Parkinson's stem cell trial approaches

A therapy for Parkinson's disease from Carlsbad's International Stem Cell Corp. is expected to get approval for testing in Australia as soon as February, the company said this week.

The publicly traded company has grown neural stem cells, which can mature into cells making the neurotransmitter dopamine, deficient in Parkinson's. The company plans to implant these stem cells into the the brains of Parkinson's patients, restoring dopamine production and normal movement in the patients.

If approved, the trial will be the first test of therapy with the company's cells, derived from unfertilized, or parthenogenetic human egg cells. The cells, which in theory can produce nearly all types of cells found in the body, are grown into neural stem cells. These cells will be implanted and mature in place.

Parthenogenetic cells have much the same potential as embryonic stem cells without the ethical objections some have, says International Stem Cell, which has 38 employees. In addition, these parthenogenetic stem cells are less likely to provoke an immune reaction, the company says.

International Stem Cell Corp. chose Australia for its first trial because its regulatory agency is more "interactive" than the U.S. Food and Drug Administration, said Simon Craw, executive vice president for business development. The FDA is inclined to give yes-or-no answers for proposed cell-based treatments, Craw said. In addition, patient recruitment takes place more slowly, which delays trial completion. The FDA does this for safety reasons.

Simon Craw / International Stem Cell Corp.

The Australian agency helps guide companies through the application process, Craw said in an interview Wednesday at Biotech Showcase, an annual life science conference in San Francisco. Craw also gave a company presentation on Tuesday at the conference.

"We're in the process of submitting the (application)," to Australian regulators, Craw said. "We're going back and forth with them right now. We expect to hear back from them by the end of February."

The trial will primarily assess safety, but also look for evidence of efficacy, Craw said.

The trial will take place at Royal Melbourne Hospital, Craw said. The hospital is headquartered in Parkville, in the state of Victoria. The principal investigator, Dr. Andrew Evans, will recruit patients from his own practice.

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Parkinson's stem cell trial approaches