Abstract:

BACKGROUND: Tissue engineered medical products are eventually implanted into body, the biocompatibility of implanted products determines their long-term function in body. Therefore, safety evaluation is critical to determine whether tissue engineered medical products are used in clinical practice.
OBJECTIVE: To introduce the methods of safety evaluation of extracellular matrix materials from cell toxicity, interaction with blood test, local reactions after implantation, immunological evaluation.
METHODS: Using “tissue engineering, extracellular matrix, biocompatibility, safety evaluation” in Chinese and English as key words, a computer search was performed in VIP database, Pubmed database, Elsevier database for relevant articles. Articles related with safety assessment of extracellular matrix materials were included, repeated researches were excluded.
RESULTS AND CONCLUSION: A total of 218 articles were screened out, unrelated duplicated literatures were eliminated, remaining 22 articles were reviewed. Currently there is no overall safety evaluation method of the extracellular matrix material, the structural and functional properties of biological materials as well as biocompatibility are assessed according to ISO 10993 series of biological evaluation of medical devices. With extracellular matrix materials have been widely used, more and more attention have been paid on the safety evaluation of extracellular matrix, many questions still to be explored.