Stem cell research company Geron Corp (GERN.O) said it reached an agreement with U.S. health regulators which may enable it to restart the early stage trials of its cell therapy to treat complete thoracic spinal cord injury.
The treatment was pioneered at UC Irvine by Dr. Hans Keirstead, as part of a joint UC Discovery grant with Geron Corporation. The trial represents the first embryonic stem cell treatment tested in humans and has initially focused on acute thoracic spinal cord injuries.

Recent results from a cervical rodent study published by Dr. Keirstead and doctoral candidate and lead author Jason Sharp in Stem Cells discovered that stem cells not only rebuild myelin, but prevent tissue death and trigger nerve fiber re-growth. The cells also suppress the immune response, causing an increase in anti-inflammatory molecules.
UCI scientist Hans Keirstead hopes the data will prompt the FDA to authorize clinical testing of the treatment in people with both types of spinal cord damage. About 52 percent of spinal cord injuries are cervical and 48 percent thoracic.

In August, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Geron's investigational new drug application after some of the animals developed cysts in the injury site.

While the early stage trial still remains on clinical hold, a recent agreement with the FDA outlines what is necessary to move the spinal cord injury program forward, Merriman Curhan Ford analyst Joe Pantginis said in a note to clients.
"Geron, which expects to re-initiate the early stage trial in the third quarter of 2010, said the FDA has advised that positive data from an ongoing preclinical study using its product can be used to support both release of the clinical hold and the drug's expansion to cervical patients.

Adopted from source - Anand Basu, Reporter, Bangalore Thompson Reuters 2009.
UCI behind world's first embryonic stem cell study in humans

FDA approves Geron Corp. clinical trial for spinal cord injury treatment 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. Gabriel 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.

-- Jennifer Fitzenberger, University Communications