The Experts below are selected from a list of 576 Experts worldwide ranked by ideXlab platform
William T. Decarbo - One of the best experts on this subject based on the ideXlab platform.
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Special segment: soft tissue matrices--Apligraf bilayered skin substitute to augment healing of chronic wounds in diabetic patients.
Foot & ankle specialist, 2009Co-Authors: William T. DecarboAbstract:Chronic wounds are wounds that fail to heal or fail to progress to healing within an appropriate time frame. Standard wound care consists of debridement of all nonviable tissue, off-loading, and maintaining a moist environment, typically with saline-moistened gauze. Infection control, blood flow, and nutrition also play pivotal roles in wound healing. Bioengineered tissue, Apligraf, has been shown to be both efficacious and safe when used in chronic wounds. Apligraf delivers growth factors and cytokines to the wound environment to help complete closure and decrease healing time.
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Special Segment: Soft Tissue Matrices—Bilayered Bioengineered Skin Substitute to Augment Wound Healing
Foot & ankle specialist, 2009Co-Authors: William T. DecarboAbstract:Wounds that fail standard wound care for more than 4 weeks are often very difficult to heal. Several factors including senescent cells, an inflammatory wound environment, unavailable growth factors, and the presence of bacteria inhibit chronic wounds from healing. Bioengineered tissue, such as Apligraf (Organogenesis Inc, Canton, Massachusetts), has been shown to be both safe and effective in decreasing healing time and increasing the incidence of complete wound closure. The science and technology behind bioengineered tissue has altered the way chronic wounds are treated.
Robert S Kirsner - One of the best experts on this subject based on the ideXlab platform.
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Topical timolol for recalcitrant wounds.
JAMA dermatology, 2013Co-Authors: Liza R. Braun, Sonia A. Lamel, Nicholas A. Richmond, Robert S KirsnerAbstract:Patient 1 A woman in her 80s with a history of venous insufficiency based on clinical presentation and vascular studies presentedwithmultiplepainfululcerationsonthebilateral ankles. She developed wounds in 1972 with subsequent trauma that led to repetitive skin breakdown.Her currentwounds began 1 year ago. The patient was initially treated with multilayered elastic compression bandages (Profore; Smith & Nephew), which were changed weekly, and various foam dressings (Allevyn; Smith & Nephew; Mepilex Ag; Molnlycke Health Care).When herwound failed to heal, adjuvant therapies, including serial applications of porcine small intestine submucosa (Oasis;HealthpointBiotherapeutics), bilayered living skin equivalent (Apligraf; Organogenesis) and an autologous splitthickness graft from the thighwere used but did not result in complete closure. After 6months, thewoundwas 3.2 cm2 and a β2-adrenergic receptor (B2AR) antagonist, topical timolol, 0.5% (Timoptic;AtonPharma),was instilled, 1dropevery2 cm of wound edge weekly, then covered with silicone foam and 3-layer compression. All wounds, including her target ulcer, were fully epithelialized after 8 weeks of treatment, and the patient was prescribed a compression apparatus (JuxtaCure; CircAid Medical Products) to prevent recurrence.
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A review of a bi-layered living cell treatment (Apligraf ®) in the treatment of venous leg ulcers and diabetic foot ulcers
Clinical interventions in aging, 2007Co-Authors: Larissa Zaulyanov, Robert S KirsnerAbstract:Apligraf® (Organogenesis, Canton, MA) is a bi-layered bioengineered skin substitute and was the first engineered skin US Food and Drug Administration (FDA)-approved to promote the healing of ulcers that have failed standard wound care. Constructed by culturing human foreskin-derived neonatal fibroblasts in a bovine type I collagen matrix over which human foreskin-derived neonatal epidermal keratinocytes are then cultured and allowed to stratify, Apligraf provides both cells and matrix for the nonhealing wound. Its exact mechanism of action is not known, but it is known to produce cytokines and growth factors similar to healthy human skin. Initially approved by the FDA in 1998 for the treatment of venous ulcers greater than one-month duration that have not adequately responded to conventional therapy, Apligraf later received approval in 2000 for treatment of diabetic foot ulcers of greater than three weeks duration. Herein, we review the use of Apligraf in the treatment of chronic venous leg ulcers and diabetic foot ulcers. Our goal is to provide a working understanding of appropriate patient selection and proper use of the product for any physician treating this segment of the aging population.
