Sunnyvale, CA, United States
Sunnyvale, CA, United States

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Patent
Fibralign Corporation | Date: 2013-06-24

In general, the present invention is related to biopolymer and biocomposite materials and structures, and methods of making and using the same. In some embodiments, the present invention is directed to oriented collagen based biocomposite materials and structures, and methods of making.


Patent
Fibralign Corporation | Date: 2013-07-24

A novel medical device and method for delivery of a scaffold for treatment of secondary lymphedema and ischemia is provided. In some embodiments a catheter medical device and magnetic guidance method are provided for delivering cell-seeded implants for guided lymphatic regeneration.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 987.97K | Year: 2016

Based on encouraging Phase I feasibility results, we propose developing a novel gene therapy approach to promote guided vascular regeneration in treating extremities after traumatic injury. Our approach is to provide thread-like implants comprised of aligned nanofibrillar collagen scaffolds loaded with Hepatocyte Growth Factor (HGF) vectors (e.g., HGF DNA plasmid, modified mRNA) designed to enhance and guide neovascularization. Such scaffolds are produced using a proprietary process and fabricated to mimic native structure of the blood vessels inner wall, which promotes cell attachment, migration and can be used for delivering transcripts that are translated into therapeutic proteins with sustained biological effect in vivo. This local secretion of the HGF protein attracts endothelial cells (EC) and stimulates EC proliferation, helping to bridge the gap(s) in the vasculature caused by vascular and soft tissue trauma. Phase II will build on this programs earlier accomplishments, with a focus on further development, optimization and testing prototypes of both HGF DNA plasmid and modified mRNA, using these constructs in small animal models for both hind limb ischemia (HLI) and volumetric muscle loss, with the final optimized product defined and tested in a large animal model pilot study for HLI.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 999.94K | Year: 2013

To address the lack of treatment options for lymphedema patients we propose the use of nanopatterned collagen thread-like scaffolds (threads) designed to create new lymphatic channels. We have engineered these nanopatterned threads to closely mimic the native structure of vascular endothelial wall and we find that they provide a favorable environment for lymphatic endothelial cells. The nanopatterned thread aligns the endothelial cells, and regulates their migration along the direction of the nanofibrils. This morphological change is associated with beneficial functional effects, such as reduced expression of endothelial adhesion molecules, and reduced adhesiveness for inflammatory cells. The material enhances human endothelial cell survival after implantation in immunodeficient mice. Finally, the nanopatterned threads enhance perfusion in the murine model of limb ischemia, indicating that the threads may act to enhance the development of collateral channels, perhaps by serving as a favorable environment for endothelial cell proliferation and migration. The nanopatterned thread properties will be tested in rabbit and pig animal models. We plan to upgrade current manufacturing process to GMP grade, and to develop a novel minimally invasive catheter/trocar system for subcutaneous thread delivery, for example, across an area of surgical scar. The optimized nanopatterned thread may also be complexed with VEGF-C.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 149.94K | Year: 2012

Lymphedema, accumulation of lymph fluid in the tissue, is a disabling condition most commonly caused by removal of lymphatic nodes during cancer surgery. There is no cure for lymphedema, and all available remedies are palliative and reduce fluid accumulation by massage and compressive garments. To address the lack of treatment for lymphedema patients we propose to guide lymphatic regeneration by the cell-seeded graft. The graft consists of multi-lumen thread made from aligned Nanoweave collagen fibrils by Fibralign patented process, seeded with human lymphatic endothelial cells (LECs). These collagen fibrils closely resemble the native structure of the inside wall of the lymphatic vessel, and provide for cell attachment and alignment. The collagen thread facilitates site-specific cell delivery, enhances the survival of implanted cells. Ultimately, the goal of the LEC-seeded graft is to bridge the gap in the lymphatics caused by surgery. Primary LECs have aligned on the collagen fibrils, and LECs seeded on the thread have demonstrated excellent survival rate after subcutaneous implantation in mice. We propose to standardize the physical properties of the collagen threads by crosslinking and to implant these constructs with and without LEC in mice to test whether the LEC will integrate into the existing lymphatics.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 149.97K | Year: 2013

This Small Business Innovation Research Phase I project will investigate manufacturability of the proposed innovation in the field of tissue engineering, overcome related research challenges, and estimate the market opportunity. We have developed, tested and patented novel process to induce self-assembly of molecular collagen into a number of collagen scaffolds with the organizations found in human tissues. The process is computer controlled and highly reproducible. The scaffolds with aligned-crimp fibrils have been implanted with and without cells into animals and have been found to induce the formation of new functional vasculature mostly aligned along the fibrils and maintain implanted cells viable for extended times in the ischemic tissue. We believe that our scaffolds could improve vascular function in conditions such as lymphedema and peripheral ischemia and be adaptable for diverse uses in tissue engineering. Therefore the goal of the project is to focus on the development of scalable manufacturing process for the preparation of nanofibrillar collagen scaffolds in a thread-like multi-luminal format and test them in-vitro and in-vivo in suitable animal models with and without plated cells. Scale-up system will include a novel collagen delivery device, semi-automated tooling to manufacture longer threads and both optical and laser inspection tools. The broader impact/commercial potential of this project is based on the nature of our platform technology. Many current repair operations, such as rotator cuff repair and ligament replacement, use cadaver derived materials. Utilizing our approach, we can produce safe, strong, biocompatible replacements whose dimensions match those of the patient. Further, our materials should be less expensive. Stem cell applications in regenerative medicine have been limited by poor survival and lack of retention in target tissue. When delivered on our multi-luminal thread-like scaffolds, we achieve good survival and localization with the potential to enhance repair and facilitate stem cell application. The issue of cell and material retention in injectable gels, as well as vascularization and nutrient diffusion in three-dimensional scaffolds, remains a challenge. Advantages of our thread-like scaffolds are: large surface area for cell attachment due to their open, multi-luminal structure; fibril alignment directing cell alignment and migration; extended survival and maintenance of cells implanted on the threads; tunable mechanical properties to achieve the desired function and persistence. Our scaffolds will be used alone as well as loaded with cells for repair and regeneration of vascular and lymphatic systems and represent a significant step toward a major unmet medical need.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 179.96K | Year: 2013

This Small Business Innovation Research Phase I project will investigate manufacturability of the proposed innovation in the field of tissue engineering, overcome related research challenges, and estimate the market opportunity. We have developed, tested and patented novel process to induce self-assembly of molecular collagen into a number of collagen scaffolds with the organizations found in human tissues. The process is computer controlled and highly reproducible. The scaffolds with aligned-crimp fibrils have been implanted with and without cells into animals and have been found to induce the formation of new functional vasculature mostly aligned along the fibrils and maintain implanted cells viable for extended times in the ischemic tissue. We believe that our scaffolds could improve vascular function in conditions such as lymphedema and peripheral ischemia and be adaptable for diverse uses in tissue engineering. Therefore the goal of the project is to focus on the development of scalable manufacturing process for the preparation of nanofibrillar collagen scaffolds in a thread-like multi-luminal format and test them in-vitro and in-vivo in suitable animal models with and without plated cells. Scale-up system will include a novel collagen delivery device, semi-automated tooling to manufacture longer threads and both optical and laser inspection tools.

The broader impact/commercial potential of this project is based on the nature of our platform technology. Many current repair operations, such as rotator cuff repair and ligament replacement, use cadaver derived materials. Utilizing our approach, we can produce safe, strong, biocompatible replacements whose dimensions match those of the patient. Further, our materials should be less expensive. Stem cell applications in regenerative medicine have been limited by poor survival and lack of retention in target tissue. When delivered on our multi-luminal thread-like scaffolds, we achieve good survival and localization with the potential to enhance repair and facilitate stem cell application. The issue of cell and material retention in injectable gels, as well as vascularization and nutrient diffusion in three-dimensional scaffolds, remains a challenge. Advantages of our thread-like scaffolds are: large surface area for cell attachment due to their open, multi-luminal structure; fibril alignment directing cell alignment and migration; extended survival and maintenance of cells implanted on the threads; tunable mechanical properties to achieve the desired function and persistence. Our scaffolds will be used alone as well as loaded with cells for repair and regeneration of vascular and lymphatic systems and represent a significant step toward a major unmet medical need.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2015

Traumatic injury leading to hemorrhage damage and ischemia is a significant cause of morbidity and mortality in wounded warfighters. Particularly significant is the loss of the microvasculature. We propose to enhance and guide neovascularization using novel plasmid-activated scaffolds. Such scaffolds are formed of multi-lumenal threads made from aligned


Patent
Fibralign Corporation and Stanford University | Date: 2012-10-11

Embodiments of the present invention relate to a therapeutic device (graft) comprising a collagen membrane having an aligned uniaxial or biaxial structure such that mammalian cells plated on the membrane align mainly along the direction of the collagen fibrils. In a further aspect, a graft comprising a substantially tubular body, wherein the body has an exterior surface, an interior surface, and at least one lumen extending therethrough such that a fluid flow through the lumen can direct mammalian cell migration. In a further aspect, mammalian cells or growth and angiogenic factors can be optionally attached to the exterior and/or interior surface of the substantially tubular body. In various aspects, the graft can be used as a vascular prosthesis, a stent, or a nerve regeneration scaffold. Methods of preparing and implanting same are also provided.


Patent
Fibralign Corporation | Date: 2014-10-10

Materials and methods are provided to direct the formation of new lymphatics and to reconnect the disrupted lymphatic network. These materials and methods enable to improve survival of lymph nodes and lymph node fragments and their integration into a lymphatic network, following lymph node and lymph node fragments transplantation. The treatment or prevention of lymphedema is also addressed. In certain embodiments, a bundle of fibers or fibrils presented in the composition is effective to stimulate and direct the formation of new lymphatic and blood vessels. The bundle of fibers or fibrils presented in the composition is effective to promote survival of the lymph node or lymph node fragments and integration of the lymph node or lymph node fragments into a lymphatic network in the mammalian subject, at the site of transfer or transplantation.

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