Burn injuries and chronic wounds present a significant burden to patients and the US healthcare system. Each year in the US, there are 450,000 burns that require medical treatment and 45,000 burn patients that require hospitalization. The mortality rate associated with severe burns can be as high as 10%, with 75% of patient deaths arising from infection. In addition to the risk of infection, delays in burn wound closure prolong pain, increase the chance of hypertrophic scarring or graft rejection, and multiply the number of operative procedures. Meanwhile, venous ulcers occur in 600,000 to 1,500,000 US patients, and 35-45% of these patients will not respond to current treatments. In addition, 15% to 20% of patients with diabetes will suffer a chronic foot wound, and up to 27% of these wounds will eventually require amputation. Stem cells can address the unmet needs in burn and wound therapy by accelerating the rate of vascularization and collagen deposition and by attenuating the inflammatory response. Adipose-derived mesenchymal stem cells (ASCs) and bone marrow-derived mesenchymal stem cells (BMSCs) secrete a broad range of proteins that are crucial for neovascularization, extracellular matrix (ECM) remodeling, and the attenuation of an inflammatory response. Multiple pre-clinical and clinical reports suggest that ASCs and BMSCs improve healing of burn injuries and acute and chronic wounds. However, the use of expanded and cultured cells increases the time and cost of medical procedures and can delay treatment. Therefore, a product that can capture ASCs or BMSCs from autologous tissue at the point-of-care would have significant advantages over the use of cultured cells. In this project, we propose to develop a peptide coating for skin substitutes to capture and retain ASCs at the point-of- care. When used to treat chronic wounds and severe burns, the peptide-coated skin substitute will accelerate vascularization and healing and provide substantially better outcomes for patients.

Public Health Relevance

Adult stem cells provide numerous advantages to speed up the healing process of burn injuries and wounds. In this application, we propose to modify skin substitutes with a coating that will allow surgeons to capture adult stem cells onto the skin substitute during the operation. Capturing adult stem cells at the point-of-care will reduce the costs associated with processing and expanding cells, and delivery of autologous, therapeutic cells will provide better and faster healing.

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 #
5R44GM101759-03
Application #
8925905
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cole, Alison E
Project Start
2012-07-01
Project End
2017-08-31
Budget Start
2015-09-01
Budget End
2016-08-31
Support Year
3
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Affinergy, LLC
Department
Type
DUNS #
078296854
City
Durham
State
NC
Country
United States
Zip Code
27709