Aggregated News
The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday.
At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.
This assumes that the Food and Drug Administration gives Geron a green light to proceed with the human test. Okarma said the FDA will set a "high bar" in regulating this new type of science.
Ren Benjamin, analyst for Rodman & Renshaw, believes the regulatory process could be time-consuming, because it's unprecedented.
"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise," he said.
Geron (GERN), based in Menlo Park, Calif., is also in early-stage studies with stem cell-based drugs for diabetes and heart failure. All of...
At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.
This assumes that the Food and Drug Administration gives Geron a green light to proceed with the human test. Okarma said the FDA will set a "high bar" in regulating this new type of science.
Ren Benjamin, analyst for Rodman & Renshaw, believes the regulatory process could be time-consuming, because it's unprecedented.
"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise," he said.
Geron (GERN), based in Menlo Park, Calif., is also in early-stage studies with stem cell-based drugs for diabetes and heart failure. All of...