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FDA Finds Gaps In Cesca's Stem Cell Trial Plan For Critical Limb Ischemia

This article was originally published in The Gray Sheet

Executive Summary

The agency noted deficiencies in Cesca Therapeutcs' investigational device exemption submission for the CLIRST III pivotal study of its SurgWerks stem cell therapy system in critical limb ischemia. But the company says the overall message for the 224-patient study is positive.

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