Creation of the First Nanostructured Synthetic Regenerative Bladder Graft Materia

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$210,755.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43CA136033-01A2
Agency Tracking Number:
CA136033
Solicitation Year:
n/a
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
NANOVIS, INC.
5865 EAST STATE ROAD 14, COLUMBIA CITY, IN, 46725
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
788290687
Principal Investigator:
CHANG YAO
() -
Business Contact:
() -
matt.hedrick@nanovisinc.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Bladder cancer is the fourth most common cancer among men and the seventh most common cancer in women with a life expectancy of only five years after diagnosis. Repair of the mid stage of this cancer requires excision o f the diseased area. Surprisingly however, regional repair of the genitourinary system and specifically including the repair of the bladder after mid stage (T2) bladder cancer has surprisingly few surgical options despite the recent advances in the develop ment of regenerative scaffolds for other tissues. The most commonly used option for patients requiring resection and replacement of part of their bladder for any reason is the replacement of the resected area with a section of the intestine. The resected t issue can cause serious complications for the patient because it secretes mucus into the bladder, causing stone formation and potentially cancer. Options under development include seeded scaffolds which are likely to offer a solution for replacement of lar ge portions of the bladder but potential procedural complexity and expense may limit their suitability for partial/regional repairs. Acellular matrices offered promise upon introduction to the market but have since been criticized for a lack of long term m echanical strength. For these reasons, the goal of this project is to develop the first synthetic nanostructured regenerative bladder graft material. Nanostructured materials have become a key area of tissue engineering research due to their ability to mim ic the roughness and, consequently, the surface energy of natural tissues. Prior work has demonstrated a nanosurface controlled mechanism of moderating protein adsorption driven cell attachment and growth and unexpectedly a bladder repair graft material th at reduces bladder stone formation. The proposed product will leverage these findings to create a simple and elegant product solution. The present proposal will reach this goal by focusing on the use of nanostructured multilayered biodegradable polymer mat rices. Nanovis will prepare these graft prototypes and evaluate their regenerative properties in vitro and characterize their mechanical and biocompatibility properties. In this manner the specific aims of the proposal will : (i) prepare layered and graded porous nanostructured biodegradable matrices from polyurethane (PU) and poly-lactide-co-glycolide (PLGA) (75:25 wt.% PU:PLGA) scaffolds and characterize its mechanical and chemical properties, (ii) use in vitro models to assess the urothelial and smooth m uscle cell functions and the likelihood of calcium stone or bacterial colonization on nanoscale PU and PLGA, and (iii) conduct a preliminary in vivo assessment of the best nanostructured bladder constructs within the budget limitations. PUBLIC HEALT H RELEVANCE: Surgical repair of the bladder and urogential system is a common procedure yet surprisingly a synthetic regenerative graft material is not available. Nanovis' proposal seeks to develop a synthetic nanostructured bladder graft material that is resistant to bladder stone formation suitable to help the over 50,000 U.S. patients per year in need of such a procedure.

* information listed above is at the time of submission.

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