U.S. approves first embryonic stem-cell trial

California, January 23: Geron Corp.’s first embryonic stem-cell trial got a green signal from the FDA, revealed the company’s officials.

With this clearance, the company can now move ahead with the world’s first study of a human embryonic stem cell-based therapy in man.

This study is likely to unveil a new era for medicine, and paralyzed patients can now look forward to receiving a therapy based on human embryonic stem cells.

Thomas Okarma, the chief executive of Geron, which developed the treatment, stated: “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.”

The FDA’s ruling will allow physicians to inject specialized spinal cells grown from embryonic tissue into patients who have been recently paralyzed from the chest down.

Considering the few treatment options available, the trial, if successful, will open new prospects for thousands of people.

The injections will be made in the spine just at the site of damage and the work will be performed in four to sever medical centers around the country, stated Dr. Okarma.

The treatment will be instrumental in promoting immediate regeneration of damaged nerves, restoration of sensation and movement of people. The idea is “not to make somebody... get up and dance the next day,” said Okarma, but rather to provide some level of ability that can be improved by physical therapy.

However, the treatment can prove beneficial only to those who seek treatment within 15 days after having suffered a spinal injury and not those who are already paralyzed.

Therapies based on human embryonic stem cells could be used to treat paralysis, Parkinson’s disease and diabetes.

Talking about the costs involved for such a therapy, Okarma assured of it being cost-effective for most patients. “This is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides,” he stated.

Based in Menlo Park, California, Geron Inc. is considered to be the first biotechnology company and the world’s leading embryonic stem cell developer. It has spent nearly $100 million on human embryonic stem cell research.

Although the U.S. Food and Drug Administration has denied any political considerations, whatsoever, in its decision, approval does coincide with the inauguration of the newly elected President Barack Obama, who intends to do away with at least some, if not all, of the financing restrictions placed by the Bush administration.

Mr. Obama, in his inaugural address, pledged to “restore science to its rightful place”, and to end White House obstruction of stem-cell research.

Similarly, Geron’s chief executive, Thomas Okarma, stated on Thursday that the Bush administration’s objections to embryonic stem cell research did not play any role in the FDA’s delay in approval of the trial. “We really have no evidence,” Okarma said, “that there was any political overhang.”

However, some still suspect this sudden change in the attitude of US government and the FDA’s approval of the trial as more than ‘just a coincidence’ with the inauguration of the new President.

“I think this approval is directly tied to the change in administration,” felt Robert Klein, the chairman of California's $3 billion stem cell research program.

Calling the approval of the first human trial as “an extraordinary benchmark”, Klein said he felt that Bush administration might have influenced the agency to delay the trial.