You are here

ECM Bioscaffold for ASD Repair

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL083627-01
Agency Tracking Number: HL083627
Amount: $102,950.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Timeline
Solicitation Year: 2006
Award Year: 2006
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
6 OLD DEE ROAD
CAMBRIDGE, MA 02138
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ALAN SPIEVACK
 (617) 547-9060
 arspievack@comcast.net
Business Contact
 TIFFANY KARP
Phone: (617) 547-9060
Email: TIFFANYKARP@ACELL.COM
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): This Phase I proposal seeks support to evaluate the feasibility of developing an extracellular matrix (ECM) biologic scaffold as a repair device for atrial septal defects (ASD). ASDs are one of the most common forms of congenital heart disease and account for approximately 30-40% of all congenital heart defects seen in adults. Closure of an ASD can be performed either surgically or percutaneously, and the success rate of this procedure is very high. However, recent reports suggest that complications with severe hemodynamic consequences do occur and are a result of the metal cage configuration of the repair device. This cage configuration serves as an abrasive surface to adjacent atrial roof and aortic tissues. The proposed studies would utilize non-abrasive, naturally occurring ECM configured in mechanically-appropriate, multilaminate form as the repair device. This Phase I proposal has three Specific Aims. The first Specific Aim would develop a prototype ECM device suitable for percutaneous delivery. The second Specific Aim would evaluate the biomechanical and biophysical properties of the device. The final Specific Aim would determine functionality in a pig model of surgically created ASD. These studies will be conducted by an experienced team of investigators at ACell, Inc., with a subcontract for the animal studies at the Center for Preclinical Studies within the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Clearly defined criteria for success are identified for each Specific Aim and a timeline for completion of the studies is provided.

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

US Flag An Official Website of the United States Government