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A review of a bi-layered living cell treatment (Apligraf®) in the treatment of venous leg ulcers and diabetic foot ulcers
Dove Medical Press, 2007Co-Authors: Larissa Zaulyanov, Robert S KirsnerAbstract:Larissa Zaulyanov, Robert S Kirsner Department of Dermatology and Cutaneous Surgery; University of Miami Miller School of Medicine, Miami, Florida, USAAbstract: Apligraf® (Organogenesis, Canton, MA) is a bi-layered bioengineered skin substitute and was the first engineered skin US Food and Drug Administration (FDA)-approved to promote the healing of ulcers that have failed standard wound care. Constructed by culturing human foreskin-derived neonatal fibroblasts in a bovine type I collagen matrix over which human foreskin-derived neonatal epidermal keratinocytes are then cultured and allowed to stratify, Apligraf provides both cells and matrix for the nonhealing wound. Its exact mechanism of action is not known, but it is known to produce cytokines and growth factors similar to healthy human skin. Initially approved by the FDA in 1998 for the treatment of venous ulcers greater than one-month duration that have not adequately responded to conventional therapy, Apligraf later received approval in 2000 for treatment of diabetic foot ulcers of greater than three weeks duration. Herein, we review the use of Apligraf in the treatment of chronic venous leg ulcers and diabetic foot ulcers. Our goal is to provide a working understanding of appropriate patient selection and proper use of the product for any physician treating this segment of the aging population.Keywords: wound healing, Apligraf®, venous leg ulcer, diabetic foot ulce
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a review of a bi layered living cell treatment Apligraf in the treatment of venous leg ulcers and diabetic foot ulcers
Clinical Interventions in Aging, 2007Co-Authors: Larissa Zaulyanov, Robert S KirsnerAbstract:Apligraf (Organogenesis, Canton, MA) is a bi-layered bioengineered skin substitute and was the first engineered skin US Food and Drug Administration (FDA)-approved to promote the healing of ulcers that have failed standard wound care. Constructed by culturing human foreskin-derived neonatal fibroblasts in a bovine type I collagen matrix over which human foreskin-derived neonatal epidermal keratinocytes are then cultured and allowed to stratify, Apligraf provides both cells and matrix for the nonhealing wound. Its exact mechanism of action is not known, but it is known to produce cytokines and growth factors similar to healthy human skin. Initially approved by the FDA in 1998 for the treatment of venous ulcers greater than one-month duration that have not adequately responded to conventional therapy, Apligraf later received approval in 2000 for treatment of diabetic foot ulcers of greater than three weeks duration. Herein, we review the use of Apligraf in the treatment of chronic venous leg ulcers and diabetic foot ulcers. Our goal is to provide a working understanding of appropriate patient selection and proper use of the product for any physician treating this segment of the aging population.
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Evaluation of Apligraf persistence and basement membrane restoration in donor site wounds: a pilot study.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society, 2006Co-Authors: Robert S Kirsner, Vincent Falanga, Tania J. Phillips, William H. EaglsteinAbstract:Apligraf® 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® 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® fibroblasts and keratinocytes in human acute partial-thickness wounds (split-thickness donor sites) treated with Apligraf®. In an open-label, within-patient, three-centered, controlled pilot study, 10 patients were treated with Apligraf®, Apligraf® dermis only (without epidermis), and a polyurethane film for donor site wounds of the same size, depth, and anatomical location. Apligraf® 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® and two Apligraf® dermis-only-treated sites had Apligraf® DNA present. Four weeks posttreatment, only one Apligraf® and one Apligraf® dermis-only sites showed the presence of Apligraf® 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® DNA persisted in a minority of patients at 4 weeks in acute partial-thickness wounds. Apligraf®'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.
William H. Eaglstein - One of the best experts on this subject based on the ideXlab platform.
