Dec 17, 2019
The progress in the emerging discipline, Orthobiologics, in part, is the result of the FDA and FTC taking on a stronger oversite role; but additionally, the data I gather contributes to these scientific advances. I will elaborate in this blog.
In order to be FDA compliant, the use of stem cells must be autogenous; that is, the cells must come from you. The orthobiologic industry finally complied so those providers with integrity have made available acellular growth factors. Three weeks ago, I learned that is some cases, Medicare and certain insurance companies will preauthorize said usage. Stay tuned on this one as to whether the product works and whether its use is indeed reimbursed.
Last week, I was made aware that the FDA had served notice to Chara Biologics and Liveyon for marketing biologic products that are unapproved. Stay tuned as more bad actors will be shut down.
https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-risk
Biologic Interventions to Avoid Joint Replacements
This past Friday, I received biologic interventions into my right and left hip and my right and left knee. It worked for me two years ago and I believe the biologics will help postpone, maybe avoid joint replacements while allowing me to keep skiing, fly fishing, cycling, and keeping fit. There were no appreciable amounts of stem cells in that which was processed from my own blood and injected. The anticipation is that the Platelets and Growth Factor Proteins will diminish the pain of arthritis, and assist in restoring full motion to my hips and knees, allowing me to continue my recreational profile.
In the presence of a single arthritic knee joint, I would have enrolled in the FDA approved Personalized Stem Cell Clinical Trial. You may learn about the Trial at www.Personalizedstemcells.com or on my web site at www.sheinkopmd.com. In the upcoming months, it is hoped that the FDA will expand approval of the PSC Trial to both knees and eventually, the hips. At this time, there are only two FDA compliant methods of allowing physicians to provide a patient with “stem cells,” one is via your bone marrow and the other via your adipose tissue. In my case, with the several joints involved and given realistic outcome possibilities, I opted for the Growth factor approach. My next step will be the Stem Cell option.
I will be testing my outcomes of the Biologic interventions next week on a bone fishing trip four-five days in Punta Allen, Mexico. While my schedule is full prior to departure, there are still some office openings available on Tuesday, December 31. To schedule an appointment at any time call (312) 475-1893
Tags: biologic intervention, orthobiologics, regenerative medicine, stem cell research, stem cell trials
Dec 5, 2019
Let me think, where did I leave off last week?
Is there any chance of postponing, or perhaps avoiding a joint replacement, either total or partial? The answer to the question is why I “graduated” from joint replacement to the new discipline of Cellular Orthopedics or Orthobiologics: In the attempt to relieve pain, improve function, restore motion, and stop the progression of osteoarthritis with a needle instead of a knife is based on cells, platelets, and proteins – the latter known as Growth Factors. In order to be FDA compliant, the cells and platelets must be autologous; that is, they must come from you. It is most desirable and effective to use Growth Factors from your bone marrow or circulating blood. Recently, Medicare and some private insurance carriers have pre-authorized amniotic fluid as long as it is produced for pain relief and as a source of Growth Factors but, without stem cells (acellular). Is there the possibility of cartilage regeneration? Or is the goal joint restoration under any set of circumstances?
Orthobiologics Treatment Options
Up until now, other than a Total Joint Replacement, the treatment options for arthritis have been limited in duration of effect, that is palliative. Even a Total Knee Replacement has a limited survivorship or duration of success; indeed, there are some short-term failures and always the risk of a need for revision. In the world of biologics, a repeat intervention is still with a needle, followed by a short-term rehabilitation. Our data indicates that those who repeat a biologic intervention have a better and longer lasting outcome than that following a single injection. Our successes have been focused on blood derived Growth Factors and Platelets and Bone Marrow Concentrate. The latter are autologous (come from you) and FDA compliant.
Returning to the beginning of the Orthobiologics Informed Consent message, I haven’t forgotten about my nephew; the previously very athletic one with the Grade 2 to 3 Osteoarthritis of the knee. The therapeutic recommendation is to start with an injection of growth factors and Platelets obtained from his circulating blood. The benefits should be realized in less than six weeks and last two to three years. After that time, he could repeat the initial injection process or advance to a Bone Marrow Concentrate intervention. Bone marrow contains stem cells introducing regenerative potential a swell as providing a wealth of Growth Factors. Both blood derived platelets with Growth Factors and Bone Marrow Concentrate are Evidence Based therapies.
Recently, a third option became available to me; Stromal Vascular Fraction or Stem cells derived from your adipose tissue. At this time, there are seven centers in the United States, approved by the FDA, participating in the Personalized Stem Cell Trial; I am one of the investigators. The PSC Trial is that of a drug created from your adipose tissue, the latter harvested from your own fat and processed under very stringent governmental controls, processed and injected into your knee. To learn more about the PSC Trial visit www.PersonalizedStemCells.com. You may visit my web site at www.sheinkopmd.com to become familiar with my treatment options and participate in my webinars. Your consultation may be scheduled by calling (312) 475-1893.
Tags: cellular regeneration, orthobiologic consent, orthobiologics, stem cell trials
