Welcome to the Podiatry Arena forums, for communication between foot health professionals about podiatry and related topics.
You are currently viewing our podiatry forum as a guest which gives you limited access to view all podiatry discussions and access our other features. By joining our free global community of Podiatrists and other interested foot health care professionals you will have access to post podiatry topics (answer and ask questions), communicate privately with other members (PM), upload content, view attachments, receive a weekly email update of new discussions, earn CPD points and access many other special features. Registered users do not get displayed the advertisments in posted messages. Registration is fast, simple and absolutely free so please, join our global Podiatry community today!
If you have any problems with the registration process or your account login, please contact contact us.
Apligraf is supplied as a living, bi-layered skin substitute.† Like human skin, Apligraf consists of living cells and structural proteins. The lower dermal layer combines bovine type 1 collagen and human fibroblasts (dermal cells), which produce additional matrix proteins. The upper epidermal layer is formed by promoting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis
is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells
and used to be made by Smith & Nephew until they sold it to Advanced BioHealing.
Both products have similar indications, but are essentially competitors.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Background Chronic wounds represent a major problem to our society. Therefore, advanced wound-healing strategies for the treatment of these wounds are expanding into the field of tissue engineering.
Objectives To develop a novel tissue-engineered, autologous, full-thickness skin substitute of entirely human origin and to determine its ability to heal chronic wounds.
Methods Skin substitutes (fully differentiated epidermis on fibroblast-populated human dermis) were constructed from 3-mm punch biopsies isolated from patients to be treated. Acellular allodermis was used as a dermal matrix. After a prior 5-day vacuum-assisted closure therapy to prepare the wound bed, skin substitutes were applied in a simple one-step surgical procedure to 19 long-standing recalcitrant leg ulcers (14 patients; ulcer duration 0·5–50 years).
Results The success rate in culturing biopsies was 97%. The skin substitute visibly resembled an autograft. Eleven of the 19 ulcers (size 1–10 cm2) healed within 8 weeks after a single application of the skin substitute. The other eight larger (60–150 cm2) and/or complicated ulcers healed completely (n = 5) or continued to decrease substantially in size (n = 3) after the 8-week follow-up period. Wound healing occurred by direct take of the skin substitute (n = 12) and/or stimulation of granulation tissue/epithelialization (n = 7). Skin substitutes were very well tolerated and pain relief was immediate after application.
Conclusions Application of this novel skin substitute provides a promising new therapy for healing chronic wounds resistant to conventional therapies.
Tissue-engineered biological dressings offer promise in the treatment of burns, chronic ulcers, donor site and other surgical wounds, and a variety of blistering and desquamating dermatologic conditions. For example, the prevalence of diabetic foot ulcers ranges from 4.4% to 10.5% of diabetics, resulting in 82,000 lower extremity amputations annually; venous leg ulcers affect 0.18% to 1.35% of the population; and pressure ulcers are found in 5.0% to 8.8% of institutionalized patients and 14.8% of patients in acute care facilities. Despite the large number of potential beneficiaries, cellular tissue-engineered products have suffered setbacks in recent years and have garnered considerably lower market share than commercial promoters anticipated. The mechanism of action of these products is not universally agreed upon, but delivery of growth factors and extracellular matrix components to the wound is thought to be important; graft "take" is not usually considered to occur. These "engineered" products do not specifically match a treatment modality to an underlying pathology. Clinical effect is often modest, and sometimes not justi- fiable from a cost-benefit perspective. Nevertheless, clinical reports in the literature of uses of tissueengineered biological dressings continue to mount, indicating that these products are finding niche applications where clinical utility is high and the cost can be defended. Despite commercial setbacks, the first-approved products, Dermagraft((R)), Apligraf((R)), and Cultured Epidermal Autograft (Epicel((R))) are still being marketed, and new ones, such as OrCel((R)), continue to be developed. The major indications for these products are summarized and a brief review of the available clinical literature is offered.
