Geron Anticipates Embryonic Stem Cell Trials in 2008

Just in time for the Presidential election, Geron CEO Tom Okarma hopes to begin clinical trials for acute spinal cord injury in early 2008. If true, the timing couldn't be worse for embryonic stem cell proponents.

“The world’s spotlight will be on this trial,” Tom Okarma, Geron’s chief executive, told the Bio conference in Boston. To get it right, the company has carried out several years of preparatory work in collaboration with its academic partners at the University of California, Irvine.

Geron’s product will have been tested in 2,000 animals before it goes into its first patient, Mr Okarma said. It consists of immature oligodendrocytes – specialised nerve cells – grown from human embryonic stem cells. The animal tests show that these can repair spinal cord injuries in rats, by growing new nerves with the myelin sheaths they need to work properly. Paralysed rats can walk again.

Assuming the first patients treated with embryonic stem cells made magnificent recoveries, proponents would tout it as a huge success, but even Okarma has doubts about that happening. As he told me in an interview last year:

Our fondest hope is that, even in cases that have no hope of spontaneous recovery, we actually provide value. Now that may not happen. We may not see any responses in the first cohorts of patients who have complete lesions, which is why we're progressing thereafter to patients with incomplete lesions which resemble more closely the animal model, which is where the excitement began. Those animals are models of incomplete lesions. But for reasons of ethics and safety and appropriateness, we can't start with patients who resembled the animal model. You have to start way upstream.

If no recovery is seen in those first patients -- who won't match the animal model
-- opponents of embryonic stem cell research will argue that embryonic stem cells are a failure and don't deserve federal funding.

"The ideological right is not asleep,” said [Bob] Klein, who chairs California Institute of Regenerative Medicine’s governing board. “They will be prepared to spin [any problems] to promote their opposition to embryonic stem cell research, and we’ll need a sophisticated fast-response messaging team to put across our message.”

Of course, if the first patients do see improvements, opponents of embryonic stem cell research will argue that President Bush's 2001
decision to restrict the number of lines eligible for federal funding does not interfere with progress -- as the results of the trial show.
(The stem cell lines Geron will use for the trial are two of the ones currently approved for federal funding.)

All that said, there's no guarantee the clinical trials will begin in 2008.

In 2005, Okarma indicated that he hoped to begin trials in mid-2006. In 2006, Okarma said the first quarter of 2007. Earlier this year at the Stem Cell Meeting in San Francisco -- and also on a conference call after reporting
Geron's quarterly earnings -- Okarma said he hoped trials would begin in the fourth quarter of 2007.

He's now saying 2008, but who knows what tomorrow will bring?

Embryonic Stem Cells Trial on Track to Start [Financial Times]