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Evaluation of Apligraf persistence and basement membrane restoration in donor site wounds: a pilot study.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society, 2006Co-Authors: Robert S Kirsner, Vincent Falanga, Tania J. Phillips, William H. EaglsteinAbstract:Apligraf® 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® 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® fibroblasts and keratinocytes in human acute partial-thickness wounds (split-thickness donor sites) treated with Apligraf®. In an open-label, within-patient, three-centered, controlled pilot study, 10 patients were treated with Apligraf®, Apligraf® dermis only (without epidermis), and a polyurethane film for donor site wounds of the same size, depth, and anatomical location. Apligraf® 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® and two Apligraf® dermis-only-treated sites had Apligraf® DNA present. Four weeks posttreatment, only one Apligraf® and one Apligraf® dermis-only sites showed the presence of Apligraf® 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® DNA persisted in a minority of patients at 4 weeks in acute partial-thickness wounds. Apligraf®'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.
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tissue engineered skin Apligraf in the healing of patients with epidermolysis bullosa wounds
Archives of Dermatology, 2000Co-Authors: Anna Falabella, Isabel C Valencia, William H. Eaglstein, Lawrence A. SchachnerAbstract:Background At present, wound treatment of inherited epidermolysis bullosa (EB) is only supportive. Objective To determine the safety and clinical effects of tissue-engineered skin (Apligraf; Organogenesis Inc, Canton, Mass) in the healing of wounds of patients with different types of EB. Design An open-label uncontrolled study of 15 patients with EB treated with tissue-engineered skin. Each patient received tissue-engineered skin on up to 2 wounds on each of 3 clinic visits: day 1, week 6, and week 12. They were evaluated 7 (± 3) days and 6 weeks after each round of treatment. A quality-of-life survey was administered during week 6. Setting University of Miami, Miami, Fla. Patients Volunteers with EB. Main Outcome Measure Safety and wound healing. Results A total of 69 different acute wounds received tissue-engineered skin at the day-1 (24 wounds), week-6 (23 wounds), and week-12 (22 wounds) visits. Overall, 63 wounds (79%) were found healed at the day-7 visit. Of the acute wounds, 82% (51/62) were healed 6 weeks after being treated, 75% (27/36) after 12 weeks, and 79% (11/14) after 18 weeks. Nine chronic wounds were also treated. Four were healed at 6 weeks; however, 7 were still open at the last clinic visit (week 18). There were no signs of rejection or clinical infection and no adverse events related to the tissue-engineered skin. The quality of life for most patients improved after treatment. Compared with patients' recollection of wounds treated with standard dressings, healing was faster and less painful. Conclusion In this series of patients, tissue-engineered skin induced very rapid healing, was not clinically rejected, and was devoid of adverse effects. It was felt by the patients and families to be more effective than conventional dressings for EB wounds.
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The use of tissue-engineered skin (Apligraf) to treat a newborn with epidermolysis bullosa
Archives of dermatology, 1999Co-Authors: Anna Falabella, Isabel C Valencia, Lawrence A. Schachner, William H. EaglsteinAbstract:Background Inherited epidermolysis bullosa (EB) is a mechanobullous disorder. The Dowling-Meara variant, a subtype of EB, is characterized by widespread blister formation that may include the oral cavity and nails. Many patients with the Dowling-Meara phenotype are at increased risk of sepsis and death during infancy. The treatment of EB is generally supportive. The tissue-engineered skin used (Apligraf) is a bilayered human skin equivalent developed from foreskin. It is the only Food and Drug Administration–approved skin equivalent of its kind. It is approved for the treatment of venous ulcers of the lower extremities. It has also been used to treat acute wounds, such as graft donor sites and cancer excision sites. Observation To our knowledge, we describe the first case in which a newborn with EB, Dowling-Meara variant, was treated with bilayered tissue-engineered skin. The areas treated with the tissue-engineered skin healed faster than the areas treated with conventional therapy. Most of the areas treated with tissue-engineered skin have remained healed, without developing new blisters. These areas appear to be more resistant to trauma. Conclusions Our early success with tissue-engineered skin in this patient may have a significant impact on the future treatment of neonates with EB simplex. Future studies are needed to determine if the beneficial effects of tissue-engineered skin are reproducible in other neonates with EB simplex and in patients of all ages with different subtypes of EB.
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Acute excisional wounds treated with a tissue-engineered skin (Apligraf).
