Mesoblast gets ethics nod for diabetes trial

Mesoblast (ASX:MSB) has secured ethics approval for a phase II trial of its adult stem cells in diabetic nephropathy.

The Australian ethics committees overseeing the trial have signed off on a 12-week trial of Mesoblast’s mesenchymal precursor cells (MPCs) in patients with type 2 diabetes and advanced kidney disease.

The committees made their decision after reviewing the safety data from a phase II trial evaluating a single dose of MPCs in patients with early-stage type 2 diabetes without kidney disease.

The randomised, dose-escalating phase II trial will involve 30 patients with stage 3b or 4 diabetic nephropathy. It will measure the safety and efficacy of a single intravenous infusion of 150 million or 300 million MPCs over a 12-week period, as compared to a placebo.

Mesoblast CEO Professor Silviu Itescu said preclinical research suggests that MPCs can reduce inflammation and reverse vascular endothelial dysfunction in the kidneys, while also lowering glucose levels in animals.

“The prognosis for patients with diabetic kidney disease is grim,” he said. “Despite advances in dialysis and kidney transplantation, fewer than 50% of those with end-stage kidney disease are alive five years after diagnosis. We believe that our proprietary MPCs may provide a benefit to patients suffering from diabetic nephropathy.”

Mesoblast in March raised $170 million to fund trials of its MPCs in various conditions including spinal fusion and rheumatoid arthritis.

Mesoblast shares were trading 0.18% lower at $5.42 as of around 2.30 pm on Wednesday.