FDA Approves First Human Embryonic Stem Cell Therapy

by VR Sreeraman on  January 25, 2009 at 10:38 AM Genetics & Stem Cells News   - G J E 4
US authorities have approved the first human trials using embryonic stem cells to test a pioneering therapy to help paralyzed patients regain movement, the FDA said Friday.
 FDA Approves First Human Embryonic Stem Cell Therapy
FDA Approves First Human Embryonic Stem Cell Therapy

"The FDA has granted its clearance for a new drug application of Geron Corp for a phase one 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 called GRNOPC1.

"The clearance enables Geron to move forward with the world's first 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, between seven to 14 days 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, 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," said Geron's president Thomas Okarma.

Embryonic stem cells are highly versatile, primitive cells capable of developing into any tissue of the body.

"The neurosurgical community is very 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 provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

The company stressed the therapy had been developed using cells derived from the existing 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 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 under President Barack Obama.

Obama said before his inauguration on Tuesday that he hopes Congress will introduce legislation to overturn the ban, telling CNN he was still exploring the idea of issuing an executive order to revoke Bush's ban.

Stem cells are a source of huge 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 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 process, prompting some religious groups to brand the process 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.

Research 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 long championed stem cell research after his 1995 accident, and even accused Bush of obstructing medical research which might 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 treatment was effective among lab mice and rats.

The so-called Phase One trial will be conducted among a small group of patients with "functionally complete" spinal cord injury, mainly to see whether the treatment is safe.

Under a cautious three-phase procedure, two further sets of trials then take place among progressively larger groups to see if the therapy is both effective as well as safe.

Source: AFP

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