Aastrom Says FDA Lifts Stem Cell Trial Halt

NEW YORK (AP) — Aastrom Biosciences Inc., which develops adult stem cells to treat heart diseases, said Thursday the Food and Drug Administration has lifted a halt on a clinical trial.

Aastrom said it will resume enrolling patients in the midstage trial, called IMPACT-DCM, because the FDA has completed an investigation into the death of a patient. The FDA concluded that the patient died of dilated cardiomyopathy and not from treatment, the company said.

In afternoon trading, shares of the Ann Arbor, Mich., company climbed 8 cents, or 21.8 percent, to 46 cents.

In the IMPACT-DCM study, Aastrom is testing the ability of autologous stem cells, or stem cells from the patient's own body, to treat dilated cardiomyopathy, which is a severe form of chronic heart failure that causes the heart to swell and impairs circulation.

Aastrom said the study was suspended May 22. The company said it still expects to finish enrolling patients by the end of the year. The company has enrolled 14 patients in the trial, out of a planned goal of 40.