Phase I study of H5.020CMV.PDGF-beta to treat venous leg ulcer disease.
Venous leg ulcers are a prevalent nonhealing wound of the lower extremity. Although topically applied growth factors successfully improve wound repair in animal studies, similar studies on humans with venous leg ulcers have not been successful. This study was designed to evaluate the acute safety and biologic feasibility of peri-ulcer injection of a replication-incompetent adenoviral construct expressing platelet-derived growth factor-beta (PDGF-beta). In this phase I study, we demonstrate the initial safety, feasibility, and biologic plausibility of using H5.020CMV.PDGF-beta to treat venous leg ulcer disease.
Margolis
David J
DJ
Center for Clinical Epidemiology and Biostatistics, 815 Blockley Hall, 423 Guardian Drive, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. margo@mail.med.upenn.edu
Morris
Lee M
LM
Papadopoulos
Maryte
M
Weinberg
Linda
L
Filip
Jennifer C
JC
Lang
Stephanie A
SA
Vaikunth
Sachin S
SS
Crombleholme
Timothy M
TM
D000256:Adenoviridae / Q000235:genetics; D000328:Adult; D003587:Cytomegalovirus / Q000235:genetics*; D004742:Enhancer Elements, Genetic / Q000235:genetics; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects / Q000379:methods*; D005822:Genetic Vectors / Q000235:genetics; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018919:Neovascularization, Physiologic; D010982:Platelet-Derived Growth Factor / Q000235:genetics / Q000502:physiology*; D011401:Promoter Regions, Genetic / Q000235:genetics; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy*
D010982:Platelet-Derived Growth Factor