Jan 24, 2019
Why Should This Blog Matter To You?
- Stem cell treatments are NOT FDA cleared in the United States
- FDA is scrutinizing physicians and centers that are marketing stem cells
Beware of centers that are offering to:
- Relieve pain
- “Regeneration” of tissues
- Avoid surgery
- Treating a variety of inflammatory, degenerative, or autoimmune conditions
Beware of Stem Cells Clinics!
- Many of these “stem cell clinics” are operated by chiropractors or providers that do NOT have a specialty or advanced training in the musculoskeletal system.
- They simply do not have the training necessary to perform these injections nor are they licensed to so do.
- In some cases, surgery is needed. These providers may not evaluate the need for a surgical procedure.
Federal Trade Commission Press Release: https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic
FTC Court Documents: https://www.ftc.gov/enforcement/cases-proceedings/172-3062/regenerative-medical-group-inc
The Complaint filed by the FTC on October 12th states the following:
Defendant Henderson is aware that the vast majority of amniotic clinical studies in the scientific literature has been conducted on animal models. There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases of health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. (p. 4)
The representations set forth in Paragraph 21 […Defendants have represented…that their stem cell therapy: cures [everything]…Is comparable to or superior to conventional medical treatments in curing, mitigating, or treating specific diseases or health conditions including [everything]…] are false or were not substantiated at the time the representations were made. (p. 21)
The FTC essentially has said that there is no clinical basis to claim a therapeutic benefit to treating patients with amniotic stem cells, so the claims and representations by Dr. Henderson constitute deceptive practices and false advertisement.
If you connect the dots, it would suggest that Dr. Henderson engaged in fraud by taking money from patients and treating them with a preparation for which there is no clinically valid proof of therapeutic benefit. Regardless of whether the Department of Justice gets after him for a criminal complaint of fraud or not, I think organizations that offer up a worthless therapy consisting of amniotic stem cells (until proven otherwise with Level 1 studies) could be good targets for class action lawsuits by defrauded patients. The same situation doesn’t apply to PRP and BMC, (what I do) since there is plenty of clinical evidence of therapeutic benefit including my scientific article published in December, 2018.
Sheinkop, et.al Transnational Medicine – published Dec. 13 2018
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis; a randomized control trial with 2 year follow-up.
If you want to complain to the FDA about having received Amniotic Fluid without benefit, use this link:
https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118859.htm
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, amniotic stem cells, Bone Marrow Concentrate, Clinical Studies, clinical trial, Clinical Trial. Mitchell B. Sheinkop, Cord blood, FDA, joint pain, joint regeneration, joint replacement, Osteoarthritis, Regenerative, research, stem cell, surgery
Dec 20, 2018
How long will the benefits last?
Yesterday, an individual presented in the office on a professional matter for a scheduled business meeting and during our discussions, related that he had undergone right hip arthroscopy, eight weeks earlier. He had an antalgic (painful) gait while walking into the meeting room so I discussed the rationale for undergoing a Platelet Rich Plasma concentrate/Growth Factor Concentrate intervention when he returned to his home base. The individual elected to become my patient on the spot so I performed a physical assessment and noted asymmetrical hip motion with limitation on the right side. His pre-arthroscopic diagnosis was a torn acetabular labrum. In 45 minutes, my team had drawn his blood and prepared the concentrated injectate followed by my completing an ultrasound guided intraarticular right hip injection. Within five minutes, his inability to fully spread his legs, flex and extend his hip, and tolerate internal and external rotation had been corrected. This is not an infrequent observation following a Cellular Orthopedic intervention to the hip; yet I have no explanation for the immediate pain relief and return of joint function. He left the office with almost no discernable limp.
This past Monday, the office received this communication from a patient who began treatment with Bone Marrow Concentrate to her knees about four years ago; returning on several occasions until she reached maximum medial improvement at 18 months post intervention.
“I wanted to write to you and Dr Sheinkop to congratulate you on the published study in the Journal of Translational Medicine in which I was a participant. It is really satisfying to see that results finally in print. I want to thank you both for allowing me to participate, even though I was outside of the Chicago area.
