The argument frequently advanced by orthopedic surgeons in response to a patient’s inquiry concerning stem cells for arthritis is that it is too early, there is not enough research, It is better to have a major surgical procedure. For those of you who have read my blog or have sought orthopedic consultation in my office, I have emphasized that my recommendations are evidence based. Each patient, for whom I have completed a cellular orthopedic intervention for arthritis, has been entered into a registry or clinical outcomes data base, IRB approved. Just as I pioneered the integration of clinical care with clinical research over 37 years as a joint replacement surgeon, so too do I now partake in the growth and development of the clinical pathways for regenerative medicine.
Last month, I exhibited a poster at a large regenerative medicine meeting wherein I shared my preliminary outcomes and thus educated other professionals using Intraarticular and Subchondral Bone Injection of Autologous Bone Marrow Concentrate and General Fluid Concentrate for Osteoarthritic Knees-A Prospective Clinical Study. Osteoarthritis is an organ disease that affects most structures of joints including cartilage, synovium and subchondral bone. Pathology in subchondral bone contributes to the initiation, progression and pain of Osteoarthritis. In previous European studies, the injection of autologous bone marrow concentrates into bone supporting the joint significantly relieved pain and improved function of the affected knee. The preliminary outcomes in the study that I presented via a poster exhibit, investigated the effectiveness of injections of Bone Marrow Concentrate with General Fluid Concentrate (Growth factors), into both the knee joint and the subchondral bone. The study recorded all the standard Endpoints I had previously used in joint replacement clinical outcomes trials.
Bone Marrow was collected from the pelvis and a filtration system allowed for concentration of Mesenchymal Stem Cells, Platelets, Precursor Cells and Growth factors such as A2M, IRAP, EGF, PDGF, TNF-B blocker, etc. After preparation, a mixture of Bone Marrow Concentrate and Growth factor Concentrate was injected into the bone (subchondral) and into the joint.
In the study, all patient injections went well and there were no complications. The Preliminary Results documented diminished pain and improved function. We concluded that injection of Bone Marrow Concentrate and Growth factor Concentrate into both the subchondral bone area and joint cavity significantly improved function of the affected knee joints and significantly reduced joint pain. While there are many stem cell providers to be found because of their marketing, choose the center of excellence in Cellular Orthopedics that is evidence based.
Call to schedule a scientific based consultation from an orthopedic surgeon 1 (847) 390-7666.
You may access my web site at www.SheinkopMD.com.
Tags: avascular necrosis, bone lession, bone marrow, Cartilage, cellular orthopedics, clinical study, Growth Factors, IRAP, joint pain, joint replacement, knee pain, knee replacement, meniscus tear, Osteoarthritis, platelets, PRP, regenerative medicine, sports medicine, stem cells, subchondral bone
On Wednesday, I completed several bone marrow concentrate procedures for patients with arthritic knees. You will recall that Concentrated Bone Marrow contains living Adult Mesenchymal Stem Cells, Growth Factors, Platelets, Exosomes, Precursor Cells and more allowing for pain relief, improved function and possible regeneration in those afflicted by arthritis. In the afternoon, four patients underwent Autologous Platelet and Growth Factor interventions; two in the hip and two in their knees. An example of the outcome, now four months following intervention in my own knees and hips, I spent last weekend hiking along several spring creeks, fly fishing in Southwest Wisconsin in the morning and planting over 150 Lilly bulbs in the afternoon. Admittedly, I slept well on Saturday and Sunday night but visited the health club on these past Tuesday and Wednesday evenings for my fitness routines.
On Monday, we finalized and edited a manuscript reporting the results of 56 patients with arthritic knees, followed for 2 to 4 years having received Bone Marrow Concentrate. Using the same outcome metrics and statistical tabulation methods I had employed as a joint replacement surgeon, this study is one of the most significant trials ever completed and to be published in Cellular Orthopedics. Our study not only will help determine the indications for a “stem cell” procedure, but also assist in determining how long the benefits will last, and provide a road map for when adjunct or repeat interventions are indicated. Now the physician will be better prepared to help a patient decide between a Total Joint Replacement and a Cellular Orthopedic intervention on an evidence based knowledge.
