FDA approves first brain stem cell transplant

updated 6:55 p.m. ET Oct. 20, 2005

SAN FRANCISCO - Federal regulators on Thursday approved what would be the first transplant of fetal stem cells into human brains, a procedure that if successful could open the door to treating a host of neural disorders.

The transplant recipients will be children who suffer from a rare, fatal genetic disorder.

The Food and Drug Administration said that doctors at Stanford University Medical Center can begin the testing on six children afflicted with Batten disease, a degenerative malady that renders its young victims blind, speechless and paralyzed before it kills them.

An internal Stanford review board must still approve the test, a process that could take weeks.

The stem cells to be transplanted in the brain aren’t human embryonic stem cells, which are derived from days-old embryos. Instead, the cells are immature neural cells that are destined to turn into the mature cells that makeup a fully formed brain.

Parkinson’s disease patients and stroke victims have received transplants of fully formed brain cells before, but the malleable brain cells involved here have never before been implanted.

Batten disease is caused by a defective gene that fails to create an enzyme needed in the brain to help dispose of brain cellular waste. The waste piles up and kills healthy cells until the patient dies. Most victims die before they reach their teens.

The idea is to inject the sick kids with healthy, immature neural stem cells that will “engraft” in a brain that will direct them to turn into cells able to produce the missing enzyme.

Such an experiment showed promise in Batten-afflicted mice, but such an ethically charged test has never been tried before in humans.

“I’m sure there is no threat to anyone’s identity,” said Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics. “But we are starting down that road.”

What’s more, some of the brain cells to be implanted will be derived from aborted fetuses, which Caplan also said raised ethical concerns for some.

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