Just to follow up, my knees have been doing really well for the past year. I enjoyed a long summer of bicycling, including regular 20-30 mile rides as well as a 40 and 50-mile ride, without significant pain. I also have been able to use the elliptical pain free and just in the past two weeks I started running on the treadmill (alternating one minute of running & walking for about 20-25 minutes on a 4% incline). I’m starting really slow -but I never thought I would be able to run relatively pain-free again”.
There is no way of predicting how soon and for how long a cellular orthopedic intervention will have an effect. Our ongoing outcomes observations for over six years may eventually help answer the question; but in the meantime, we ask our patients to return periodically so we may learn from them and intervene if needed.
To learn how you may benefit from a Cellular Orthopedic intervention schedule a consultation by calling (847)-390-7666. My web site is at www.sheinkopmd.com.
Tags: Adult Mesenchymal Stem Cells, arthritis, Bone Marrow Concentrate, cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Interventional Orthopedics, Knee Pain Relief, Mesenchymal Stem Cell, micro-fractured fat, Orthopedics, Platelet Rich Plasma, Platelet Rich Plasma concentrate/Growth Factor Concentrate, stem cells, Subchondroplasty, torn labrum
Sep 27, 2018
Until 2002, the patient seeking a joint replacement consultation would ask me “how long will new joint last”? Then came the era of minimally invasive surgery -I played a major role in the introduction-and now the question became “how long is the incision?” and “how long will I stay in the hospital?” While the number of “Regenerative Medicine” options for the treatment of osteoarthritis continues to increase, in the current medical marketplace, it is via direct to consumer advertising that “breakthroughs” are brought to the attention of those impacted by the symptoms and limitations of Degenerative Joint Disease. Whereas patients historically would base their personal medial decision making on consultation and guidance from the medical community, such is no longer the case. Media marketing is now the primary reason a patient makes the decision for which Regenerative option to choose. The problem is there is little if any scientific evidence to support the ad claims. In the one or two approaches where there is a paucity of evidence, the latter is on a handful of subjects at less than six months. Witness the recent reversal on insurance reimbursement for several placental derived products because of the absence of benefit at six months in clinical trials.
Included among the reasons featured in ads promoting Stem cells for arthritis, you will find,” it worked for me”. More recently it is a product that “recruits” your Stem Cells. On it goes with promotions for Stem Cells in cord blood, Stem Cells in Wharton’s Jelly, and Stem cells derived from your adipose tissue (fat). Missing from the entire marketing campaign in almost every scenario is outcomes data. I am an orthopedic surgeon who, prior to my Cellular Orthopedic initiative, played a major role in joint replacement surgery as Professor of Orthopedics and head of a prominent joint replacement program at a large Medical Center in Chicago. While performing clinical trials with new generations of hip and knee implants, it was well accepted in the orthopedic community that a minimum of two year follow up would be required before a scientific paper would be considered for publication. When I entered the emerging specialty of Cellular Orthopedics, I continued the integration of clinical practice with clinical research so that my interventional recommendations would be evidence based. Below are two of the manuscripts I co-authored; one having been accepted for publication and the other recently submitted for publication.
Safety and Efficacy of Percutaneous Injection of Lipogems Micro fragmented Adipose Tissue for Severe Osteoarthritic Knees
A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial with 2 Year Follow-Up
What I won’t promote is anything wherein there is not two years minimum of evidence concerning safety, efficacy and satisfactory clinical outcomes. I am not opposed to progress but best practices demand clinical trials of new options and those trials should be underwritten by the pharmaceutical company; not by a patient paying relatively large sums without meeting inclusion criteria and without follow-up leading to minimum two-year outcomes evidence.
