With better drugs and stem-cell therapies, using these biologics, we hope to repair cartilage — or prevent damage — before osteoarthritis sets in or an operation is needed. A sports injury or trauma to cartilage around the knee, hip, or shoulder joint can lead to osteoarthritis later in life — or, worse yet, the need for a new joint. So can the wear and tear that comes with age. It had been predicted that one day, new drugs and stem-cell therapies may stop the degeneration before it starts; that day may have arrived with timely intervention.
Update | The Next Personalized Stem Cell Clinical Trial
For those interested in the next Personalized Stem Cell Clinical Trial, I received this message on Tuesday, November 30, from the Medical Director, Personalized Stem Cells, Inc: “We met with a CRO this week and intend to have study design completed before end of year. FDA will review early next year and hope to begin enrollment soon after.” You may learn more about adipose-derived stem cells, the first PSC CP 001 Knee Arthritis Clinical Trial recently completed, and the announcement regarding patient recruitment for the next trial at www.PersonalizedStemCells.com. In response to my inquiry: “Will I be involved in the next trial?”; the Medical Director stated, “I’m counting on it.”
Extracellular Vesicles | Signal & Influence
Beyond Stem cells, Extracellular Vesicles (EVs) are the means by which Stem Cells signal and influence. The three main types of extracellular nanoparticles include 1) Microvesicles 2) Apoptotic Bodies 3) Exosomes. The three forms of EVs may be extracted from Mesenchymal Stem Cells or found circulating in your blood. At this time, the FDA does not approve the use of donor extracellular vesicles.
Is it possible that non-manipulated biologics containing the nanoparticle fraction harvested from that patient’s blood would meet the FDA guidelines for use in arthritis? Stay tuned as I am meeting with the key players next week to learn more.
Needless to say, Regenerative Medicine and Orthobiologics is a dynamic discipline, rapidly evolving. The purpose of my Blog is to keep the reader updated. To learn more, visit my website at www.sheinkopmd.com. To schedule an office visit call (312) 475-1893.
What is Orthobiologics?
Orthobiologics refers to the use of biological substances to help musculoskeletal injuries heal quicker as well as treat the symptoms and functional impairments imposed by Osteoarthritis. They are used to improve the healing of fractured bones and injured muscles, tendons, and ligaments as well as stop pain and inflammation. It is inflammation that causes pain and leads to limited function in Osteoarthritis. Biologics are derived from substances that are naturally found in the body.
The substances include bone grafts, autologous blood, platelet-rich plasma (PRP), autologous conditioned serum, and stem cells.
In determining the appropriate treatment for your arthritic knee, for instance, the following criteria are taken into account:
• Function-Limiting Pain at Moderate to Long Distances
• Function-Limiting Pain at Short Distances
• Pain at Rest or Night
Range of Motion Extension/Flexion
• Full Range of Extension/ Flexion
• Lack of Full Extension (> 5-degree flexion contracture) and/or Flexion (< 110 degrees)
Ligamentous Instability (not to include antalgic giving way)
• No Ligamentous Instability
• Ligamentous Instability
Pattern of Arthritic Involvement
• Arthritic Involvement Predominantly in One Compartment
• Arthritic Involvement in More than One Compartment
Imaging (joint space most involved compartment)
• Mild to Moderate Joint Space Narrowing
• Severe Joint Space Narrowing
• No Varus/Valgus/Patellofemoral Deformity; bowleg /knock knee
• Varus/Valgus and/or Patellofemoral mal-alignment; knee cap
Mechanical Symptoms Compatible with Meniscal Tear or Loose Body?
• Mechanical Symptoms Present
• Mechanical Symptoms Absent
Age: physiologic and not chronologic
Different criteria are taken into account for your other joints. How Biologics, when properly chosen and properly prepared and administered, may make a difference?
The following was received from a patient with fairly advanced osteoarthritis who underwent a Bone Marrow Concentrate knee intervention over five years ago:
October 15, 2021
Here is the 2021 installment of A ____ & my taking annual trips. This year we traveled to Moab, UT and spent a week in the Arches & Canyonlands National Parks. While we didn’t log as many miles as last year, this year’s hikes were much more challenging. That is the trails in these parks are not clear & even. Rather they required a lot of scrambling (climbing up, over and around rocks and boulders). In the end all went off without a hitch and we had a wonderful time. Again, this would not have been possible without you and your staff. Next year, we will be attacking the Canadian Rockies.
You too can take a hike or bike, ski, and enjoy function without pain in your arthritic joint by calling (312) 475-1893. Visit my website at www.sheinkopmd.com. With two arthritic hips and two arthritic knees, having personally been managed with biologics these past five years, I was able to take a three-hour ride with my biking partner along the fabulous and beautiful Chicago Lakefront yesterday.
