Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): Results of a Phase 1/2 trial: ORIGINAL ARTICLE - CLINICAL SCIENCE

Wound Repair and Regeneration

Volumn 17, Issue 6, 2009, Pages 772-779

  Mulder, Gerit ^a   Tallis, Arthur J ^b   Marshall, V Tracy ^b   Mozingo, David ^c   Phillips, Laurie ^d,f   Pierce, Glenn F ^d,g   Chandler, Lois A ^e   Sosnowski, Barbara K ^e  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b Associated Foot and Ankle Specialists   (United States)

^c UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^d Selective Genetics   (United States)

^e Tissue Repair Company   (United States)

^f BIOGEN   (United States)

^g Medical Research   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; COLLAGEN ANTIBODY; CYTOKINE ANTIBODY; GAM 501; PLATELET DERIVED GROWTH FACTOR B; UNCLASSIFIED DRUG; VIRUS DNA;

ADULT; AGED; ANTIBODY BLOOD LEVEL; ANTIBODY DETECTION; ANTIBODY TITER; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DEBRIDEMENT; DIABETIC FOOT; DNA DETERMINATION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TISSUE LEVEL; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN TISSUE; MALE; MAXIMUM TOLERATED DOSE; PAIN; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SHOE; SINGLE DRUG DOSE; VIRAL GENE DELIVERY SYSTEM; VIRAL GENE THERAPY; WOUND HEALING; WOUND HEALING IMPAIRMENT;

ADENOVIRUSES, HUMAN; ADMINISTRATION, TOPICAL; ADULT; AGED; BANDAGES, HYDROCOLLOID; DEBRIDEMENT; DIABETIC FOOT; DRUG DOSAGE CALCULATIONS; FEMALE; GELS; GENE THERAPY; HUMANS; MALE; MIDDLE AGED; PROTO-ONCOGENE PROTEINS C-SIS; WOUND HEALING;

EID: 70350654437     PISSN: 10671927     EISSN: 1524475X     Source Type: Journal    
DOI: 10.1111/j.1524-475X.2009.00541.x     Document Type: Article

References (14)

1. National Diabetes Information Clearing House (NDIC). Available at : (updated 2007, cited 2009).
2. Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care 1999 22 : 157 162.
3. Gordois A, Schuffham P, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care 2003 26 : 1790 1795.
4. Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. Diabetes Care 1999 22 : 692 695.
5. Smiell JM, Wieman TJ, Steed DL, Perry BH, Sampson AR, Schwab BH. Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies. Wound Repair Regen 1999 7 : 335 346.
6. Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen 2006 14 : 680 692.
7. Cooper DM, Yu EZ, Hennessey P, Ko F, Robson MC. Determination of endogenous cytokines in chronic wounds. Ann Surg 1994 219 : 688 692.
8. Pierce GF, Tarpley JE, Tseng J, Bready J, Chang D, Kenney WC, Rudolph R, Robson MC, Vande Berg J, Reid P, Kaufman S, Farrell CL. Detection of platelet-derived growth factor (PDGF)-AA in actively healing human wounds treated with recombinant PDGF-BB and absence of PDGF in chronic nonhealing wounds. J Clin Invest 1995 96 : 1336 1350.
9. Doukas J, Chandler LA, Gonzalez AM, Gu DL, Hoganson DK, Ma C, Nguyen T, Printz MA, Nesbit M, Herlyn M, Crombleholme TM, Aukerman SL, Sosnowski BA, Pierce GF. Matrix immobilization enhances the tissue repair activity of growth factor gene therapy vectors. Hum Gene Ther 2001 12 : 783 798.
10. Gu DL, Nguyen T, Gonzalez AM, Printz MA, Pierce GF, Sosnowski BA, Phillips ML, Chandler LA. Adenovirus encoding human platelet-derived growth factor-B delivered in collagen exhibits safety, biodistribution, and immunogenicity profiles favorable for clinical use. Mol Ther 2004 9 : 699 711.
11. Somasundaram R, Schuppan D. Type I, II, III, IV, V, and VI collagens serve as extracellular ligands for the isoforms of platelet-derived growth factor (AA, BB, and AB). J Biol Chem 1996 271 : 26884 26891.
12. Kantor J, Margolis DJ. Efficacy and prognostic value of simple wound measurements. Arch Dermatol 1998 134 : 1571 1574.
13. World Health Organization. Available at : (cited 2009).
14. Gu DL, Nguyen T, Phillips ML, Chandler LA, Sosnowski B. Matrix-immbolilized growth factor gene therapy enhances tissue repair. Wounds 2004 16 : 34 41.