To learn more, schedule an appointment (312) 475-1893. You may visit my website www.Sheinkopmd.com
Tags: adipose tissue, Bone Marrow Concentrate, cellular orthopedic, lipogems, OA, PRP, stem cells
Aug 16, 2018
From the front page of the September, 2018 issue of GOLF “This Tiger is for real. He’s faster, sharper-and an up-and-down machine.” Then, from the September/October issue of Tennis, “Juan Martin del Potro He’s back…. and ready to once again conquer”. His once promising career was reaching the end owing to wrist injuries. Quoting Del Potro in the article “one doctor would say something to me; another would say something different. It was difficult to believe one or the other”; however, he demanded excellence and eventually found it
I could go on citing and quoting from all sports and recreational resources but you get the idea. These are recovery and come back examples of what motivated individuals may accomplish. Now, if you tune in to upcoming US Open later this month, you will be able to follow Rafael Nadal, another super athlete who was able to return to compete at the top of his game owing to cellular orthopedics for several potentially career ending injuries over recent years. I could go on with the examples in each and every recreational pursuit or from those who wished to regain a pain free and very active life even if not at the aforementioned level of demand. Suffice it to say, the common denominator for those with skeletomuscular restrictions is a combination of physical training, mental motivation and timely medical care.
You can put some of this Tiger in your tank and reignite your enjoyment of activities at any level if arthritic or traumatic injury of your bone and joints is holding you back. The new world, (actually it is not so new anymore) of Cellular Orthopedics may allow for a return to a virtually unlimited lifestyle with a needle instead of a knife. I choose to define myself as a Cellular Orthopedist so a patient might not be trapped in the web of so called regenerative medicine specialists. An orthopedic surgeon has dedicated many years to understand the musculoskeletal system whereas a regenerative medicine clinic frequently is populated by those who attended a two-day training seminar. While my own recreational pursuits and fitness profile is far removed from those of the famous professionals noted earlier in this blog, following cellular orthopedic interventions into my own knees in December of 2017, and for my hips in January, 2018, I returned to skiing last winter, cycling and fly fishing this summer, and I am able to enjoy a full fitness commitment in doing my part to maintain the highest possible level of performance.
You may access my website at WWW.SheinkopMD.com or call (312) 475-1893 to schedule a consultation.
Tags: BMC, Bone Marrow Concentrate, cellular orthopedis, golfers elbow, injection, Platelet Rich Plasma, PRP, regenerative medicine, sports injury, stemcell, tendon repair, tendon tear, tennis elbow
Jul 12, 2018
Just as I cringe when a new patient announces that they have “bone on bone”, so too do I squirm when I am told by a patient “I have a torn” at times meniscus or cartilage; others, a torn rotator cuff; and then again, a torn labrum. Attention please, your X-ray or MRI image is not causing pain, the inflammation in or around your joint is the pain generator. 95% of the population over age 45 will have an abnormality interpreted by the radiologist on the report their MRI, be it of the shoulder, hip or knee. Cartilage and meniscal changes at the knee, labral tears at the hip or shoulder, and rotator cuff abnormalities are part of the attritional process; alternatively, these changes are commonly over diagnosed.
Last week, a 70-year-old woman called to schedule an appointment and indicated that she had a torn acetabular(hip) labrum diagnosed on a recent MRI. I responded, “your pain generator is arthritis unless you are a hockey goalie”. I was being a bit facetious but at the same time truthful. My 37-year experience as a reconstructive orthopedic surgeon specializing in hip and knee replacement really prepared me for this life after surgery; namely, a cellular orthopedic interventionalist.
It takes a history and hands on physical examination prior to review of images to determine what is causing a painful musculoskeletal condition. The common denominator is inflammation, not a computer image. In the case of arthritis, unless the cartilage (meniscus), labrum or rotator cuff alteration is generating mechanical problems such as weakness, locking, “clunking” or giving way, we frequently need not address the former with a maximally invasive surgical procedure; a needle will suffice and deliver the platelets, Mesenchymal Stem Cells, Growth Factors and precursor cells required to address pain, improve function, increase motion, stop progression of arthritis and restore, at times regenerate the joint.
Cellular Orthopedics encompasses a full joint Preservation, Restoration and Regenerative scope of options. The notion introduced by a print media ad, that it is “one and done”, won’t help you postpone, perhaps avoid a joint replacement. In my practice, we monitor progress and intervene when necessary at five months or five years if indicated.
To learn more, visit my web site at www.SheinkopMD.com or call and schedule a consultation at (312) 475-1893
Tags: arthritis, bone lesion, Bone Marrow Concentrate, cellular orthopedics, hip pian, joint pain, joint replace, knee pain, meniscus, Osteoarthritis, PRP, Rotator cuff, stem cells, stiffness, torn labrum
