First patients recruited in Mesoblast stem cell trials

The first few patients have been formally recruited for two pilot clinical trials of Melbourne-based Mesoblast's (ASX:MSB) adult stem cell platform technology.

Two separate pilot clinical trials -- one for the repair of large bone fractures at the Royal Melbourne Hospital and the other for the treatment of cardiovascular disease at the John Hunter Hospital in Newcastle -- are recruiting up to 10 patients each.

While Mesoblast executive chairman Michael Spooner declined to give exact numbers of patients already recruited, he said that "given this is an autologous study -- so the patient's own cells are identified and expanded -- the process for recruitment should be very quick."

The trial at the John Hunter Hospital will enrol patients with multi-vessel coronary artery disease, while the trial at the Royal Melbourne Hospital will enrol patients with non-union long bone factures.

"For both clinical trials, these people have likely had a number of procedures that have not delivered a definitive treatment," said Spooner. "Therefore the delivery of these adult stem cells provides them with another option, one that has tremendous potential."

The purpose of the trials is to prove the safety and potentially efficacy of the company's stem cell manufacturing and regulatory protocols in a clinical environment.

"Our primary goal is to prove up in a clinical environment our standard operating procedures in terms of cell identification, extraction and expansion," said Spooner. "The data that's going to be obtained through that process will definitely be good adjunct data to our FDA clinical trial submissions -- our IND submissions."

Mesoblast is currently conducting a series of large animal dose escalation studies at Colorado State University in the US and intends to proceed to phase II clinical studies once its submissions are approved by the FDA.