Bone healing with MSCs

Source: Mesoblast

Melbourne biotech Mesoblast has announced results from a clinical trial of mesenchymal stem cell transplants in 10 patients suffering from non-healing, long bone fractures of the legs.

All 10 patients have now been followed up for at least six months post implantation, with no adverse events related to the cells occurring in any patient.

In a statement, Mesoblast said all patients have shown new bone formation. Seven patients have achieved union of their long bone defects within a median time period of 4.9 months, and three continue to show progressive new bone formation.

In contrast, none of the 10 had shown any evidence of new bone formation for 5-41 months prior to stem cell implantation.

All patients with successful long bone union have been able to fully weight bear and resume daily activities. Mesoblast's technology eliminated the need in these patients for a second operation to harvest bone from the pelvis.

A key result in the study was the observation of a direct relationship between increasing the dose of stem cells implanted and shortening the time to heal the bony defect, indicating that the stem cells worked in a similar way to a pharmaceutical drug.

In patients whose fractures united within four months of treatment, the median 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, said he was delighted with the six-month results.

"These results clearly show that our proprietary stem cell technology is safe and effective for speeding up bone fracture repair," he said.

"The identification of a dose-response with shorter time to healing will be central to our upcoming Investigational New Drug (IND) submission to the United States Food and Drug Administration (US FDA) to use our allogeneic, or off-the-shelf, stem cells in patients with long bone fractures."