Personal Injury Law

First Human Stem Cell Trials Planned

By Jane Akre

Three days after the inauguration of President Barack Obama, the green light has been given for the first study of human embryonic stem cell therapy testing. 

The Food and Drug Administration (FDA) gave the okay for the research on Friday, with allows Geron Corp., a biotech company in Menlo Park California, to test its product that will focus on reversing paralysis from spinal cord injuries.  

The eight to 10 patients in the trial will be those recently injured with severe spinal cord injuries and no hope of recovery below the injury. Nerve cells will be injected directly into the injury site. Geron says the patients will be monitored for a year to see if they regain any function. So far research has restored some movement to paralyzed rats. 

The trials should begin this summer.

Embryonic stem cell lines are able to turn into any one of the body's 200 cell types, but there are only about 60 stem cells lines that remain viable created from embryos that were destroyed prior to August 2001, according to BBC News.  The cell lines can be grown indefinitely.

Company chief, Dr. Tom Okarma said: "What stem cells promise for a heart attack or spinal cord injury or diabetes is that you go to the hospital, you receive these cells and you go home with a repaired organ, that has been repaired by new heart cells or new nerve cells or new islet cells that have been made from embryonic stem cells."

Okarma said that Geron did not use federal funding for its research but spent about $45 million of its own money.  The company says it has seven types of cell lines in its pipeline.   Okarma  tells CNN that Bush restrictions had "devastated the field." 

President Bush approved funding research for those cell lines already in existence before August 2001. Fewer than two dozen have proven useful for research.   Abortion opponents oppose lifting the funding restrictions.

Hopes are the stem cell lines might be able to address Alzheimer's, Parkinson's, and diabetes. Ending the current restrictions on federally funded stem-cell research was at the top of an Obama agenda on medical issues. Chief of Staff Rahm Emanuel said the approach would be "pragmatic and progressive".

Though he could issue an executive order to reverse the prohibition, Mr. Obama has indicated he may let Congress take the lead on that issue.

Upon the news, Geron shares surged 25 percent. #  

Full post as published by InjuryBoard on January 23, 2009 (boomark / email).