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Substitute blood plan hits FDA snag

Published July 14, 2006

WASHINGTON - The effort to develop substitutes for human blood, for use in emergencies from highways to battlefields, suffered a setback Thursday.

In response to a lawsuit, the Food and Drug Administration canceled what was to have been a closed-door meeting Friday to discuss the U.S. Navy's proposed experiment using a product derived from cow blood on as many as 1,000 unsuspecting civilian trauma victims.

If the experimental trial is ultimately approved, the product from Biopure Corp., called Hemopure, would join another blood substitute already being tested on patients who have lost dangerous amounts of blood. Researchers hope the substitutes one day could step in to perform one of the vital roles of the real stuff: carry oxygen from the lungs throughout the body.

The substitutes would be given to patients only when and where donor blood was unavailable. They also would replace the saline fluids typically now given to bleeding victims in the field or on the way to the hospital. That salt water can counter a dangerous drop in blood pressure but cannot carry oxygen.

A lasting and constant font of donor blood would be ideal. The problem with using real blood is that it has a 42-day shelf life. Other problems include scarcity of donors, difficulty in matching blood types between donors and recipients and perennial concerns about the transmission of disease.

The solution, researchers hope, could be the blood substitutes that can be churned out regardless of donor availability. They also could last for years.

A second company, Northfield Laboratories Inc., is wrapping up clinical trials begun in 2004 of another product, called Polyheme, amid ongoing ethical concerns. Polyheme is being given to trauma patients without their consent as they're being whisked to - and later, at - more than 20 hospitals.

Now, Biopure, together with the Navy and backed by military funding, seeks FDA permission to begin trials of Hemopure, on 900 to 1,000 civilian trauma victims.

[Last modified July 14, 2006, 02:50:54]

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