Final Rules Broaden Pool for Stem Cell Research

MONDAY, July 6 (HealthDay News) -- The U.S. government issued final guidelines Monday describing which embryonic stem cell lines will be eligible for government funding, effectively expanding the universe of stem cells that can be used for research.

Going forward, researchers will have to demonstrate that embryonic stem cells used in research were obtained from fertility clinic embryos that otherwise would have been discarded. Also, the stem cells must come with the informed consent of the parents or mother.

But stem cells developed earlier will not require such precise documentation, representing a departure from draft guidelines issued in April by the U.S. National Institutes of Health.

According to published reports, earlier stem cell lines must meet the "spirit" of the new guidelines, if not the "letter," to qualify for taxpayer-supported funding.

The crucial test, The New York Times reported, is whether the embryos used to create the older stem cell lines were created for reproductive purposes and whether donors freely consented to their use in research procedures. At a news conference Monday, Dr. Raynard S. Kington, acting director of the NIH, noted that some researchers had used videos instead of written forms in the past and that such a minor difference in protocol would not make that research ineligible for financing, the newspaper said.

The new guidelines still ban federal financing for research on stem cell lines derived from embryos created solely for research.

In March, President Barack Obama signed an executive order that he said would allow federal taxpayer dollars to fund significantly broader research on embryonic stem cells because "medical miracles do not happen simply by accident."

The executive order overturned a long-standing Bush administration policy limiting government funding of human embryonic stem cell research to cell lines already in existence as of August 2001.

Since the draft guidelines were issued by the NIH in April, "the question was what about the embryonic stem cells that have already been in use since 2001," said Paul R. Sanberg, director of the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine in Tampa. "There are many in those cases that didn't get informed consent."

"The more information we have about these cells that are used for research or potential treatment, the better off we'll be," Sanberg said. "It's important that there be documentation on tissue, on embryonic cells, that informed consent was received."

Different medical societies applauded the new guidelines, including the American Society for Reproductive Medicine (ASRM) and the Juvenile Diabetes Research Foundation (JDRF).

"The guidelines released today reflect the tremendous importance of embryonic stem cell research, while assuring that federal funds will only be available for use on stem cell lines derived under appropriate ethical supervision," ASRM spokesman Sean Tipton said in a prepared statement. "The scientific community is pleased that the policymaking is complete and is ready to get to work at learning how to tap the power of embryonic stem cells to relieve human suffering."

Alan J. Lewis, JDRF president and chief executive, "applauded" the new guidelines. "We particularly want to commend the NIH for including in the guidelines a provision under which existing stem cell lines derived in an ethically responsible manner would be eligible for federally funded research," he said in a news release. "This provision will ensure that a process is in place so researchers can build on the stem cell advancements made to date and accelerate research on cell lines with the greatest potential to facilitate treatment of the disease."

Embryonic stem cells are the most basic human cells, believed to be capable of growing into any type of cell in the body. Working as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells. The scientific hope is that stem cells may, at some point in the future, become capable of treating a variety of diseases and conditions, such as Parkinson's disease, diabetes, heart disease and spinal cord injuries, according to the NIH.

Stem cell research received a boost in January when the U.S. Food and Drug Administration approved the first-ever human trial using embryonic stem cells as a medical treatment. Geron Corp., a California-based biotech company, was given permission to implant embryonic stem cells in eight to 10 paraplegic patients who can use their arms but cannot walk.

The new guidelines take effect Tuesday. The NIH will create and make available a registry of approved stem cell lines.

"There will be an opportunity to work with a lot more cells under these guidelines," Sanberg said. "But as scientists, we clearly need to continue to think about the ethical issues."

National polls continue to find that the majority of Americans favor embryonic stem cell research, although some surveys have found that support has declined somewhat in recent years.

Many people object to the use of embryonic stem cells, contending that the research requires the destruction of potential life because the cells must be extracted from human embryos.

More information

The U.S. National Institutes of Health has more on the new stem cell guidelines.

SOURCES: Paul R. Sanberg, Ph.D., director, Center of Excellence for Aging and Brain Repair, University of South Florida College of Medicine, Tampa; July 6, 2009, The New York Times; American Society for Reproductive Medicine, news release, July 6, 2009; Juvenile Diabetes Research Foundation, news release, July 6, 2009; National Institutes of Health (