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A novel method to pack cryopreserved amniotic membrane for wound dressing-the pathway through validation of a new biological product.
Ogliari, Karolyn Sassi; Grudzinski, Patrícia Bencke; da Silva, Camila Gomes; Immig, Mônica Luiza; Halon, Maria Laura; Loth, Fabrízio Blank; Ogliari, Alicia Sassi; Tovo, Monique Blauth; Beckenkamp, Liziane Raquel.
Afiliação
  • Ogliari KS; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • Grudzinski PB; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • da Silva CG; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • Immig ML; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • Halon ML; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • Loth FB; Hemocord Biotecnologia, São Leopoldo, Brazil.
  • Ogliari AS; Panamerican School of Porto Alegre, Porto Alegre, Brazil.
  • Tovo MB; Universidade do Vale do Rio dos Sinos, São Leopoldo, Brazil.
  • Beckenkamp LR; Hemocord Biotecnologia, São Leopoldo, Brazil.
Biomed Mater ; 18(4)2023 05 12.
Article em En | MEDLINE | ID: mdl-37116514
Amniotic membrane (AM) has been widely used as a biological dressing for many pathologies and illnesses worldwide, and products derived from this tissue have been commercially available in several countries. In Brazil, regulatory agencies have recently authorized its clinical use as a non-experimental therapy for burns, diabetic and venous stasis ulcers, and intrauterine adhesions. In this study, we present our pathway through validating the first available service in the country of AM cryopreservation, with a protocol for long-term storage in high-efficiency nitrogen cryogenic freezers and a specific way of packing the tissue for optimal clinical handling and efficient storage space utilization while preserving live cells and the tissue's biological properties. Using gauze as support, cryoprotectant dimethyl sulfoxide and product presentation as a multilayer roll exhibited the best cell viability results and maintained the tissue integrity and presence of stem/progenitor cells. Essential proteins involved in tissue regeneration and immune and antimicrobial control were detected from the secretome of cryopreserved tissue similar to fresh tissue. Furthermore, immunogenic markers, such as human leukocyte antigens, were detected at very low levels in the tissue, confirming their low immunogenicity. Finally, we demonstrate that the tissue can be kept under refrigerated conditions for up to 7 d for further use, maintaining sterility and considerable cell viability. Our cryopreservation and storage protocol kept the AM viable for at least 20 months. In conclusion, this study enabled us to determine a novel efficient protocol for long-term AM preservation for future clinical applications.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Âmnio Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Biomed Mater Assunto da revista: ENGENHARIA BIOMEDICA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Âmnio Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Biomed Mater Assunto da revista: ENGENHARIA BIOMEDICA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido