In October, 12 years after human embryonic stem cells were first isolated, a therapy derived from such cells was tested in humans for the first time (First Human Tests of Embryonic Stem Cell Therapy Underway). The therapy, developed by Geron, is designed to treat spinal-cord injury with an injection of differentiated neural cells into the injury site.
Because the clinical trial is the first of its kind, Geron has had to forge a new path forward with the U.S. Food and Drug Administration as the agency figures out how to regulate embryonic-stem-cell therapies and assess the safety of these cells. The company initially won approval to begin clinical tests last year, but a few months later these were put on hold because animal tests raised new safety concerns.(FDA lets stem cell trials resume)
To read the full, original article click on this link: The Year in Biomedicine - Technology Review
Author: Emily Singer
