Clinical Validation of Allogeneic Morphogenetic Protein: Donor Intervariability, Terminal Irradiation and Age of Product is not Clinically Relevant

Abstract

Donor to donor variation has long been a concern of the allograft industry. DBM and stem cell products have been particularly susceptible to intervariability between donors, regardless of the process used to manufacture these products. Manufacturers of allograft based products have often utilized in vitro or small animal models to help predict reliability, yet little data is available correlating preclinical outcomes with clinical efficacy. OsteoAMP is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. An analysis of radiographic results comparing fusion outcomes was conducted for 285 consecutive cervical and lumbar spinal fusion patients utilizing OsteoAMP bone grafts from 114 donors of varying ages. A blinded radiological fusion assessment, performed by an independent radiologist, showed all patients, except one, fused within 18 months (average time to fusion was 189.9 days). This evidentiary analysis shows that OsteoAMP fusion success did not show donor intervariability and that fusion rate/time is not dependent on donor age. In addition, the implant retained bioactivity over time and terminal sterilization via low-dose gamma irradiation did not impair the bioactivity of the grafts.