Abstract

This is a dual phase 1 set of studies on venous leg ulcer therapy, the goals of which are to (1) determine the maximum tolerated dose of an adenovirus vector based gene transfer of PDGF/B into chronic wounds, and (2) determine the feasibility and safety of this approach for the treatment of venous stasis leg ulcers over a 24 week course. The investigators will evaluate the safety and feasibility of this approach in the trial and the ancillary studies will investigate the persistence of the transferred genetic material in the patient, critical for advancing the use of the therapy.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research and Development Contracts (N01)
Project #
N01AR092238-000
Application #
6158395
Study Section
Project Start
1999-09-30
Project End
2004-09-29
Budget Start
1999-09-30
Budget End
2000-09-29
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
University of Pennsylvania
Department
Dermatology
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104

  Publications

Bradley, Todd; Ferrari, Guido; Haynes, Barton F et al. (2018) Single-Cell Analysis of Quiescent HIV Infection Reveals Host Transcriptional Profiles that Regulate Proviral Latency. Cell Rep 25:107-117.e3
Margolis, David J; Morris, Lee M; Papadopoulos, Maryte et al. (2009) Phase I study of H5.020CMV.PDGF-beta to treat venous leg ulcer disease. Mol Ther 17:1822-9