Theregen, Inc., San Francisco, California, USA.
Tissue Eng Part A. 2011 Sep;17(17-18):2177-86. doi: 10.1089/ten.TEA.2010.0680. Epub 2011 Jun 14.
The current study's purpose was to evaluate the safety and biological effect of a scaffold-based three-dimensional human dermal fibroblast culture (3DFC, also known as Anginera™) to treat chronically ischemic canine hearts. It was hypothesized that treatment with 3DFC would be safe and significantly improve ventricular performance and wall motion. In this study, chronic myocardial ischemia was induced in 40 animals through the surgical placement of an ameroid constrictor. Approximately 30 days after ameroid placement, animals were randomized into four test groups: (1) sham treatment, (2) one unit of acellular 3DFC, (3) one unit of viable 3DFC, and (4) three units of viable 3DFC. Animals were necropsied 30 or 90 days after treatment. Evaluation of the safety endpoint demonstrated the safety of 3DFC at all dosing levels and at both time points. Additionally, parameters of cardiac output, left ventricular ejection fraction, left ventricular end systolic volume index, and systolic wall thickening support the conclusions that 3DFC stimulates a positive biologic effect on ischemic canine hearts. Further, these data support the conclusion that treatment with viable 3DFC improves ventricular performance and ventricular wall motion in chronically ischemic canine hearts 30 days after treatment.
本研究旨在评估基于支架的三维人真皮成纤维细胞培养（3DFC，也称为 Anginera™）治疗慢性缺血性犬心脏的安全性和生物学效应。假设用 3DFC 治疗是安全的，并能显著改善心室功能和室壁运动。在这项研究中，通过手术放置一种缩窄环在 40 只动物中诱导慢性心肌缺血。在放置缩窄环约 30 天后，动物随机分为四组进行测试：（1）假手术处理，（2）一个单位的去细胞 3DFC，（3）一个单位的活细胞 3DFC，和（4）三个单位的活细胞 3DFC。动物在治疗后 30 或 90 天进行尸检。安全性终点评估表明，3DFC 在所有剂量水平和两个时间点都是安全的。此外，心输出量、左心室射血分数、左心室收缩末期容积指数和收缩壁增厚等参数支持这样的结论，即 3DFC 对缺血性犬心脏产生积极的生物学效应。此外，这些数据支持这样的结论，即治疗活细胞 3DFC 可改善慢性缺血性犬心脏治疗后 30 天的心室功能和室壁运动。
