This past Sunday morning, I was reading the Chicago Tribune sports section to learn about the pundits’ opinions regarding the basketball game played by Duke and North Carolina on Saturday night, one of the most amazing basketball games I have ever seen, (incidentally, Auburn versus LSU was great, as well) when I came across the Golf Headline “Mickelson’s short game pays off big”. Why my interest? Phil Mickelson has psoriatic arthritis controlled by TNF-Alpha blocker, a Growth Factor. Another golfer whose career was restored by Growth Factors is Tiger Woods. In Woods’ case, he had received Platelet Rich Plasma (PRP) with Growth factors; Platelets produce those biologic agents. Then there is the story of Kobe Bryant, who had traveled to Germany in 2012 to extend his professional career for seven years with Interleukin One Receptor Antagonist Growth Factors recovered from circulating blood. At the time, Bryant travelled to Germany, the treatment he was to receive was not FDA approved in the United States. There is now an innumerable list of professionals and amateurs who have returned to the game or prolonged a career through Growth Factors thanks to the recreational impact of biologics.
If you surf the internet for Regenerative Medicine and Biologic alternatives, you encounter the term “Stem Cells”. The reality is that as of this time, there is no FDA or legal way to avail yourself of Stem Cells alone; the only access is by concentrating your bone marrow and injecting the concentrate into the arthritic joint since there are Adult Mesenchymal Stem Cells in your bone marrow.
Concentrated Platelets, Growth Factors, and Concentrated Bone Marrow have been the regenerative and restorative mainstays in my practice until now.
Looking to the future, because I have been involved with several Cellular Orthopedic Clinical Trials over the past five years, my practice is assisting in the creation of pathways for yet another biologic trial in 2020. Most exciting is the FDA approved Personalized Stem Cell Clinical Trial in which ours is one of seven designated and FDA approved centers. The PSC FDA-approved Clinical Trial was launched in August of last year. In September of 2017, the FDA warned that by November of 2020, all biologics would be reclassified as drugs. Personalized Stem Cells was granted FDA approval to create a drug from your own adipose tissue. The abdominal fat is recovered by Liposuction and processed in a facility that has met all FDA and Good Practice Management governmental requirements. The resultant Stromal Vascular Fraction (Stem Cells recovered from fat) number in the tens of millions and are made available for injection into an arthritic knee. You may learn more at WWW.PSC.Com or on my web site www.SheinkopMD.com. To schedule an appointment or consultation, call (312) 475-1893
Tags: biologics, orthobiologics, recreational impact of biologics
Saturday evening, we returned from four days of fly fishing for Bone Fish, Permit, Jacks, Tarpon and Snook in Punta Allen, Mexico, three hours south of Cancun. The adventure involves standing on the front of a boat for up to six hours a day, with an occasional break. It becomes arduous and exhausting; but exceedingly gratifying and that’s why we do it year after year. Situated in the Mexican State of Quintana Roo in the Si’an Ka’an biosphere, Punta Allen is a perfect base for the type of fishing we love while allowing us to enjoy the Pelicans, Pink Spoonbills, Frigates, mockingbirds, Flamingoes and occasional crocodile, dolphin and manatee. The beaches on the ocean side are pristine so a 5PM swim after fishing allows the knee and hip rehabilitation to continue.
In anticipation of the physical demands, I underwent an autologous concentrated Platelet, Plasma, and Growth Factor Protein knee and hip intervention two weeks prior. My blood was recovered via a standard blood draw, placed in a centrifuge after which it was processed and filtered. The resulting concentrate was then injected under ultrasound guidance into my knees and hips. While my hips were quite uncomfortable for 72 hours following the injections, by time we arrived in Mexico, I had no limitations or symptoms requiring me to alter my activities.
Let me explain why I chose the blood born option in anticipation of my needs rather than that of Bone Marrow Concentrate or participation in the Adipose Fat based Personalize Stem Cell Clinical Trial. If I were younger, the Bone Marrow Concentrate option makes a lot of sense as we have scientific outcomes data to support said alternative. Seeing how the number of Adult Mesenchymal Stem cells in bone marrow diminish with age, my eyes are set on the PSC Trial. Science tells us that the number of stem cells in adipose tissue do not diminish with age. My particular issue is that both of my knees are affected by advanced Osteoarthritis so I have to wait for FDA approval of the bilateral Personalized Stem cell Trial. Given my excellent response to the Blood derived Platelets, Plasma and Growth Factor Proteins following the injections two years ago, I elected to take advantage of the opportunity to repeat the interventions while waiting for the FDA approval of the PSC Trial allowing both knees to receive millions of stem cells.
