Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed.

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Aims This study aimed to evaluate the relationship between sleep duration, sleep quality and hyperlipidemia in middle-aged and older Chinese. Methods We included 20,712 individuals at baseline from September 2008 to June 2010, and they were followed-up until October 2013. Hyperlipidemia was defined according to the Chinese guidelines on the prevention and treatment of dyslipidemia in adults. Sleep duration was self-reported and sleep quality was evaluated with a questionnaire that was designed according to the Pittsburgh Sleep Quality Index. Logistic regression and Cox proportional hazard models were conducted to explore the associations. Results In the cross-sectional analyses, longer sleep duration (≥10 h) was significantly associated with higher prevalence of hyperlipidemia (odds ratio (OR) = 1.17, 95% confidence interval (CI) = 1.02–1.35) after adjusting for potential confounders. The ORs of hyperlipidemia were significantly elevated among participants with impaired sleep quality (OR = 1.14, 95% CI = 1.08–1.22) and poor sleep quality (OR = 1.20, 95% CI = 1.08–1.34) when compared to those with good sleep quality. In the longitudinal analyses, compared to participants with a sleep duration of 7–<8 h, those with a sleep duration of 9–<10 h (hazard ratio (HR) = 1.19, 95% CI = 1.04–1.35) and ≥10 h (HR = 1.27, 95% CI = 1.02–1.58) showed significantly higher risk of hyperlipidemia after adjusting for potential confounders. However, no statistically significant association was found between impaired or poor sleep quality and hyperlipidemia. Conclusions Longer sleep duration was significantly associated with higher risk of hyperlipidemia. Impaired or poor sleep quality were associated with elevated prevalence of hyperlipidemia, but not with the incidence of hyperlipidemia.