Over 700,000 surgical hernia repairs are performed each year in the United States and despite recent advances, a significant rate of recurrence persists. Of these surgeries, 100,000 are for incisional or visceral hernia repairs, which cost 1.7B annually and have a recurrence rate that can be up to 60%. The incorporation of biocompatible mesh to strengthen the abdominal fascia has largely replaced high-tension suturing techniques in surgical hernia repair. Currently, the preferred biomaterials include durable synthetic mesh, which bears all the pitfalls of a permanent foreign body;absorbable mesh which does not provide enough long- term support;or bioprosthetics, which are bioabsorbable but still fail at an unacceptably high rate causing recurrent hernias. Surgeons are therefore left to choose between poor options for a repair. Our goal is to accelerate healing rates after hernia repair by using bioprosthetics containing adipose-derived stem cells (ASCs). ASCs were identified in 2001, and have been used for cell therapy in many indications including bone fractures, myocardial repair and soft tissue repair. Their prohealing function is largely mediated through paracrine factors secreted at the site of injury to promote vascularization and tissue remodeling. The product will be a point-of-care ASC seeded bioprosthetic that will promote faster healing times, prevent infection, and leave a biologic repair. Our bioprosthetic is designed to prevent recurrence of incisional hernias, thereby reducing inpatient follow-up care, additional surgeries, and patient distress.

Public Health Relevance

Improving the rate of healing after surgical hernia repair will reduce pain, discomfort and follow-up care. The use of adult stem cells in soft tissue healing represents a potential improvement for surgical procedures. This proposal will develop a novel bioprosthetic for the local retention of cells to improve healing rates and reduce recurrence of incisional hernia repairs.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44GM099488-02
Application #
8392845
Study Section
Special Emphasis Panel (ZRG1-SBIB-V (12))
Program Officer
Cole, Alison E
Project Start
2011-09-10
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
2
Fiscal Year
2012
Total Cost
$913,033
Indirect Cost
Name
Affinergy, LLC
Department
Type
DUNS #
078296854
City
Durham
State
NC
Country
United States
Zip Code
27713