Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Healing of Diabetic Neuropathic Foot Ulcers: Comparative Analysis Versus Standard of Care.

To compare outcomes of diabetic foot ulcers (DFUs) treated with a collagen Wound Conforming Matrix (WCM) or standard of care (SOC). WCM, a highly purified homogenate of 2.6% fibrillar bovine dermal collagen that conforms to the wound surface, was evaluated in comparison to daily saline-moistened gauze dressing changes (SOC) as part of a retrospective subset analysis of a randomized controlled trial in DFU.

The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic.

Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004.

Intervention with Formulated Collagen Gel for Chronic Heel Pressure Ulcers in Older Adults with Diabetes.

Chronic pressure ulcers (PrUs), ulcers that fail to progress through the expected phases of wound healing in a timely fashion, are not only a concern for the patients afflicted with them, but are also a significant burden for the long-term-care facilities in which patients reside. The heel is the second most common location for PrUs. Morbidity and mortality rates for heel PrUs, particularly in the diabetic population, are alarming.

Serial sharp debridement and formulated collagen gel to treat pressure ulcers in elderly long-term care patients: a case study.

Clinicians treating pressure ulcers in the elderly in long-term care often face psychosocial, financial, and patient quality-of-life challenges; as such, they seek to identify products that meet wound healing goals as expeditiously as possible. The purpose of this case series was to evaluate outcomes of serial sharp debridement and the application of a formulated collagen gel in patients with chronic, nonhealing pressure ulcers. Three patients (two women ages 82 and 74 years of age and one man 82 years old, all incontinent of bladder and bowel with numerous comorbidities) had wounds >18 months' duration on the buttocks or coccyx that failed to improve despite the use of a wide variety of treatments, including negative pressure wound therapy.

Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers.

We assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF-B (GAM501) compared with Standard of Care (SOC) in patients with 1.5-10.0 cm(2) chronic diabetic neuropathic foot ulcers that healed <30% during Run-in.

Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): results of a phase 1/2 trial.

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.

Adenovirus encoding human platelet-derived growth factor-B delivered to alveolar bone defects exhibits safety and biodistribution profiles favorable for clinical use.

Platelet-derived growth factor (PDGF) gene therapy offers promise for tissue engineering of tooth-supporting alveolar bone defects. To date, limited information exists regarding the safety profile and systemic biodistribution of PDGF gene therapy vectors when delivered locally to periodontal osseous defects. The aim of this preclinical study was to determine the safety profile of adenovirus encoding the PDGF-B gene (AdPDGF-B) delivered in a collagen matrix to periodontal lesions.

Adenovirus encoding human platelet-derived growth factor-B delivered in collagen exhibits safety, biodistribution, and immunogenicity profiles favorable for clinical use.

We have developed a therapeutic approach to wound repair involving immobilization of gene transfer vectors within biocompatible matrices (gene-activated matrix, or GAM). The matrix also serves as a scaffold for cellular in-growth and subsequent gene uptake and expression. An adenoviral vector encoding human platelet-derived growth factor-B delivered in collagen (AdPDGF-B/GAM) has demonstrated efficacy in models of wound repair.

Platelet-derived growth factor B, but not fibroblast growth factor 2, plasmid DNA improves survival of ischemic myocutaneous flaps.

Hypothesis: Tissue flaps are commonly used for surgical reconstruction, especially to cover difficult wounds and in breast reconstruction following mastectomy. Complications due to inadequate flap perfusion are a source of morbidity and, in the lower extremity, can result in amputation.

Setting: Laboratory.

Identification of FGF receptor-binding peptides for cancer gene therapy.

Linear FGF receptor-binding heptapeptides were identified by phage display using sequential rounds of biopanning against cells with displacement of phage by FGF2. The consensus motif MXXP was iterated after four to five rounds and the peptide MQLPLAT was studied in depth. Phage bearing MQLPLAT showed high levels of binding to FGF receptor positive cells, with over 90% of phage bound being eluted competitively by adding free FGF2.

Delivery of FGF genes to wound repair cells enhances arteriogenesis and myogenesis in skeletal muscle.

Tissue repair is driven by migratory macrophages and fibroblasts that infiltrate injury sites and secrete growth factors. We now report the enhancement of skeletal muscle repair by targeting transgene delivery to these repair cells using matrix-immobilized gene vectors. Plasmid and adenovirus vectors immobilized in collagen-gelatin admixtures were delivered to excisional muscle wounds, and when encoding either fibroblast growth factor-2 (FGF2) or FGF6 transgenes, produced early angiogenic responses that subsequently remodeled into arteriogenesis.