Cell-Based, Chronic Wound Gene Therapy for Older Adults

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R42AG026174-02A2
Agency Tracking Number: AG026174
Amount: $1,186,080.00
Phase: Phase II
Program: STTR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
DUNS: 160392168
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (608) 441-2756
Email: rbarnard@stratatechcorp.com
Research Institution
DESCRIPTION (provided by applicant): To date no biological treatment options specifically targeting the proteolytic nature of chronic wounds have been developed and marketed. Chronic skin wounds constitute an important medical problem for the growing age d population. 18% of diabetic patients over the age of 65 suffer from chronic, non-healing foot ulcers, and it is estimated that over 50,000 lower extremity amputations are due to diabetes in this same age group annually. 2.1 million Americans are diagnose d yearly with pressure ulcers, and the yearly incidence of venous ulcers is estimated to be 900,000. The creation of a cell-based gene therapy product with these properties would specifically target the needs of patients to reduce pain, risk of infection, and other complications thereby raising their quality of life. A persistent biochemical imbalance between proteinases and their inhibitors exists in the chronic wound bed. This imbalance may lead to abnormal degradation of the extracellular matrix, degrada tion of critical growth factors, and the breakdown of their respective cellular receptors within the wound environment further contributing to cellular dysfunction. Successful completion of Phase I milestones not only demonstrated the proof of principle th at our human keratinocytes could be genetically modified to express and secrete bioactive proteinase inhibitor in monolayer culture, but identified a subset of clones to take into subsequent Phase II studies. The tissue evaluated in Phase II will mimic Exp ressGraftTMShield, the engineered final product that will combat the excess proteolytic activity associated with chronic cutaneous wounds. Advances in ex vivo genetic engineering of a patented human keratinocyte cell line at Stratatech Corporation has made it uniquely positioned to complete this work. This Phase II study will 1) continue candidate clone screening in monolayer based on migration properties, as well as genomic integration, 2) examine their ability to form tissue that expresses a bioactive pro teinase inhibitor, 3) perform preclinical animal efficacy studies, 4) identify the ideal candidate clone that will compose ExpressGraftTMShield, and 5) complete FDA-mandated safety testing. Successful completion of these milestones will expedite submission of an IND application to the FDA for initiation of a human clinical safety trial.

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

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government