‘Game Changer’ for Stem-Cell Research?

ANOTHER ADVANCE. Michael Gazzia, biological manufacturing analyst at Stemnion, holds a cryovial Sept. 23 inside the ‘clean room’ at the new facility in Clearwater, Fla. The Pittsburgh-based regenerative medicine company recently opened the Florida lab near a Catholic hospital where placentas are donated for use in adult stem-cell research.
ANOTHER ADVANCE. Michael Gazzia, biological manufacturing analyst at Stemnion, holds a cryovial Sept. 23 inside the ‘clean room’ at the new facility in Clearwater, Fla. The Pittsburgh-based regenerative medicine company recently opened the Florida lab near a Catholic hospital where placentas are donated for use in adult stem-cell research. (photo: CNS photo/Tim Boyles, courtesy Catholic Health Association)

BOSTON — A new research breakthrough at the Harvard Stem Cell Institute has revived the debate over public funding for embryonic stem-cell research.

The Christian Medical Association hailed the Harvard group’s progress towards turning ordinary skin cells into pluripotent stem cells useable in medical treatments, arguing, “It should stop federal funding of obsolete, embryo-destroying research.”

The CMA, which speaks for 16,000 doctors, is co-sponsoring a lawsuit to stop such funding that recently suffered an apparent legal setback. A federal judge’s temporary injunction blocked federal funding for new embryonic stem-cell research, but it was stayed on appeal.

Stem cells are the philosopher’s stone of medical research, because they differentiate into the specialized cells specific to all parts of the body. Researchers are experimenting on human embryonic stem cells from donated embryos to find ways to regenerate diseased organs such as hearts and livers, but experiments using human embryonic stem cells on animals have triggered fatal cancers and foreign tissue rejection.

Christian pro-life groups concerned with the killing of embryos oppose this approach and hold up two alternatives that avoid use of embryonic tissue: adult stem cells and induced pluripotent stem cells (iPSCs).

Both use cells from a specific patient as the building block for that patient’s personalized therapy (unlike human embryonic stem cells) and so avoid tissue rejection. Adult stem cells have, in fact, been used for decades in treatments, and their application is widening, but they are hard to grow outside the body.

Induced pluripotent stem cells are the new kids on the block: The first were developed in 2006, and they also are difficult to reproduce and could provoke cancerous growth in the recipient.

The Harvard research, reported in the Sept. 30 issue of the online medical journal Cell Stem Cell, takes induced pluripotent stem cells three giant steps closer to practical use. First, as team leader Derrick Rossi told a news conference, the team has created synthetic messenger RNA that can be introduced into skin cells with “instructions” to turn them into induced pluripotent stem cells. The previous method of inducing pluripotent cells used viruses to get the instructions into the skin cells’ genetic code. This caused both tumors and tissue rejection.

Once they had turned skin cells into stem cells, they then used messenger RNA to carry new instructions into the stem cells, ordering them to change into the specific tissue type needed to treat patients. Finally, the team found that by daily reinstructing the induced pluripotent stem cells their output of the desired cells could be increased a hundredfold.


‘Game Changer’

David Stevens, head of the Christian Medical Association, said, “This use of induced pluripotent cells will be a game changer just as antibiotics was. Because of antibiotics, people no longer die of infections; now they die of chronic illnesses such as heart disease, diabetes or osteoporosis involving degenerated tissues. Induced pluripotent cells will regenerate tissues where they have been destroyed.”

What’s more, the technique developed by the Harvard team need not be lethal to embryos.

“It’s 100 times more efficient in producing the desired cells,” said Stevens. “And it poses the question: Why should any more public money be spent on embryonic stem-cell research? When President Obama approved funding for new embryonic stem-cell lines he framed it as a matter of science trumping faith. This research just reinforces that the science is on the pro-life side, Mr. President.”

Other Christian voices joined with Stevens’: C. Ben Mitchell, professor of moral philosophy at Union University in Jackson, Tenn., and a consultant to the Southern Baptist Ethics & Religious Liberty Commission, reportedly said, “Even some of the most skeptical proponents of embryo-destructive research are getting the message. There are no good reasons to kill human embryos for research. Human embryos belong in a mother’s body, not in a research lab.”

And Richard Doerflinger, associate director of the Secretariat of Pro-Life Activities at the U.S. Conference of Catholic Bishops, told The Washington Post, “With each new study it becomes more and more implausible to claim that scientists must rely on destruction of human embryos to achieve rapid progress in regenerative medicine.”

The Harvard Stem Cell Institute doesn’t see things quite that way. Spokesman B.D. Colen commented, “We are devoting literally years of man- and woman-hours of research in an effort to develop iPSCs that duplicate the properties of embryonic stem cells. And we need embryonic stem cells to compare our results with.”


Embryonic Research

Colen was echoing comments by Francis Collins, head of the National Institutes of Health, the main federal funder of medical research, who said, “iPS research must continue to be conducted side by side with human embryonic cell research.”

Meanwhile, an Aug. 23 court ruling that temporarily stopped all NIH grants for human embryonic stem-cell research has been reversed after the federal government appealed.

However, a member of the pro-life legal team that is seeking a permanent injunction against such funding says the adverse ruling is actually a good thing at the political level.

“We never asked for a temporary injunction,” said Bart Waxman, a staff counsel with Advocates International, which is acting for the Christian Medical Association and two adult stem-cell researchers in the case. Federal Judge Royce Lamberth “decided to grant it on his own.”

“We were almost afraid of a win,” Waxman said. The anti-stem cell team’s fear was that the injunction’s initial success would provoke the Democratically controlled Congress into quickly exempting human embryonic stem-cell research from the Dickey-Wicker Amendment. Dickey-Wicker is a pro-life rider attached to spending measures every year that prevents federal money being spent in a way that is lethal to a fetus.

So far, the courtroom argument has concentrated on a technicality: whether continuing the funding until the main issue can be tried will hurt adult stem-cell researchers more than halting the funding will hurt embryonic stem-cell researchers.


Ultimate Question

But the ultimate question is whether funding for embryonic stem-cell research kills fetuses. If it does, said Advocates International’s Waxman, it violates Dickey-Wicker. This question could go to trial as soon as the end of this month.

Said Waxman: “There’s a sense the courts are passing the buck, waiting to see if Congress passes legislation exempting embryonic stem-cell research from Dickey-Wicker.” Legislation to that effect, twice passed and twice vetoed by President George W. Bush, now sits in committee.

If the fall elections return a Republican majority to either or both houses of Congress, says Waxman, it would be much less likely that Dickey-Wicker will be overturned.

Register correspondent Steve Weatherbe writes from Victoria, British Columbia.