Study design and criteria for patient enrollment
nonunion, fracture, infection, allergies, fracture nonunion, femoral fracture
HYPERTROPHIC, ADVERSE EVENTS, FRACTURE NONUNION, INFECTION, ALLERGIES
The following inclusion criteria were used: (a) tibial shaft fracture or femoral fracture (excluding intra-articular fracture); (b) fracture nonunion for over 6 months after previous surgery for fracture treatment; (c) fracture nonunion without infection; (d) plan to undergo autologous bone grafting (ABG) for nonunion surgery; (e) patient age of 20–69 years; and (f) provision of written informed consent. ABG was used when there was a bone gap in the nonunion site or when the type of nonunion was not hypertrophic. The exclusion criteria included a high risk of G-CSF adverse events (AEs), leukapheresis, and lack of CD34 + cells, and are listed in Additional file After obtaining informed consent from patients, the eligibility of each candidate to undergo cell-based therapy was evaluated at each institute. Examinations were undertaken to obtain baseline data. An intradermal reaction test, using atelocollagen gel to detect allergies, was performed; thereafter, the trial was initiated within 4 weeks after registration. The patients were followed for 52 weeks after CD34 + cell transplantation.The following treatments were prohibited during the trial period: BM and cell-based therapies other than CD34 + cell therapy, gene therapy, or treatment with angiogenesis inducers, such as fibroblast growth factor, study drugs, and medical devices used in other clinical trials, low-intensity pulsed ultrasound, and teriparatide (parathyroid hormone 1–34).