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- Title
Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): Results of a Phase 1/2 trial.
- Authors
Mulder, Gerit; Tallis, Arthur J.; Marshall, V. Tracy; Mozingo, David; Phillips, Laurie; Pierce, Glenn F.; Chandler, Lois A.; Sosnowski, Barbara K.
- Abstract
The results from a Phase 1/2 study of a replication-defective adenovirus encoding human platelet-derived growth factor (PDGF)-B formulated in a bovine collagen (Ad-5PDGF-B; 2.6% collagen; GAM501) gel for nonhealing neuropathic diabetic foot ulcers is reported. The primary objectives of the study were to evaluate the safety, maximum-tolerated dose, and preliminary biological activity of GAM501. Fifteen patients enrolled into the study with chronic, nonhealing ulcers received either a single administration of GAM501 at one of three dose levels, or up to four administrations of GAM501 at 1-week intervals. All patients received standard of care treatment including debridement and were required to wear an off-loading shoe. GAM501 was found to be safe and well tolerated with no evidence of systemic or local toxicity at all doses so no maximum-tolerated dose was reached. Serum antibody titers to platelet-derived growth factor-B homodimer and collagen were negative and adenoviral DNA was not detected in the blood. In the 12 patients that completed the study, ulcer closure was observed by Month 3 in 10 patients, seven of whom received a single application of GAM501. In conclusion, GAM501 did not appear to have any toxicity at doses that showed biological activity. GAM501 holds promise as a potentially effective treatment for nonhealing diabetic foot ulcers.
- Subjects
FOOT ulcers; DIABETIC foot; PLATELET-derived growth factor; MEDICAL research; WOUND healing
- Publication
Wound Repair & Regeneration, 2009, Vol 17, Issue 6, p772
- ISSN
1067-1927
- Publication type
Article
- DOI
10.1111/j.1524-475X.2009.00541.x