Burst Biologics has received institutional review board approval to begin a multicentre prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood. Fifteen clinical sites will participate throughout the US with a total enrolment of 450 patients.
Ira Fedder, a spinal surgeon from Towson, USA, explains, “As we continue to try to understand the mechanisms that lead toward successful fusion, it is critical that we consider the cellular content and activity that may contribute to positive outcomes. Patients that have compromised health and/or healing potential may stand to be the biggest benefactors of this type of technology. It is imperative that surgeons demand that companies demonstrate that their products have a positive impact on patient outcomes. A registry is a simple step in that direction.”
As Chris Jones, chief executive officer of Burst Biologics, explains, “An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies. Stringent inclusion-exclusion criteria narrow the patient population and usually involve only single-level procedures, not allowing previous surgery or fusion attempts, and excluding other high-risk conditions.”