Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study

Zelen, Charles M.; Serena, Thomas E; Fetterolf, Donald

doi:10.1016/j.wndm.2013.10.008

Cited by 39 publications

(27 citation statements)

References 16 publications

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“…It has been shown in vitro that fibroblasts and keratinocytes remain viable and proliferate when attached to decellularized amniotic scaffolds, similarly to the StemWrap tested in this study . Several human clinical trials and case series have also used decellularized and, often, dehydrated amniotic membrane products with associated growth factors to treat chronic nonhealing wounds, including diabetic foot ulcers and venous leg ulcers . In these studies, production of granulation tissue was not assessed or quantitated, but decreased time to healing was reported with these products as well as resolution of wounds that had previously failed with standard‐of‐care treatment.…”

Section: Discussionmentioning

confidence: 95%

“…in vivo studies in man have substantiated these in vitro findings that these products improve the rate of wound healing . Furthermore, several case series have documented the use of decellularized amniotic membrane scaffolds facilitating the healing of pharyngocutaneous fistulas, burns, bed sores, and chronic wounds that were nonresponsive to standard‐of‐care treatments in human patients . Human amniotic membrane products have been commercially available and used clinically over the past decade in human medicine .…”

Section: Introductionmentioning

confidence: 94%

“…24,25,46,47 Furthermore, several case series have documented the use of decellularized amniotic membrane scaffolds facilitating the healing of pharyngocutaneous fistulas, burns, bed sores, and chronic wounds that were nonresponsive to standard-of-care treatments in human patients. 23,[48][49][50] Human amniotic membrane products have been commercially available and used clinically over the past decade in human medicine. 21,24,47,50 Similar equine products have recently become commercially available, including a decellularized and dehydrated equine amniotic membrane scaffold (StemWrap; AniCell Biotech, Chandler, Arizona) and an injectable acellular liquid morselized amniotic membrane product (2 mL/vial) reported to contain growth factors and extracellular matrix particles (StemWrap+; AniCell Biotech).…”

Section: Introductionmentioning

confidence: 99%

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Effects of acellular equine amniotic allografts on the healing of experimentally induced full‐thickness distal limb wounds in horses

et al. 2019

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Objective To characterize the growth factors contained in equine amniotic membrane allograft (eAM; StemWrap scaffold and StemWrap+ injection) and to evaluate the effect of eAM on equine distal limb wound healing. Study design Prospective experimental controlled study. Sample population Eight adult horses. Methods Transforming growth factor (TGF)‐β1, vascular endothelial growth factor (VEGF), epidermal growth factor, platelet‐derived growth factor‐BB, and prostaglandin E2 (PGE2) concentrations in StemWrap+ were assessed with enzyme‐linked immunosorbent assay. Two full‐thickness 6.25‐cm2 skin wounds were created on each metacarpus. On one forelimb, one wound was treated with eAM, and the other was left untreated (eAM control). On the contralateral limb, one wound was treated with a silicone dressing, and the other served as negative control. Three‐dimensional images were obtained to determine wound circumference and surface area analyses at each bandage change until healed. Excessive granulation tissue was debrided once weekly for 4 weeks. Biopsy samples were taken to evaluate quality of wound healing via histologic and immunohistochemistry assays. Results StemWrap+ contained moderate concentrations of TGF‐β1 (494.10 pg/mL), VEGF (212.52 pg/mL), and PGE2 (1811.61 pg/mL). Treatment of wounds with eAM did not affect time to healing or histologic quality of the healing compared with other groups but was associated with increased granulation tissue production early in the study, particularly on day 7. Conclusion Application of eAM resulted in increased granulation tissue production while maintaining appropriate healing of experimental wounds. Clinical significance Use of eAM is likely most beneficial for substantial wounds in which expedient production of large amounts of granulation tissue is desirable.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

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Effects of acellular equine amniotic allografts on the healing of experimentally induced full‐thickness distal limb wounds in horses

et al. 2019

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“…68 Eighteen of 22 patients from the randomized and crossover phases of the trial were followed up for 9-12 months, and 94.4% (17/18) of wounds remained closed. 69 The second study, a single-center, open label, randomized trial compared weekly versus biweekly EpiFix application. Twenty patients with DFUs were treated in each arm.…”

