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
Aug 29, 2017
Patients receiving either Hyaluronic Acid (HA- Synvisc, Supartz, Euflexxa) or Platelet Rich Plasma (PRP) injections will experience modest-term pain relief according to an article appearing in Orthopedics Today, August, 2017. In the study reviewed, Ultrasound Guided injections were given weekly for three weeks and patient-reported outcome measures (PROMS) were recorded for up to one year. “Both the PRP and HA groups demonstrated an improvement in PROMS at 24 weeks that declined to near baseline levels at one year” according to the article. “Patients with lower grade Osteoarthritis and lower weight responded more favorably to intra-articular injections”. The effect of both Hyaluronic Acid and Platelet Rich Plasma appeared to be modest and temporary.
Why I chose this topic this week for my Blog has to do with my preparation for the upcoming talks I am invited to give September 21st and 22nd in St. Petersburg, Russia at the meeting of 1200 orthopedic surgeons from Russia, Ukraine and neighboring countries both in Europe and Asia. As I indicated last week, this will be the first time a non-operative intervention of a cellular orthopedic, regenerative nature, as I practice, will have been introduced into this region of the world. While Hyaluronic Acid and Platelet Rich Plasma may offer short term pain diminution for individuals limited in function by the symptoms of Osteoarthritis, it becomes clear by scrutinizing my data base that not only does concentrated bone marrow afford long term relief, the Mesenchymal Stem Cells and Growth Factors found in bone marrow when concentrated participate in regenerative possibility thereby delaying and perhaps even avoiding a joint replacement. My presentations will be evidence based without the false news and unsupported marketing claims ever present in the media.
What we have learned about Amniotic Fluid (AF) from my role as principal investigator in several multisite studies is that AF does have concentrated Hyaluronic Acid and therein may offer six to 12 months decrease in symptoms and increase in function, the effect is limited in duration; and with no viable stem cells in Amniotic Fluid Concentrate, there is no regenerative potential. Owing to the absence of inherent absence of stem cells and hence regenerative potential, I will not include amniotic fluid in my presentations.
As a scientific invitee, my responsibility is to introduce that for which we have scientific support and clinical evidence. If you want to gain a better understanding of Regenerative Medicine and Cellular Orthopedic and learn how you may postpone or perhaps avoid a joint replacement for the symptoms and limitations imposed by osteoarthritis, make an appointment, visit my web site and watch my webinar.
312-475-1893
www.sheinkopmd.com
www.ilcellulartherapy.com
Tags: arthritis, hyaluronic acid, Interventional Orthopedics, Knee Pain Relief, Orthopedics, Osteoarthritis, PRP, Regenerative, stem cells
Aug 4, 2017
Most readers know that I “graduated” from joint replacement surgery into an emerging field of Regenerative Medicine about five years ago. Prior to that time, I had dedicated 37 years to Reconstructive Orthopedic Surgery and played an active role in a joint replacement practice combining research with education as I improved the quality of life for my patients. By the end of my surgical career, I had authored more than 90 scientific papers in the field of hip and knee replacement as well serving in the leadership of the joint replacement program at a major medical center in Chicago.
That was “back in the day” of joint replacement surgery; but rather than live in the past, I have elected to partake in the present and advance Cellular Orthopedics into the future. I now have the largest and most comprehensive clinical outcomes data base in the United States concerning Bone Marrow Concentrate, Mechanical preparation of Adipose Graft, and Amniotic Fluid injection used in the treatment of knee arthritis. This information has allowed me, up until now, to make a scientifically based recommendation as to the best regenerative option for dealing with an arthritic joint.
In my initiative to advance the discipline of Cellular Orthopedics, the next innovation will be to offer a prior analysis of the stem cell content for the patient seeking the regenerative option as a means of postponing or avoiding a joint replacement. Should a patient present with osteoarthritis seeking to determine if she, he or hir will benefit from Adult Mesenchymal Stem Cells and Growth Factors, I am able to offer the equivalent of a bone marrow biopsy and determine the amount of viable cellular orthopedic content available in that individual’s bone marrow. My recommendations then would be based on actual number of cells and not on age related or disease influenced averages or estimates. Predictability of an individual’s outcome in determining whether to proceed with the regenerative intervention would be customized and not generalized. Where this scientific leap forward would be of particular interest includes patients over age 70, those who have received immune altering systemic management for a co-morbidity or for patients whose medication requirements up until now would have eliminated them from a regenerative consideration.
To learn more schedule an appointment 847 390 7666
You may access my web site and watch my Webinar at www.Ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, cellular orthopedics, Orthopedic Surgeon, Osteoarthritis, regenerative medicine, stem cell 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
