CellMed AG, a BTG Company, 63755 Alzenau, Germany.
J Microencapsul. 2013;30(4):315-24. doi: 10.3109/02652048.2012.726281. Epub 2012 Sep 17.
Glucagon-like peptide-1 (GLP-1) CellBeads are cell-based implants for the sustained local delivery of bioactive factors. They consist of GLP-1 secreting mesenchymal stem cells encapsulated in a spherically shaped immuno-isolating alginate matrix. A highly standardized and reproducible encapsulation method is described for the manufacturing of homogeneous CellBeads. Viability and sustained secretion was shown for the recombinant GLP-1 and the cell endogenous bioactive factors like vascular endothelial growth factor, neurotrophin 3 (NT-3) and glial cell line-derived neurotrophic factor. Manufacturing and quality control is performed in compliance with good manufacturing practice and fulfils all regulatory requirements for human clinical use. GLP-1 CellBeads combine the neuro- and cardioprotective properties of both GLP-1 and mesenchymal stem cells. First promising results were obtained from preclinical studies and an ongoing safety trial in humans but further studies have to prove the overall potential of CellBead technology in cell-based regenerative medicine.
胰高血糖素样肽-1 (GLP-1) 细胞珠是一种基于细胞的植入物,用于持续局部递送生物活性因子。它们由 GLP-1 分泌的间充质干细胞封装在球形免疫隔离藻酸盐基质中。本文描述了一种高度标准化和可重复的封装方法,用于制造均匀的细胞珠。已证明重组 GLP-1 和细胞内源性生物活性因子(如血管内皮生长因子、神经营养因子 3 (NT-3) 和胶质细胞源性神经营养因子)具有活力和持续分泌能力。制造和质量控制符合良好生产规范,并满足人类临床使用的所有监管要求。GLP-1 细胞珠结合了 GLP-1 和间充质干细胞的神经和心脏保护特性。已从临床前研究和正在进行的人体安全性试验中获得了初步的有希望的结果,但还需要进一步的研究来证明细胞珠技术在基于细胞的再生医学中的整体潜力。