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Chinese Scientists Set to Pioneer First CRISPR Trial in Humans

posted by martyb on Friday July 22 2016, @04:55PM   
from the CRISPR-sounds-like-a-new-snack-food dept.

fork(2) writes:

Nature is reporting that a Chinese team will attempt to treat lung cancer with CRISPR-modified cells in August. From the article:

A team led by Lu You, an oncologist at Sichuan University's West China Hospital in Chengdu, plans to start testing such cells in people with lung cancer next month. The clinical trial received ethical approval from the hospital's review board on 6 July.

"It's an exciting step forward," says Carl June, a clinical researcher in immunotherapy at the University of Pennsylvania in Philadelphia.

There have been a number of human clinical trials using an alternative gene-editing technique, including one led by June, that have helped patients combat HIV. June is also a scientific adviser on a planned US trial that would also use CRISPR-Cas9-modified cells for the treatment of cancer.

Last month, an advisory panel of the US National Institutes of Health (NIH) approved that project. But the trial also requires a green light from the US Food and Drug Administration (FDA) and a university review board. The US researchers have said they could start their clinical trial by the end of this year.

[Continues...]

[...] Lu says that the review process, which took half a year, required that the team invest a lot of time and human resources, including close communication with the hospital's internal review board (IRB). "There was a lot of back and forth," he says. The NIH's approval of the other CRISPR trial "strengthened ours and our IRB's confidence in this study", he adds.

China has had a reputation for moving fast -- sometimes too fast -- with CRISPR, says Tetsuya Ishii, a bioethicist at Hokkaido University in Sapporo, Japan.

According to Lu, his team was able to move fast because they are experienced with clinical trials of cancer treatments.

June is not surprised that a Chinese group would jump out in front on a trial such as this: "China places a high priority on biomedical research," he says.

Ishii notes that if the clinical trial begins as planned, it would be the latest in a series of firsts for China in the field of CRISPR gene editing, including the first CRISPR-edited human embryos, and the first CRISPR-edited monkeys. "When it comes to gene editing, China goes first," says Ishii.

"I hope we are the first," says Lu. "And more importantly, I hope we can get positive data from the trial."

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Original Submission

• Re:Olympic Games (Score: 2) by takyon on Saturday July 23 2016, @06:36AM

  by takyon (881) <takyonNO@SPAMsoylentnews.org> on Saturday July 23 2016, @06:36AM (#378947) Journal

  I think I loosely based it off this, but it doesn't really support my statement:

  DOI: 10.1089/hum.2015.091

  Then there's this:

  https://www.broadinstitute.org/files/news/pdfs/PIIS0092867415017055.pdf [broadinstitute.org]
  DOI: 10.1016/j.cell.2015.12.041

  Three years ago, scientists reported that CRISPR technology can enable precise and efficient genome editing in living eukaryotic cells. Since then, the method has taken the scientific community by storm, with thousands of labs using it for applications from biomedicine to agriculture. Yet, the preceding 20-year journey—the discovery of a strange microbial repeat sequence; its recognition as an adaptive immune system; its biological characterization; and its repurposing for genome engineering—remains little known.

  [...] If there are molecular biologists left who have not heard of CRISPR, I have not met them. Yet, if you ask scientists how this revolution came to pass, they often have no idea.

  [...] Mojica went out to celebrate with colleagues over cognac and returned the next morning to draft a paper. So began an 18- month odyssey of frustration. Recognizing the importance of the discovery, Mojica sent the paper to Nature. In November 2003, the journal rejected the paper without seeking external review; inexplicably, the editor claimed the key idea was already known. In January 2004, the Proceedings of the National Academy of Sciences decided that the paper lacked sufficient ‘‘novelty and importance’’ to justify sending it out to review. Molecular Microbiology and Nucleic Acid Research rejected the paper in turn. By now desperate and afraid of being scooped, Mojica sent the paper to Journal of Molecular Evolution. After 12 more months of review and revision, the paper reporting CRISPR’s likely function finally appeared on February 1, 2005 (Mojica et al., 2005).

  [...] Siksnys submitted his paper to Cell on April 6, 2012. Six days later, the journal rejected the paper without external review. (In hindsight, Cell’s editor agrees the paper turned out to be very important.) Siksnys condensed the manuscript and sent it on May 21 to the Proceedings of the National Academy of Sciences, which published it online on September 4.

  That article is disputed here [nature.com].

  I'll take a look at it again later.

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