Sep 13, 2018
I rode my bike this past Saturday and Sunday through the Chicago Forest Preserve bike trails and I had some time to reflect. Just as in fly fishing, cycling is meditation time. I tried to answer questions that came to mind such as how could Abraham have fathered both Izsak and Ishmael in his late 90s? Was it the triumph of stem cells or something more? I reflected on this through the Monday service without resolution other than we are still dealing with the ramifications.am
On Tuesday morning, the usual and customary ad in the Chicago Tribune paid for by the Stem Cell Institutes of America appeared inviting readers to a seminar to learn more about their approach to pain from arthritis and assuring the reader that their techniques are FDA compliant. Their approach is based on Amniotic Fluid injection. What I do know is FDA compliance requires that the stem cells must be yours (autologous) and that amniotic fluid once processed, sterilized, frozen and fast thawed has no viable stem cells. I also am cognizant of the large body of scientific evidence supporting the notion that pain of arthritis is generated by the supporting bone as cartilage has no nerve supply. How does a single and costly injection of amniotic fluid result in long term benefit? I have to deal on a daily basis with the fallout of this marketing campaign.
Next the Wednesday, September 12, addition of the Chicago Sun Times carried an ad sponsored by The Pain Relief Institute headlining Stem Cell Recruitment. As I understand the approach, Amniofix, a placental derivative, micronized, is reconstituted and injected into the arthritic joint. Reader please note that the first bullet states “FDA Regulated”. Of interest is the fact that I refused and still refuse to use Amniofix in my practice as there are no evidence based clinical trials to support any clinical claims. Those trials are taking place now. Amniofix is a product rushed to market before there was scientific proof to support use. You may learn more about Amniofix by searching the product online. If you don’t count cells with a hemoanalyzer, how could you know what is being “recruited”?
My commitment is to stand up for my patient in this regenerative medicine chaos. I resolve to do better in the upcoming year with introspection and ongoing review of the discipline.
With best wishes for a happy and healthy 5779
You may visit the website at www.sheinkopmd.com
Schedule an appointment by calling (312) 475-1893
Tags: amniofix, amniotic fluid, autologous, cellular therapy, FDA, regenerative medicine, stem cell
Aug 8, 2018
Last week, I assessed three different patients for Cellular Orthopedic joint restoration; and each patient asked about the reason behind my fee schedules? One patient had told me of a friend who had attended a seminar by the Stem Cell Institutes of America and who was quoted a fee somewhat lower than my charges. As I have previously emphasized, the Stem cell Institutes of America use Amniotic Fluid that is concentrated and once processed and thawed, has no viable stem cells or regenerative potential. There may be proteins that survive but basically, a patient receives an injection of hyaluronic acid that cushions the joint for up to six months at best and for which there is no supportive outcomes data.
The second patient had been quoted a fee for cord blood. The latter is provided in frozen form and much of the value is lost during the thawing process. While significantly less costly than a bone marrow concentrate and growth factor concentrate intervention, there is no outcomes data to support usage. The FDA has warned against the use of “stem Cells” derived from anyone or anything other than your own (autologous). So if amniotic fluid and cord blood did deliver viable stem cells, their use would be contrary to FDA guidelines; but let’s move on since neither has living cells when thawed.
Then there are the adipose derived globules, notice I didn’t use the term stem cells. Fat globules are prepared after liposuction and the fat is mechanically broken down but the stem cells aren’t released. In order to release stem cells from the fat, the tissue has to be treated with collagenase. The FDA prohibits use of collagenase in fat unless it is for a cosmetic indication.
My knowledge base is the result of first having completed three clinical trials using Amniotic Fluid for arthritis and in each trial, the outcomes were not satisfactory after six months. I next traveled to Southern California to investigate cord blood. I was skeptical at best but tried the product in three knees, all with very unsatisfactory results. Two years ago, I completed a clinical trial on a mechanically derived adipose based product; the manuscript for that study was accepted by highly regarded orthopedic journal and will be published later this year.
When all is said and done, you may save money with the bottom feeders who advertise and market without data or outcomes to support their claims or you can avail yourself of my knowledge, expertise and statically proven outcomes. To schedule a consultation, call 847 390 7666. You may visit my web site at WWW.SheinkopMD.com
Tags: amniotic fluid, Cord blood, joint pain, joint restoration, regenerative medicine, stem cell
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
Mar 16, 2017
As most readers of this Blog already know, for more than 37 years, I was a reconstructive joint replacement surgeon at a major Chicago medical center, where I served as the director of the joint replacement program. I retired as emeritus professor seven years ago; after having pioneered the integration of a clinical practice with joint replacement research and education. While I had completed over 20,000 hip and knee replacements during my career and played a major role in authoring over 85 major orthopedic publications, one of the highlights of my career was the recognition by the resident staff of awarding me the teacher of the year award in orthopedic surgery. At the same time, I had the opportunity to share my joint replacement knowledge around the world. I addition, many orthopedic surgeons from across the globe would come to observe and learn my techniques. One such group came from Norway. What I learned from them during their visit was that no procedure would be allowed within the scope of the government health care system for which there wasn’t a ten-year outcome data base. Their health care system wouldn’t pay for that which didn’t have a track record and for which there wasn’t safety and efficacy studies.
I am continually amazed at the epidemic of web sites promising regenerative medicine treatments for which there is no data of success and for which there are no safety and efficacy studies. This false news seems to be an increasingly common phenomenon; more bothersome though are anecdotal outcomes cited in media placements without a scientific foundation. Last week, a major news outlet focused on a patient who had received stem cells in amniotic fluid. The hospital PR division scored a major success by placing the ad; but the Television Channel that broadcast the story apparently failed to do any independent scientific investigation to support the claims of living stem cells in commercially available amniotic fluid concentrate. The center behind the placement and the physician involved must have been influenced by the false news now commonplace; namely, amniotic fluid has living stem cells when concentrated, sterilized, irradiated, cryopreserved and fast thawed. Certainly, the video of the patient climbing stairs was a tribute to the success of the procedure; however, the success of unknown duration had nothing to do with the claim that the end result was based on regeneration attributable to stem cells.
Amniotic Fluid Concentrate has good things in it but not viable, living stem cells and there is no regenerative potential. I am able to so state as I am the principal investigator in a national ongoing amniotic fluid clinical trial to determine safety, efficacy, duration of effect and appropriate dosage.
To schedule an appointment call (312) 475-1893
To visit my web site go to www.sheinkopmd.com
To watch my webinar visit www.ilcellulartherapy.com
Tags: amniotic fluid, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, cryopreserved, Interventional Orthopedics, Osteoarthritis, regenerative medicine, stem cell treatment, stem cells
Dec 19, 2016
I use bone marrow derived stem cells because they have been proven to be most effective at treating orthopedic conditions when compared to adipose derived stem cells. There have been 13 papers published showing bone marrow superiority to adipose tissue in regards to treating orthopedic conditions and to the best of my knowledge, none reporting adipose derived results for arthritis. In addition to Adult Mesenchymal Stem Cells, bone marrow has 1,000-10,000x more hematopoietic stem cells than adipose tissue; the former is necessary for muscle repair. Recently, we learned that bone marrow also has osteochondral reticular cells which are not found in adipose tissue and serve as orthopedic repair cells. While adipose tissue and bone marrow both have stem cells, the skeletomuscular specific cells only found in bone marrow make it the best at treating orthopedic conditions. I don’t have a stake in doing bone marrow derived stem cells, I practice evidence based medicine and do what’s been shown to provide the best results. If with continued research something superior to bone marrow derived stem cells becomes available, then I will gladly adopt that protocol.
http://www.regenexx.com/fat-vs-bone-marrow-stem-cell-video/
- As I have reported on this Blog many times, research has shown the amniotic fluid samples being marketed as having stem cells actually do not have any viable stem cells when received and viewed in the laboratory. I do use amniotic fluid concentrate from time to time for its concentrated hyaluronic acid effect.
http://www.regenexx.com/amniotic-stem-cells-great-deception/
- Since we manually process bone marrow when aspirated, I am able to customize PRP which we call SCP or super concentrated platelets. The ubiquitous beside centrifuge only has one setting for volume and concentration so those using this approach are treating every patient without concern for individual differences. With the addition of the Abbott Ruby Hemocytometer, I am able to customize the treatment of the individual patient. We can concentrate our SCP from 3-40X over baseline-with or without red or white blood cells. From my outcomes data base, I know what volume and concentration works best for treating the various body parts.
- We’ve developed HD BMC or high dose bone marrow concentrate which is far superior to that produced with bedside centrifuges used by most claiming expertise in Regenerative Medicine
- I perform BMAs in compliance with the peer-reviewed literature recommendations as well as in keeping with my internal best practices research to maximize MSC yield. As stated, I count cells and know the quality in addition to the quantity of the injectate. Most doctors don’t count cells and have no idea what dose they are giving their patients
Tags: adipose tissue, amniotic fluid, arthritis, BMA, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Mesenchymal Stem Cell, MSC, PRP, Regenerative, SCP, stem cells
