FDA allows first-ever human embryonic stem cell clinical trials
23 January 2009 - For the first time in history, the United States Food and Drug Administration is allowing clinical trials in stem cell research.
The Obama Administration is expected to be more receptive to trials and lift funding restrictions.
A California-based firm, Geron, is expected to carry out its first trials on patients with severe spinal cord injuries.
"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 restoration of organ and tissue function achieved by the injection of healthy replacement cells," Geron chief executive Thomas B Okarma said in a statement.
The therapy uses embyronic stem cells - cells which can form any type of human tissue, from organs to blood. It would be expected to treat a wide range of conditions which severely affect quality of life, such as chronic injuries, Parkinson's disease, cancer, and the need for an organ transplant.
Some of these conditions, such as spinal injuries, have yet to see another effective treatment.
"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University, said.
"If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."
Opponents have cited several moral issues, such as the right-to-life of human embryos, in the argument against stem cell research.
See also Geron's information and webcast on this new development and their own embryonic stem cell research.
The National Institute of Health provides background information on how stem cell and stem cell research work.