WASHINGTON, Jan 23: The US Food and Drug Administration has cleared the way for the first trial to see if human embryonic stem cells can treat people safely, a company involved in the controversial research said on Friday.
Geron Corp, a California biotechnology company, said it planned a clinical trial to try to use the stem cells to re-grow nerve tissue in patients with crushed, but not severed, spinal cords.
The issue of human embryonic stem cell research has been a political touchstone, with anti-abortion forces backed by former president George W. Bush arguing the technique involved the destruction of human embryos. Advocates say it can transform medicine.
“For us, it marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing,” Geron chief executive Dr Thomas Okarma said in a telephone briefing.
Geron will recruit eight to 10 recently injured patients and inject them with small numbers of human embryonic stem cells manipulated to become the oligodendrocyte cells that insulate nerves, and that produce compounds to stimulate the growth of nerve cells.
An FDA spokeswoman said: “Before FDA allowed the study to proceed, Geron worked with FDA to address important scientific questions.”
Mr Okarma said the treatment should eventually become cheap and easy to mass produce because the cells could be grown in vats. He believes the cells may be useful for other diseases such as multiple sclerosis, in which nerve cells are stripped of their insulating sheaths, and perhaps strokes.
The Phase I trial will be designed to show that patients do not develop tumours, or damage to their nervous systems. But Mr Okarma believes it will also indicate whether the stem cells may repair the damaged spinal cords.—Reuters