Phase III clinical trial of autologous CD34 + cell transplantation to accelerate fracture nonunion repair.

ABSTRACT:

Background

We previously demonstrated that CD34 + cell transplantation in animals healed intractable fractures via osteogenesis and vasculogenesis; we also demonstrated the safety and efficacy of this cell therapy in an earlier phase I/II clinical trial conducted on seven patients with fracture nonunion. Herein, we present the results of a phase III clinical trial conducted to confirm the results of the previous phase studies using a larger cohort of patients.

Methods

CD34 + cells were mobilized via administration of granulocyte colony-stimulating factor, harvested using leukapheresis, and isolated using magnetic cell sorting. Autologous CD34 + cells were transplanted in 15 patients with tibia nonunion and 10 patients with femur nonunion, who were followed up for 52 weeks po

SUBMITTER: Kuroda R 

PROVIDER: S-EPMC10557317 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature