New York Times, July 30, 2010, 11:21 AM EDT: "F.D.A. Clears Way for Embryonic Stem Cell Trial Using Patients":
The world’s first authorized test in people of a treatment derived from human embryonic stem cells has been cleared to begin by the Food and Drug Administration. The trial will test cells developed by Geron Corporation and the University of California, Irvine in patients with new spinal cord injuries.
United Press International, July 30, 2010 at 9:28 PM: "FDA: Stem cell trial can proceed":
The Food and Drug Administration has given approval to proceed with the world's first human clinical trial of a human embryonic stem cell-based therapy. Geron Corp., headquartered in Menlo Park, Calif., says it will proceed with its trial of GRNOPC1, a stem-cell therapy intended to treat patients with acute spinal cord injury, a company release said Friday.
Bloomberg News, July 30, 2010: "FDA: Stem cell trial can proceed":
Geron Corp. said it was cleared by U.S. regulators to proceed with the first human test of an embryonic stem-cell therapy, aimed at patients with spinal-cord injuries. The shares rose 17 percent. The Food and Drug Administration lifted a clinical hold on the study imposed last August when the company revealed that mice used in experimental work had developed cysts, Geron said in a statement. The company may start recruiting patients with new spinal cord injuries in about one month, said Thomas Okarma, Geron’s president and chief executive officer, in a telephone interview today.
The FDA’s action will allow the company to proceed with a long-awaited milestone -- the first authorized clinical trial in the world using stem cells derived from human embryos. The approval comes after almost a year of Geron’s testing and genetic analysis to resolve FDA questions, and paves the way for future trials.
San Jose Mercury News, July 31, 2010 : "FDA approves Geron's groundbreaking study of embryonic cells":
A Menlo Park biotech firm said Friday that federal regulators will let it proceed with the world's first human test of a treatment made from embryonic stem cells, a much-anticipated but controversial study of patients with spinal cord injuries that had been placed on hold for nearly a year because of safety concerns.
If the treatment from Geron works, it 'would be revolutionary,' said Dr. Richard Fessler, a neurological surgeon at Northwestern University, who will lead the study of a stem-cell treatment designed to be injected into patients with spinal injuries to restore their motor function. "The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."
Associated Press, July 30, 2010: "Geron says FDA lifts hold on stem cell trial":
NEW YORK — Regulators on Friday gave the all-clear to a clinical trial that will test embryonic stem cells as a treatment for spinal cord injury, potentially the first time embryonic stem cells are tested on humans. The developer of the treatment, Geron Corp., said the Food and Drug Administration removed a clinical hold on its GRNOPC1 therapy. The FDA accepted Geron's study application in January 2009, which gave the company clearance to test GRNOPC1 on humans. But the FDA placed any potential study on hold in August because some mice treated with GRNOPC1 developed microscopic spinal cysts.
Geron hopes to start testing GRNOPC1 on humans by year-end. The company plans to enroll eight to 10 patients in the study at sites nationwide. The trial will take about two years, with each patient being studied for one year. Early-stage clinical trials are primarily designed to test a therapy's safety, although Geron said it will also measure the effectiveness of GRNOPC1.
A successful test would lead to larger and longer studies that would focus on the effectiveness of GRNOPC1. The company plans to continue monitoring patients for a total of 15 years for safety.
KGO-TV, San Francisco, CA, July 30, 2010: "Menlo Park-based Geron resumes stem cell trials":
MENLO PARK, CA (KGO) -- The Food and Drug Administration has given Menlo Park-based Geron the green light to resume trials of a stem cell treatment that could help repair injured spinal cords. The new drug by Geron will be injected into patients within seven days of a spinal cord injury.
