Source: Stanford University Medical Center
Date: January 24, 2011
Summary:
The first clinical trial of cells derived from human embryonic stem cells began in October 2010 in a paralyzed patient at the Shepherd Center in Atlanta. Today, Stanford University School of Medicine and Santa Clara Valley Medical Center became the third site to participate in the trial, which will enroll up to 10 patients with spinal cord injuries at up to seven institutions nationwide.
The FDA-approved, phase-1 trial is meant to test only the safety of the cells, which can develop into neural support cells called oligodendrocytes found in the brain and central nervous system. If the investigational treatment is shown to be safe for use in humans, larger clinical trials will be designed to test whether the cells are better able than conventional treatments to improve a patient’s condition. Because the cells must be administered within two weeks of the initial spinal cord injury, the trial is open only to those with very recent trauma and only upon physician referral.
The oligodendrocyte precursors (GRNOPC1) are produced from stem cells that were originally derived from a single embryo created through in vitro fertilization. Such excess embryos are usually discarded when no longer needed, but can be donated for research by the parents under informed consent. The U.S. Food and Drug Administration approved the human clinical trial in 2009 after extensive tests in laboratory animals. The first patient was treated in October at the Shepherd Center in Atlanta; Northwestern University in Chicago is also open for patient enrollment. Other participating sites have not yet been identified. For more information about the study, including the major eligibility criteria, please refer to this ClinicalTrials.gov link.
