Irvine – On Jan. 23, the first treatment derived from embryonic stem cells was approved for human clinical trials. The treatment, discovered by a group of researchers at UC Irvine, may be able to heal acute spinal cord injuries.
In 2005, a team of researchers helmed by UCI neuroscientist Hans Keirstead successfully developed a treatment to heal acute spinal cord injuries in rats. This treatment is now being assessed for its potential to cure paralyzed humans.
Geron Corp., a biotechnology company with headquarters in Menlo Park, Calif., has been contracted by the Food and Drug Administration to conduct the clinical trials on humans.
The therapy, which abbreviates to the mouthful GRNOPC1, uses stem cells programmed to seek damaged areas in a patient’s spine and repair injuries to the nervous system to cure paralysis.
In animal trials, the stem cells injected into paralyzed rats migrated to the damaged areas of the rats’ spinal cords, wrapped themselves around injured neurons and rebuilt materials crucial to the nervous system. Eventually, the treatment allowed the rats in the trial to recover from their spinal injury and regain the ability to walk.
According to Thomas Okarma, Geron’s president and CEO, the FDA’s approval of this embryonic stem cell treatment has opened new doors in the field of medicine.
“The FDA’s clearance of our GRNOPC1 is one of Geron’s most significant accomplishments to date,” Okarma said in a press release. “This marks the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing. … The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of [human embryonic stem cell]-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord.”
According to Geron’s Web site, Geron Corp. is choosing up to seven medical centers to participate in the study. People who have suffered various degrees of spinal injuries may volunteer for the treatment seven to 14 days after the injury occurred. If the trials prove useful, Geron plans to test the treatment on patients with more mature spinal injuries.
Keirstead said the treatment was undergone extensive examination and will hopefully improve the lives of patients with spinal cord injuries.
“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.”