UCI behind world's first embryonic stem cell study in humans

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UCI behind world's first embryonic stem cell study in humans

FDA approves Geron Corp. clinical trial for spinal cord injury

treatment

http://www.eurekalert.org/pub_releases/2009-01/uoc--ubw012309.php

A therapy developed at UC Irvine that made paralyzed rats walk again

will become the world's first embryonic stem cell treatment tested in

humans.

The U.S. Federal Drug Administration has approved the therapy, based

on work by a research team led by Hans Keirstead, co-director of the

UCI Sue and Bill Gross Stem Cell Research Center, for a clinical

trial in patients with acute spinal cord injury.

Geron Corp. of Menlo Park, Calif., will conduct the clinical trial.

" This trial was approved only after rigorous safety testing and

consultation of countless experts in the field, " Keirstead said. " Any

benefit to the patient, even an incremental one, would be a

resounding victory. "

The therapy contains human embryonic stem cells destined to become

spinal cord cells called oligodendrocytes. These are the building

blocks of myelin, the biological insulation for nerve fibers that is

critical for maintaining electrical conduction in the central nervous

system. When myelin is stripped away, through injury or disease,

paralysis can occur.

In laboratory tests, Keirstead and his colleague, Dr. Nistor,

developed a technique for prompting human embryonic stem cells to

develop into oligodendrocyte cells.

Injected into rats with spinal cord injuries, the precursor cells

turned into oligodendrocytes and migrated to the injured area of the

spinal cord. As the cells wrapped around damaged neurons, new myelin

tissue formed, allowing electrical conduction to resume and the rats

to walk again.

This success, published in the Journal of Neuroscience in 2005, was

the subject of dozens of media stories, including a " 60 Minutes "

segment.

According to Geron, patients eligible for the phase-one trial must

have a certain type of spinal cord damage and be willing to receive

injections 7-14 days after injury. Geron has selected up to seven

U.S. medical centers that may participate in the study.

UCI has a robust stem cell research program that has received more

than $52 million from the California Institute for Regenerative

Medicine. UCI's scientists are pioneers in regeneration, large-scale

production of specialized cells with very high purity, and methods

for treating damaged tissues.

UCI recently broke ground for a four-story building dedicated to stem

cell research. When finished in 2010, the building will house the

stem cell center, dozens of laboratory-based and clinical

researchers, a stem cell techniques course, a master's program in

biotechnology with an emphasis on stem cell research, and programs

and activities for patients and public education.