ABSTRACT: Apligraf is supplied as a ready-to-use living fibroblast and keratinocyte bilayer in culture. This therapy has been shown to facilitate healing of venous ulcers and diabetic foot ulcers. Several case reports suggest that Apligraf may also be effective in healing acute excisional wounds and complicated surgical defects. Apligraf can, in appropriate settings, be used as an alternative to autografts, avoiding the morbidity of donor site wounds. The present case review summarizes outcomes in 16 patients with 18 complicated surgical and nonsurgical wounds treated with Apligraf, which was meshed or fenestrated as needed to obtain better wound coverage and to allow drainage. Of 16 patients, 15 (94%) experienced complete healing (16 of 18 wounds; 89%). Both surgical and nonsurgical wounds responded well, with healing times ranging from 21 to 550 days. Patients generally stated that they were satisfied with their degree of healing and with the opportunity to avoid the surgical procedures associated with autograft donor sites.
Evaluation of Apligraf(R) persistence and basement membrane restoration in donor site wounds: a pilot study.
Hu S, Kirsner RS, Falanga V, Phillips T, Eaglstein WH. Wound Repair Regen. 2006 Jul-Aug;14(4):427-33.
Quote:
Apligraf((R)) is a bilayered tissue-engineered product consisting of a bovine collagen matrix with neonatal fibroblasts, overlaid by a stratified epithelium containing living keratinocytes. The United States Food and Drug Administration has approved its use for venous leg ulcers and neuropathic diabetic foot ulcers. Apligraf((R)) provides a dermal matrix and produces cytokines similar to the human skin. However, its mechanism of action and ultimate fate in host wounds are unclear. The aim of this study was to evaluate the persistence of Apligraf((R)) fibroblasts and keratinocytes in human acute partial-thickness wounds (split-thickness donor sites) treated with Apligraf((R)). In an open-label, within-patient, three-centered, controlled pilot study, 10 patients were treated with Apligraf((R)), Apligraf((R)) dermis only (without epidermis), and a polyurethane film for donor site wounds of the same size, depth, and anatomical location. Apligraf((R)) DNA persistence was the primary outcome measure. Basement membrane components, cosmetic outcome, time to wound healing, and safety parameters were secondary outcome measures. One week after the initial treatment, reverse transcription polymerase chain reaction analysis found that two Apligraf((R)) and two Apligraf((R)) dermis-only-treated sites had Apligraf((R)) DNA present. Four weeks posttreatment, only one Apligraf((R)) and one Apligraf((R)) dermis-only sites showed the presence of Apligraf((R)) DNA. There was no difference between the three treatment modalities in establishing basement membrane in donor site wounds. No differences in other secondary outcomes were found. Apligraf((R)) DNA persisted in a minority of patients at 4 weeks in acute partial-thickness wounds. Apligraf((R))'s success in speeding healing of acute wounds appears to be related to factors other than the persistence of donor DNA or effect on basement membrane restoration.
BACKGROUND AND OBJECTIVE Various types of allogenic skin substitutes composed of cryopreserved keratinocytes, fibroblasts, or both have been used for treatments of diabetic foot ulcers, but the effects have generally not been dramatic because cryopreservation impairs cell activities. The purpose of the study was to evaluate the use of non-cryopreserved fresh human fibroblast allografts in treating diabetic foot ulcers.
MATERIALS AND METHODS Human dermal fibroblasts from healthy teenagers were cultured and applied over the foot ulcers of 37 patients with diabetes. Control treatment was performed in 18 patients. Eight weeks after treatment, the percentages of complete healing, mean healing times, and patient satisfaction were compared, with follow-up ranging from 6 to 40 months.
RESULTS Our study showed that 83.8% of the treated group and 50.0% of the control group experienced complete healing. The times required for complete healing were 30.9+/-10.1 and 47.2+/-7.8 days in the treated and control groups, respectively. Patient satisfaction with fresh fibroblast treatment was also superior to satisfaction with the conventional method (mean scores: 8.0+/-1.0 and 4.9+/-1.4, respectively). No adverse events related to the study treatment occurred.
CONCLUSION The use of fresh human fibroblast allografts was found to be a safe and effective treatment for diabetic foot ulcers. The authors have indicated no significant interest with commercial supporters.
Dermagraft
Linear Mode
