FDA Approves Human Trials with Embryonic Stem Cells

By Susan Brinkmann, OCDS
Staff Writer

A U.S. biotech company has been given permission by the Food and Drug Administration (FDA)  to perform the first human trials with cells derived from embryonic stem cells.

Geron Corporation of Menlo Park, California received permission this week to inject eight to 10 paraplegic patients with embryonic stem cells within two weeks of their injury. The study, which is scheduled to begin this summer, 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.

The idea is “not to make somebody … get up and dance the next day,” said Dr. Thomas Okarma, president and CEO of Geron, “but rather to provide some level of ability that can be improved by physical therapy.”

In the Geron study, stem cell injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country. The study will then follow each patient for at least a year.

Even though some overseas doctors claim to be using human embryonic stem cells in their clinics, experts say they know of no previous human studies that use these 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 Inc. Baetge told Fox News his company hopes to begin a similar human study for treating diabetes in a few years.

One spinal cord 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 clinical research has been frustrated with problems such as unexplained tumor growth and rejection during animal testing. The research has also caused heated controversy because embryos must be destroyed to obtain the cells. In addition, pluripotent stem cells, which are derived from adult cells and pose no threat to human life, have been found to provide the same advantages of embryonic stem cells, making the more controversial research seem unnecessary.

Scientists around the world will be focused primarily on safety issues. Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, California said, “The one hope that everybody has is that nothing bad happens.”

The timing of the approval has many wondering if President Barack Obama’s promise to relax the Bush administration’s restrictions on federal financing for such research had anything to do with it. Okarma said no, and added that the stem cells involved in the project were eligible for federal funding under Bush.

Okarma said he can’t estimate how much such a therapy would cost if it proves effective, but that “this is not going to be a $500,000 price tag. It will be remarkably affordable … in the context of the value it provides.”

Geron Corp. has spent at least $100 million on human embryonic stem cell research. The company is considered the world’s leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.

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