Work Item
ASTM WK78974
New Guide for Pre-clinical Testing Considerations for Materials Used to Regenerate Muscle following Volumetric Muscle Loss Injuries
1. Scope
1.1 This guide covers general evaluation guidelines for assessment of skeletal muscle and measures that inform skeletal muscle function in animal models of injury, in particular volumetric muscle loss (VML) injury. 1.2 Guidelines include a description and rationale of various animal models utilizing a range of species such as mice, rats, dogs, sheep, and pigs. Outcome measures based on the functional capacity of skeletal muscle, proportional measures, or on histologic and biochemical analyses are briefly described and referenced. The user should refer to specific test methods for additional detail. 1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of product(s). ASTM standards for these steps are available in Reference Documents. 1.4 The values stated in SI units are to be regarded as the standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
Keywords
volumetric muscle loss; muscle regeneration; muscle injury
Rationale
VML injuries can range widely, from relatively small to those that require entire muscles to be removed, and no standardized methods or guides are available to assist investigators through their studies. This standard guide will be used by academic and industry users.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 11-18-2021
Technical Contact: Michael McClure
Item: 000
Ballot:
Status: