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Home » Guidance: Enroll Metabolically Unstable Diabetics in Islet Cell Trials
Guidance: Enroll Metabolically Unstable Diabetics in Islet Cell Trials
May 28, 2008
Clinical investigators and sponsors of trials of allogeneic pancreatic islet cell products to treat Type 1 diabetes are advised to enroll adults who have had the disease for at least five years with well-documented chronic histories of severe metabolic instability, severe hypoglycemia or both, according to a new draft guidance from the FDA.