I receive a continuous flow of questions from patients pertaining to Regenerative Medicine; fundamentally, the majority have to do with FDA approval, safety, and efficacy? In general, my response may be summarized under two bullets:
1) An understanding of the term “off label”
2) The difference between the biologic and the kit used for preparation
It is important to differentiate between a drug and the use of cells or tissues, the latter having been taken from your body. I will focus on Human Cells, Tissues, and Cellular-Based Tissue Products (HCT/P’s). Within the standard of the Practice of Medicine, as long as your cells and tissues are processed by FDA-approved techniques including preparation and the preparation kits, your cells and tissues may be used to relieve the pain and limited function caused by osteoarthritis. At times, grafts from donor sources may be used as long as they do not contain living cells.
The dilemma in the decision as to which biologic might be indicated is dependent on whether the problem is Osteoarthritis without inflammation; Osteoarthritis with inflammation; or a combination of Osteoarthritis with structural defects be those defects occurring in the articular cartilage, in the supporting bone (subchondral) or the menisci. In general, Platelet Rich Plasma (PRP) works through Growth Factors, proteins that are anti-inflammatory. Bone Marrow Aspirate Concentrate contains Mesenchymal Stem Cells that regulate via nano proteins called exosomes, additionally performing an anti-inflammatory function but with regenerative attributes as well.
Let’s switch to something more mundane, the first time you visit a physician for a painful joint, more likely than not, the recommendation will be a “cortisone” injection. In general, one or two steroid injections will do no harm; it is the preservative that harms cartilage cells. Triamcinolone is a corticosteroid that prevents the release of substances that cause inflammation and will benefit without harm. Should you receive a recommendation for a PRP injection into a joint, Leukocyte Poor is best for a joint while Leukocyte Rich is better for soft tissue.
Finally, what is the best treatment for the osteoarthritic joint? OA is multifactorial so the treatment of the process, not only the symptoms, is based on the understanding of causation:
1) Bone driven (subchondral lesions)
2) Metabolic (gout is the most common form)
3) Trauma (mechanical disruption of the bone supporting the cartilage or of the cartilage)
4) Cartilage (structural defects, meniscal tears)
5) Inflammatory (Rheumatoid Arthritis, Psoriatic Arthritis)
Now that I raised more questions than I answered, visit my website at www.sheinkopmd.com and schedule an office consultation by calling (312) 475-1893.
Updates in Regenerative Medicine
“The Future of Everything covers the innovation and technology transforming the way we live, work and play” according to Laura Landro in her article published September 9, 2021, in the Wall Street Journal wherein the headline reads “A Knee or Hip Replacement Without Surgery? It’s on the Horizon”. I have been working to that end for the past ten years; and while we are not there yet, progress is being made.
Actually, I have several successful anecdotes using stem cells as featured in my Blogs. In addition, with the understanding that Platelet Rich Plasma is a generic term, our recent patient review found that the proprietary approach we have adopted provides prolonged pain relief up to 18 months post-injection in the presence of painful knee arthritis. Our proprietary PRP injections outperformed corticosteroids and hyaluronic acid.
On October 1, 2021, The American Academy of Orthopedic Surgeons will hold an all-day webinar: Orthobiologics in Non-Surgical Treatment of Knee Osteoarthritis: Risks and Benefits. The AAOS has finally immersed itself in Regenerative Skeletomuscular Medicine and is providing leadership in the research and evidence-based care of an arthritic joint. Just as the FDA on May 31, 2021, put an end to the clinics and pharma companies failing to comply with the law, so too will the patient seeking to postpone or avoid a joint replacement for an arthritic joint be assured of a scientific reason for a biologic application by choosing a Board-Certified Orthopedic Surgeon using Orthobiologics.
Prevention and Treatment of Arthritis | A View to the Future
Next, I would like to introduce you to the possible future of pharmacologic management of arthritis both from the standpoint of prevention and treatment. Senolytics are a class of drugs that selectively clear senescent cells; the drugs target the fundamental aging mechanisms that are “Root Cause” contributors to multiple disorders including, but not limited to osteoarthritis. These drugs are now being used in clinical trials; for instance, In Sweden, a trial for injected Nutlin3a for osteoarthritis. The Senolytics are a whole new world; as we can learn from research at the Mayo Clinic on this subject.
I digress, so I will return to the subjects of reversing your pain and altered function imposed by an arthritic or injured joint. To explore an evidence-based biologic/stem cell/growth factor/structural approach to your arthritic joint, visit my website at www.sheinkopmd.com
A better approach is to schedule an office visit by calling (312) 475-1893 and learn about our full menu of biologic options and become aware of new clinical trial opportunities.
