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
Nov 22, 2017
As regular readers of this Blog are aware and as well, those patients who seek consultation in my office, my cellular orthopedics practice is based on clinical evidence. While the largest marketer of stem cells in the Midwest, bases a recommendation for a product without scientific evidence or even anecdote, my practice is evidence based. While it is true that I can site anecdote after anecdote about a successful outcome, the scientific process requires that I provide statistical support for what I do. The subject of this particular blog is to share with you how far I will go to gather that evidence.
About six months ago, I completed a combined Bone Marrow Concentrate Intra-articular (into the joint) /Subchondroplasty (into the bone) in the right knee of a dairy farmer, in his early 60s, living in Southwest Wisconsin. He was able to follow up at my office in Des Plaines twice following the intervention; but owing to the fall harvest, he had been unable to return for the third follow up in a timely manner. My desire is to assure the success of the procedure, rather than having completed a telephone interview, my wife and I headed out this past weekend to Dodgeville, Wisconsin, where I completed the full evaluation in a booth at the local Culvers. In addition to the usual historical review of progress, I completed a Physical Examination of the patient including circumferential measurement of the thigh, knee and calf using a tape measure and an assessment of his range of motion using a goniometer for accuracy. I think that the diners at Culvers were just as fascinated at what was taking place in our booth as I was watching the customers in the drive through ordering an early lunch while carrying a recently harvested buck in the back of their pickups. It is deer season in Wisconsin.
Suffice it to say that my patient was thrilled at my willingness to save him a trip to Chicago but he was even happier about the outcome in his arthritic knee. I was thrilled at his response to care. Whereas prior to the right knee intervention, he had constant pain and limitation in function, at six months, the pain and swelling are gone and he has unlimited function be it on stairs, kneeling or climbing in and out of the tractor. What separates me from the madding crowd is the data and evidence for which my recommendations are advanced. Incidentally, two blogs ago, I listed our clinical trials, the basis for our evidence based practice. Below is the trial in which my Wisconsin patient is enrolled and for which I sought follow up:
- Stem Cell Counts and the Outcome of Bone Marrow Concentrate intra-articular and intra-osseous (subchondroplasty) interventions at the knee for grades 2 and 3 OA. (supported in part by Celling). Ongoing
His results are so good that his wife decided to be next in line for her knee that did not respond well to arthroscopic surgery two years ago.
Whether you didn’t respond to surgery or haven’t had surgery, call 312 475 1893 to schedule an appointment or watch my webinar on the website www.ilcellulartherapy.com
This Thanksgiving week, let me give thanks to those who read this Blog
Tags: arthritis, bone marrow, Bone Marrow Concentrate, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Knee Pain Relief, Mesenchymal Stem Cell, Osteoarthritis, 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
Jul 20, 2017
We now are approaching five-year outcomes regarding the use of Bone Marrow Concentrate for Osteoarthritis of the hip, knee, shoulder and ankle. Bone Marrow contains Adult Mesenchymal Stem (MSC) cells and Growth Factors. In the beginning, the entire informed consent process focused on the MSC in bone marrow as the agent responsible for diminishing pain, improving motion, stopping, at times reversing the progression of osteoarthritis, and potentially regenerating the joint itself. Now we know that equally important to the MSC are the growth factors produced and stored in the bone marrow. Some of the key proteins (Growth factors) include Interleukin-1 Receptor Antagonist Protein (IRAP), Alpha-2-Macroglobulin (A2M), fibrinogen, PDGF, VEGF, and TGF-B to name a few.
The reason we directed our clinical initiatives to Bone Marrow Concentrate is that while Amniotic Fluid contains Hyaluronic Acid, once harvested, sterilized and fast thawed for clinical application, there are no living stem cells left, so Amniotic Fluid Concentrate has no regenerative potential. When it comes to Adipose Derived Stem Cells, in order to liberate the stem cell from the adipocyte, an enzyme, collagenase must be employed. The latter is not approved by the FDA. Additionally, there is no evidence of Growth Factor content in adipose derived tissue.
