Biological Characterization of a Novel Air-dried Human Amniotic Membrane Allograft (dHAM*) for Wound Healing Applications

Introduction: Chronic wounds pose a significant healthcare challenge, with impaired healing attributed to unresolved inflammation, inadequate cellular proliferation, poor vascularization, and fibrotic remodeling. De- hydrated human amniotic membrane (dHAM) allografts have previously demonstrated safety and efficacy in treating chronic wounds, offering a biocompatible matrix comprising bioactive factors. Despite its growing clinical adoption, the biological characterization of dHAM in dermal repair processes is lacking. This study aims to characterize the structural properties and functional effects of air-dried dHAM* on in vitro cellular responses essential to dermal wound healing processes. Methods: Human amniotic membrane tissue was prepared using a proprietary process* including gentle cleansing, air-drying, and terminal sterilization. Biocompositional analyses were conducted using histologi- cal methods and multiplex protein arrays to quantify extracellular matrix (ECM) constituents, growth factors, angiogenic regulators, and cytokines/ chemokines present in dHAM. To evaluate in vitro functional treatment effects, proliferation, IL-1β-induced inflammation, and TGF-β1-induced fibrosis assays were conducted using human dermal fibroblasts (HDFs). Results: The results demonstrate dHAM retains an intact ECM and a wide spectrum of signaling proteins that function to stimulate granulation, angiogenesis, and aid in reducing inflammation and fibrosis. Notably, dHAM treatment inhibits IL-1β-induced inflammatory protein expression, promotes HDF proliferation, and suppresses TGF-β1-induced gene expression. Discussion: AM’s therapeutic benefit in chronic wound care is asso- ciated with its ability to deliver soluble regulatory factors released from a biocompatible ECM reservoir to provide a favorable wound microen- vironment. This study provides an in vitro characterization of air-dried dHAM, highlighting its multifaceted properties that aid in dermal wound healing mechanisms.