Three and a half years ago, I performed a Bone Marrow Concentrate for the arthritic hip of a visiting orthopedic surgeon, who had sought me out so as to help him postpone, perhaps avoid a joint replacement. Given professional discretion, I am unable to disclose specifics other than he is considered to be one of the preeminent joint replacement surgeons in Europe and Asia. We had first met in 2003 in St Petersburg, Russia. The orthopedic surgeon had contacted me today to report how well he was doing and still not in need of a joint replacement. Between 2001 and 2007, I frequently had been invited as a visiting Professor to teach joint replacement surgery and present my clinical outcomes research at international meetings around the world including 37 countries and 76 cities.
Evidence-Based Cellular Orthopedics
Times have changed and I retired from surgery graduating into my next role; assisting patients in postponing, perhaps avoiding a joint replacement in an arthritic joint by using a needle instead of a knife. The Adult Mesenchymal Stem Cells, Growth Factors, Precursor Cells, Platelets, and other Biologics found in bone marrow when concentrated, serve to stop the pain, reverse scarring and at times repair and possibly regenerate the joint damaged by osteoarthritis. While the Bone Marrow Concentrate is the backbone of my practice, over the past several years I have introduced Biologics concentrated from your circulating blood in addition to the Bone Marrow Concentrate, or when indicated, in lieu of the BMC. 14 months ago, I was part of the clinical research group, that performed an FDA approved Adipose-Derived Stem Cell Trial, the first of its kind in the United States. Our team is now preparing a second phase Trial using Adipose-Derived Stem Cells; watch this Blog or visit www.PersonalizedStemCells.com to monitor the FDA approval process.
Innovation & Advancing Quality Care
While all the above continues, there are new additions to my menu of biologic services that you may learn more about by visiting my website at www.sheinkopmd.com or scheduling an office evaluation by calling (312) 475-1893. As an example of the constant advances taking place in Cellular Orthopedics and Biologics, when a patient contacted me today concerning a follow-up “stem cell” injection for his several arthritic joints, I recommended an updated evaluation and images because so much has advanced during the last three and a half years when he initially had undergone Biologic and Stem Cell applications for his arthritic joints.
Last week, I received an update from Personalized Stem Cells, Inc. indicating that the trial submission to the FDA concerning a third Adipose-Derived Mesenchymal Stem Cell Study for the arthritic knee would take place in late September or early October. You may learn more about the Trials completed or planned by visiting www.Personalizedstemcells.com or by following my future blog postings.
Adipose-Derived Mesenchymal Stem Cells
Shortly after the discovery of the hematopoietic stem cell by Till and McCulloch, a scientist named Alexander Friedenstein discovered mesenchymal stem cells (MSCs) in bone marrow. But it would be several decades before MSCs were discovered in adipose tissue. Though there are multiple types of stem cells, PSC works exclusively with MSCs (You can learn more about MSCs in this blog.) More specifically, we work with adipose (fat) derived mesenchymal stem cells.
Since the discovery of adipose-derived stem cells (ADSCs) in the early 21st century, they have been a hot topic of study. Numerous studies all over the world have evaluated the use of ADSCs in various disease categories ranging from orthopedics, autoimmune disorders, and even respiratory diseases such as COVID-19.
We Must Continue to Research
In the grand scheme of things, ADSCs are relatively new to the stem cell playing field and thus, more research is necessary to determine the safety and efficacy of such treatments. The FDA strictly regulates cell-based therapies and to this day, there are no FDA-approved fat-derived stem cell products on the market. But the research and results continue to accumulate via various FDA-approved clinical trials. We are fortunate enough to contribute to this research with our own FDA-approved clinical trials and resulting data. We hope to one day see adipose-derived stem cell therapy become a readily available and easily accessible treatment for those who may benefit from it.
Stem Cell Institute of America sued, accused of falsely marketing treatments for ortho pain
Alan Condon – Wednesday, August 18th, 2021
The co-founders of the Stem Cell Institute of America are being sued, accused of marketing stem cell therapy to seniors by falsely claiming that it is an effective treatment for orthopedic conditions such as arthritis and joint pain.
The lawsuit, filed Aug. 17 by the Federal Trade Commission and the Georgia attorney general, alleges that defendants Steven Peyroux and Brent Detelich “promoted the false or unsubstantiated claim that stem cell therapy is comparable or superior to surgery, steroid injections and painkillers,” the FTC said in a news release.
The defendants also provided marketing materials and training to chiropractors that deceived consumers about the results of stem cell therapies, according to the complaint.
Evidence-Based Regenerative Medicine
The goal of my evidence-based practice is to eliminate unsound and illegal practices by shifting my decision-making from tradition, intuition, and unsystematic experience to firmly grounded scientific research. To learn if I might minimize, perhaps eliminate your arthritic symptoms and improve your function with a needle, not a knife schedule an office visit by calling (312) 475-1893. You may visit my website www.sheinkopmd.com.