Human stem cells trial gets green light12th October 2010
The United States drug regulatory body has given the go-ahead for the use of human embryonic stem cells in the treatment of people with spinal injuries.
Doctors have now begun the first official trial of the controversial cells in patients, and the first patient was treated at the Shepherd Center in Atlanta, Georgia.
The US Food and Drug Administration awarded the licence to California-based biotech company Geron to use the treatment.
Stem cells are sought after because of their ability to become many different types of cell, including nerve cells.
Trials in humans are now under way at an Atlanta hospital to establish whether or not the treatment is safe.
Silicon Valley-based Geron developed the treatment for spinal cord injury at a cost of US$170 million.
In the trial, the stem cells will be coaxed into becoming nerve cells, which with then be injected into the spinal cord.
Paralysed rats who were given the treatment regained some ability to move, but the effects on humans are as yet unknown.
Experts welcomed the news, but urged caution. Ian Wilmut, head of the Medical Research Council Centre for Regenerative Medicine in Edinburgh, said the objective of trials at this stage was to confirm that no harm would be done to patients.
The United States alone sees around 12,000 people sustain spinal cord injuries annually, mostly from car accidents, gunshot wounds, falls and sporting activities.
The trial will offer the stem cell treatment to patients who have sustained such an injury within the last 14 days.
Geron president Thomas Okarma said the trial was the result of extensive research and development, and plenty of innovation.
Further trials will be necessary over a number of years to determine whether the treatment is both safe and effective.
Ben Sykes, executive director of the UK's National Stem Cell Network, said that everyone in the field of regenerative medicine would be awaiting the results of the trial with great anticipation.
UK-based stem cell researchers said they planned to begin their own trials next year with a treatment for macular degeneration, which is a leading cause of blindness in older people.
Many people have already been treated with stem cells originating from adult tissue, such as bone marrow, but the US trial is the first that has been allowed to use stem cells from human embryos.
Their use is controversial because they can only be obtained by destroying a human embryo.
Share this page
There are no comments for this article, be the first to comment!
Post your comment
Only registered users can comment. Fill in your e-mail address for quick registration.
Title: Human stem cells trial gets green light
Author: Luisetta Mudie
Article Id: 16355
Date Added: 12th Oct 2010