Sterilizing Blood

Several hundred transfusion recipients around the country - adults undergoing heart surgery and children with certain inherited anemias - are being enrolled in a bold experiment: They'll receive donated blood that has essentially been sterilized.

Today's blood supply is very safe because it undergoes numerous tests to ensure that donated pints containing infections like the AIDS virus are thrown out.

Testing isn't perfect, however, and a few tainted pints slip by. Last month's discovery that West Nile virus apparently can be spread through transfusions highlights another problem: Blood banks can't prevent what they can't test for, and there's no test yet for West Nile in donated blood.

A technology called "pathogen inactivation" is being promoted as the solution. A chemical added to a donated bag of blood is supposed to break up the genetic material of any viruses or bacteria lurking inside so they can't infect, essentially offering the first way to sterilize blood.

"This is a paradigm shift in the way we deal with protecting the safety of the blood supply," says Dr. Laurence Corash of Cerus Corp., one of several companies developing the technology. "In the past we have relied upon testing. Testing will never put you in front of a new pathogen like West Nile virus when it first occurs."

Now Cerus and a competitor, V.I. Technologies, are beginning the first major U.S. studies, in 520 patients, to see if it's safe to give people pathogen-inactivated red blood cells.

Cerus has won European approval to sterilize platelets, one component of blood, and marketing should begin there late this month.

But don't expect sterilization of red blood cells - the typical transfusion - for at least several more years, as researchers study some serious questions: Does the cleaning alter blood so it doesn't function normally? Does the leftover cleanser residue pose any risk, or alter any cells in a way that might encourage cancer formation?

The Food and Drug Administration calls pathogen inactivation highly promising. It even took the unusual step of asking Cerus and Vitex to turn over evidence that their technologies could destroy West Nile virus in transfusions, raising the prospect of additional clinical trials if the mosquito-borne virus renews its threat next summer before a blood test, expected by then, is working.

"The promise is somewhat in the future," cautions FDA's Dr. Jesse Goodman. The FDA will demand stringent proof that altering blood to eliminate a bug found in, say, one of every 5,000 donated pints won't pose a new and different risk to the other 4,999.

Cerus and Vitex use different compounds, but the end result is the same: the molecules target and break up the genetic DNA and RNA that viruses and bacteria use to multiply, so the pathogens are no longer infectious.

Both companies cite success in killing a variety of bugs, from the HIV virus to the malaria parasite. Vitex, working with the Agriculture Department, recently proved it can kill the West Nile virus; Cerus is doing similar experiments.

Red blood cells, plasma and platelets, blood's major components, contain no nuclear DNA or RNA and so are not destroyed. White blood cells contain the genetic material, but as they're not needed in transfusions, destroying them does no harm.

Both companies say what little cleanser residue is left isn't harmful.

But blood banks cite the cautionary tale of an earlier attempt to scrub infections out of plasma that won FDA approval only to have doctors discover later that it could cause a serious side effect in certain patients. That and marketing problems caused this "solvent detergent plasma" to fail.

So blood banks are closely watching Cerus and Vitex. The companies' clinical trials aren't large enough to prove the technology reduces infections, but they're crucial to see if sterilized blood causes side effects that blood tested in the regular way wouldn't.

Participating in Cerus' study are Yale University, the University of Minnesota, the University of Virginia, Boston's Brigham & Women's Hospital, and the University of Florida. Vitex is now picking study sites.

If the studies go well, both companies hope to seek FDA approval for sterilized red blood cells in 2004.

By Lauran Neergaard