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 2 of his presentation, he indicated that the study by Wolf and his group was observational and retrospective, so there are some missing data. They enrolled patients based on provocation discography, which you hope would result in better outcomes. He stated that this number, 50 percent of people saying that they are 50 percent better is very common in pain literature. He wouldn’t say it is favorable. Over and over, these are the numbers we see that turn out to be dead ends. These are non-compelling data unless we are able to show they are non-placebo. You need RCTs to do that. He is a huge proponent of observational studies. They can give you very meaningful clinical information, but unfortunately for a new technology like this, we need at least some evidence that these things are doing something beyond placebo. Next, he indicated the discussion in his presentation would shift to discussing some RCTs that have been published more recently. As of right now, however, the totality of evidence because of the negative RCTs in the research done today, stem cells do not work as a treatment for disc-related low back pain. He then described four new RCTs that came out in the last two years that will shed some new light. The first study involved a comparison with saline treatment. Unwanted side effects, such as infections and other complications have occurred as a result of the treatments in the four studies. Safety continues to be a concern in developing effective treatments using stem cell and PRP approaches.