Ratcliffe A.,Synthasome, Inc.
Tissue Engineering - Part B: Reviews
The fields of tissue engineering and regenerative medicine have the capacity to substantially impact clinical care through the introduction of new products that can address unmet clinical needs, or significantly improve on present therapies. These products will be developed through the demonstration of therapeutic effectiveness, adequate safety, and meeting regulatory requirements. The technology used in the product will dictate the product development and manufacturing costs; the regulatory pathway; and the time taken to complete clinical trials, gain regulatory approval, and become commercialized. A comparison of the required investment of time and funds, with the potential revenue generated, allows for a determination of the likely commercialization opportunity. Ultimately, the long-term success of a product will be dependent on its clinical effectiveness and commercial viability. © 2011, Mary Ann Liebert, Inc. Source
Sah R.L.,University of California at San Diego |
Ratcliffe A.,Synthasome, Inc.
Tissue Engineering - Part B: Reviews
The National Institutes of Health-sponsored workshop "Translational Models for Musculoskeletal Tissue Engineering and Regenerative Medicine" was held to describe the utility of various translational models for engineered tissues and regenerative medicine therapies targeting intervertebral disc, cartilage, meniscus, ligament, tendon, muscle, and bone. Participants included leaders in the various topics, as well as National Institutes of Health and Food and Drug Administration. The Food and Drug Administration representatives provided perspectives and needs for studies supported by animal models. Researchers described animal models for specific tissues and addressed the following questions: (1) What are the unmet musculoskeletal clinical needs that may be addressed by tissue engineering and regenerative medicine? (2) Are there appropriate models available? (3) Are there needs to develop standardized animal models? (4) What are the translational pathways that lead to clinical trials and therapeutic development? The workshop provided an effective and succinct summary of the status of various animal models in musculoskeletal regenerative medicine. Although many models are available and serve well to answer a variety of questions, the general consensus was that there is a substantial need for improved and standardized animal models for tissue engineering and regenerative medicine of the musculoskeletal system, and that animal models, especially large animal models, are critical to the preclinical step of translating research from bench to bedside. © Copyright 2010, Mary Ann Liebert, Inc. Source
The Regents Of The University Of California and Synthasome, Inc. | Date: 2010-10-06
A measuring system may provide quantitative information relating to condition of cartilage. Negative pressure may be applied to cartilage to induce flow of fluid from or through the cartilage. A level of negative pressure needed to induce a particular flow of the fluid may be employed to provide a quantitative indicia of cartilage condition. An averaged level of negative pressure measured over a period of time may be used to calculate hydraulic resistance of the cartilage.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 323.00K | Year: 2010
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.
Synthasome, Inc. | Date: 2013-11-05
The present disclosure provides a biocompatible composite and method for its use in repairing tissue defects, including defects in cartilage. The biocompatible composite includes a fibrous polymeric component and a polymerizable agent, which is capable of forming the biocompatible composite in situ at the site of a tissue defect. In embodiments, the repair site at which the biocompatible composite is to be applied may be treated with a priming agent, permitting polymerization of the polymerizable agent to the tissue located at the repair site.