There is an immense need for developing clinically effective treatments of chronic wounds. Estimates of the costs for treating chronic wounds range into the billions of dollars annually. As Western society continues to age, the problem of chronic wounds will likely increase. Recent studies indicate proteases released during an over exuberant neutrophil response may have a significant role in the pathophysiology of chronic wounds. The objective of this proposed study is to test the feasibility of designing and developing dressings with the ability to sequestered/inhibit neutrophil derived proteases. Focus will be on the utilization of modified cellulosic-based materials. Cellulosic-based materials will be modified so as to introduce functional modalities that are predicted to bind neutrophil elastase and possibly other cationic neutrophil-derived proteases. In vitro assays will be used to assess the ability of several modified products to remove proteolytic activities from wound fluids. Candidate materials with desired sequestering properties will e further examined for pH stability, sterilization stability, and cytotoxicity. Besides their basis on a rational strategy, such a modified cellulosic-based material will have the additional advantage of being relatively inexpensive and thus have a high potential for use in the world-wide market. Once the principle has proved on a simple cellulosic dressing material, experiments will be conducted to expand the potential for other more sophisticated substrates for use as dressing materials (patents pending) and expanding the range of sequestering/inhibiting compounds onto the dressing or in the form of an ointment cream lotion.

Proposed Commercial Applications

The total cost for treating chronic wound sis estimated at $22-26 bn (Page 11), the cost of dressings used is in excess of $1 bn (Page 13). When compared with both currently available wound care products and those in development the technology has the following significant advantage: non invasive method of treatment; low cost of manufacture; potential to enter the 3rd world markets and bring affordable health care to this normally overlooked segment of the population; comparable clinical performance to the pharmaceutical growth factors that are priced at $300 per tube. This unique set of factors combine to offer a sales potential estimated at $95MM in the US and triple that number worldwide.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM063303-01A1
Application #
6444874
Study Section
Special Emphasis Panel (ZRG1-SSS-8 (10))
Program Officer
Somers, Scott D
Project Start
2002-04-12
Project End
2003-10-11
Budget Start
2002-04-12
Budget End
2003-10-11
Support Year
1
Fiscal Year
2002
Total Cost
$125,825
Indirect Cost
Name
Tissue Technologies Holding, LLC
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23219