Graphic: stem-cell treatment for spinal injuries

Paralysed patients will this summer become the first people in the world to receive a therapy based on human embryonic stem cells, in a study that promises to open a new era for medicine, The Times has learnt.

The first human trial of the technology, which has huge potential to cure disease yet is considered unethical by “pro-life” groups because it involves destroying embryos, will today be cleared to proceed by US regulators.

The decision marks a sea-change in US government attitudes to stem cells, as President Obama prepares to lift restrictions imposed by President Bush that hampered progress in the field. Mr Obama pledged in his inaugural address to “restore science to its rightful place”, and to end White House obstruction of stem-cell research.

Today’s ruling by the Food and Drug Administration (FDA) will allow doctors to inject specialised spinal cells grown from embryonic tissue into patients who have just become paralysed from the chest down. It is hoped that the cell transplants will prompt regrowth of damaged nerves, restoring sensation and movement to people who would otherwise have been paralysed for life. The treatment will be used on people a week or two after they suffer their spinal injury; it cannot help those already paralysed.

A successful trial would transform the prospects of thousands of people for whom few treatment options currently exist. If results are positive, the therapy could be approved for wider use within three to five years.

Thomas Okarma, chief executive of the Geron Corporation, which developed the treatment, said: “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 by the injection of healthy replacement cells. The ultimate goal is to achieve restoration of spinal cord function.”

Embryonic stem cells are master cells found in human embryos, which give rise to more than 200 specialised types of tissue in the adult body. They have vast medical potential, because the can be grown into any kind of tissue to replace cells damaged by injury or disease. Stem-cell therapies could eventually be used to treat conditions such as diabetes and Parkinson’s disease, as well as paralysis.

Use of embryonic stem cells, however, is contentious because they must be harvested from human embryos, which are destroyed in the process. This has raised moral objections from those who believe embryos have the same rights as living people and see the technology as unethical.

The issue is especially acute in the US, where it has become entwined with the fraught politics of abortion. Opposition to stem-cell research is led by the evangelical Christian lobby, whose influence prompted President Bush to ban most federal funding in 2001 — the Geron work was financed entirely by the private sector. Stem cell research is legal in Britain, where it is encouraged and funded by the Government.

Though the FDA is independent of the White House, the timing of its backing for the Geron trial is symbolic of the Obama Administration’s fresh approach. The new President is expected to start unwinding the funding ban as early as next week.

Polls suggest that most Americans support stem-cell research, and Congress has voted for more federal funding, but in 2006, President Bush used his first veto to block a Bill that would have delivered this. Dr Okarma said: “The people who will take part in our trials are currently walking around, like you and me. But the delay caused by the White House has meant that there are people out there who might have benefited, but who now cannot.”

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