ASTM WK28783

    New Guide for Pre-clinical in vivo evaluation of TEMPs for use in rotator cuff repair

    (What is a Work Item?)

    Developed by Subcommittee: F04.44 | Committee F04 | Contact Staff Manager


    1. Scope

    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


    tendon; shoulder; soft tissue repair

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Barbara Blum

    Draft Under Development