New guidelines released to promote 'responsible' stem cell research

The International Society for Stem Cell Research (ISSCR), the largest international professional organization of stem cell scientists, on Thursday released newly updated guidelines aimed at promoting "responsible" stem cell research.

"The field of stem cell research is growing at a rapid pace, with scientists and physicians developing new therapies that can help patients around the world who suffer from a wide variety of conditions," Sean Morrison of ISSCR president said in a statement.

"These guidelines are essential to protect the integrity of the research and to assure that stem cell treatments are safe and effective," said Morrison, also director of the Children's Medical Center Research Institute at the University of Texas Southwestern Medical Center.

The new guidelines, an update to two earlier versions released in 2006 and 2008, respectively, covered new discoveries and techniques such as gene editing in human embryos, which "offer bold possibilities while also posing ethical conundrums."

Under the new guidelines, a specialized oversight process is recommended for research involving human embryos, in recognition of the "unique sensitivities" surrounding such research.

The ISSCR said it supported laboratory-based research that entails gene editing of the nuclear genomes of human sperm, egg, or embryos, when performed under rigorous review, but held that any attempt to apply this clinically would be premature and should be prohibited at this time.

In the meantime, the guidelines tried to further advance research involving induced pluripotent stem (iPS) cells, or adult cells that are genetically reprogrammed to an embryonic stem cell-like state.

For this to happen, the ISSCR recommended excluding the generation of iPS cells from specific stem cell research oversight, and instead relying on the existing human subjects review processes to oversee donor cell recruitment.

The new guidelines also made it clear that compensating women who donate eggs for research can be ethically permissible so long as a review reveals no undue financial inducement for them to participate.

In addition, they urged all groups, included scientists, clinicians, industry, science communicators, and media, to present accurate, balanced reports of progress and setbacks related to stem cell science and medicine.

"The public recognizes that stem cell research holds promise for treating diseases and disorders affecting millions of people around the world," said George Daley, member of the ISSCR Guidelines Update Steering Committee and professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.

"We remain steadfast in our commitment that only safe and effective treatments based on proven science should be marketed to patients," he said.

In an article published in the U.S. journal Science, several of the experts that warned against what they called science "hype," in which the state of scientific progress or the potential applications of research are exaggerated.

"This raises the risk of harmful consequences, including misleading the public, creating unrealistic expectations, misinforming policy debates, devaluing methodical approaches to research, and driving premature or unwarranted clinical use," they wrote.

The new guidelines were developed by an international task force of 25 experts in stem cell science, clinical research, and bioethics from nine countries, including China.