US approves first human embryonic stem cell therapy
http://www.nirob.com
WASHINGTON (AFP) – U.S. authorities approved the first human trials using embryonic stem cells to test cutting-edge therapy to help paralyzed patients regain movement, the FDA said Friday.
“The FDA granted its approval for a new drug of Geron Corp. for a phase one clinical trial of a stem cell embryionic based therapy in patients with acute spinal cord injury,” FDA spokeswoman Susan Cruzan told AFP.
Previously, the California biotech company Geron Corp. announced the U.S. Food and Drug Administration (FDA) has been cleared to carry out human trials of a novel called GRNOPC1 therapy.
“The game enables Geron to go ahead with the world’s first study of a human embryonic stem cell therapy for humans,” said Geron.
The aim is to inject the cells in bones paralyzed volunteers, between seven and 14 days after they are injured, hoping this will prompt the regrowth of damaged nerve cells, enabling them to recover at the end feeling and movement.
“This marks the beginning of what is potentially a new chapter in medical treatment – which reaches beyond pills to a new level of healing: the restoration of organs and tissue function achieved by the injection of healthy replacement cells, said President Geron’s Thomas Okarma.
Embryonic stem cells are extremely versatile primitive cells capable of developing into any tissue of the body.
“The neurosurgical community is very excited by this new approach to treat devastating spinal cord injury,” said Richard Fessler, a professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.
“If safe and effective therapy could provide a viable treatment option for thousands of patients suffering from severe spinal cord injuries each year.”
The company said the therapy was developed using cells derived from the existing line H1 human embryonic stem cells, created before Aug. 9, 2001 when former President George W. Bush may not use the new lines of such cells for research.
Bush has banned all federally-funded research on new embryonic stem cell lines, but the FDA’s announcement could mark the beginning of a change in policy of the nation’s stem cell research under President Barack Obama.
Obama said before his inauguration on Tuesday he hopes Congress introduce legislation to overturn the ban, saying CNN was still exploring the idea of issuing an executive order to lift the ban on Bush.
Stem cells are a source of great interest in medical research. Supporters point to the vision of material that can be grown in the laboratory and then transplanted, regenerating tissues destroyed by disease, accident or war.
Embryonic stem cells have sparked the most enthusiasm, but in the U.S. have been overshadowed by the controversy.
It is not at an early stage embryos that are destroyed in the process, leading some religious groups to label the process as unethical.
In block federal funding for stem cell research, Bush sided with the religious conservatives who argue that research on embryos destroys human life, even in its early stage of development.
Research into spinal injuries has been given high-profile support from “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 accident in 1995, and Bush also accused of impeding medical research that could help him.
Geron said it had submitted a dossier of 21,000 pages to the FDA to support its request for the study, citing evidence that the treatment has been effective in laboratory mice and rats.
The so-called phase A study will be conducted among a small group of patients with “functionally complete” spinal cord injury, mainly to see if the treatment is safe.
Under a three-step procedure cautious, two new series of tests then take place among larger and larger groups to see if the therapy is effective and safe.
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