Medical Research

First FDA Approved Human Stem Cell Trial Begins in Atlanta

October 11, 2010 turned out to be a watershed moment in the treatment of spinal cord injuries, as Atlanta’s Shepherd Center became the first facility in the United States to host a human trial of embryonic stem cell research. In collaboration with Silicon Valley-based Geron Corporation, Shepherd Center surgeons have successfully injected the trial’s first patient with about 2 million “human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells,” also known as GRNOPC1, in the hopes that the cells will form a restorative coating around the damaged spinal cord.

“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”

The Geron study has been lauded by excited scientists and patient advocates alike, who have longed for stem cell clinical trials to move out of the laboratory and on to actual patients. That excitement has been intensified in light of similar testing on hundreds of rats, resulting in partially paralyzed animals regaining the ability to walk.

It should be noted, however, that although doctors will be conducting tests to see whether the treatment restores sensation or enables the patient to regain movement, Geron has clearly stated that this Phase I trial will not be aiming to cure patients. The company eventually hopes to test the cells for many different medical problems, but this first trial will focus only on testing the “safety and tolerability” of stem cells on patients with new spinal cord injuries and will involve 10 patients who were partially paralyzed by a spinal cord injury in the one to two weeks prior to their enrollment in the study.

The biggest leap forward here comes from the fact that the Geron trial is the first to have been fully vetted by a government entity. In a press release published yesterday, Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO stated that, “Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies.”

According to a Reuters article, Geron is not subject to limitations on federal funding for human embryonic stem cell research, because it is a privately funded company. Although it does not have government funding, what Geron does have is the very first U.S. Food and Drug Administration license to use human embryonic stem cells to treat people. The only one other company with a human stem cell treatment close to FDA approval is Massachusetts-based Advanced Cell Technology.

David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center added, “This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.”

Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury and brain injury. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. Shepherd is one of seven sites participating in the study and is located mere minutes from the nationwide home office for AMS Vans Vans, Inc..

For more information regarding the Geron study, the press release states:

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website and on the NIH clinical trials registry, ClinicalTrials.gov. Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.