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Method for Producing Biomaterial Scaffolds

Organization:Tufts University, MA, US
I.P. Brief:This method for producing biomaterial scaffolds involves laminating multiple layers of polymers with well-defined pore sizes and is coated with nanoscale fibrils of cellulose.
Summary of I.P.:Tissue engineering (about 25 years old) using a scaffold (aka matrix) for cell growth has great potential in the biomedical device market to treat tissue-damaging diseases and heal wounds from accidents. One of the problems for the advancement of this technology is the lack of understanding of the cell-matrix response. Traditional scaffolds (e.g., salt leached materials) lack the consistent geometrical control from nanoscale to microscale in order to facilitate fluid flow, maintain structural integrity, and provide enough surface area for cellular proliferation. The problem is that existing methods and manufacturing techniques do not provide adequate geometric control of pore sizes and surface characteristics. The IP does provide a method to fabricate well-defined 3D pores in a scaffolds as well as a coating the scaffold with nanofibrils of bacterial cellulose that can enhance cellular growth bcause of increased surface area. This technology is valuable to tissue engineering researchers to do cell-matrix studies, biomedical device companies (small and large) to develop new treatment and research capabilities, hospitals and medical centers to serve doctors and patients with tissue treatments.
Patent:PCT/US2005/036724
Keywords:tissue engineering, biomaterial, scaffold
Primary Industry:Health & Medical Devices
Specific Market:Tissue Engineering Market
Market Size:One market report (http://www.bioportfolio.com/reports/DMD_TISSUE.htm) estimates that the tissue engineering market for regeneration of bone, cartilage, and other connective structural treatments is approximately $15 billion.
State of the Art:Currently, tissue engineering for hard (i.e., bone, teeth, and cartilage) and soft tissues (i.e., skin and internal organs) encompasses scaffolds, growth factors, stem cells, and some injection treatments. Scaffolds are currently gels, resins, and other relatively simple materials that do not allow for engineered structures and surfaces.
Competition:Scaffolds, growth factors, stem cells, and injections are individually growing areas; and they also have cross-fertilization possibilities (e.g., a scaffold infused with growth factors and stem cells supplemented with injections to enhance growth). Scaffold threats include other materials, methods, and coatings that may be developed by others.
Figures of Merit:The advantages of this technology are the well-defined 3D control of pore sizes, cellulose coatings to enhance growth, low-cost manufacturability through micro-molding and lamination, and usage of biocompatible products.
Tech.  Obstacles:Technical challenges include tailoring material structure and properties for certain applications (e.g., filling awkward spaces), developing manufacturing processes for automation (issues: precision and layer lamination); coating processes for bacterial cellulose (issues: consistent cellulose production and cleaning); and packaging for sterility and storage (issues: ensuring sterility and possible degradation).
Market Obstacles:The five key milestones to market include: 1. development of an automated manufacturing process 2. validation of the standard outcomes of the IP against current standard scaffolds for different cell types 3. validation of standard outcomes of the IP against alternative technologies for different cell types 4. FDA biomedical device approval 5. Marketing in hospitals and medical centers with doctors
Publications:1. Svensson A, Nicklasson E, Harrah T, Panilaitis B, Kaplan DL, Brittberg M, and Gatenholm P, Bacterial cellulose as a potential scaffold for tissue engineering of cartilage. Biomaterials 2005;26:419-431. 2. Lee JW, Deng F, Yeomans WG, Allen AL, Gross RA, Kaplan DL. Direct incorporation of glucosamine and N-acetylglucosamine into exopolymers by Gluconacetobacter xylinus (=Acetobacter xylinum) ATCC 10245: production of chitosan-cellulose and chitin-cellulose exopolymers. App Environ Microbio 2001;67:3970-3975.
Research Team:The research team is led by co-inventors, Dr. Peter Wong (Research Professor in Mechancial Engineering Department) and Dr. David Kaplan (Professor in Biomedical Engineering Department, Director of the Tufts Tissue Engineering Research Center). The research team is composed of graduate and undergraduate students from mechanical and biomedical engineering departments.

 

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