A trial at an Australian hospital using adult stem cells to repair bone fractures has had excellent results.
The trial at the Royal Melbourne Hospital involved 10 patients with leg fractures which refused to heal and results released show that all patients treated with the stem cell therapy have had new bone growth, while seven patients had their fractures completely healed within six months.
The mesenchymal stem cells were produced by Melbourne biotech company Mesoblast; they are multipotent stem cells that can differentiate into a variety of cell types.
Mesoblast says all 10 patients have been monitored for at least six months since the implantation, and no adverse events related to the cells have been reported.
All the patients have apparently new bone formation and seven patients have achieved union of their long bone defects within an average of 4.9 months; three others continue to show progressive new bone formation.
Before the stem cell implantation none of the 10 had shown any evidence of new bone formation for 5 to 41 months; the seven with the successful long bone union have been able to fully weight bear and resume daily activities.
The technology has removed the need for these patients to undergo a second operation to harvest bone from the pelvis.
The study found there was a direct relationship between increasing the dose of stem cells implanted and shortening the time to heal the bony defect, which the researchers say indicates that the stem cells work in a similar way to a pharmaceutical drug.
In patients whose fractures united within four months of treatment, the average dose of stem cells implanted was 14 per cent higher than in those uniting later, and 33 per cent higher than those who have not yet achieved union.
Mesoblast's founder, Professor Silviu Itescu, says he is delighted with the results which clearly show that the stem cell technology is safe and effective for speeding up bone fracture repair.
Mesoblast says the trial results will be used as part of a submission to the United States Food and Drug Administration (FDA) for approval for the stem cell therapy to be used in patients with long bone fractures.