1.1 This guide will cover general guidelines for the in vivo assessment of tissue-negineered medical products (TEMPs) intended to repair or regenerate bone in metaphyseal bone. TEMPs included in this guide may be composed of natural or syntehtic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document are critical size defects which, by defeinition, will not heal without treatment and therefore represent a stringent test of the materials ability to induce or augment bone growth.
A standard currently exists to describe critical size defect animal models in diaphyseal bone. Due to differences between metaphyseal and diaphyseal bone structure, healing, etc, a standard is needed to better educate researchers re: existing models, and to help standardize models, in the metaphyseal region of bone.
Keywordsanimal models, biomaterials, bone, bone regeneration, bone repair, defect generation, devices, implants, in vivo, synthetic biomaterials, TEMPs, mechanical testing
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development