ReNeuron files world's first neural stem cell therapy IND with FDA

UK-based stem-cell therapeutics developer ReNeuron says it has filed an Investigational New Drug application with the US Food and Drug Administration requesting approval for the initiation of US clinical studies of ReN001, its developmental stroke therapy. The firm explained that ReN001 is designed to treat patients who have been disabled by a stroke, a group for whom there are no currently approved drugs.

ReNeuron said that, assuming the IND is approved, it will conduct the clinical program at the University of Pittsburgh Medical Center, with the initial Phase I study being run as an open-label, two-dose assessment in stroke patients. The firm added that an initial efficacy assessment will also be made to provide an indication of therapeutic potential, prior to further examination.