Human Amniotic Membrane Allograft: Comparison of two preservation methods in biocompatibility assays

C. LACERRA; R. COMÍN; M. P. CID; T. LÓPEZ LOZANO; D.M. SCHMETS; R. IBARRA THEILER; G. MÁSCOLO; C.B. SOBRERO; N. A. SALVATIERRA

IFMBE PROCEEDINGS

Springer

Año: 2023

1680-0737

Human amniotic membrane is widely used in regenerative medicine(ophthalmology, dermatology, reconstructive surgery, soft tissue augmentation,and dentistry) and tissue engineering. It is an immuno-compatible tissue that hasimmunomodulatory, antimicrobial and no mutagenic effects, and is also a sourceof growth factors and cells with stem cell properties that combines adequatemechanical properties with good capacity for cell adhesion to structuralcomponents of the extracellular matrix. Several methods are currently used toprepare, store, and sterilize human amniotic membrane allografts that mayaffect safety and biological properties. The aim of this study was to obtainhuman amniotic membrane allografts preserved by two methods,cryopreservation and the combination of lyophilization and irradiation, at theTissue Bank of Laboratorio de Hemoderivados, National University of Córdoba.Subsequently, biocompatibility was evaluated using cytotoxicity, direct irritationand systemic toxicity tests, recommended by ISO 10993:5, 10993:10 and10993:11, respectively. Results showed that the processing method, as well as thedifferent conservation methods of the amniotic membrane (cryopreserved, andlyophilized and irradiated) were adequate. In the cytotoxicity test, both amnioticmembranes showed cell viability greater than 70%, in compliance with ISO10993:5. In addition, no negative evidence was observed in the primary skinirritation score, nor were there changes in body temperature due to the systemicadministration of extracts at the different times tested. Allografts obtained andpreserved both by cryopreservation and by the combination of lyophilization andirradiation reveal a good profile making their use in regenerative medicine andtissue engineering very promising.