Work Item
ASTM WK87040
New Test Method for Standard Test Method using a goat in vivo model for Testing Articular Cartilage Repair or Regeneration
1. Scope
1.1 This method is intended for the in vivo testing of product intended to repair or regenerate articular cartilage. Products used for the repair may be composed of natural or synthetic biomaterials, or composites. For the purpose of this standard, the scope is limited to products that do not contain thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, cDNA, or drugs. The study design is intended to evaluate single defects, multiple plugs within one defect is outside the scope of this standard.
1.11.2 The method is intended to test the in vivo therapeutic effectiveness of the product, with the understanding that the test is in an animal model and is not truly representative of the human application.
1.11.3 The method assesses the therapeutic effectiveness of the product in the knee. The results are not intended to indicate effectiveness in other joints (for example, hip, shoulder, ankle), however the results may provide some indication of potential therapeutic effectiveness in those joints.
1.11.4 The outcome measures include histology, imaging, biomechanical and biochemical assessments, intended to provide a comprehensive assessment of the repair or regeneration. These outcome measures are briefly described and referenced, and the user should refer to the specific test methods for additional detail.
1.11.5 Include in this section the system of units to be used. Refer to the above ASTM Standards Units toolbar button for a dropdown menu of ASTM’s Form and Style Manual statements.
1.11.6 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 limitations prior to use.
Keywords
animal models; biomaterials; cartilage; cartilage regeneration; cartilage repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs
Rationale
A standard test method and reproducible animal model is needed for testing products to regenerate articular cartilage.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 07-06-2023
Technical Contact: Anthony Ratcliffe
Item: 000
Ballot:
Status: