Abstract
External fixation pins with a fibroblast growth factor (FGF)-2-apatite composite layer (Ap-FGF pins) contribute to reduce pin-tract infection rate. So, a translational research for the Ap-FGF pins was carried out. Preparation and quality control methods of Ap-FGF pins were summarized as protocols in consideration of good manufacturers practice (GMP). According to the protocols, Ap-FGF pins conforming to a standard can be prepared successfully. The phase I/IIa clinical study of the Ap-FGF pins was approved by ethical committees in both university of Tsukuba and AIST, and has just started from December, 2011.