First US Human Embryonic Stem Cell Study for Spinal Injury Approved

January 23, 2009

A biotech company has gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells. Dr. Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, Calif. says it plans to start this summer the world’s first study of a treatment based on human embryonic stem cells — a long-awaited project aimed at spinal cord injury. The patients in the study will be paraplegics, who can use their arms but can’t walk. They will receive a single injection within two weeks of their injury.

This first 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, Okarma confirmed. 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. Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn’t be needed, Okarma said. The study will follow each patient for at least a year.

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.

“There’s a lot riding on it,” said Dr. John Kessler, of the Northwestern University Stem Cell Institute. “If this trial goes ahead and is not successful, rightly or wrongly, it will be used as a judgment as to whether embryonic stem cell is effective.”

The Geron Corp.’s experimentation has been privately funded Dr. Okarma, after a ban was put on federally funded research into stem cells by the Bush administration. This has put plenty of obstacles in the way, and while there is hope that President-Elect Barack Obama will reverse that ban, in the meantime, they are still on their own. Geron Corp. has spent at least $100 million on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.


Comments

One Response to “First US Human Embryonic Stem Cell Study for Spinal Injury Approved”

  1. Rose on January 23rd, 2009 11:50 am

    I think it’s great that this is progressing to human trials, but I’m disappointed that no federal funding was involved. If the trials are successful the possible cure to spinal cord injuries is sitting in the hands of Private Industry. This company has spent 45 million dollars to get to this point and they are going to want to make their money back and more. Basically rich people with injuries will be able to buy the cells and poor people are going to be left out again! Thanks federal government for looking out for the people!–Not!

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