Geron, a California company developing therapies derived from embryonic stem cells, announced on Monday that the first patient has been treated in its landmark trial for spinal cord injury. The therapy, which involves injecting differentiated neural cells into the injury site, is the first such treatment to be tested in humans. Other experimental stem cell therapies involve adult stem cells or cells derived from fetuses.

Geron first garnered approval for the tests from the U.S. Food and Drug Administration in January of 2009. But that approval was put on hold several months later due to new safety concerns from animal tests. Because cells can behave unpredictably, regulators want to make sure the transplanted cells don't develop into teratomas, a type of tumor associated with the injection of embryonic stem cells.The FDA gave permission to resume testing in July, after another round of animal safety tests. This early stage trial is designed to assess the safety of the therapy in humans and will involve a small number of patients with new injuries; the treatment must be delivered within 14 days of the injury.

The cell therapy 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. These cells are often damaged in spinal cord injury, while the underlying nerve cells remain intact. When the new cells are injected into the site of the injury in animals, they coat exposed nerves and restore communication to the nervous system.

In 2005, Hans Keirstead and collaborators at the University of California, Irvine, showed 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.

The first patient in the study was enrolled at the Shepherd Center, a private, not-for-profit rehabilitation hospital in Atlanta, Georgia. It is one of seven potential sites in the United States that may enroll patients in the clinical trial. According to Geron,

Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron's website and on the NIH clinical trials registry, ClinicalTrials.gov.

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.