A UW-Madison bioethicist has stirred up the stem-cell world by saying scientists who created some of the embryonic stem-cell lines approved for federal funding didn't properly obtain consent from embryo donors.

A study by Robert Streiffer, a professor of bioethics and philosophy, raises new questions about President Bush's policy limiting federal research grants to the 21 lines, or colonies, of stem cells derived before August 2001.

Researchers have argued that newer lines are scientifically better because they have more genetic diversity and aren't contaminated with animal products as the older lines are.

Now Streiffer says the newer lines, most made after a more thorough consent process, also have ethical advantages.

"There is an ethical cost to restricting federal funding to that first wave of stem-cell lines," Streiffer said,

Embryonic stem cells are extracted from days-old embryos left over from fertility clinics in a process that destroys the embryos. Scientists are using the cells, thought capable of becoming all of the types of cells in the body, to better understand and potentially treat many diseases, including diabetes and Parkinson's.

Streiffer's study of consent forms has led universities, including UW-Madison, to consider banning the use of some stem cells. The topic will be discussed at the 2008 World Stem Cell Summit today and Tuesday at Madison's Alliant Energy Center.

The three stem-cell lines most in question — from BresaGen, of Athens, Ga. — were derived from embryos for which donors signed a standard consent form for fertility treatment, Streiffer said. The seven-page form contains one sentence with a vague reference to research.

"I'm surprised the (National Institutes of Health) even let those lines on the registry," Streiffer said.

Allan Robins, chief technical officer of Novocell, which merged with BresaGen in 2004, said BresaGen's consent form was appropriate and did mention the possibility of research.

Story Landis, chief of the NIH Stem Cell Task Force, said the agency has no plans to remove the BresaGen lines from the registry. Informed consent "has been a moving target," so it's not surprising that newer consent forms might be better, Landis said.

UW research questions

Streiffer said the consent forms for the 18 other stem-cell lines on the NIH registry were more transparent, including UW-Madison's form for the five lines derived by campus researcher James Thomson.

But some of those forms also raise questions, he said.

UW-Madison's form says the embryonic cells won't be mixed with human or animal embryos. But it doesn't address mixing the cells with animal fetuses or putting derivatives of the cells in animal embryos, both of which have been done.

Thomson and a researcher from the University of Nevada have put human embryonic stem cells, and blood stem cells grown from them, into fetal sheep, Streiffer said. UW-Madison's Su-Chun Zhang has placed nerve cells grown from human embryonic stem cells in chick embryos.

"You could have a situation where some of the donors are going to say, 'Wow, if I knew that was going to happen, I probably wouldn't have donated,' " Streiffer said.

The studies by Thomson and Zhang "probably shouldn't have been done with those lines," he said.

Thomson and Zhang said a university committee approved their research.

Possible bans

Streiffer's study was based on a Freedom of Information request to the NIH seeking the consent forms for the 21 stem-cell lines. The study was published in the May-June issue of the Hastings Center Report, a bioethics journal.

His report said the consent form for two stem-cell lines from Cellartis, of Sweden, also is problematic. The form, he wrote, said the embryonic cells would be destroyed — when in fact they've been sent to many researchers.

Since Streiffer's study was published, Cellartis has presented a newer consent form showing that the company asked the donors in 2004 if their cells could be grown and be distributed.

"It looks like that has been resolved," Streiffer said.

The National Stem Cell Bank, the only official repository of the 21 stem-cell lines, is kept at the WiCell Research Institute in Madison under a contract with the NIH. WiCell will continue to distribute the stem cells, including the BresaGen lines, unless it hears otherwise from the NIH, said WiCell spokeswoman Janet Kelly.

UW-Madison's Embryonic Stem Cell Research Oversight Committee will review requests from campus researchers to use the BresaGen lines, said Streiffer, a member of the committtee.

The committee doesn't know of any scientists at the university who have used the BresaGen cells, he said. Most researchers here study the cells derived by Thomson.

Bush's policy, enacted three years after Thomson grew the world's first human embryonic stem cells in a lab, was designed as a compromise. It let some research go forward but banned federal spending on work involving newly destroyed embryos.