Jan 6, 2017
In reviewing the plethora of proliferating Regenerative Medicine web sites, I found one with multiple points of service in metropolitan Chicago offering platelet rich plasma, fat graft, adipose derived stem cells and bone marrow derived stem cells in an office setting for the treatment of ALS, Alzheimer’s, Erectile Dysfunction, Alopecia, Autism, Cerebral Palsy, Aesthetic improvement and so on and more. There was no end to the promises advanced. At no time was there any evidence of success posted and absolutely no data.
For the first 37 years of my orthopedic practice, I collected outcomes data for every patient in whom I performed a hip or knee replacement. Prior to a surgical procedure, I provided the patient with meaningful outcomes data concerning success and length before a revision surgery might be required. That scientific documentation was scientifically published and used globally for informed consent by orthopedic surgeons around the world. Anticipating the future, actually the present if you live in Alabama, not only do I quantitate that which is injected into an arthritic joint, I am able to qualitate the injectate. I refer to Alabama because that State requires a physician to know exactly what is being injected into a patient when a she or he administers such or the physician is not complaint with that state’s law. With the incorporation of Abbott’s Ruby hemoanalyzer into my Cellular Orthopedic practice, I meet ethical, moral, legal and scientific guidelines and anticipate what I believe will shortly become an FDA compliance requirement. My practice is limited to that which has data to support my recommendations for a symptomatic, arthritic joint; while at the same time documenting the quality and quantity of the combination of Bone Marrow Concentrate, Growth Factors and Platelet Rich Plasma I am injecting.
There is the beginning of an initiative to comply with an anticipated more stringent oversite by the FDA concerning the developing subspecialty of Interventional Orthopedics and I am thrilled to be part of that small group. The FDA is a governmental agency responsible for the well-being, health and safety of the public. While likesome charlatans might get by in the short term, I am thrilled to be part of this initial group of responsible Board Certified Orthopedic Surgeons, Physiatrists and Pain Management specialists providing scientifically supported, FDA compliant, Cellular Orthopedic and Regenerative Medicine options in Sports Medicine and for management of an arthritic joint.
You may schedule an appointment by calling 312 475 1893
My Website is reached at www.Sheinkopmd.com
You may watch my webinar at www.ilcellulartherapy.com
Tags: Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Knee Pain Relief, Platelet Rich Plasma, PRP, stem cells
Oct 27, 2016
I recently received the yearly publication from the Orthopedic and Rheumatology Institute of the Cleveland Clinic; the latter recognized as one of the 10 most prestigious orthopedic centers in the nation. Every year the publication, a marketing exercise by the Cleveland Clinic, focuses on certain subspecialty areas within the discipline of the care and treatment of the musculoskeletal system. The obvious purpose of such a yearly event is to recruit referrals from practicing orthopedic surgeons and rheumatologists as well as the medical community in general.
This year the focus was on Adult Total Hip Arthroplasty for Osteoarthritis and Adult Unilateral Total Knee Arthroplasty for Osteoarthritis. I will summarize the results; let’s start with the hip:
“Hip-Related Pain 1 Year After Surgery: “on average, 92% of patients reported clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain).”
“On average, 90% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function).”
The knee doesn’t fare as well:
“On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain).”
“On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function).”
The data was derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed.
In my practice, every patient who undergoes a Bone Marrow Concentrate intervention is entered into an outcomes data base with both subjective and objective data points measured. It is quite comprehensive and numbers over 500 patients extending over a span now of 4 and ½ years. While the Cleveland Clinic report is based on subjective parameters and ours on both subjective and objective scores, I am able to extract subjective measures alone. I am pleased to report that in the case of the hip and the knee, our outcomes with a needle are equal to or better than those of the major surgery with a scalpel. Then factor in the prompt rehabilitation of a stem cell procedure compared with the prolonged rehabilitation inherent in a joint replacement. Lastly, consider the relative absence of complications of a stem cell intervention compared to the morbidity and mortality of a joint replacement.
Perhaps of greater significance to the stated advantage of a Bone Marrow Concentrate procedure for Osteoarthritis is the fact that no bridges are burned. If the patient is not satisfied at one year or five, a stem cell procedure may be repeated with a needle. If the arthritis progresses to an advanced stage, the fall back option is a joint replacement. The only choice following an unsatisfactory joint replacement is to accept the surgically induced impairment or undergo a risky revision surgery with a high likelihood of a complication or less than satisfactory outcome. Call 312 475 1893 to schedule an appointment today.
For more information watch my Regenerative Medicine Webinar Video
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, knee replacement, Orthopedic Care, Orthopedics
Aug 4, 2016
There are now available six month follow up Outcomes Data regarding 20 patients who underwent a fat graft harvest, micro-fracture of the fat graft and intervention in an arthritic knee, the latter so severe that the original recommendation to the patient had been a Total Knee Replacement. 85% of this group are very satisfied at this time with the post intervention pain relief and functional improvement. One patient did elect to undergo a Total Knee Replacement eight weeks after the initial intervention. While six-month Data is very preliminary and doesn’t lend itself to a scientific journal publication, I am told the results will become the subject matter of a White Paper, an authoritative report, while the outcomes of the 20 patients will continue to be monitored.