To learn more about your treatment options for an osteoarthritic joint, visit my website at www.sheinkopmd.com. You may call to schedule an appointment or consultation, (312) 475-1893.
For those interested, The Personalized Stem Cell trial web site is www.PersonalizedStemCells.Com.
Tags: autologous platelet concentrate, blood plasma, Concentrated Stem Cell Plasma, stem cell
The science and art of my biologic initiative to help a patient deal with the symptoms and limitations imposed by osteoarthritis requires the right tools for each situation. Concentrated Bone Marrow Aspirate or Platelet Rich Plasma has emerged as an important biologic tool for me because I have scientific evidence to support what I recommend.
Mesenchymal Stem Cells are undifferentiated cells that influence healing and growth of tissues making up the musculoskeletal system. MSCs are found in bone marrow.
Osteogenic Precursor Cells are derived from MSCs but basically have the potential to produce bone. Hematopoietic Stem cells are precursors to all red blood cells, white blood cells, platelets and other cells influencing bone density. They are found in bone marrow
Platelets are small, colorless bodies found in blood. They contain alpha granules which play a vital role in blood clotting, inflammation and wound healing. They are found in bone marrow.
White Blood Cells (Leukocytes) provide the body with protection against foreign matter. There are several types of white blood cells and they play a role in inflammation and the immune response
I started this Blog with the sentence “The science and art of my biologic initiative.” At times, the art favors the delivery of autologous, Concentrated Growth Factors contained in your blood so as to reverse inflammation. It is inflammation that generates the pain associated with Osteoarthritis.
By centrifuging your Blood and Bone Marrow, I am able to deliver a large number of stem cells, progenitor cells, and growth factors directly to your arthritic bone and joint thus harnessing the body’s biologic potential. I use a proprietary approach having evolved from our research, when possible, introducing concentrated Platelet Rich Plasma before and after the Concentrated Bone Marrow injection or occasionally all together.
In spite of the misinformation found in the marketplace, the Amniotic Fluid Products do not provide a living source of Mesenchymal Stem Cells. They do contain various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1) and may have some value.
As I have indicated, Regenerative Medicine and Cellular Orthopedics is both an art and a science. This morning, I am working on the science as a co-author on the outcomes of the subchondroplasty manuscript. To learn more, visit my website at www.sheinkopmd.com.
You may schedule and an appointment or consultation by calling (847) 390-7666.
Tags: arthritis, Bone Marrow Concentrate, Platelet Rich Plasma
Following injury or wear, limitations need not be limited to professional, college and high school athletes
Last week, my column focused on the post traumatic ravages of the National Football League season; and getting ready for next cycle of body demolition. Those who watched the championship game saw several players assisted off the field following violent trauma. Even the President announced that he would prefer his son not play football. While professional, college and high school competitive sports enjoy high profile, there are the average recreational sports and fitness enthusiasts who progressively experience a diminution of ability to participate in a sought-after activity by virtue of injury or wear and tear; be it basketball, running, cycling, skiing, hockey, fitness endeavors, volleyball, golf, soccer, sailing; so, on and so forth.
As an example, a 67-year-old man presented in my office last week after having read my column, with progressive pain in his left knee and inability to partake in his long-time recreational passion, volleyball. I completed his intake centered on the taking of his medical history, completed an orthopedic physical examination, and ordered X-rays. He brought a recent MRI study to the appointment. The physical therapist who assists me objectively documented his physical findings so we would have pretreatment measurements. Additionally, my therapeutic recommendation is always based on more than an X-Ray and MRI, but also includes the objective and reproducible Range of Joint Motion and assessment of joint stability.
After review of all the above, I administered informed consent for a Bone Marrow Concentrate intervention into his left knee as a means of postponing, perhaps avoiding a Total Knee Replacement and assisting in his return to recreational volleyball. While there are several options for intervention into the arthritic or injured joint including adipose and blood-based alternatives, I recommended Bone Marrow Concentrate for his moderately arthritic knee as a means of providing Concentrated Platelets, Concentrated Growth Factors, anti-inflammatory Cytokines, Adult Mesenchymal Stem Cells, Precursor Cells, Marrow Adipose Tissue, and Hematopoietic Cells, all consistent with FDA compliance requirements. There are mandatory Federal Drug Administration and Federal Trade Commission regulatory standards of compliance in Regenerative Medicine; patients must be cautious when choosing the minimally invasive Cellular Orthopedic option. It takes an office visit, physical assessment and review of images by a board-certified specialist in the regenerative medicine decision making process; not merely attendance at a seminar. Some patients will not meet inclusion criteria, their needs would be better served by accepted surgical norms.
