Research ArticleStroke

Results of a preclinical randomized controlled multicenter trial (pRCT): Anti-CD49d treatment for acute brain ischemia

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Science Translational Medicine  05 Aug 2015:
Vol. 7, Issue 299, pp. 299ra121
DOI: 10.1126/scitranslmed.aaa9853

Tested, just like a human

Over the last few decades, clinical trial design and analysis have become increasingly stringent. These refinements—designed to ensure valid conclusions for formal drug approval—have improved clinical trial reliability. Now, Llovera et al. have applied the principles of the gold-standard randomized, controlled clinical trial to a preclinical investigation. They tested an antibody to CD49d, which inhibits leukocyte migration into the brain, in two mouse models of stroke. Data from their six-center, preclinical, randomized controlled trial in mice show that the antibody significantly reduced both leukocyte invasion and infarct volume after a small cortical stroke but that it did not have any effect in the other model, in which the animal suffered a larger injury. The authors outline the many lessons learned from their experience for further application of preclinical randomized controlled trials to translational research.

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