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Literature DB >> 19638959

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

David J Margolis¹, Lee M Morris, Maryte Papadopoulos, Linda Weinberg, Jennifer C Filip, Stephanie A Lang, Sachin S Vaikunth, Timothy M Crombleholme.

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.

Entities: Disease Gene Species

Mesh：

Substances：

Year: 2009 PMID： 19638959 PMCID： PMC2835007 DOI： 10.1038/mt.2009.169

Source DB: PubMed Journal: Mol Ther ISSN： 1525-0016 Impact factor: 11.454

31 in total

1. Origins of circulating endothelial cells and endothelial outgrowth from blood.

Authors: Y Lin; D J Weisdorf; A Solovey; R P Hebbel
Journal: J Clin Invest Date: 2000-01 Impact factor: 14.808

Review 2. Adenoviral-mediated gene transfer in wound healing.

Authors: T M Crombleholme
Journal: Wound Repair Regen Date: 2000 Nov-Dec Impact factor: 3.617

3. Guidance for industry: chronic cutaneous ulcer and burn wounds-developing products for treatment.

Authors:
Journal: Wound Repair Regen Date: 2001 Jul-Aug Impact factor: 3.617

4. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease.

Authors: M Vasa; S Fichtlscherer; A Aicher; K Adler; C Urbich; H Martin; A M Zeiher; S Dimmeler
Journal: Circ Res Date: 2001-07-06 Impact factor: 17.367

5. Surrogate endpoints for the treatment of venous leg ulcers.

Authors: Joel M Gelfand; Ole Hoffstad; David J Margolis
Journal: J Invest Dermatol Date: 2002-12 Impact factor: 8.551

6. Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial.

Authors: V Falanga; R M Fujitani; C Diaz; G Hunter; J Jorizzo; P F Lawrence; B Y Lee; J O Menzoian; L L Tretbar; G A Holloway; J Hoballah; G R Seabrook; D E McMillan; W Wolf
Journal: Wound Repair Regen Date: 1999 Jul-Aug Impact factor: 3.617

7. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology.

Authors: David R Bickers; Henry W Lim; David Margolis; Martin A Weinstock; Clifford Goodman; Eric Faulkner; Ciara Gould; Eric Gemmen; Tim Dall
Journal: J Am Acad Dermatol Date: 2006-09 Impact factor: 11.527

8. Stroma formation and angiogenesis by overexpression of growth factors, cytokines, and proteolytic enzymes in human skin grafted to SCID mice.

Authors: Claus J Gruss; Kapaettu Satyamoorthy; Carola Berking; John Lininger; Mark Nesbit; Helmut Schaider; Zhao-June Liu; Masahiro Oka; Mei-Yu Hsu; Takashi Shirakawa; Gang Li; Thomas Bogenrieder; Peter Carmeliet; Wafik S El-Deiry; Stephen L Eck; Justi S Rao; Andrew H Baker; Jean T Bennet; Timothy M Crombleholme; Omaida Velazquez; Jagajan Karmacharya; David J Margolis; James M Wilson; Michael Detmar; Mihaela Skobe; Paul D Robbins; Clayton Buck; Meenhard Herlyn
Journal: J Invest Dermatol Date: 2003-04 Impact factor: 8.551

9. The accuracy of venous leg ulcer prognostic models in a wound care system.

Authors: David J Margolis; Lynne Allen-Taylor; Ole Hoffstad; Jesse A Berlin
Journal: Wound Repair Regen Date: 2004 Mar-Apr Impact factor: 3.617

10. Venous thromboembolism and other venous disease in the Tecumseh community health study.

Authors: W W Coon; P W Willis; J B Keller
Journal: Circulation Date: 1973-10 Impact factor: 29.690

12 in total

Review 1. Gene therapy for skin diseases.

Authors: Emily Gorell; Ngon Nguyen; Alfred Lane; Zurab Siprashvili
Journal: Cold Spring Harb Perspect Med Date: 2014-04-01 Impact factor: 6.915

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

1. Origins of circulating endothelial cells and endothelial outgrowth from blood.

Review 2. Adenoviral-mediated gene transfer in wound healing.

3. Guidance for industry: chronic cutaneous ulcer and burn wounds-developing products for treatment.

4. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease.

5. Surrogate endpoints for the treatment of venous leg ulcers.

6. Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial.

7. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology.

8. Stroma formation and angiogenesis by overexpression of growth factors, cytokines, and proteolytic enzymes in human skin grafted to SCID mice.

9. The accuracy of venous leg ulcer prognostic models in a wound care system.

10. Venous thromboembolism and other venous disease in the Tecumseh community health study.

Review 1. Gene therapy for skin diseases.

2. Adenovirus-Antibody Complexes Contributed to Lethal Systemic Inflammation in a Gene Therapy Trial.

3. Venous leg ulcerations: a treatment update.

Review 4. Novel and emerging therapies in the treatment of recessive dystrophic epidermolysis bullosa.

5. Platelet-derived growth factor-coated decellularized meniscus scaffold for integrative healing of meniscus tears.

Review 6. Regenerative Medicine: Charting a New Course in Wound Healing.

Review 7. Clinical application of growth factors and cytokines in wound healing.

8. Platelet-Rich Fibrin Lysate Can Ameliorate Dysfunction of Chronically UVA-Irradiated Human Dermal Fibroblasts.

Review 9. A Current View of Functional Biomaterials for Wound Care, Molecular and Cellular Therapies.

10. Effect of sustained PDGF nonviral gene delivery on repair of tooth-supporting bone defects.