As I have previously reported, I personally am taking a Principal Investigator role in a Clinical Trial centered on the most contemporary ortho-biologic methodology for processing Amniotic Fluid Concentrate. What piqued my interest is the continued marketing placements in our media: ”Stem Cell therapy is an exciting new therapy option that treats arthritis”. “Free Educational Seminar”. “Stem cell regeneration utilizes amniotic stem cells”. I am reminded of the prank I used as a child on my playmates “Pete and Repeat were sitting in a boat, Pete fell out, who was left?” As I have written on my Blog multiple times, there are no viable stem cells in amniotic fluid once processed, irradiated, frozen and fast thawed. That is not to say that AFC may not act as an anti-inflammatory eventually replacing visco-supplementation in attempting to improve the well-being of patients affected by arthritis; but it has no regenerative potential. My interest in leading a Multi-Center Clinical Trial -no out of pocket expense for those who meet the inclusion criteria-is to learn appropriate dosage and duration of effect if any. Subchondroplasty continues to be a subject of increasing interest in the orthobiologic world. I will be serving as a Principal Investigator in a stem cell based subchondroplasty clinical trial as soon as there is IRB approval toward the end of August. I hope to determine if a combined intraarticular and extra-articular Bone Marrow Concentrate approach will result in superior outcomes when contrasted to the standard intraarticular approach.
Be advised and reminded the Regenerative Medicine discipline is evolving and the over seer is the FDA. Make sure that should you decide to pay unreasonable amounts for unproven therapies, those marketing such are doing so under an IRB regulatory methodology. To learn more, schedule an appointment:
312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
Jul 18, 2016
For those new to this Blog, my focus on Regenerative Medicine has just started its fifth year. Prior to that time, I was an orthopedic surgeon surgically replacing hips and knees at a major academic Chicago Medical center for almost 40 years. I then graduated into Regenerative Medicine where I have dedicated the past four years helping patients avoid or at least postpone when possible, a joint replacement for an arthritic hip, knee, shoulder or ankle. You may have learned from that previously written, during my joint replacement years, every patient undergoing a hip or knee replacement became part of a comprehensive database wherein by integrating research with patient care, I would continue to stay in the forefront of reconstructive orthopedics. I would present my findings at various orthopedic seminars around the world and share my knowledge with interested orthopedic surgeons so they could determine the best prostheses, the best surgical approaches, the best rehabilitation techniques, how to prepare a patient for a procedure, and how to achieve the best possible outcome both functionally and from the standpoint of survivorship of components.
When I entered the emerging discipline of Interventional Orthopedics, I introduced my knowledge of orthopedic research as well as my support team, adapting joint replacement clinical research methodology for stem cell intervention outcome surveillance. Owing to my long tenure as a clinician and my Emeritus Professorship designation, many now are seeking my advice and counsel on how to maximize outcomes from a Bone Marrow Concentrate intervention in an arthritic joint. All this being said, within the last several days, I have provided stem cell consultation to a retired professional baseball player of note, and to a medical tourist from the United Arab Emirates, where I had taught joint replacement surgery over 11 times between 2001 and 2007. Today, my office received a call requesting a consultation from a family of Turkish tourists visiting Chicago. Between 2002 and 2006, I had visited Turkish Orthopedic Centers in Izmir, Ankara and Istanbul to demonstrate hip and knee replacement procedures while also lecturing on five separate occasions by invitation around the country.
The point is that there are those of us who are qualified intellectually, experientially, and clinically to assist the patient limited by arthritis of a major joint using Evidence Based Medicine for stem cell care; while there are those who recruit patients by placing a marketing ad with unsupported claims in the media. If you want a consultation based on Best Regenerative Medicine Practices, call for that consultation: 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Clinical Studies, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Regenerative, Regenexx, treatment
Jun 30, 2016
Out is routine Medicare and insurance coverage indemnification of hyaluronic acid injections for osteoarthritic joints other than the knee. Additionally, several insurance carriers are now requiring pre-certification to determine if they will even cover hyaluronic acid injections of the knee. The phenomenon was first reported in Florida but now the reduction in coverage is spreading across the country including Illinois. A physician may decide to proceed with the single, thee part or at times five part injection series but it would be at the expense of the patient if insurance and Medicare deny coverage. The reason behind the decision has to do with long-term studies that fail to validate the claims of the many advertisements you may see on television or find in the newspaper concerning the various forms of hyaluronic acid as a gel.
Increasingly in is Amniotic Fluid Concentrate for Osteoarthritis even though not covered by Medicare or Insurance. The clinical trial regarding outcomes for said therapy are incomplete; and to the best of my knowledge, the only source of Amniotic Fluid Concentrate providers seriously investigating results is MiMedx, out of Marietta, Georgia. Nevertheless, there seems to be an ever-increasing presence of Amniotic Fluid Concentrate offerings in the medical marketplace; unfortunately with unsupported claims of a stem cell content. There does seem to be a benefit from amniotic fluid concentrate in relieving the symptoms of an osteoarthritic joint but we have to wait for completion of current clinical trials to understand proper dosage and the length of action.
If you are a regular reader of this Blog, you will have become familiar with the term Subchondroplasty, an adjunct that I have been offering on occasion in conjunction with Bone Marrow Concentrate/Stem cell procedures into the joint. The successes of Subchondroplasty are such that the attention to the bone supporting the joint when working inside the joint is a subject gaining increased attention on a national basis. It looks like the future will be an increasing combination of both intra-articular and extra-articular intervention. While no one is able to confirm why the decompression of the bone adjacent to a joint relieves pain and why the adjunct of biologics improves longer-term outcomes, attention to bone defects in the area around the joint is proving to make a major difference in outcomes for arthritis. The question now is whether the best approach is Bone Marrow Concentrate inside and outside the joint or Bone Marrow Concentrate inside the joint with a synthetic augment outside the joint?
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, Subchondroplasty, treatment
Jun 20, 2016
This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (312) 475-1893 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
