WASHINGTON (AFP) US authorities have authorized the very first human trials using embryonic stem cells to test a pioneering therapy to help paralyzed patients regain movement, the FDA stated 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 named GRNOPC1.
"The clearance enables Geron to move forward with the world's very first study of a human embryonic stem cell based therapy in man," Geron stated.
The aim is to inject cells into the spines of paralyzed volunteers, among seven to 14 days right after they are injured, hoping this will prompt the damaged nerve cells to regrow, enabling them to ultimately recover feeling and movement.
"This marks the starting 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 healthy replacement cells," stated Geron's president Thomas Okarma.
Embryonic stem cells are very versatile, primitive cells capable of creating into any tissue of the body.
"The neurosurgical community is really excited by this new method to treating devastating spinal cord injury," stated Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.
"If safe and successful, the therapy would present a viable therapy selection for thousands of patients who suffer serious spinal cord injuries each year."
The provider stressed the therapy had been created using cells derived from the current H1 human embryonic stem cell line, created before August 9, 2001 when former president George W. Bush banned using new lines of such cells for investigation.
Bush banned all federally-funded investigation on new lines of embryonic stem cells, but the FDA's announcement will probably mark the start of a shift in the nation's stem cell investigation policy beneath President Barack Obama.
Obama stated before 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 supply of large interest in medical investigation. Supporters point to the vision of material that can be grown in a lab dish and then transplanted, regenerating tissues destroyed by disease, 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 course of action, prompting some religious groups to brand the course of action as unethical.
In blocking federal funding for stem cell investigation, Bush sided with religious conservatives who argue that investigation on embryos destroys human life, albeit at its earliest stage of development.
Investigation into spinal injuries was given high-profile help by "Superman" actor Christopher Reeve, who was paralyzed in a riding accident at the height of his career and died in October 2004.
Reeve extended championed stem cell investigation right after his 1995 accident, and even accused Bush of obstructing medical investigation which could possibly help him.
Geron stated 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 successful amongst lab mice and rats.
The so-named Phase A single trial will be conducted amongst a small group of patients with "functionally total" spinal cord injury, mainly to see whether the therapy is safe.
Beneath a cautious 3-phase procedure, two further sets of trials then take spot amongst progressively bigger groups to see if the therapy is each successful as nicely as safe.
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