Burst Biologics received Institutional Review Board approval for a U.S. prospective clinical study of BioBurst cellular allograft in spinal fusion patients. BioBurst Fluid, derived from umbilical cord blood, will be studied at 15 clinical sites enrolling 450 patients. Targeted follow-up is one year.
A multicenter patient registry was created as an observational study to document use of Burst Biologics' products by spine and neurosurgeons, along with patient outcomes, focusing on fusion outcome, instrumentation integrity and clinical outcomes (symptom and function improvement) based on surgeon- and patient-based outcome assessments.
Burst Biologics has also established a registry to observe use of its products by foot and ankle surgeons in bone grafting procedures. Estimated enrollment of 300 subjects is expected to complete in October 2018.
Sources: Burst Biologics; clinicaltrials.gov