Mesoblast takes first step towards clinical trials

Newly-listed stem cell company Mesoblast (ASX: MSB) has taken its first step toward initiating its pilot human clinical trials by appointing Peter MacCallum Cancer Centre-based company Cell Therapies to produce mesenchymal precursor cells (MPCs) under GMP conditions.

According to Mesoblast founder and CSO Prof Silviu Itescu, the initial pilot trials will be performed in Australia, initially using autologous cells -- stem cells from the patient's own body -- to provide proof of concept. Later trials will use allogeneic cells -- cells isolated from a donor.

The company is likely to perform trials not only for its own bone, cartilage and joint program but also for the cardiac and vascular programs underway at US company Angioblast Systems, which is 33.3 per cent owned by Mesoblast.

Itescu said the decision to use Cell Therapies for the isolation, processing, and expansion of the MPCs was an easy one.

"In our opinion, they are probably the most experienced group in Australia in terms of cell processing, expansion and use, and they meet TGA requirements and in large part FDA requirements," he said.

"We are really looking to have a harmonised process that will allow us to move from pilot trials in Australia to FDA-sanctioned trials in the US and Australia."

Mesoblast was preparing to submit applications for ethics approval to a number of medical centres in Australia, and Itescu said he expected that trials could begin this year.

"This is step number one -- we have got to have an FDA compliant process in place to make cells for use in the clinic," Itescu said.

"We're certainly getting off the ground."