Sahlgrenska Academy, Institution of Medicine, Wallenberg Laboratory, Department of Molecular and Clinical Medicine, Blå Stråket 5 B, 41345 Gothenburg, Sweden.
RISE Research Institutes of Sweden, Methodology, Textile and Medical Device, Brinellgatan 4, 50462 Borås, Sweden.
Biomater Sci. 2023 May 30;11(11):3860-3877. doi: 10.1039/d2bm02011d.
Tissue engineering is a promising methodology to produce advanced therapy medicinal products (ATMPs). We have developed personalized tissue engineered veins (P-TEV) as an alternative to autologous or synthetic vascular grafts utilized in reconstructive vein surgery. Our hypothesis is that individualization through reconditioning of a decellularized allogenic graft with autologous blood will prime the tissue for efficient recellularization, protect the graft from thrombosis, and decrease the risk of rejection. In this study, P-TEVs were transplanted to in pig, and the analysis of three veins after six months, six veins after 12 months and one vein after 14 months showed that all P-TEVs were fully patent, and the tissue was well recellularized and revascularized. To confirm that the ATMP product had the expected characteristics one year after transplantation, gene expression profiling of cells from P-TEV and native were analyzed and compared by qPCR and sequencing. The qPCR and bioinformatics analysis confirmed that the cells from the P-TEV were highly similar to the native cells, and we therefore conclude that P-TEV is functional and safe in large animals and have high potential for use as a clinical transplant graft.
组织工程是一种很有前途的方法，可以生产先进的治疗性药物产品（ATMP）。我们已经开发了个性化组织工程静脉（P-TEV），作为用于重建静脉手术的自体或合成血管移植物的替代品。我们的假设是，通过用自体血液对脱细胞同种异体移植物进行再处理来实现个体化，将组织预先准备好进行有效的再细胞化，防止移植物血栓形成，并降低排斥反应的风险。在这项研究中，将 P-TEV 移植到猪体内，在 6 个月、12 个月后 6 根静脉和 14 个月后 1 根静脉的分析表明，所有 P-TEV 均完全通畅，组织得到了很好的再细胞化和再血管化。为了确认移植后一年 ATMP 产品具有预期的特性，通过 qPCR 和测序分析和比较了 P-TEV 和天然 中细胞的基因表达谱。qPCR 和生物信息学分析证实，P-TEV 中的细胞与天然细胞高度相似，因此我们得出结论，P-TEV 在大型动物中是安全有效的，并且具有作为临床移植移植物的高应用潜力。
