A federal appeals court temporarily suspended an injunction, issued last month, that had halted federal funding for research on embryonic stem cells. The injunction had thrown the field into disarray, as the National Institutes of Health stopped all research on embryonic stem cells within the institute and suspended reviews of grants involving the cells. The Justice Department had asked that the injunction be stayed while the court considers the government's appeal of the ruling.

As I noted in my previous blog,

Researchers say the decision--even if it is later reversed--will have a damaging effect on the field, stunting promising medical research that was just building momentum. All grants under review at the nation's largest funding agency, the National Institutes of Health (NIH), that involve human embryonic stem cells have been put on hold while the NIH and other government agencies try to get the injunction reversed.

..."I've been working with embryonic stem cells for nine years and seen the waves come and go," says Sean Palecek, a stem-cell researcher at the University of Wisconsin, Madison. "Right now is the most restrictive that it's ever been." Palecek and others worry that this latest blow will discourage young scientists from entering the field. "It's really disheartening," he says. "It's hard enough to come up with cutting-edge ideas and to get funding. The possibility of having funding pulled at any time sends the wrong message."

The order states:

... the district court's August 23, 2010 order be stayed pending further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion.

The National Institutes of Health, the nation's largest biomedical funding agency, halted all ongoing research at the agency that involves human embryonic stem cells. The order comes in response to a federal injunction issued last week blocking use of federal funding for the research. (See my story, New Court Ruling Could Cripple Stem-Cell Research, for more details.)

According to Science Insider:

According to a furious NIH staffer who read the e-mail to ScienceInsider over the telephone, this morning's message from NIH intramural research chief Michael Gottesman states: "HHS [the Department of Health and Human Services] has determined that the recent preliminary injunction ... is applicable to the use of human embryonic stem cells in intramural research projects. In light of this determination, effective today, intramural scientists who use human ES cell lines should initiate procedures to terminate these projects. Procedures that will conserve and protect the research resources should be followed."

The agency has eight research projects that use hESCs, most if not all of which use lines approved under the Bush Administration, say NIH officials. It also has a unit that characterizes lines added to the NIH registry of approved hESC lines.

The shutdown is the first immediate halt to research since Lamberth issued the preliminary injunction. NIH Director Francis Collins has said that extramural researchers can continue their projects for now and that the injunction will affect only future grant payments. ("Intramural" means researchers in labs on the NIH campus; "extramural" refers to researchers at universities and other outside institutions who receive NIH grants.)But some biomedical research lobbyists worry that that interpretation of the ruling may have been too optimistic, and a shutdown of all ongoing NIH-funded hESC research could be imminent.

The Department of Justice is expected to ask the courts to stay the injunction as soon as today, an NIH source tells ScienceInsider.

The Food and Drug Administration has cleared Geron, a stem cell company based in Menlo Park, CA, to move forward with clinical tests of its experimental cell therapy for spinal cord injury, which is derived from embryonic stem cells. The company, which has been working on cell based therapies for the last decade, first won permission to begin clinical testing in January of 2009. But the trials were put on hold last August due to new safety concerns from animal tests. The clinical trial marks the first human tests of a therapy derived from embryonic stem cells.

The cell therapy, called GRNOPC1, is made by transforming embryonic stem cells into oligodendrocytes--a type of brain cell that wraps itself around neurons, forming a fatty insulation layer that allows electrical messages to be conducted throughout the nervous system. In many spinal-cord injuries, these cells are damaged, but the underlying nerve cells remain intact. The new cells are then injected into the site of the injury, coating exposed nerves and restoring communication to the nervous system.

As I noted in a previous post:

Scientists published the results of a successful study testing the therapy in animals in 2005, showing that paralyzed rats injected with the cells were able to walk again. Since then, Geron has been conducting numerous studies intended to show the safety of the cell-based therapy, as well as developing production methods that would make the cells as easy to use as more traditional treatments. Geron researchers have also developed a way to reliably freeze and thaw brain cells, so that they can be manufactured in a central location, and then shipped to the hospitals where they will be used.

According to a statement from Geron:

The clinical hold was placed following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site in the spinal cord of animals injected with GRNOPC1 than had previously been noted in numerous foregoing studies. In response to those results, Geron developed new markers and assays as additional release specifications for GRNOPC1. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA for the clinical hold to be lifted.

Advanced Cell Technology, a stem cell company based in Marlborough, MA, hopes to follow Geron. The company announced this week that it has submitted new materials to the FDA in regards to its application, first filed in November, to begin clinical trials of a cell therapy for patients with Stargardt's Macular Dystrophy, an inherited eye disease.