Phase I Study of H5.020CMV.PDGF-β to Treat Venous Leg Ulcer Disease

Phase I Study of H5.020CMV.PDGF-β 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 an...

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Veröffentlicht in:Molecular therapy 2009-10, Vol.17 (10), p.1822-1829
Hauptverfasser: Margolis, David J, Morris, Lee M, Papadopoulos, Maryte, Weinberg, Linda, Filip, Jennifer C, Lang, Stephanie A, Vaikunth, Sachin S, Crombleholme, Timothy M
Format: Artikel
Sprache:eng
Schlagworte:
Adenoviridae - genetics
Adult
Cytomegalovirus - genetics
Enhancer Elements, Genetic - genetics
Female
Genetic Therapy - adverse effects
Genetic Therapy - methods
Genetic Vectors - genetics
Humans
Leg Ulcer - therapy
Male
Middle Aged
Neovascularization, Physiologic
Original
Platelet-Derived Growth Factor - genetics
Platelet-Derived Growth Factor - physiology
Promoter Regions, Genetic - genetics
Treatment Outcome
Varicose Ulcer - therapy
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Zusammenfassung: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-β (PDGF-β). In this phase I study, we demonstrate the initial safety, feasibility, and biologic plausibility of using H5.020CMV.PDGF-β to treat venous leg ulcer disease.
ISSN:1525-0016
1525-0024
DOI:10.1038/mt.2009.169