Mesoblast gets go-ahead from FDA to manufacture stem cells

Mesoblast (ASX:MSB) has reached a milestone with the US FDA in regards to phase III trials of its mesencymal precursor cells (MPCs) in congestive heart failure.

The regenerative medicine company said it has negotiated an agreement regarding the manufacturing process for MPCs in the congestive heart failure trial, and for phase III trials in additional indications.

The parties have also established a pathway for eventual commercial manufacturing supply of Mesoblast's cell therapy products.

The FDA made the decision based on comparability data from the initial set of manufacturing runs for the MPCs to be used in a phase III congestive heart failure trial, which is at the design stage.

In agreeing to the manufacturing process, the FDA has approved Mesoblast's proposed procedures to demonstrate the potency of the MPCs, and to compare manufacturing processes with similar products.

Assays to measure the potency of the cells will be a key requirement to FDA approval of the phase III trial.

Mesoblast was recently forced to reassure its investors that it is still actively working with partner Teva Pharmaceutical Industries on the design of the trial, in response to a resurgence of rumours that Teva is not committed to their MPC alliance.

Some financial experts have blamed these rumours for a steep negative spike in the company's share price last week.

Mesoblast (ASX:MSB) shares were trading 1.14% higher at $5.320 as of around 3pm on Tuesday.