I am writing this Blog while flying to San Jose, California where I am partaking in advanced training that will allow me to expand my regenerative medicine practice to the low back. Again and again, patients ask as to what I might offer to address low back pain and disc disease now that I have successfully intervened in an arthritic hip or knee. Indications and techniques for addressing the lumbar spine will make up the curriculum enabling me to add discogenic and degenerative arthritic conditions of the low back to my scope of regenerative care by mid May.
To the patient who called, “I heard through the grapevine that it doesn’t work”, you may avoid falling victim to the Fake Stem Cell claims in newspaper ads or via celebrity testimonials; those in amniotic fluid are dead on arrival to you. Seek scientific evidence at (847) 390-7666 or learn more on my web site where you may watch my webinar www.Ilcellulartherapy.com.
Tags: Adult Mesenchymal Stem Cells, arthritic conditions, back pain, cellular orthopedics, Concentrated Bone Marrow, degenerative disc disease, discogenic, Exosomes, Growth Factors, Hip pain, joint pain, knee pain, Osteoarthritis, platelets, Precursor Cells, Regenerative Pain Center, shoulder pain, stem cell therapy
Every year at this time, we each recall and celebrate several significant events of historic, cultural and spiritual importance. No matter what your roots or upbringing or present belief, these past eight days usually involve a gathering of friends and family to jointly read and remember that which happened long ago and still impacts us today. Whether done in a house of worship or in the home, somehow, we ask similar questions and teach our children and grandchildren that which befell us in ancient days. To underscore those similarities, some years ago, when my son had his Bar Mitzvah at the Western Wall, a Franciscan Monk who I had come to know invited us the next day to a Pre-Easter service at the Church of the Holy Sepulchre. Other than The Gregorian chants and the frankincense, the superstructure of the 90-minute service was quite familiar.
I use this yearly celebration to reflect and meditate; it also initiates the spring cleaning ritual in our house. Having grown up in Humboldt Park and later Albany Park to parents who left Europe in time, Passover meant it was time to clean and wash the kitchen cabinets, recycle, and dispose of certain foods. On Division Street, we lived near my orthodox grandparents; in Albany Park, they lived with us, so the everyday plates and silverware were taken to the basement and exchanged for special settings reserved for this time of year.
Certainly, times have changed and we have assimilated; but my wife still prepares the appropriate meals for the week and makes sure the house is immaculate. Then the family and company visits end and we are challenged by the need to address the residual back scuffs on our wood kitchen floor; lots of them and pronounced. Here is where the ultimate test of the cellular orthopedic intervention to my own hips and knees, now almost four months ago comes into play.
With the coverage varying between the Masters, Cubs, and Sox games in the background, we genuflexed, spread the Murphy Oil Soap and started rubbing away with microfiber wipes. This exercise lasted about two hours, admittedly with several breaks. Nevertheless, we accomplished our mission and I got up unassisted to head to the health club for my strength training respite.
This morning, Section one of the Chicago Tribune carried three full pages, in color, competing ads concerning Regenerative Medicine; none giving much information about science or outcomes but certainly employing one-time prominent athletes as spoke persons. Is it worth a free lunch to become a marketing dupe? As readers of my Blog know, I myself had Cellular Orthopedic intervention to my knees at the end of 2017 and to my hips at the start of 2018. This morning I scheduled two ski trips in 2019 to Vail; on Saturday morning, I am headed to Southwest Wisconsin for a long weekend to bike and fly fish; and I am on standby at any time to genuflex and spread that murphy oil soap.
So as advertised on Friday night Cable, you may receive a $250 gift certificate for attending a Stem Cell Seminar, or you may get examined and receive counsel from this orthopedic surgeon focusing on Cellular orthopedics. For the latter call 312 475 1893 to schedule an appointment, one on one. You may access my web site and watch the webinar at www.Ilcellulartherapy.com
Tags: arthritis, genuflex, Hip pain, Hip Replacement, knee arthritis, knee injury, knee pain, Osteoarthritis
I am sitting at my computer this morning writing the weekly Blog posting and not attending the IOF meeting taking place today in Broomfield, Colorado; yet I am reporting about the meeting. Instead of attending, I am preparing for a week-long ski adventure with my family next week in Vail, Colorado while trying to catch up in my practice. How is it than possible that I know what is taking place at the meeting? Listed below are five of the 10 ongoing or completed cellular orthopedic clinical trials in which I am a principal investigator or co-researcher. The preliminary and final data resulting from these clinical research initiatives is the outcomes foundation for what is being presented at the IOF podium today and tomorrow.
