WEDNESDAY, March 3, 2004 (HealthDayNews) -- In a move that could let many researchers circumvent the Bush administration's restrictions on stem cell research, scientists have created 17 new human embryonic stem cell lines and will make them available to other researchers at little or no cost.
"These cells are easy to grow. They're much more user-friendly [than existing lines], which means that you don't have to spend all your time starting your car. You can drive somewhere," says Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, which is publishing the research in the March 25 issue and releasing it online March 3. Drazen also co-authored an accompanying editorial on the study.
"Researchers who are fighting to find cures for disease should have the best tools available," he says. "This is a big step forward."
In addition to being a scientific and perhaps political milestone, the move, which doubles the number of stem cell lines available, also marks a major landmark in the personal odyssey of one man.
Douglas Melton, who spearheaded the effort, has two children with type 1 diabetes. His lab at Harvard is dedicated to trying to make insulin-producing pancreatic beta cells to treat or cure this disease. The newly available stem cells will give a considerable boost to his efforts.
"There is the possibility that this can have a helpful effect on my children's disease, but in that respect I'm like any other father," he says.
The study comes just days after Harvard announced it was launching a multimillion-dollar center to grow and study human embryonic stem cells. Funding came from Harvard, the Howard Hughes Medical Institute and the Juvenile Diabetes Research Foundation.
Embryonic stem cells can turn into any type of adult cell and therefore have enormous scientific potential. It is hoped that one day they may be a source of cells to replace damaged or lost ones.
Stem cells to be used in federally funded research is limited to those derived before Aug. 9, 2001 at 9 p.m., a Bush administration policy. The National Institutes of Health (NIH) has about 15 such lines available, but by most accounts, they are difficult to obtain and ill-equipped for rigorous research. There are some lines available from private sources, but they are expensive and also subject to restrictions.
Enter Melton, who "had determined that, of the available lines, most were not going to be available to us and almost all of them had not been properly published." Stem cells obtained by his lab did not grow well.
"There was just too much red tape to deal with, and I tend to be an impatient person so I just decided to get this on my own," he says. Melton adds this decision was not related to President Bush's restrictions on stem cell research.
Bush and the NIH faced criticism Tuesday from members of Congress who say that only a small portion of the cell lines the government said would be eligible for research will be available anytime soon. A letter from U.S. Reps. Henry Waxman (D-Calif.) and Louise Slaughter (D-N.Y.) says the administration may have "misinformed the public" about what would be available, a charge the administration denies, according to the Associated Press.
The stem cells of the current endeavor came from fertilized human eggs, which were obtained from Boston IVF, an in vitro fertilization clinic near Harvard. Drazen maintains this method is "ethically justifiable" because "the materials used to create these stem cells were part of materials that had been made so people could undergo IVF, and they've completed their need for those and they're about to be destroyed."
"Here you take something that somebody's about to destroy, and suddenly it could be a potentially lifesaving therapy for someone else," he continues. "The arguments I've heard on the other side are specious." All of the egg and sperm donors gave their consent for this use of what are sometimes called "excess fertilized eggs." According to Melton, between 200,000 and 400,000 frozen fertilized eggs are slated for destruction in the United States. "We used a tiny portion of that," he says.
The stem lines were coaxed with an enzyme, a more efficient process than that used for the NIH lines, and Melton believes they are "hardy" and "user-friendly."
The one problem is that they were grown on mouse feeders, meaning they are not perfectly compliant with human cells.
They are, however, thoroughly documented, with information on chromosomal content, amount of time it takes to double the number of cells, and passage number (the number of times a cell divides before it overgrows the dish).
Melton said he "sincerely hopes" the effort does not compromise his own ability to get federal funds, and this research was strictly segregated from other efforts. All work was done in a newly outfitted basement facility that had not before been used for experiments. All equipment, including petri dishes and microscopes, was earmarked and divided according to the source of funding.
Melton hopes any qualified researchers, noncommercial and commercial, will benefit from the initiative. "My own opinion is that anyone who wants to do experiments should have access, including industry," he says. The group has not filed any patents and has no intellectual property.
Many frozen vials have been prepared in anticipation of demand. For legal reasons, recipients will have to pay their own shipping costs, and they cannot use the stem cells for any federally funded research.
The Drazen editorial calls for the cell lines to eventually become part of the NIH Human Embryonic Stem Cell Registry for research funded by the government.
Melton himself is "fully focused on turning these cells into pancreatic beta cells."
"My own view on this is rather simple-minded," he adds. "I naively believe that if we can do that, the administration will reconsider policy."
For more on stem cells, check out the Batten Support & Research Trust. You can also try the National Institutes of Health or the Society for Developmental Biology. More on the current research can be seen at Melton's lab.