#Dr. ries ifactor trial#

P-15 was found to be effective, safe, and have similar outcomes to autograft at 2 years post-op for cervical radiculopathy due to cervical degenerative disc disease. There is also an FDA-approved bioactive molecule for bone regeneration, a peptide P-15. PDGF-BB grafts in studies have shown PDGF had similar fusion rates to autologous grafts and fewer adverse effects. BMP-7 is no longer an option for bone regeneration as it has withdrawn off the market. BMP-2 may also be advantageous for patients not willing to give up smoking as it shows bone regeneration success with smokers. BMP-2 has many adverse effects such as inflammatory complications such as massive soft-tissue swelling that can compromise a patientвЂ™s airway, ectopic bone formation, and tumor formation. Although, BMP shows promising results as being an alternative to autograft, it also has its own downfalls.

Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. To induce bone regeneration there is a complex cascade of growth factors. This chapter will discuss these products along with their supporting clinical data. The OP-1 Implant (rhBMP-7) was marketed for a period of time, but it has been removed from the market. the other technologies, which are autograft extenders. Both of these products have been shown to be effective autograft replacement options, vs. Currently, there are only two PMA-supported Class III drug-device bone graft substitutes with Level I data that demonstrate equivalence to autograft for safety and effectiveness in spine: InfuseВ® (rhBMP-2) and i-FACTOR (P-15 peptide).

#Dr. ries ifactor trial#

Drug-device combination bone grafts are Class III and require an investigational device exemption (IDE) clinical trial followed by a premarket approval (PMA) application with the FDA to review safety and effectiveness. Synthetic bone grafts and demineralized bone matrices (DBMs) fall under Class II and require a 510(k) for market clearance, generally on the basis of an animal study. Nonstructural allograft and cellular allograft products that do not rely on the metabolic activity of living cells are HCT/P products, which require no premarket review for safety and efficacy. He enjoys long distance running, skiing, and reading.ДЇor an appointment, call our Brooklyn Center Clinic 76.This chapter is focused on the USFDA regulation and the related efficacy evidence of bone graft materials, especially Class III drug-device combination products for use in the spine. Ries enjoys spending time with his wife and two daughters. He serves in an administrative leadership capacity for his practice and Allina Health Mercy Hospital and is actively involved in patient quality improvement and care delivery projects in this role. Ries has participated in clinical research since 1999 and has been a Principal or Subinvestigator on over 300 clinical trials spanning all phases of drug development with Twin Cities Clinical Research and Prism Research. He has been voted one of Minnesota's Top Doctors for Nephrology. He has practiced with Kidney Specialists of Minnesota since 2001 and has a broad variety of clinical interests including critical care nephrology, fluid balance and electrolyte disorders, treatment of acute and chronic kidney disease, all modalities of dialysis, and clinical research. He completed a Fellowship in Nephrology at the University of Colorado Medical Center in Denver, Colorado Experience He completed his Internal Medicine Internship and Residency at Duke University Medical Center in Durham, North Carolina. Ries obtained his undergraduate degree from Carleton College and his medical degree from the University of Minnesota.