Human amnion-based regenerative platform for chronic wounds and burns management

Abstract

Chronic non-healing wounds and burn injuries constitute a significant global health challenge, contributing to over 8 million disability-adjusted life years (DALYs), with the majority burden borne by low- and middle-income countries. India alone accounts for ~20% of global fire-related deaths, with chronic wounds—especially diabetic foot ulcers (DFUs)—leading to approximately 100,000 amputations annually. The average DFU healing time is 28 weeks, often imposing a financial burden equivalent to 5.7 years of a patient's income. Both burn and chronic wounds are marked by complex pathophysiology involving cellular damage, microbial infiltration, oxidative stress and excessive exudate accumulation, resulting in delayed healing, infection, and functional loss. Human amnion has emerged as a promising bioactive therapeutic option due to their inherent abundance of growth factors and multifaceted biological properties including anti-inflammatory, angiogenic and anti-scarring effects. Clinical evidence has consistently demonstrated the superiority of amnion grafts over conventional dressings, leading to accelerated epithelialization and improved cosmetic outcomes. Building on these attributes, we have developed human amnion-based regenerative platform for managing different types of chronic wounds and burns. A unique tissue processing technology was used to produce lyopreserved, decellularized amnion grafts with off-the-shelf advantages. This gentle yet effective process ensures maximal retention of bioactive components, as validated by high-throughput proteomic profiling. In preclinical studies using rodent models of diabetic wounds (blood glucose ≥300 mg/dL), these grafts demonstrated 50% faster wound closure compared to standard of care dressings, along with upregulated vascular endothelial growth factor expression, indicating enhanced angiogenesis. While the grafts—ranging in thickness from 30 to 500 μm—are ideally suited for superficial and partial-thickness wounds and burns, their limited ability to manage wound exudate necessitated the development of advanced delivery formats. To address this, we formulated amnion-derived bioactive powder, hydrogel and engineered 3D-printed hybrid dressings that integrate bioactive amnion bioink with absorbent, silver-impregnated polyurethane foam substrates. These hybrid dressings were evaluated in Staphylococcus aureus infected rodent wounds, demonstrating substantial bacterial reduction and temporally regulated CD31 expression pattern mirroring the natural healing cascades. To identify the optimal wound management strategy, both processed amnion grafts and hybrid dressings were tested in porcine model of MRSA-infected deep partial-thickness burns against leading commercial comparators—silver dressings (Biatain®, Coloplast) and lyophilized human amnion-chorion grafts (Amchoplast®, Lifecell, India). By day 36, hybrid dressings achieved significantly greater reduction in wound area and bacterial load compared to the comparators. All evaluations were conducted in adherence to BSEN, ASTM, and ISO standards, and preclinical trials were executed in a CDSCO-accredited medical device testing facility. These findings position the human amnion-derived regenerative platform as a robust and scalable solution for chronic and complex wounds, offering accelerated healing, broad applicability, and strong potential for clinical translation and commercialization.