Phase I study of H5.020CMV.PDGF-beta to treat venous leg ulcer disease.

Abstract

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.

• Authors: David J Margolis, Lee M Morris, Maryte Papadopoulos, Linda Weinberg, Jennifer C Filip, Stephanie A Lang, Sachin S Vaikunth, Timothy M Crombleholme
• Journal: Molecular therapy : the journal of the American Society of Gene Therapy (Mol Ther) Vol. 17 Issue 10 Pg. 1822-9 (Oct 2009) ISSN: 1525-0024 [Electronic] United States
• PMID: 19638959 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Platelet-Derived Growth Factor

Topics

• Adenoviridae (genetics)
• Adult
• Cytomegalovirus (genetics)
• Enhancer Elements, Genetic (genetics)
• Female
• Genetic Therapy (adverse effects, methods)
• Genetic Vectors (genetics)
• Humans
• Leg Ulcer (therapy)
• Male
• Middle Aged
• Neovascularization, Physiologic
• Platelet-Derived Growth Factor (genetics, physiology)
• Promoter Regions, Genetic (genetics)
• Treatment Outcome
• Varicose Ulcer (therapy)