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A Bioscaffold for Repair of Congenital Defects

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 1R43DK059686-01
Amount: $100,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
6 OLD DEE RD
CAMBRIDGE, MA 02138
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ALAN SPIEVACK
 () -
Business Contact
Phone: (617) 547-9060
Research Institution
N/A
Abstract

DESCRIPTION (Verbatim from the Applicant's Abstract): This Phase I SBIR
application seeks support to develop and evaluate a naturally-occurring
extracellular matrix (ECM) bioscaffold material for tissue engineering
applications; specifically, the repair and/or restoration of congenital defects
in which lost or missing tissue is the limiting factor for surgical
reconstruction. Porcine derived ECM harvested from the urinary bladder (UBM)
represents a cellular biodegradable scaffold material that supports cell
attachment, migration, proliferation and differentiation, and wound healing.
Processed single sheets of UBM and other ECMs have shown excellent remodeling
capabilities in both pre clinical animal studies and early human clinical
studies. With SBIR Phase I support, we propose to develop a multilaminate sheet
form of UBM with the appropriate mechanical and biologic properties that allow
for post surgical tissue growth and thus obviate the need for repeat surgeries
as the patient matures. An experimentally-created diaphragmatic hernia will be
used as the model of a congenital defect. There are three specific aims. First,
we will determine the manufacturing method required to develop a prototype
multilaminate UBM device with the mechanical strength that exceeds by a factor
of 2 the normal mammalian diaphragm. Secondly, we will evaluate the effect of
two different methods of sterilization, gamma irradiation and ethylene oxide,
upon the mechanical strength of the prototype UBM device. The third specific
aim will evaluate the utility of the sterilized multilaminate UBM device in a
dog pilot study in which an experimentally-created diaphragmatic hernia will be
repaired in 10-weekold dogs and evaluated over time until the point of physical
maturity. Currently, there are limited options for the surgical
repair/reconstruction of body structures that require surgical repair as a
result of congenital abnormalities. The proposed studies are critical in the
decision-making process of determining whether or not to pursue development of
this product. Each objective/specific aim has well-defined criteria for
success, and the proposed studies will be conducted by an experienced and
knowledgeable tissue engineering research team. A time line for the proposed
work is provided, and the technology involves an innovative tissue engineering
approach in a medical field with significant unmet needs.
PROPOSED COMMERCIAL APPLICATION:
The use of UBM-ECM for the tissue engineering applications that involve the restoration
of missing tissue as a result of congenital anomalies is in many ways an orphan market.
Most biomaterials currently available for such use are inadequate beause they do not
"grow" as the infant grows and, thus, repeat surgical procedures are required. Many
currently available materials result in scar tissue formation with extensive morbidity. The
development of new materials for these applications is not cost effective for many large
companies due to the relatively small number of patients requiring this material each year.
However, these patients desperately need a better alternative to existing materials, and
successful development of this product could lead to broader surgical applications.

* Information listed above is at the time of submission. *

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