Geron Starts First Human Embryonic Stem-Cell Study
Geron Corp. (GERN) used a therapy made from stem cells taken from human embryos to treat a patient paralyzed by a spinal-cord injury in the first U.S.-authorized test of the technology.
The patient was treated Oct. 8 at Shepherd Center, a rehabilitation hospital in Atlanta, the company said today in a statement. The study is designed to test the safety of Geron’s therapy in patients with spinal cord injuries. The U.S. Food and Drug Administration gave permission in July for Geron to start the study after a halt of almost a year over safety concerns.
Scientists have pursued studies of stem cells for more than a decade as potential treatments for Parkinson’s disease, multiple sclerosis, spinal cord injuries and diabetes. Geron is one of just three U.S. companies working with embryonic cells, which can grow into any kind of tissue and hold the potential to repair or regenerate damaged organs.
“We’re all pretty excited that we finally crossed the great divide and that a patient passed all the inclusion criteria and consented to have the cells,” said Thomas Okarma, the company’s president and chief executive officer, in a telephone interview today. “The first one is always the toughest.”
Geron rose 34 cents, or 6.4 percent, to $5.67 at 4 p.m. in Nasdaq Stock Market composite trading. The shares have gained 2.2 percent this year.
The goal of the treatment is to restore some sensation and enable patients to participate in physical therapy that could restore a degree of mobility, Okarma said. With the first patients, the goal is even more modest -- to be certain the therapy doesn’t make things worse or cause unwanted side effects, he said.
The company will be limited to treating one patient a month until doctors and FDA regulators are convinced the therapy is doing no harm, Okarma said. After that, doctors will be allowed to treat patients with greater doses of cells. As many as 10 patients will be treated in the study, he said.
Patients must be treated between seven and 14 days after their injury, Okarma said. To take part in the trial, they must have badly damaged, though not severed, their spinal cords in the region that starts below the neck, the company said.
The patients have to make the decision to take part in the trial at a time when they are reeling from the effects of a devastating injury, Okarma said.
“You can’t imagine what they go through to hear that they’re paralyzed from the waist down,” he said.
Geron has developed a process to make embryonic stem cells into glial cells, a type of nerve cell that helps support the work of neurons. In spinal-cord injuries, nerve cells can no longer transmit information down the spine, resulting in paralysis.
Advanced Cell Technology Inc. (ACTC) of Marlborough, Massachusetts, is awaiting FDA approval to start a clinical trial in patients with Stargardt’s macular dystrophy, an eye disorder that causes severe vision loss.
Viacyte, formerly known as Novocell Inc., a closely held San Diego company, is working on methods of turning embryonic stem cells into insulin-secreting cells for the treatment of diabetes.
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