FDA's green light for stem cell trial thrills scientists

The FDA's decision to allow Geron to launch the first clinical trial of an embryonic stem cell therapy has sent a jolt of optimism--along with an undercurrent of fresh anxiety--coursing through the fledgling stem cell field. Stem cell researchers were clearly excited that the FDA--now operating under a new administration--would give Geron an approval to get started after first delaying a trial launch. But some also expressed some anxiety that Geron's work will proceed under a spotlight of public attention likely to magnify any success or failure.

"When you're the first, the whole world's eyes are on you," Advanced Cell Technology's Robert Lanza tells the Washington Post. "We all have our fingers crossed that everything goes smoothly and nothing happens."  

ACT is preparing to ask the FDA for approval to begin a clinical trial of an ESC-based therapy for blindness. And Geron will push ahead with its own trial after recruiting eight to 10 subjects with spinal cord damage.

"Today's news about Geron's embryonic stem cell clinical trials is a milestone in the new era of hope and adds to the momentum for policy change when it comes to embryonic stem cell research," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research.

- read the report from the Washington Post

Suggested Articles

Antibiotics dubbed odilorhabdins (ODLs), inspired by soil-dwelling nematodes, hold promise for treating antibiotic-resistant infections.

A PureTech startup is developing an immune-responsive hydrogel that releases a corticosteroid into arthritic joints based on their level of inflammation.

A trial of a retinal implant built from embryonic stem cells produced encouraging results in patients with dry age-related macular degeneration.