Dr. Byron Schneider: Grand Rounds Part 1

Dr. Byron Schneider is currently an associate professor with the Department of Physical Medicine and Rehabilitation at Vanderbilt University Medical Center and serves as the Director of the Interventional Spine and Musculoskeletal Medicine Fellowship. Previously, he completed his residency and interventional spine fellowship at Stanford University. He has nearly 100 publications, with a research focus on the safety and outcomes of interventional spine procedures. He has given over 100 lectures at national and international meetings. He currently is on the Spine Intervention Society Board of Directors as the Chair of Research, and within the North American Spine Society is Chair of the Interventional Spine and Musculoskeletal Section as well as Co-Chair for the Coverage Committee. In Part 1 of his presentation, the focus was on a systematic review that was done of how stem cells and PRP pertain to back pain. He began by going over the history and regulations. Traditionally as it pertains to all biologics, they were largely exempt from the pathway of the FDA. Because they did not go through that process, these medicines were allowed to be done, but really did not have any insurance coverage. They became a cash cow for those offering fee-for-service treatment for things that did not have a lot of evidence behind them yet. It led to much public confusion, but that gap has shrunk in recent years. The FDA began issuing more restrictive language in 2020 regarding treatments that were not approved by that agency. The primary purpose of the aforementioned review was to look at 50 or more percent relief of low back pain at a six-month outcome. Based on those criteria, the number of citations was whittled down from 3,000 citations reviewed to 37, then finally down to only 12 that actually met the criteria. Those results should be alarming given that hundreds of clinics in the U.S. were providing treatments for cash payments that were based on only 12 research papers. Only one paper was on PRPs and one on stem cell treatment. He then described a study on PRP in 2015. He also provided summaries of other investigations that entailed PRP and stem cell treatments.