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], 1999Co-Authors: William H. Eaglstein, Oscar M. Alvarez, Michael J. Auletta, David Leffel, Gary S. Rogers, John A. Zitelli, James E.c. Norris, Isabelle Thomas, Manuel Irondo, Jessica L. FewkesAbstract:Background. Tissue-engineered products are usually composed of living cells and their supporting matrices that have been grown in vitro, using a combination of engineering and life sciences principles. Apligraf is a bilayered product composed of neonatal-derived dermal fibroblasts and keratinocytes, and Type I bovine collagen. Objective. To evaluate in a prospective, multicentered open study, the effects of tissue therapy with a tissue-engineered skin (Apligraf) with partial or full-thickness excisional wounds. Methods. One hundred and seven patients participated in this study. The tissue-engineered skin was applied once, immediately after excisional surgery, usually for skin cancer, and patients were followed for up to one year. Results. The safety results were impressive, with no clinical or laboratory evidence of rejection. Clinically, graft persistence was good to excellent in 77 of 105 (73.3%) of patients at one week, falling to 56.6% and 53.6% at two weeks and one month respectively. Conclusion. To date, this is the largest experience with a tissue-engineered skin product in acute wounds, and this study suggests that tissue therapy may be safe and useful.
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Tissue engineering and the development of Apligraf a human skin equivalent.
Advances in wound care : the journal for prevention and healing, 1998Co-Authors: William H. Eaglstein, V FalangaAbstract:In recent years, skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue-engineered living skin replacements. This review details the pioneering work of numerous investigators that led to the following precursors of tissue-engineered skin replacement: cultured autologous keratinocyte grafts, cultured allogeneic keratinocyte grafts, autologous/allogeneic composites, acellular collagen matrices, and cellular matrices. It also discusses the rationale for the development of the newer products and describes the technical advances leading to the development of Apligraf, a tissue-engineered human skin product.
Patricio Meneses - One of the best experts on this subject based on the ideXlab platform.
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129 Mist‐Assisted Healing: The Use of MIST™ Ultrasound for Wound Bed Preparation Prior to the Use of Bioengineered Tissue (Apligraf®)
Wound Repair and Regeneration, 2008Co-Authors: William J. Ennis, Marianne Gainer, Patricio MenesesAbstract:The understanding of bioengineered tissue has evolved over the past 5 years. Now considered “cell therapy,” bioengineered tissue can provide a nonhealing wound with the appropriate complement of cytokines, growth factors, and healthy cells to promote the patient’s healing process. As clinicians have gained experience with Apligraf*, the process of wound bed preparation has proven to be a critical step in order to achieve optimal outcomes with the tissue construct. Recently, the investigators have evaluated a novel device, MIST† ultrasound , recently FDA cleared for the cleansing and debriding of wounds. A subgroup from a total of 23 patients in a research trial using MIST therapy for nonhealing wounds received an Apligraf as part of their treatment regimen. The'bioengineered tissue remained intact for a full 4 weeks postapplication and the appearance of the graft was quite different than our prior experience with the product. On removal of the wound/graft eschar, patients had achieved complete epithelialization. This report describes the patients who underwent this combination of technologies along with wound photographs, measurements and patient histories. As we learn more about the biochemistry of healing we are able to “look” at how we combine and use advanced wound care technologies. Acknowledgments: This study was supported from a grant from Celleration Inc. Product notation: * Apligraf® is a registered trademark of Novartis, Inc., East Hanover, NJ © 2004 Organogenesis, Inc., Canton, MA † MIST™ ultrasound is a registered trademark of Celleration Inc., Eden Prairie, MN.
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129 mist assisted healing the use of mist ultrasound for wound bed preparation prior to the use of bioengineered tissue Apligraf
Wound Repair and Regeneration, 2008Co-Authors: William J. Ennis, Marianne Gainer, Patricio MenesesAbstract:The understanding of bioengineered tissue has evolved over the past 5 years. Now considered “cell therapy,” bioengineered tissue can provide a nonhealing wound with the appropriate complement of cytokines, growth factors, and healthy cells to promote the patient’s healing process. As clinicians have gained experience with Apligraf*, the process of wound bed preparation has proven to be a critical step in order to achieve optimal outcomes with the tissue construct. Recently, the investigators have evaluated a novel device, MIST† ultrasound , recently FDA cleared for the cleansing and debriding of wounds. A subgroup from a total of 23 patients in a research trial using MIST therapy for nonhealing wounds received an Apligraf as part of their treatment regimen. The'bioengineered tissue remained intact for a full 4 weeks postapplication and the appearance of the graft was quite different than our prior experience with the product. On removal of the wound/graft eschar, patients had achieved complete epithelialization. This report describes the patients who underwent this combination of technologies along with wound photographs, measurements and patient histories. As we learn more about the biochemistry of healing we are able to “look” at how we combine and use advanced wound care technologies. Acknowledgments: This study was supported from a grant from Celleration Inc. Product notation: * Apligraf® is a registered trademark of Novartis, Inc., East Hanover, NJ © 2004 Organogenesis, Inc., Canton, MA † MIST™ ultrasound is a registered trademark of Celleration Inc., Eden Prairie, MN.
