US firm gets approval for stem cell research

US watchdogs have approved pioneering stem cell research into spinal injuries.

A biotech company was given federal permission this week to inject eight to 10 patients with cells derived from embryonic cells.

The patients will be paraplegics, who can use their arms but cannot walk. They will receive a single injection within two weeks of their injury.

The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, said Dr Thomas Okarma of Geron, California.

Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the US – a field where debate spilled out of the laboratory long ago and into national politics.

While doctors in other countries claim to use human embryonic stem cells in their clinics, experts said they knew of no previous human studies that use such cells.

“It’s a milestone and it’s a breakthrough for the field” because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell. His company hopes to begin a similar human study for treating diabetes in a few years.

Spinal injury researcher Dr Wise Young of Rutgers University said “a lot of hope of the spinal cord injury community is riding on this trial.”

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.

President Barack Obama has promised to relax the Bush administration’s restrictions on federal financing for such research.

But Mr Obama’s arrival in the White House had nothing to do with the US Food and Drug Administration’s granting permission for the new study.

The company said the project involved stem cells that were eligible for federal funding under Mr Bush.

In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centres around the country, Dr Okarma said.

Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.

Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Dr Okarma said. The idea is “not to make somebody ... get up and dance the next day,” he said, but rather to provide some level of ability that can be improved by physical therapy.

Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications should not be needed. The study will follow each patient for at least a year.

Geron has spent at least $100m (€77m) on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.

However, the company is considered the world’s leading embryonic stem cell developer thanks to its claims on several key stem cell technologies.