Case Report: Freeze-Dried Human Amniotic Membrane Allograft for the Treatment of Chronic Wounds: Results of a Multicentre Observational Study

Abstract

An inability of the human body to heal acute wounds under certain conditions results in the formation of chronic ulcers. Chronic wounds not only cause significant pain and discomfort for patients but also serve as an entry for microorganisms into the human body, which can result in serious life-threatening problems and become a significant burden for the patients and society. The current work present results of a multicentre prospective observational study demonstrating the use of a lyophilized amniotic membrane (AM) in the treatment of chronic wounds (various etiologies). Lyophilized AM produced under the commercial brand Amnioderm® was used as an allograft material for therapy of chronic wounds, in addition to chronic ulcer standard-of-care (SoC) protocols. The duration of wounds considered for the application of AM ranged between 2 months and 11 years. In total, 16 patients were enrolled to the study, of which eight were completely healed, six demonstrated a significantly reduced ulcer size, and two did not respond to the AM therapy. The current study unambiguously demonstrates an effective alternative to the standard of chronic wound care and confirms a significant effect of the AM application for chronic wound management as a new SoC.

A minimally manipulated preservation and virus inactivation method for amnion/chorion

“…They are used in various types of corneal ulcers, including chemical ulcers, bacterial infection ulcers, viral infection ulcers, and rheumatological ulcers ( Kim et al, 2001 ; Kara, 2018 ; Hopkinson et al, 2020 ; Schuerch et al, 2020 ). In the last decade, amnion and chorion have been intensively used for chronic skin wounds, including diabetic foot ulcers and venous ulcers, as a skin substitute and with the function of inducing recovery and regeneration ( Sheikh et al, 2014 ; Bianchi et al, 2018 ; Didomenico et al, 2018 ; Zelen et al, 2018 ; Dhall et al, 2019 ; Tettelbach et al, 2019 ; Schmiedova et al, 2021 ). Clinical evidence showed its proven functionality in skin regeneration.…”

Human Amniotic Membrane Usage from Bench to Bedside in Congenital Defects and Wounds in Paediatric Surgery: A Systematic Review

“…21. After birth, all perinatal tissues are considered biological waste, which in turn makes them easier to use for other patients from an ethical perspective 27 .…”

“…Amnioderm preserves the healing properties of hAM for at least 5 years (shelf-life) at room temperature. Amnioderm is easily available in many developing countries 27 . But the cost is a big issue for people from low socioeconomic status.…”

Hydrogel foam dressings with angiogenic and immunomodulatory factors from mesenchymal stem cells

“…There are several strategies to achieve active healing of chronic wounds. Autologous and allogenic skin grafts provide biological scaffolds with embedded skin cells, bioactive factors, and extracellular matrix (ECM) that have shown great efficacy in revitalizing burns and chronic wounds with accelerated wound closure 2–5 . The use of autologous grafts is limited by the availability of donor skin tissues and additional injury to the donor site; whereas, allogenic graft use carries the risks of immunogenic rejection and viral transmission 6,7 .…”