1.1This 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 thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, cDNA, or drugs. 1.2The 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. 1.3The 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. 1.4The 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. 1.5This method does not intend to address all of the safety concerns, if any, associated with the use of the product being tested. It is the responsibility of the user of this standard to establish appropriate safety data regarding the product being assessed.
Articular repair following injury or degeneration represents an acknowledged major and growing clinical problem, and joint replacement is generally regarded as appropriate only for the older patient with advanced cartilage loss [1, 2]. For the younger patient, the treatment modalities have significant limitations [1-8]. There are a growing number of new technologies and methodologies attempting to address articular cartilage repair, however there is no uniform method of assessing their safety and effectiveness or efficacy. The objective is to establish an ASTM Standard Method (a large animal model and outcome measures) for assessing the safety and effectiveness or effectiveness of products for articular cartilage repair. There are multiple animal models for articular cartilage repair and regeneration, ranging from rodents to very large animals including horses. There are a large number of different analyses that can be performed used as outcome measures. This leads to an inability to uniformly assess potential clinical performance, compare performance between potential therapies, or develop a consistent understanding of underlying mechanisms of repair. There is therefore a substantial need to develop an in vivo of assessing cartilage repair that can be used to support clinical studies, is consistent between users, and is clinically relevant. At the same time there is substantial variation in the outcome measures used, adding to the non-uniformity of the assessments being made.
Keywordscartilage:articular cartilage:repair:regeneration:goat:animal model
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development