? This Phase I SBIR application seeks support to develop a three dimensional acellular scaffold composed of particulate extracellular matrix (ECM). Products composed of the two dimensional (sheet form) of ECM derived from porcine urinary bladder have been marketed by ACell in the field of veterinary medicine and have received regulatory approval for entry into the human market. The physical limitations of a two dimensional from which to manufacture devices dictates that strategies for constructing three dimensional scaffolds be developed.
Three Specific Aims i n this development process are included in this proposal: #1 - to characterize the size and shape distribution of ECM particles that are manufactured by two different test methods; #2. to create 2 cm tubed scaffolds from ECM particles which have a minimum suture retention strength of 9.0 N; and finally, #3 - to evaluate the ability of two separate cell types to proliferate upon and invade (migrate into) a 2 cm tubed scaffold constructed of ECM particles. Successful completion of these Specific Aims will result in manufacturing methods that assure uniform and consistent three dimensional scaffolds that have the physical properties that will enable their clinical use and the biocompatibility that will support constructive remodeling in patients. The study to complete the three Specific Aims will be conducted by an experienced interdisciplinary group of scientists along a time line that is clearly described and with measurable endpoints. ? ?
