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May 31, 2018

FDA halts one of the first human CRISPR studies before it begins

  • Government
  • Agency
  • Industry
  • Genetics/Genomics

MIT Technology Review – A trial planning to use the gene-editing tool CRISPR on sickle-cell patients has been put on hold because of unspecified questions from US regulators.

CRISPR Therapeutics, which is developing the therapy, sought approval from the US Food and Drug Administration in April to begin the study. The therapy involves extracting stem cells from a patient’s bone marrow and editing them with CRISPR in the lab. The idea is that the edited cells, once infused back into the patient, would give rise to healthy red blood cells.

But according to a statement on Wednesday from CRISPR Therapeutics, the FDA ordered the company not to proceed with its study until it answers questions about its treatment (the company didn’t provide any further details about what those questions are, however).

Read more at MIT Technology Review.

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