FDA Green Lights Stem Cell Trial

February 10th, 2009 | Sources: Economist


It’s a debate whether the Big O’s trillion-dollar economic Hail Mary will work and how well, but no one can argue that the man instantly put America back in the stem cell business.

greenbaypackerstemcellsJust 3 days after the inauguration, the FDA green-lighted Geron to carry out the nation’s first clinical trial of stem cell technology.

We can’t even get a pizza delivered in 3 days! 

Geron was free to seek approval and the FDA free to grant it before the election since the Bush Administration’s ban did not impact privately funded research.  But Bush appointees at the FDA weren’t going to give the light of day to any stem cell proposals.

And when Bush banned federal funding for stem cell research, the firestorm frightened off private investors too. Hopefully when the Big O waves the magic wand these investors come back.

In the Geron trial, scientists will recruit 8-10 people with recent severe spinal-cord injuries to assess whether it’s safe to administer oligodendrocytes into the injured tissue one to 2 weeks after the injury. 

Of course everything will be scoured for signs the underlying condition has changed. A successful outcome would beget larger safety trials and on we go. 

Geron’s scientists can transform embryonic stem cells into oligodendrocytes which are not nerves but rather nearby cells that produce myelin, which in turn is a gummy substance that forms a sheath around neurons. Myelin is essential to the neurons’ ability to transmit electrical signals down their length.

In rats, oligodendrocytes administered this way help repair native myelin sheaths and yes, restore to some extent the neuron’s ability to transmit signals.

But since neurons themselves are not being replaced, the treatment proposed by Geron will have limited applications. Still, it’s a critical step towards eventually reconnecting the brain and extremities of people with spinal cord injuries.


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