Nexell Will Seek FDA OK for Stem-Cell Trial

Nexell Therapeutics Inc. said Wednesday that it will seek Food and Drug Administration approval to start its own trial of engineered stem-cell grafts, based on the results of a study conducted by the National Institutes of Health.

The Irvine biotechnology company said in a press release that the previous study showed “marked improvement” in the immune function of patients with chronic granulomatous disease, or CGD, despite the death of three volunteers.

CGD causes recurrent, often life-threatening infections and the formation of inflammatory nodules called granulomas in patients’ lungs, livers and other organs. More than 1,000 Americans and 25,000 people worldwide have CGD.