions.
“This is spectacular,” says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. “This is the right thing to do.”
Daley praised the FDA’s promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on “snake-oil salesmen” marketing unproven treatments.
Stem-cell research is “a major revolution in medicine. It’s bound to ultimately deliver cures,” Daley says. “But it’s so early in the field,” he adds. “Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven’t been proven to work and may be unsafe. “Others agreed “I see this is a major, positive step by the FDA,” says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics. “I’m hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell “treatments” that may not be real treatments,” Knoepfler says.
“Don’t stop now”. Say I. This Blog has been asking for FDA intervention in those settings where Amniotic Fluid is being marketed as a source of stem cell regeneration for over a year. There is only one way to be safe and not sorry:
You may access my web site Ilcellulartherapy.com and watch my webinar Or call for an appointment — 312-475-1893
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Concentrated Stem Cell Plasma, Growth Factors, Orthopedics, Osteoarthritis, Pain Management, Regenerative, stem cell treatment, stem cells, treatment
Jun 1, 2017
It is now over four years since I began the most comprehensive outcomes clinical trial ever undertaken in which Bone Marrow Concentrate was used to reduce pain, improve function, increase activities and alter the progression of osteoarthritis in a knee joint. At the start, it was generally believed that the adult mesenchymal stem cells would reproduce themselves and emerge as cartilage therein regenerating the joint. Continued scientific investigation has taught us that the adult mesenchymal stem cell acts as the conductor of a complex bio-immune process in conjunction with growth factors. One such growth factor is an endogenous polypeptide molecule, Transforming Growth Factor -Beta (TGF-ẞ). There are many other growth factors derived from the Bone Marrow Concentrate that play a role but that discussion is beyond the scope of this Blog. Additionally, be aware that Platelet-derived growth factor attracts mesenchymal stem cells and can stimulate proteoglycan production and chondrocyte proliferation. Incidentally, should you decide to seek consultation with one of the plethora of so called regenerative medical specialists populating the internet and advertising in the media, before you go, print my blog and ask them relevant questions pertaining to the science. You make be surprised to learn you as a potential regenerative consumer know more about the subject than the highly visible marketing provider.
Getting back to the clinical trial, the recruiting process of 50 patients ended two years ago and now we have two to four year of outcomes data to statistically analyze; that scientific process will be completed next week and presented at the Orthobiologic Institute meeting taking place in Las Vegas, June 8 to 10. For the first time, real outcomes data having been analyzed using the same criteria I used in my 37- year career as a joint replacement surgeon and head of a joint replacement program at a major medical center in Chicago will be presented to the regenerative medicine community. Unfortunately, I am unable to control the charlatans and camp followers who will attend the meeting and even try to use my data for their marketing. I choose to share my data as a challenge to those who seek to market and advertise stem cells for every malady known to mankind.
If you want to become better informed, you may access my website www.sheinkopmd.com.
You may watch my webinar www.ilcellulartherapy.com or call to schedule a consultation 312 475 1893.
Tags: bone marrow, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Mesenchymal Stem Cell, proteoglycan, stem cells, Transforming Growth Factor -Beta
