For some time now, I have been telling patients and writing in my blog about upcoming clinical trials using adipose-derived stem cells for arthritis management. While the stem cells in bone marrow continue to be used for lessening the symptoms and improving the functional capacity of those affected by an arthritic knee, hip, or shoulder; the number of stem cells in bone marrow diminishes with age.
Such is not the case with stem cells surrounded by fat leading to my interest in Adipose Tissue (fat) as a source of Stem Cells. The volume of inquiries to my office, as to when trial enrollment would begin, is increasing. Why do you have to wait so long for the FDA approval of the next clinical trial? Orthopedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopedic devices annually cleared or approved by the FDA for marketing in the United States. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard public health. The FDA uses multiple, different preclinical pathways for biologics and combination products based on the perceived risk of a novel product. More than 97% of orthopedic devices go through the FDA’s 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive preclinical approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Post surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products.
I would hope that the above explanation helps the reader to understand why the delays in announcing enrollment recruitment. On the other hand, if you have symptoms or limitations imposed by osteoarthritic joints, call and schedule a consultation at (847) 390-7666. At the time of your office assessment, I can update you regarding the appropriate biologic treatments indicated as well as advise you as to whether you will meet the inclusion criteria of the upcoming clinical trials. Learn more by visiting my website www.sheinkopmd.com. The website PersonalizedStemCells.com is an informational resource, as is the Lipogems website.