WASHINGTON (AFP) US authorities have approved the 1st human trials making use of embryonic stem cells to test a pioneering therapy to help paralyzed patients regain movement, the FDA said Friday.
"The FDA has granted its clearance for a new drug application of Geron Corp for a phase a single clinical trial of an embryionic stem cell based therapy in patients with acute spinal cord injury," FDA spokeswoman Susan Cruzan told AFP.
Earlier, the California-based biotech firm Geron Corp. announced the US Food and Drug Administration (FDA) had been cleared to carry out human trials of a novel therapy known as GRNOPC1.
"The clearance enables Geron to move forward with the world's 1st study of a human embryonic stem cell based therapy in man," Geron said.
The goal is to inject cells into the spines of paralyzed volunteers, in between seven to 14 days just after they are injured, hoping this will prompt the damaged nerve cells to regrow, enabling them to eventually recover feeling and movement.
"This marks the beginning of what is potentially a new chapter in medical therapeutics -- a single that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of wholesome replacement cells," said Geron's president Thomas Okarma.
Embryonic stem cells are extremely versatile, primitive cells capable of creating into any tissue of the body.
"The neurosurgical community is pretty excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.
"If safe and effective, the therapy would give a viable therapy solution for thousands of patients who suffer severe spinal cord injuries every year."
The enterprise stressed the therapy had been developed making use of cells derived from the existing H1 human embryonic stem cell line, created prior to August 9, 2001 when former president George W. Bush banned making use of new lines of such cells for research.
Bush banned all federally-funded research on new lines of embryonic stem cells, but the FDA's announcement may mark the start of a shift in the nation's stem cell research policy beneath President Barack Obama.
Obama said prior to his inauguration on Tuesday that he hopes Congress will introduce legislation to overturn the ban, telling CNN he was nevertheless exploring the notion of issuing an executive order to revoke Bush's ban.
Stem cells are a source of significant interest in medical research. Supporters point to the vision of material that can be grown in a lab dish and then transplanted, regenerating tissues destroyed by illness, accident or war.
Embryonic stem cells have triggered the most enthusiasm, but in the United States they have been shadowed by controversy.
They are taken from early-stage embryos, which are destroyed in the approach, prompting some religious groups to brand the approach as unethical.
In blocking federal funding for stem cell research, Bush sided with religious conservatives who argue that research on embryos destroys human life, albeit at its earliest stage of development.
Investigation into spinal injuries was given high-profile assistance by "Superman" actor Christopher Reeve, who was paralyzed in a riding accident at the height of his profession and died in October 2004.
Reeve lengthy championed stem cell research just after his 1995 accident, and even accused Bush of obstructing medical research which could help him.
Geron said it had submitted a 21,000-page dossier to the FDA to back up its request for the study, citing evidence that the therapy was effective among lab mice and rats.
The so-known as Phase One trial will be conducted among a small group of patients with "functionally complete" spinal cord injury, mainly to see no matter if the therapy is safe.
Under a cautious three-phase process, two additional sets of trials then take place among progressively bigger groups to see if the therapy is both effective as properly as safe.
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