Aastrom achieves milestone in Phase IIb critical limb ischemia study

This milestone marks the first step toward interim data retrieval from this clinical trial evaluating Aastrom’s vascular repair cells (VRCs) in the treatment of patients suffering from the most severe form of peripheral arterial disease (PAD), critical limb ischemia (CLI). After the 30th patient has been followed for one year the company will be able to unblind and analyze the interim data.

The Restore-CLI clinical trial is a prospective, controlled, randomized, double-blind, multi-center study that is reviewed quarterly by a sponsor-appointed, independent data and safety monitoring board (DSMB). The DSMB has unblinded access to all available patient data.

George Dunbar, president and CEO of Aastrom, said: “These patients face a high risk of major limb amputation and may benefit from Aastrom’s VRC treatment.”