At age 67, there is little chance at Cartilage Regeneration for my patient, but there is a high probability of Joint Restoration; that is increased motion, diminution of pain and the return of ability, in this patient’s case to play volleyball. He will wear an off-loader brace for six weeks, partake in physical therapy and then gradually return to his Chicago Park District three games a week routine. The patient will have reached his competitive goals through care based on the scientific evidence and outcomes documentation. As long as I introduced the subject of competitive goals, off I go to ski in Colorado next week; about a year after having undergone Cellular Orthopedic interventions to both of my arthritic hips and both of my arthritic knees. Without the biologics, not only would I be unable to ski, I would be ready for two knee replacements and two hip replacements. I should have listened to my mother and stuck to the piano and violin.
To learn more about continuing to reach your competitive goals, visit my web site www.sheinkopmd.com or call and schedule a consultation 847-390-7666).
Tags: arthritis, board-certified, Bone Marrow Concentrate, bone marrow edema, cellular orthopedics, FDA, football, Growth Factors, hematopoietic cell, joint pain, Mesenchymal Stem Cell, OA, Orthopedic Surgeon, Osteoarthritis, Physical Therapy, soccer, sports injuries, sports medicine, tear, volleyball
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:
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
Nonobstructive meniscal tears
There is increasing evidence to suggest that patients with meniscal tears at the knee that do not cause “clunking”, giving way, or locking; hence nonobstructive, may benefit from Cellular Orthopedic intervention coupled with physical therapy. Previous studies involving patients over 45 years of age comparing arthroscopy with physical therapy for nonobstructive meniscal tears as seen on an MRI justify an initial conservative approach; but patient satisfaction may require 24 months to achieve. For those patients who undergo arthroscopic surgery, there is a significant increased risk of repeat knee surgery. In our practice, those patients electing to use the Physical Therapy option without surgery but with a Cellular Orthopedic intervention minimized the length of time needed to return to full activity.
Number of stem cells in amniotic fluid
The functionality of stem cells in amniotic fluid as sold today is a myth. Research shows that 250cc of fresh C-section delivered amniotic fluid, when introduced immediately into culture, only yields 40 stem cells. This means there are 0.16 stem cells per 1 cc of full-term amniotic fluid. Scientific literature referred to by the amniotic fluid marketing forces is based on amniotic fluid collected early in pregnancy.
Acetabular Labral Tear
A hip (acetabular) labral tear is damage to cartilage and tissue in the hip socket. In some cases, it causes no symptoms. In others it causes pain in the groin. Just because a tear is seen in the hip labrum on an MRI, it does not mean the tear is necessarily the cause of the pain. Before initiating treatment, the orthopedic surgeon must exclude that an underlying arthritic condition within the hip is not the real pain generator. More recently recognized is predisposition for a tear in those with abnormal acetabular architecture.
On biologics for knee osteoarthritis
Orthobiologics may become a mainstream treatment for knee osteoarthritis. While Platelet-rich plasma and hyaluronic acid injections are the most established biologics-based treatments for knee osteoarthritis so far, it’s not too early to make confident use of stem cells. At the same time, I must continually warn patients to be particularly careful about claims for these substances. All recommendations for intervention must be FDA compliant and evidence based. (To learn about my contributions to the cellular orthopedic scientific evidence, visit www.sheinkopmd.com. Under the information bullet on the top, you will find published articles)
Eventually, I believe the science and FDA will triumph over quackery and orthobiologics will become an essential part of every knee surgeon’s armamentarium. Available orthobiologics, include:
- Hyaluronic acid
- Platelet-rich plasma
- Cytokine modulation
- Stem Cells
- Adipose tissue
To learn more or to schedule an evidence based consultation, call (847) 390-7666
Tags: adipose tissue, amniotic fluid, biologics, bone marrow, cytokine modulation, Exosomes, fat, hyaluronic, joint, labral tear, Micro-Fractured Adipose, orthobiologics, Osteoarthritis, pain, Platelet Rich Plasma, PRP, renovation, stem cell, torn meniscus