The first person ever received a human embryonic stem cell injection Monday, Oct. 11, announces Geron Corporation
After years of animal trials, the first human was injected with human embryonic stem cells Monday, initiating the first clinical trial by Geron Corporation, CNN reports.
“This is the first human embryonic stem cell trial in the world,” Geron President/CEO Dr. Thomas Okarma told CNN.
Geron’s clinical trial aims to assess patient reaction to the stem cell therapy during treatment of spinal cord injury
The primary objective of Geron’s study, according to a company press release, is to “assess the safety and tolerability” of a group of human embryonic stem cell-derived injection called GRNOPC1 in patients with new complete thoracic spinal cord injuries, rendering them paraplegic from the chest down.
CNN reports those with such an injury can still move their arms and breathe independently, they cannot control their bowel or bladder nor can they move their legs. Also, according to CNN, there is no hope for recovery through physical therapy.
In order to be eligible for participation in the study, patients must receive the GRNOPC1 injection within one to two weeks of injury, according to Geron’s statement.
The first patient to receive the GRNOPC1 injection was treated at Shepherd Center, a spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta and one of seven facilities that may enroll patients in the clinical trial, Geron announced.
What is GRNOPC1?
GRNOPC1 is a set of embryonic stem cells that have been “coaxed into becoming early myelinated glial cells, a type of cell that insulates nerve cells,” CNN reports. The injected cells multiply to replace the tissue lost in the injury, which Okarma explained to CNN, is like “repairing a large electrical cable.”
In the case of a spinal cord injury, these new stem-cell derived glial cells creep in between all the fibers and rewrap the nerve with myelin, which is like patching the cable. The goal is to permanently repair the damage that caused the paralysis from the spinal cord injury.
“We’re not treating symptoms here – we’re permanently regenerating tissue,” says Okarma.
“A milestone” in human embryonic stem cell-based therapy
“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” Okarma said in the press release. “When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials.”
According to CNN, the FDA first approved Geron’s trial in January 2009, then required further research before giving the company final approval in July of this year. While controversial, CNN reports the GRNOPC1 therapy is derived from stem cells that were harvested from leftover embryos from fertility clinics and “zero federal funds” were used in its development.
Geron’s ultimate goal, according to CNN, “is to shift the outcome for someone who has just suffered a serious spinal cord injury, and go from a place where there’s no hope for improvement to a situation where they can respond to physical therapy.”
“If we could do that, this would be a spectacular result,” Okarma told CNN.
See the full story from CNN, including video and ensuing debate, here.