The first human trials start this summer, and the first to 10 patients will be those with recent spinal cord injuries. But this long-sought federal approval is being celebrated by many.
It only took an instant for Roman Reed to break his neck during a college football game. He's spent 15 years fighting from his wheelchair believing he could someday walk away from it.
"This is a momentous day for all people like me who suffer and could be cured from stem cell research. Thank you President Barack Obama," said Reed.
Although the FDA says its decisions aren't political, less than a week into the new administration, it's reversed its previous position and gave Menlo Park-based Geron Corporation permission to begin human testing of embryonic stem cell therapy.
Roman and his family were the inspiration for early state funding of the research.
"On march one 2002 I got to hold in my hand a rat that had been paralyzed but walked again," said Roman's father Don Reed.
Geron says it believes what worked on rats will not only work on humans but that embryonic stem cell therapy can be used to rebuild body parts in ways that go beyond pills and surgery.
Applications could range from heart disease to diabetes.
"We're trying to reach a new level of healing that doesn't just treat symptoms of the disease, but one actually restores Oregon and tissue function that's been lost to disease or injury," said Geron Corporation CEO Dr. Thomas Okarma.
Geron's research labs use discarded embryos from in-vitro fertilization procedures that would be destroyed.
USF professor Raymond Dennehy is appalled and critics call the research another form of abortion.
"What you're doing is using a human being for a mere means to an end, and this certainly strikes at the very heart of Democratic society, where people are suppose to have inviolable rights to life, especially the innocent," said Professor Dennehy.
The ethical debate will continue but now the world's first human trials will move forward, right along with Roman's dreams.
"I've already promised I'm going to walk with my wife on the beach. That was my promise to her and I will make that happen," said Reed.
It's important to know that the first research group will receive low doses of cell therapy, and Geron hopes for modest incremental increases and improvements in mobility.
