1.1 This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to enhance healing of repaired rotator cuff tendons. TEMPs included in this guide may be composed of natural or synthetic 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 focus of this guide is on models for use in evaluating healing of tendons trather than the tendon/ bone interface.
There is a growing number of orthopedic membranes commercially available, but no universally accepted method(s) of evaluating them in vivo. It is expected that the guide will primarily be used by developers of new technologies
Keywordstendon; shoulder; soft tissue repair
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development