The Scientific Education and Research Institute is closely affiliated with, the non-profit research entity The Spine Education and Research Institute which focuses on clinical research and investigation for device FDA approval as well as prospective outcome-based studies. In recent history, we have completed a study assessing surgical techniques for treating cervical spondylotic myelopathy. We have also recently completed a study evaluating the outcomes and efficacy of ProDisc for the lumbar spine. We strive to uphold good clinical practices and compliance. In doing so, we continue to work in research in the hopes that we will enrich the minds and futures of patients and clinicians around the world.
Current Studies – In Progress:
- Pfizer Begins Phase 2b Study Of Its Investigational Multi-antigen Staphylococcus aureus Vaccine In Adults Undergoing Elective Spinal Fusion Surgery
Surgical Site Infections (SSIs) are a significant and growing concern. SSIs caused by S. aureus account for approximately 20 percent of all SSIs in the U.S., and are associated with an estimated annual treatment cost of $12.3 billion in the U.S.2,3 Patients who suffer such infections due to antibiotic resistant (MRSA) or antibiotic sensitive (MSSA) S.aureus have worse clinical outcomes, including increased mortality in comparison with non-infected patients.“We are pleased to take this important next step in the development of our S. aureus vaccine,” said Dr. Kathrin Jansen, senior vice president and chief scientific officer of Vaccine Research and Development for Pfizer. “To date, there is no licensed vaccine available to prevent invasive S. aureus disease. We believe results from this study, if positive, will bring us closer to a potential preventive measure for this challenging disease that is associated with considerable morbidity and mortality.”
The primary outcome of the study, with an estimated enrollment of 2600 subjects, will measure the number of subjects in each treatment group with postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 90 days after elective posterior instrumented lumbar spinal fusion. Secondary outcomes will also measure postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 180 days after surgery, and postoperative S. aureus surgical site infections occurring within 90 and 180 days after elective posterior instrumented lumbar spinal fusion. Estimated completion of the study is 2017. More information on the trial can be found at: https://clinicaltrials.gov/
Pfizer’s S. aureus vaccine was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2014. The Fast Track process facilitates the development and expedites the review of drugs which treat severe conditions and fulfill an unmet medical need.5 Fast Track designation also enables Pfizer to continue to have ongoing discussions with the FDA on the development of its S. aureus vaccine.
About Staphylococcus aureus Investigational Vaccine
Pfizer’s multi-antigen S. aureus vaccine is designed to prevent a wide-range of clinical disease manifestations, caused by S. aureus, by facilitating killing of the bacteria at the early stages of invasive infection by targeting multiple virulence mechanisms.
About Staphylococcus aureus
Staphylococcus aureus is a leading cause of healthcare-associated infections, resulting in a substantial burden to health care systems. It is a particularly challenging pathogen, with an arsenal of virulence factors that enable host immune evasion and resistance to antibiotics. S. aureus has the potential to induce a wide spectrum of clinical manifestations, ranging from mild skin infections to deep wound and surgical site infections, bacteremia and sepsis, potentially leading to death.
- The Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using A Novel Stand-Alone Interbody Fusion Device (ROI-A)
- ProDiscTM– C Total Disc Replacement Post-Mark, Prospective, Controlled Clinical Trial
- An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation
If you are interested in learning more about our ongoing clinical research, please contact us