A therapy developed at UC Irvine that allowed paralyzed rats to walk again has won federal approval for clinical trials, making it the world's first embryonic stem cell treatment that will be tested in humans, it was announced. The treatment, whose success was first detailed in the Journal of Neuroscience in 2005, has been under scrutiny and has now received the go-ahead for trials with patients with acute spinal cord injury. The therapy is based on work by a research team led by Hans Keirstead, cor-director of the UCI Sue and Bill Gross Stem Cell Research Center.
"This trial was approved only after rigorous safety testing and consultation of countless experts in the field," Keirstead said.
"Any benefit to the patient, even an incremental one, would be a resounding victory."
The therapy contains human embryonic stem cells destined to become spinal cord cells called oligodendrocytes that are building blocks of myelin, which acts as insulation for nerve fibers and is critical for maintaining electrical conduction, Keirstead said. When myelin is stripped away, through injury or disease, paralysis can occur, he said. Keirstead and his colleague, Dr. Gabriel Nistor, developed a technique for prompting human embryonic stem cells to develop into oligodendrocyte cells.
Injected into rats, the cells migrate to the spinal cord, and as they wrapped around damaged neurons, new myelin tissue formed that allowed electrical conduction to resume and the rats to walk again, Keirstead said. The trials will be conducted by Geron Corp. of Menlo Park, which has selected up to seven U.S. medical centers that may participate in the study. According to Geron, patients eligible for the phase-one trial must have a certain type of spinal cord damage and be willing to receive injections seven to 14 days after injury, Keirstead said.
The stem cell research program at UCI has received more than $52 million from the California Institute for Regenerative Medicine.