Section: Commercial Placental Membrane Productsmentioning

confidence: 99%

Use of Placental Membranes for the Treatment of Chronic Diabetic Foot Ulcers

Brantley

Verla

2015

Advances in Wound Care

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Significance: Chronic diabetic foot ulcers (DFUs) remain a challenge for physicians to treat. High mortality rates for DFU patients have pointed to the low effectiveness of standard care and lack of quality wound care products. The composition (collagen-rich tissue matrix and endogenous growth factors and cells) and functional properties (anti-inflammatory, anti-bacterial, and angiogenic) of placental membranes are uniquely suited to address the needs of chronic wounds. This led to the commercialization of placental membranes, which are now widely available to physicians as a new advanced wound treatment option.Recent Advances: Progress in tissue processing and preservation methods has facilitated the development of placental products for wounds. Currently, a variety of commercial placental products are available to physicians for the treatment of chronic DFUs and other wounds. This review summarizes the key factors that negatively impact DFU healing (including social factors, such as smoking, vascular deficiencies, hyperglycemia, and other metabolic abnormalities), describes the structure and biology of placental membranes, and overviews commercially available placental products for wounds and data from the most recent DFU clinical trials utilizing commercial placental membranes.Critical Issues: Although the effects of diabetes on wound healing are complex and not fully understood, some of the key factors and pathways that interfere with healing have been identified. However, a multidisciplinary approach for the assessment of patients with chronic DFUs and guidelines for selection of appropriate treatment modalities remain to be implemented.Future Directions: The biological properties of placental membranes show benefits for the treatment of chronic DFUs, but scientific and clinical data for commercially available placental products are limited. Therefore, we need (1) more randomized, controlled clinical trials for commercial placental products; (2) studies that help to understand the timing of placental products' application and criteria for patient selection; and (3) studies comparing the functional properties of different commercially available placental products.

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“…In this form, the material is stable at room temperature, with a shelf life of up to 5 years. However, while multiple studies have shown that the dehydration of the amnion does not affect its efficacy as a wound treatment , there are still significant limitations in the delivery and application of this intact amnion to large or irregular shaped wounds. This includes in the majority of treatment cases where an amnion sheet does not conform to an irregular wound size or topology.…”

Section: Introductionmentioning

confidence: 99%

Solubilized Amnion Membrane Hyaluronic Acid Hydrogel Accelerates Full-Thickness Wound Healing

Murphy

Skardal

Song

et al. 2017

Stem Cells Translational Medicine

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The early and effective treatment of wounds is vital to ensure proper wound closure and healing with appropriate functional and cosmetic outcomes. The use of human amnion membranes for wound care has been shown to be safe and effective. However, the difficulty in handling and placing thin sheets of membrane, and the high costs associated with the use of living cellularized tissue has limited the clinical application of amniotic membrane wound healing products. Here, we describe a novel amnion membrane-derived product, processed to result in a cell-free solution, while maintaining high concentrations of cell-derived cytokines and growth factors. The solubilized amnion membrane (SAM) combined with the carrier hyaluronic acid (HA) hydrogel (HA-SAM) is easy to produce, store, and apply to wounds. We demonstrated the efficacy of HA-SAM as a wound treatment using a full-thickness murine wound model. HA-SAM significantly accelerated wound closure through re-epithelialization and prevented wound contraction. HA-SAM-treated wounds had thicker regenerated skin, increased total number of blood vessels, and greater numbers of proliferating keratinocytes within the epidermis. Overall, this study confirms the efficacy of the amnion membrane as a wound treatment/dressing, and overcomes many of the limitations associated with using fresh, cryopreserved, or dehydrated tissue by providing a hydrogel delivery system for SAM. STEM CELLS

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Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study

Cited by 39 publications

References 16 publications

Effects of acellular equine amniotic allografts on the healing of experimentally induced full‐thickness distal limb wounds in horses

Effects of acellular equine amniotic allografts on the healing of experimentally induced full‐thickness distal limb wounds in horses

Use of Placental Membranes for the Treatment of Chronic Diabetic Foot Ulcers

Solubilized Amnion Membrane Hyaluronic Acid Hydrogel Accelerates Full-Thickness Wound Healing

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