Below is a summary of media coverage from various sources of the recent announcement by Geron Corporation that it received federal regulatory approval from the Food and Drug Administration to begin human clinical trials using human embryonic stem cells to attempt to treat spinal cord injuries:
Wall Street Journal, January 23, 2009:"First Embryonic Stem-Cell Trial Gets Approval From the FDA":
"In a watershed moment for one of the most contentious areas of science and American politics, the U.S. Food and Drug Administration cleared the way for the first-ever human trial of a medical treatment derived from embryonic stem cells. Geron Corp., a Menlo Park, Calif., biotechnology company, is expected to announce Friday that it received a green light from the agency to mount a study of its stem-cell treatment for spinal cord injuries in up to 10 patients. The announcement caps more than a decade of advances in the company's labs and comes on the cusp of a widely expected shift in U.S. policy toward support of embryonic stem-cell research after years of official opposition."
Associated Press, January 23, 2009: "US approves 1st stem cell study for spinal injury":
"A U.S. biotech company says it plans to start this summer the world's first study of a treatment based on human embryonic stem cells — a long-awaited project aimed at spinal cord injury. The company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells, said Dr. Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, Calif."
"The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury. The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said."
"Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States — a field where debate spilled out of the laboratory long ago and into national politics."
New York Times, January 23, 2009: "F.D.A. Approves a Stem Cell Trial":
"In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells. Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Obama, who has pledged to remove some of the financing restrictions placed on the field by President George W. Bush. The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data."
New Scientist, 14:09 23 January 2009: "Historic trial to treat spinal injury with stem cells":
"Patients with spinal cord injuries will be first humans to receive repair cells derived from embryonic stem cells. The first ever clinical trial using stem cells derived from embryonic stem cells (ESCs) received the go-ahead today from the US Food and Drug Administration. Geron Corporation, a company based in Menlo Park, California, hopes to mend the spines of patients paralysed from the chest down by injecting injury sites with stem cells that restore connections and repair damage."
The Times, January 23, 2009: "Stem-cell therapy gives hope to accident victims":
"Paralysed patients will this summer become the first people in the world to receive a therapy based on human embryonic stem cells, in a study that promises to open a new era for medicine, The Times has learnt. The first human trial of the technology, which has huge potential to cure disease yet is considered unethical by “pro-life” groups because it involves destroying embryos, will today be cleared to proceed by US regulators."
Reuters, January 23, 2009 2:32pm EST: "FDA allows first test of human stem cell therapy":
" The U.S. Food and Drug Administration has cleared the way for the first trial to see if human embryonic stem cells can treat people safely, a company involved in the controversial research on Friday. Geron Corp, a California biotechnology company, said it plans a clinical trial to try to use the stem cells to regrow nerve tissue in patients with crushed, but not severed, spinal cords."
United Press International, January 23, 2009: "FDA OKs embryonic stem-cell human trial":
"The U.S. Food and Drug Administration approved the first-ever human trial of a medical treatment derived from embryonic stem cells. "...Geron, a California bio-technical company, was approved to begin a study of its stem-cell treatment for spinal cord injuries in up to 10 patients, ..."
Technology Review, January 23, 2009: "FDA Clears First Embryonic-Stem-Cell Therapy Trials":
"Geron, a California-based cell-therapy company that has been working with embryonic stem cells for the last decade, finally received clearance from the U.S. Food and Drug Administration to begin clinical trials of its cell-based therapy for spinal-cord injury. The trial is limited to eight patients with newly acquired spinal-cord injuries who will receive injections of the cell therapy, called GRNOPC1, within two weeks of their accident. GRNOPC1 is made by transforming embryonic stem cells into oligodendrocytes--a type of brain cell that wraps itself around neurons, forming a fatty insulation layer that allows electrical messages to be conducted throughout the nervous system. In many spinal-cord injuries, these cells are damaged, but the underlying nerve cells remain intact. These cells are then injected into the site of the injury, coating exposed nerves and restoring communication to the nervous system."
Los Angeles Times, January 24, 2009: "Stem cell therapy to be tested on spinal cord injuries: The FDA approves the first clinical trial using human embryonic stem cells, which now appear safe enough to use on humans.":
"Ushering in a new era in medicine, the U.S. Food and Drug Administration said Friday that it had cleared the way for the world's first clinical trial of a therapy derived from human embryonic stem cells. By early summer, a handful of patients with severe spinal cord injuries will be eligible for injections of specialized nerve cells designed to enable electrical signals to travel between the brain and the rest of the body. When the cells were administered to rats that had lost control of their hind legs, they regained the ability to walk and run, albeit with a limp."
"As a Phase I trial, the study will primarily assess the safety of the treatment, which has been under development by Menlo Park, Calif.-based Geron Corp. for nearly a decade. But scientists, doctors and patients said they were most eager to see whether low doses of the cells would produce any therapeutic benefit. If so, it would help validate years of hope and investment in the nascent field of regenerative medicine. Besides patients with spinal cord injuries, stem cell therapies could ultimately benefit people with such intractable diseases as Alzheimer's, Parkinson's and multiple sclerosis."
Television News Coverage:
CNBC News: "FDA Greenlights Testing of Geron's Stem Cell Treatment."
ABC News:"FDA Approves Stem Cell Study for Spinal Injuries."
CBS News, January 24, 2009: "New Stem Cell Breakthrough."
KABC-TV, Los Angeles: "Human stem cell research approved."
KGO-TV, San Francisco: "U.S. approves 1st stem cell spine study."
CBS2 LOS Angeles: "First Ever Human Embryonic Stem Cell Study OK'd"
KPIX-TV, San Francisco: "Geron's Stem-Cell Trial Spotlights Prospects"
CNN.com, Fri., January 23, 2009, updated 3:57 a.m. EST: "FDA approves human embryonic stem cell study":
"Federal regulators have cleared the way for the first human trials of human embryonic stem-cell research, authorizing researchers to test whether the cells are safe to use in spinal injury patients, the company behind the trials announced Friday. Embryonic stem cells are blank cells found in embryos, which have the ability to turn into any cell in the body. The tests could begin by summer, said Dr. Thomas Okarma, president and CEO of the Geron Corporation. The Food and Drug Administration has approved the trials, which will use human stem cells authorized for research by then-President George W. Bush in 2001. The patients will be those with the most severe spinal cord injuries, called complete spinal cord injuries."
News Hour, January 29, 2009: "Scientists Hope to Renew Stem Cell Advances."
Radio News Coverage:
NPR: Talk Of The Nation, January 23, 2009 : "FDA Approves Embryonic Stem Cell Trial In Humans":
"Biotech company Geron Corp. will conduct a human clinical trial on patients with spinal cord injuries, using a federally approved line of embryonic stem cells. The approval is the first of its kind in the world. Stem cell experts discuss the significance of the decision."
