Abstract
Aim
To evaluate the efficacy of bone marrow derived stromal cells (BMSC) for the treatment of non-unions in fractures.
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.
Results
The study had 21 males and 14 females with a mean age of 51.2±13.2 years (range 18–76). The average duration of non-union was 3±2 years (range 1–10 years) with mean 3.5 (range 1–12) surgical interventions prior to BMSC insertion. Independent assessment of ‘test’ and ‘control’ side revealed that the callus formation and fracture bridging was slow although a trend to improvement on the side of the BMSC insertion was observed at 9–12 months. At final follow-up 22 patients progressed to bony union; 13 patients had persisting non union.
Conclusion
BMSC can achieve progression to union in substantial number of cases of resistant non-unions where the alternative is extensive reconstructive procedures or amputations. Larger trials are required to study the pattern of early healing following cell therapy in such cases.
