First green light for stem cell clinical trials

By Phil Taylor

- Last updated on GMT

Related tags: Stem cells, Stem cell

The US Food and Drug Administration (FDA) gave the go-ahead to the first clinical trials of a stem cell-based therapy late last week, in a major boost to the development of the technology.

Geron Corp has been cleared start trials of GRNOPC1 in patients with acute spinal cord injury – the first time anywhere in the world that an embryonic stem cell therapy has been cleared for testing in humans.

The treatment uses stem cells to regrow the damaged spinal cord cells and - it is hoped - restore function in people with spinal injuries.

This early round of testing will focus on safety, although the study is also designed to measure some measures of efficacy such as improved neuromuscular control or the return of sensation below the site of the injury.

Dr. Thomas Okarma, Geron's president and CEO, said: "This marks the beginning of what is potentially a new chapter in medical therapeutics.”

It “reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells​,” he continued.

Geron’s shares rocketed on the day of the announcement and continued to gain yesterday, closing at $8.15. The company was formed in 1992 but has yet to bring a product to market.

Through the George W Bush administration US researchers operated under a moratorium on research using stem cells derived from embryos, at least for publicly-funded organisations. Embryos are destroyed in the process of harvesting the stem cells sparking strong opposition from the pro-life lobby to this type of research.

Because Geron does not rely on federal funding for its research programmes it was not subject to the moratorium, although it was unlikely to have been unaffected by political pressure on the FDA as it brought the GRNOPC1 project through product development.

The timing of the FDA’s approval, mere days after the new Obama administration came into being, has led to renewed speculation that the new President may consider loosening the noose around federal stem cell research. Obama promised to look into relaxing the restrictions whilst on the campaign trail.

The news was welcomed by the International Society for Stem Cell Research, which issued guidelines on taking stem cell therapies into clinical trials last month. However, the greeting also came with a rider.

The go-ahead to test products of embryonic stem cells in patients is an important first step, but only the first step on a very long journey​, “ said George Daley, immediate past-president of the ISSCR and associate director of the Stem Cell Program at Children’s Hospital Boston.

We have so much more to learn about stem cells, and this first trial is only the beginning.​”

Related topics: Clinical Development, Phase I-II

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