WASHINGTON (AFP) US authorities have authorized the very first human trials applying embryonic stem cells to test a pioneering therapy to aid paralyzed patients regain movement, the FDA mentioned Friday.
"The FDA has granted its clearance for a new drug application of Geron Corp for a phase 1 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 referred to as 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 mentioned.
The objective is to inject cells into the spines of paralyzed volunteers, between seven to 14 days immediately 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 beginning of what is potentially a new chapter in medical therapeutics -- 1 that reaches beyond pills to a new level of healing: the restoration of organ and tissue function accomplished by the injection of healthy replacement cells," mentioned Geron's president Thomas Okarma.
Embryonic stem cells are very versatile, primitive cells capable of developing into any tissue of the physique.
"The neurosurgical community is rather excited by this new strategy to treating devastating spinal cord injury," mentioned Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.
"If protected and powerful, the therapy would deliver a viable treatment choice for thousands of patients who suffer serious spinal cord injuries each and every year."
The enterprise stressed the therapy had been developed applying cells derived from the existing H1 human embryonic stem cell line, created ahead of August 9, 2001 when former president George W. Bush banned applying new lines of such cells for analysis.
Bush banned all federally-funded analysis on new lines of embryonic stem cells, but the FDA's announcement may very well mark the start off of a shift in the nation's stem cell analysis policy under President Barack Obama.
Obama mentioned ahead of his inauguration on Tuesday that he hopes Congress will introduce legislation to overturn the ban, telling CNN he was nonetheless exploring the notion of issuing an executive order to revoke Bush's ban.
Stem cells are a supply of huge interest in medical analysis. 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 process, prompting some religious groups to brand the process as unethical.
In blocking federal funding for stem cell analysis, Bush sided with religious conservatives who argue that analysis on embryos destroys human life, albeit at its earliest stage of improvement.
Analysis into spinal injuries was given high-profile support by "Superman" actor Christopher Reeve, who was paralyzed in a riding accident at the height of his career and died in October 2004.
Reeve lengthy championed stem cell analysis immediately after his 1995 accident, and even accused Bush of obstructing medical analysis which might aid him.
Geron mentioned it had submitted a 21,000-page dossier to the FDA to back up its request for the study, citing evidence that the treatment was powerful among lab mice and rats.
The so-referred to as Phase One trial will be conducted among a tiny group of patients with "functionally full" spinal cord injury, mainly to see regardless of whether the treatment is protected.
Under a cautious 3-phase procedure, two additional sets of trials then take place among progressively larger groups to see if the therapy is each powerful as properly as protected.
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