This web site uses cookies to deliver its users personalized dynamic content. You are hereby informed that cookies are necessary for the web site's functioning and that by continuing to use this web sites, cookies will be used in cooperation with your Web browser.
OSTEOproSPINE is a novel bone regeneration therapy composed of OSTEOGROW (recombinant human bone morphogenetic protein 6 [rhBMP6] delivered in autologous peripheral blood coagulum) reinforced with allograft (a compression resistant matrix). OSTEOproSPINE is designed to guide the formation of new bone at extra-skeletal site and replace autograft harvested from patient’s iliac crest for the fusion of lumbar vertebrae. By generating new bone, OSTEOproSPINE will restore the spine’s weight bearing function, reduce the severity of back pain and improve the success rate of posterolateral spinal fusion surgery. The program consortium of 13 partners from 6 EU member states has been assembled to conduct a Phase II, randomised, patient and evaluator-blinded clinical trial of OSTEOproSPINE. Four clinical centers will enrol 180 patients suffering from degenerative disc disease to assess OSTEOproSPINE efficacy and safety in comparison with standard of care (autograft) and Osteogrow.
A positive outcome of the proposed trial will confirm OSTEOproSPINE’s potential to form a functioning new bone in human and by this restore the spine’s function and improve the quality of life in patients with degenerative disc disorders using the ground principle of regenerative medicine: “provide the correct molecular signals to a population of presumptive cells in a permissive microenvironment”.
Short description of the task performed by Croatian partner