June 18, 2009 / 11:54 AM / 10 years ago

UPDATE 1-Aastrom: FDA lifts clinical hold from heart study

* To resume enrollment at 5 initiated clinical sites

* On track to complete trial enrollment by 2009 year-end

* Shares jump 39 pct in premarket trade

June 18 (Reuters) - Aastrom Biosciences Inc ASTM.O said U.S. health regulators removed the clinical hold from the company’s mid-stage trial of a treatment for congestive heart failure, sending its shares up 39 percent in premarket trade.

The company said it would resume patient enrollment at all five initiated clinical sites.

In May, the U.S. Food and Drug Administration (FDA) decided to put the trial on hold following a patient’s death, leading Aastrom to temporarily suspend enrollment and patient treatment in the trial, called IMPACT-DCM. [ID:nBNG147123]

Patients in the trial were treated with Aastrom’s cardiac repair cells (CRC), a product that contains stem and early progenitor cells produced from the patient’s own bone marrow.

The FDA, the clinical site’s principal investigator and an independent Data Safety Monitoring Board (DSMB) attributed the patient’s death to progression of the disease and determined it was unrelated to the CRC treatment, Aastrom 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,” Chief Executive George Dunbar said in a statement.

Shares of the company were up 15 cents at 53 cents in premarket trade. They closed at 38 cents Wednesday on Nasdaq.

For the alerts double-click [ID:nWNAB0918] . (Reporting by Anand Basu in Bangalore; Editing by Aradhana Aravindan)

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