Research Project
7992859
DESCRIPTION (provided by applicant): 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. For the younger patient, the treatment modalities have significant limitations. 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 of this SBIR project is to establish ASTM Standard Methods (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. Our interdisciplinary team has substantial experience in using large animal models for cartilage repair, and recently we and others have successfully used the goat as a method of assessing cartilage repair. Team members have also established a number of key outcome measures that are valuable in providing a quantitative assessment of cartilage repair. Our team also has substantial experience in developing ASTM standards. We therefore propose to combine the animal model expertise, the analytical expertise, and the standards expertise, to generate a set of standard methods for cartilage repair, which are shown to be reproducible between research centers, and can generate uniform data that is appropriate for submission to the FDA to support initiation of clinical studies. The goal of the Phase I project is to establish the animal model, the outcome measures, and have at least one draft standard under development at ASTM. Specific Aim 1. Establish the goat model of chondral and osteochondral defect and repair. Specific Aim 2. Establish key outcome measures. Specific Aim 3. Prepare a draft ASTM standard for in vivo assessment of articular cartilage repair. If successful, the objective of the Phase II application will be to characterize the animal model at times up to 12 months after initiation of the defect, perform a 'round robin'test of the developed animal model, and to gain approval of the standard at ASTM. PUBLIC HEALTH RELEVANCE: The objective of this SBIR project is to establish ASTM Standard Methods (a large animal model and outcome measures) for assessing the safety and effectiveness or effectiveness of products for articular cartilage repair. Our interdisciplinary team has substantial experience in using large animal models for cartilage repair, providing a quantitative assessment of cartilage repair and in developing ASTM standards. We therefore propose to combine the animal model expertise, the analytical expertise, and the standards expertise, to generate a set of standard methods for cartilage repair, which are shown to be reproducible between research centers, and can generate uniform data that is appropriate for submission to the FDA to support initiation of clinical studies.
