Methods

An ethically approved single centre randomised control trial recruited 35 patients for treatment of non-unions with BMSC during 2006–2010. Autologous BMSC were culture expanded at the Good Manufacturing Practice (GMP) standard Oscell® laboratory in the hospital. Following in vitro expansion- cells in autologous serum and serum alone were randomised for insertion at one of the two fracture sides by StratOs® computer software. Patients and the operating surgeon were blinded to the side of cell insertion. Such method of randomisation created internal controls at the fracture sites- one side receiving the cell (‘test side’) and other, not (‘control’). Serial radiographs extending up to an average of twelve months were evaluated by six independent assessors blinded to side of cell insertion. Callus formation and bridging of fracture was compared for ‘test’ and ‘control’ side. Radiological and clinical outcome at final follow-up was also noted.