1) 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
2) Outcomes of Bone Marrow Concentrate (stem cell, platelet and growth factor) Intervention at the Knee for Grades 2 and 3 OA in 50 patients at 2 to 4 years. (supported in part by Regenexx)
3) Outcomes of Intra-articular Bone Marrow Concentrate versus those of combined Intraarticular and Intraosseous interventions for grades 2 and 3 OA at the knee at one year. (self-funded). Ongoing
4) How does the PRP and Mononucleated cell count affect the outcome of a BMC intervention for grades 2 and 3 Knee OA? (a joint project with Greyledge) Ongoing
5) Safety and Efficacy of Percutaneous Injection of Micro-Fractured Adipose Tissue for grade 4 Osteoarthritic Knees, minimum follow-up of 18 months in 30 patients (supported in part by Lipogems)
I had to prioritize; and since most of the arthritis data being presented is all or in part mine, I already know the subject matter. By staying home, I also found the opportunity to browse “stem cell” websites as suggested by ads in today’s newspapers or introduced by email blasts this week. Wow, a patient acting more like a consumer is really at risk for succumbing to Regenerative Medicine “false news”.
If you want to learn more about the difference between the stem cell purveyors and a legitimate, FDA compliant, evidence based, cellular orthopedics initiative, call to schedule a consultation or to get a second opinion.
You may schedule a visit at (847) 390-7666
You may access my website and watch a webinar at www.ilcellulartherapy.com
Tags: arthritis, bone marrow, Celling, cellular orthopedics, Growth Factors, Hip pain, International Orthopedics Foundation, joint pain, knee arthritis, knee intervention, knee pain, lipogems, Micro-Fractured Adipose, Osteoarthritis, PRP, regenerative medicine, Regenexx, stem cells, Subchondroplasty
On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be governed by homologous use. As I interpret the guidelines there are winners and losers:
Physicians who use compliant regenerative therapies:
- Amniotic fluid without stem cells
- Blood-derived preparations (e.g., PRP, PPP)
- Bone marrow aspirate
Physicians who use non-compliant regenerative therapies:
- Adipose tissue-derived materials obtained by enzymatic digestion
- Amniotic fluid with cells Cord blood derived materials (non-autologous treatments)
- Stem Cell Clinics that advertise about using amniotic fluid as a source of stem cells and regenerative therapy along with those clinics that treat everything from alopecia to ALS to arthritis
You might ask how is that different from the current situation? First of all, the FDA Commissioner has stated in press releases that the FDA is going to go after bad actors. The Cures Act provided for increased funding to the FDA, which we suspect the Commissioner will use in part to go after the bad actors. Also, the FDA wrote in their Guidance on Minimal Manipulation and Homologous Use that “healthcare providers” need to pay attention. We have never seen them explicitly refer to the doctors and clinics providing regenerative medicine. Finally, the FDA indicated that there would be a transition period (3 years) during which manufacturers would need to enter the RMAT program to get their non-compliant products properly approved; or else. And the reason that there could be teeth in the “or else” is that the FDA will get lots of fees from all of the non-compliant products entering the RMAT program.
Last of all, what the FDA did not address as part of consumer protection; but what I incorporate in my daily practice is evidence based intervention.
Now that you are better informed and have an idea as to the laws governing our regenerative medicine marketplace, stay away from the Charlatans and Camp Followers. Then take the next step and ask your physician for the Outcomes Evidence on which a regenerative intervention for your arthritic joint is based before undergoing a procedure. To better understand that evidence call for (312) 475 1893 to set up a consultation
You may watch my webinar by accessing my web site www.ilcellulartherapy.com.
* Minimal Manipulation and Homologous Use
Tags: adipose tissue, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip Replacement, Interventional Orthopedics, joint replacement, Mesenchymal Stem Cell, Minimal Manipulation and Homologous Use, Orthopedic Care, Orthopedic Surgeon, Platelet Rich Plasma, PRP, regenerative therapies, stem cells
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
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