Dear Readers:

This month’s issue of Wounds developed by Section Editor, Dr. Gerit Mulder, is the first on the topic Genomic, Cellular, and Recombinant Technologies. In his message, Dr. Mulder reviews some of the major historical advancements in wound treatment since the concept of moist wound healing pioneered by George Winter in 1962. That work brought a greater focus on cellular activity in wound healing and has ultimately led to the advent of interactive and active products that are in use today and many others in the development cycle. The papers of this section cover some of these new products and emerging technologies that are leading to new therapeutic approaches in wound treatment.

Eisenbud, et al., (Skin substitutes and wound healing: Current status and challenges) address the topic of skin substitutes, an area of intensive research and development over the last 5 to 15 years. The authors point out the initial goals of replacing autografts or allografts and the evolving recognition that these products stimulated wound healing in poorly healing or nonhealing chronic wounds. The authors review the designs of many of the skin substitutes in development or on the market. They present the reader with an excellent review of the advantages and disadvantages of skin substitutes as well as the challenges to improve the technology, understand mechanisms of action, simplify delivery and storage, and reduce cost of manufacture.

Demling, et al., (Small intestinal submucosa wound matrix and full-thickness venous ulcers: Preliminary results) present an interim analysis of a clinical trial involving 84 patients whose venous ulcers were treated with a biomaterial derived form porcine small intestinal submucosa (SIS) or “standard of care.” The results are promising as 71 percent of wounds treated with SIS and 46 percent of control wounds healed within 12 weeks. The authors recommend further evaluation of SIS for its efficacy in the treatment of venous ulcers as well as other wound types.

Chandler and Sosnowski (Gene therapy for cutaneous wound repair) discuss the developments of growth factor protein therapeutics for chronic wound repair, the challenges of maintaining activity of proteins in the wound bed, and the use of growth factor gene therapy to overcome these challenges and improve healing responses. While growth factor genes are obvious candidates for tissue repair, the authors suggest that other candidate genes include growth factor receptors, protease inhibitors, extracellular matrix proteins, and transcription factors.

Gu, et al., (Matrix-immobilized growth factor gene therapy enhances tissue repair) present studies on a novel gene therapy approach designed to overcome the low gene transfer efficiencies reported using other methods. The authors immobilize a gene encoding a growth factor in a biocompatible collagen matrix. This matrix can be applied to the wound to retain the DNA vector and the transgene product at the desired site. The matrix serves as a scaffold, which allows ingrowth, proliferation, and transduction of wound fibroblasts. The authors call this a gene-activated matrix (GAM). They report their findings in three animal models using the GAM to deliver an adenoviral vector encoding PDGF-B. Results showed sustained local production of PDGF-BB and rapid granulation tissue formation. Based upon these findings and safety studies (unpublished), a phase I clinical trial of the AdPDGF-B/collagen GAM in diabetic ulcers has begun.

In the last contribution to the Section, Mulder presents Recommendations for designing and implementing protocols for advanced technology clinical trials. He discusses the complexities of designing study protocols that not only meet FDA requirements of safety and efficacy, but also address the issues of clinical and commercial reality of the product under study. Mulder provides a template and guide for studying advanced wound treatments, which will be of value to both the industry and the investigator community.

In the CME/CPME-accredited Diagnostic Dilemmas, Hall, et al., report a case of linear scleroderma. They present the symptoms and history of the patient and biopsy and laboratory studies leading to diagnosis. The various forms and characteristics of scleroderma are discussed as well as the treatment options.

David T. Rovee, PhD
Editor, WOUNDS