Study approval
tibial/femoral fracture nonunion
This phase III clinical trial was designed as a multicenter, single-arm study to evaluate the safety and efficacy of autologous and G-CSF-mobilized CD34 + cells in patients with tibial/femoral fracture nonunion. The study protocol conformed to the Declaration of Helsinki and was approved by the institutional review boards of the seven participating hospitals, which included five university hospitals and two medical centers of the same scale as that of the university hospitals. A clinical trial notification was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and the study was initiated after obtaining the PMDA’s permission. Furthermore, ethical approval was obtained from all seven participating hospitals. All patients provided written informed consent to participate in this trial.