Delivery of Adipose Derived Stem Cells for Healing Surgical Hernia Repairs

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$327,042.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
1R43GM099488-01
Award Id:
n/a
Agency Tracking Number:
R43GM099488
Solicitation Year:
2011
Solicitation Topic Code:
NIGMS
Solicitation Number:
PA10-050
Small Business Information
PO BOX 14650, RESEARCH TRIANGLE PARK, NC, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
078296854
Principal Investigator:
BRUCELAMB
(919) 433-2228
blamb@affinergy.com
Business Contact:
CHRISBRASFIELD
(919) 433-2227
cbrasfield@affinergy.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): Over 700,000 surgical hernia repairs are performed each year in the United States and despite recent advances, a significant rate of recurrence persists. Incisional or visceral hernia repairs account for 100,000 of these surgeries costing 1.7B annually, and have a recurrence rate of 25% for an initial repair and 44% after a second repair. 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 fail at an unacceptably high rate causing recurrent hernias. Surgeons are therefore left to choose between a foreign body and a weak 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 secretedat the site of injury to promote vascularization, and tissue remodeling. The product prototype we envision 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 introduction of biologics into soft tissue healing represents a potential improvement for surgical procedures, but due to a lack of clinically viable delivery mechanisms, these strategies remain under utilized. This proposal will develop a novel bioprosthetic for the local retention of cells to improve healing rates and reduce recurrence of incisional hernia repairs. Because hernia repair is one of the most common surgical procedures world-wide, with more than 700,000 surgeries in the United States, this product will provide substantially improved clinical outcomes for a large number of patients.

* information listed above is at the time of submission.

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