FDA lifts the clinical hold from the Aastrom's cardiac repair cells (CRC)’s mid-stage trial

FDA lifts the clinical hold from the Aastrom's cardiac repair cells (CRC)’s mid-stage trialU. S. Food and Drug Administration lifted the clinical hold from the Aastrom Biosciences Inc's mid-stage trial of a treatment for congestive heart failure. The approval to proceed with the clinical trail on a stem cell treatment for a severe form of chronic heart failure led to surge in the shares of the company.

The trail was put on hold by FDA in May due to patient's death. Aastrom then temporarily suspended enrollment and patient treatment in the trial known as IMPACT-DCM.

Now company will resume patient enrollment at all five initiated clinical sites.

The death of the patients was caused by the progression of the disease not due to Cardiac Repair Cell treatment. The FDA, along with other investigators reached this conclusion after analyzing autopsy results and medical records.

The trails were conducted to test efficacy of Aastrom's cardiac repair cells (CRC), a product that contains stem and early progenitor cells produced from the patient's own bone marrow.

Chief Executive George Dunbar said: "We do not expect that this short delay will interfere with our goal of completing patient enrollment in this trial by the end of calendar year 2009."