Lawrence A. Schachner - One of the best experts on this subject based on the ideXlab platform.
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tissue engineered skin Apligraf in the healing of patients with epidermolysis bullosa wounds
Archives of Dermatology, 2000Co-Authors: Anna Falabella, Isabel C Valencia, William H. Eaglstein, Lawrence A. SchachnerAbstract:Background At present, wound treatment of inherited epidermolysis bullosa (EB) is only supportive. Objective To determine the safety and clinical effects of tissue-engineered skin (Apligraf; Organogenesis Inc, Canton, Mass) in the healing of wounds of patients with different types of EB. Design An open-label uncontrolled study of 15 patients with EB treated with tissue-engineered skin. Each patient received tissue-engineered skin on up to 2 wounds on each of 3 clinic visits: day 1, week 6, and week 12. They were evaluated 7 (± 3) days and 6 weeks after each round of treatment. A quality-of-life survey was administered during week 6. Setting University of Miami, Miami, Fla. Patients Volunteers with EB. Main Outcome Measure Safety and wound healing. Results A total of 69 different acute wounds received tissue-engineered skin at the day-1 (24 wounds), week-6 (23 wounds), and week-12 (22 wounds) visits. Overall, 63 wounds (79%) were found healed at the day-7 visit. Of the acute wounds, 82% (51/62) were healed 6 weeks after being treated, 75% (27/36) after 12 weeks, and 79% (11/14) after 18 weeks. Nine chronic wounds were also treated. Four were healed at 6 weeks; however, 7 were still open at the last clinic visit (week 18). There were no signs of rejection or clinical infection and no adverse events related to the tissue-engineered skin. The quality of life for most patients improved after treatment. Compared with patients' recollection of wounds treated with standard dressings, healing was faster and less painful. Conclusion In this series of patients, tissue-engineered skin induced very rapid healing, was not clinically rejected, and was devoid of adverse effects. It was felt by the patients and families to be more effective than conventional dressings for EB wounds.
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The use of tissue-engineered skin (Apligraf) to treat a newborn with epidermolysis bullosa
Archives of dermatology, 1999Co-Authors: Anna Falabella, Isabel C Valencia, Lawrence A. Schachner, William H. EaglsteinAbstract:Background Inherited epidermolysis bullosa (EB) is a mechanobullous disorder. The Dowling-Meara variant, a subtype of EB, is characterized by widespread blister formation that may include the oral cavity and nails. Many patients with the Dowling-Meara phenotype are at increased risk of sepsis and death during infancy. The treatment of EB is generally supportive. The tissue-engineered skin used (Apligraf) is a bilayered human skin equivalent developed from foreskin. It is the only Food and Drug Administration–approved skin equivalent of its kind. It is approved for the treatment of venous ulcers of the lower extremities. It has also been used to treat acute wounds, such as graft donor sites and cancer excision sites. Observation To our knowledge, we describe the first case in which a newborn with EB, Dowling-Meara variant, was treated with bilayered tissue-engineered skin. The areas treated with the tissue-engineered skin healed faster than the areas treated with conventional therapy. Most of the areas treated with tissue-engineered skin have remained healed, without developing new blisters. These areas appear to be more resistant to trauma. Conclusions Our early success with tissue-engineered skin in this patient may have a significant impact on the future treatment of neonates with EB simplex. Future studies are needed to determine if the beneficial effects of tissue-engineered skin are reproducible in other neonates with EB simplex and in patients of all ages with different subtypes of EB.