While I have blogged about the superiority of Bone Marrow Concentrate over all other non-surgical approaches for arthritis, the introduction of the intraosseous adjunct, subchondroplasty, is resulting in even superior outcomes when compared to those who were treated prior to this contemporary version of Cellular Orthopedics. It has been nine months basically since I started injecting Bone Marrow Concentrate into the marrow adjacent to the joint in addition to the intraarticular approach. We already are seeing a better outcome in those who availed themselves of the Intraosseous adjunct. Up until eight weeks ago, my ability to offer contemporary and improved treatment options was limited by preexisting contractual obligations; but now unrestricted, I have expanded my scope of offerings including elevation of subchondroplasty from a clinical trial status to usual and customary adjunct standard of practice option. As well, I now offer an increased opportunity for participation in other clinical trials for the arthritic joint when a patient meets obligatory inclusion criteria determined by the trial sponsor.
If you want to postpone, perhaps avoid a major surgical replacement for an arthritic joint, call for a consultation 847 390 7666
You may visit my web site at IlCellulartherapy.com where you may watch my webinar.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Microfracture surgery, Orthopedics, Osteoarthritis, Pain Management, stem cells, treatment
Jun 15, 2017
It was difficult for me to sit and listen to so many “show and tell” presentations not supported by scientifically overseen outcomes data. Too much anecdote about unproven methodologies; many not compliant with FDA guidance. Basically, it was frequently repeated false news. I was taken aback by what so called physicians are injecting into the joints of their patients. Florida seems to lead the way in the cook book approach to arthritis followed closely by California. Illinois is guilty as well but not the medical community. Despite my negativity about the absence of science, this gathering certainly did not begin to approach the science and integrity of presentation found in the discipline of orthopedic surgery; of particular interest to me was the universal agreement that there is no regenerative potential in Amniotic Fluid Concentrate. A matter of fact, there was not one outcomes paper presented concerning amniotic fluid. It becomes ever so important that a patient choose an experienced, scientifically oriented, regenerative medicine specialist when seeking a non-surgical option for an arthritic knee, hip, ankle or shoulder. The patient must bear in mind that the specialist’s goal is to improve function, diminish pain and postpone, possibly avoid a joint replacement for an arthritic joint. When the arthritis has reached end stage, there are those who should have a joint replacement; only a specialist is equipped to properly advise a patient.
In the orthopedic world, scientific papers are not considered to have significance unless the outcome results have been followed for a minimum of two years and more. Furthermore, the articles in order to be considered authoritative must have statistical significance. It seems that the charlatans and camp followers are offering patients an intervention that is neither FDA compliant nor for which there is scientific outcomes data. The one exception to all the fake news was the presentation by Dr. David Karli of Greyledge Orthobiologics who introduced The Method of Ratios for Assessing PRP and BMC Theraeutic Potential. This novel approach to quantitating and qualitating the injectate I am sure will soon become a standard of care for cellular orthopedics so I will quickly introduce into my practice. The Method of Ratios will allow the clinician to better understand what will be injected into a joint.
The appropriate method of advising an arthritic patient as to whether surgery may be postponed or even avoided begins with a specialty consultation including a comprehensive intake, a physical examination including functional testing, and review of images. Only those with specialty training, board certification and experience both in surgery and in regenerative medicine are able to properly advise the patient. I will again underscore the importance of choosing the Cellular Orthopedic expert and not determining what may be best for you by surfing the cloud.
If you want to become better informed, browse my website www.sheinkopmd.com.
You may watch my webinar at www.ilcellulartherapy.com or call to schedule a consultation (312) 475-1893.
Tags: Amniotic, amniotic fluid, arthritis, BMC Theraeutic Potential, bone marrow, cellular orthopedics, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Dr. David Karli, Greyledge, Interventional Orthopedics, Knee Pain Relief, OrthoBiologic Institute, Platelet Rich Plasma, Regenerative, stem cells
