FDA Approves Test to Inject Embryonic Stem Cells into Humans

Fluorescence microscopy image overlaid with phase image to display incorporation of microspheres (red) in embryoid bodies (gray clusters). CREDIT: Todd McDevitt, Georgia Tech.

The federal government has approved the first study by a company that will use human embryonic stem cells injected into a human.

The Geron corporation announce the approval today. The therapy used in the study is designed to treat spinal cord injuries by injecting stem cells — which are able to transform into the many different types of cells we need in our bodies — directly into the patients' spinal cords.

The U.S. Food and Drug Administration (FDA) granted clearance of the company's application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.

"This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," said Geron's president and CEO. Dr. Thomas B. Okarma.

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Dr. Richard Fessler, a professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.

"Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field," Fessler said in a statement released by Geron. "If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

The company's stock surged on the announcement.

The approval might be seen as part of a policy shift from the Bush Administration, which had place restrictions on federal funding for new lines of embryonic stem cells for research, to President Obama, who has promised to restore science as a driving force in policy decisions and is expected by many to lift the restrictions.

But according to Reuters, Okarma said there was no political significance to the announcement coming now.

"Before FDA allowed the study to proceed, Geron worked with FDA to address important scientific questions," Reuters quotes an FDA spokeswoman as saying.

• Stem Cell News and Information

Robert Roy Britt is the Editorial Director of Imaginova. In this column, The Water Cooler, he takes a daily look at what people are talking about in the world of science and beyond.