Embryonic Stem Cell - First Clinical Trial

First Clinical Trial

On January 23, 2009, Phase I clinical trials for transplantation of oligodendrocytes (a cell type of the brain and spinal cord) derived from human ES cells into spinal cord-injured individuals received approval from the U.S. Food and Drug Administration (FDA), marking it the world's first human ES cell human trial. The study leading to this scientific advancement was conducted by Hans Keirstead and colleagues at the University of California, Irvine and supported by Geron Corporation of Menlo Park, CA. A previous experiment had shown an improvement in locomotor recovery in spinal cord-injured rats after a 7-day delayed transplantation of human ES cells that had been pushed into an oligodendrocytic lineage. In the proposed phase I clinical study, about eight to ten paraplegics who have had their injuries no longer than two weeks before the trial begins, will be selected, since the cells must be injected before scar tissue is able to form. However, the researchers are emphasizing that the injections are not expected to fully cure the patients and restore all mobility. Based on the results of the rodent trials, researchers say restoration of myelin sheathes, and an increase in mobility is probable. This first trial is mainly testing the safety of these procedures and if everything goes well, it could lead to future studies that involve people with more severe disabilities. The trial had been put on hold in August 2009 due to concerns made by the FDA regarding a small number of microscopic cysts found in several treated rat models but the hold has been lifted as of July 30, 2010.

In October 2010 researchers enrolled and administered ESTs to the first patient at Shepherd Center in Atlanta. The makers of the stem cell therapy, Geron Corporation, estimate that it will take several months for the stem cells to replicate and for the GRNOPC1 therapy to be evaluated for success or failure. In November 2011 Geron announced it was dropping out of stem cell research for financial reasons, but would continue to monitor existing patients, and was attempting to find a partner that could continue their research.