Mesoblast trial approved

MESOBLAST has won US FDA clearance to begin a second-phase stem cell trial for the treatment of type 2 diabetes.

MESOBLAST has received a big boost by winning clearance from the US Food and Drug Administration to begin a second phase clinical trial of its adult stem cells for the treatment of type 2 diabetes.

The news lifted the company's shares 20c to $6.45 yesterday.

Mesoblast's stem cell product is the first of the biotech company's therapies to be delivered via an intravenous injection. Patients will receive increasing doses of the stem cells to determine whether blood glucose levels show sustained falls, as they have in pre-clinical trials on mice.

"The primary end point of the study will be to show safety of all three doses over three months of follow up," the company said.

"Secondary endpoints include effects of each dose on blood glucose control over this period, changes in inflammatory markers and hormones that may be abnormal in patients with type 2 diabetes, and the effects on C-reactive protein (CRP), an established major predictor of heart attacks and death in patients with type 2 diabetes."

The cell dose ranges that will be tested are based on results from Mesoblast's pre-clinical studies in 17 mice with obesity-related type 2 diabetes.

In the studies, a single dose of the cells resulted in a significant increase in blood insulin levels and sustained reduction in blood glucose levels for the entire three week follow-up period.

"This was due to restoration in the damaged pancreas of the balance between insulin-producing beta cells, which reduce blood glucose, and glucagon-producing alpha cells, which increase blood glucose," Mesoblast said.

Type 2 diabetes accounts for 90 to 95 per cent of the 230 million people with diabetes in the industrialised world. In the US alone, there were 25.8 million sufferers in 2010.