SAN DIEGO, CA, United States
SAN DIEGO, CA, United States

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Patent
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.


There are many ways to influence cell activities, and biomaterials with functional groups attached is an attractive method that clearly has the ability to modulate cell behavior. The evidence is clear that biomaterials, with or without growth factors and cells, have resulted in numerous products for the regenerative medicine field. In contrast the functionalized biomaterial products remain in the development phase. © 2011 Elsevier Ltd.


Ratcliffe A.,Synthasome, Inc.
Tissue Engineering - Part B: Reviews | Year: 2011

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.


Patent
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.


Patent
Synthasome, Inc. | Date: 2015-12-22

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.


Patent
Synthasome, Inc. | Date: 2014-10-21

A tissue engineered construct made totally or in part from biocompatible materials and mammalian cells and/or cell products is provided. These constructs are useful in regenerating complex tissues such as bone, ligament and tendon, which may fabricated into medical devices suitable for use in the treatment of injuries and maladies such as rotator cuff injuries, periodontal disease and hernia.


Patent
Synthasome, Inc. | Date: 2014-08-19

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.


Patent
Synthasome, Inc. | Date: 2011-05-03

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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.62M | Year: 2012

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 leadsto 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 goals of the Phase I project have been achieved. The Phase II project will (a) characterize the animal model up to 12 months after surgery, (b) validate the model and complete the ASTM standard for the model, (c) develop ASTM standards for quantitative outcome measures in biochemistry, bioengineering, and imaging. Specific Aim 1. Characterize the goat model of osteochondral defect and repair at 3, 6 and 12 months. Specific Aim 2. Demonstrate reproducibility of the animal model and complete the ASTM Standard Method. Specific Aim 3. Validate methods and develop ASTM standards for outcome measures. The result will be a standardized animal model appropriate for assessment of techniques and products for cartilage repair, together with standardized outcome methods. The overall outcome will be a uniform and robust methodology for assessing cartilage repair. 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 tem 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 ofclinical studies.


Grant
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.

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