Animal models for preclinical assessment of bone morphogenetic proteins in the spine.

Overview

STUDY DESIGN: A review of the rationale behind the use of animal models for the assessment of bone morphogenetic proteins (BMPs) in the spine. OBJECTIVE: To summarize the underlying principles of animal experimentation in the context of bone morphogenetic proteins and the spine. SUMMARY OF BACKGROUND DATA: Animal models aid in the collection of important information regarding the precise mechanobiologic events that occur during spinal fusion healing. Reproducible spinal fusion models have been developed in several animal species, leading to experimentation in a controlled fashion. Reliable assessment of outcome measures for osseous healing, including histology and biomechanical testing, has made preclinical testing of innovative growth factors essential before the advance to clinical trials. METHODS: These materials have initially gone through the "burden of proof" steps: proof of concept studies, feasibility studies, and efficacy studies. RESULTS AND CONCLUSIONS: Bone morphogenetic proteins have undergone extensive scrutiny in the preclinical arena. This article summarizes the evolution of animal experimentation with BMP including the background and future directions.