Pluripotent Stem Cells in Translation: A Food and Drug Administration-National Institutes of Health Collaboration.

Pluripotent Stem Cells in Translation: A Food and Drug Administration-National Institutes of Health Collaboration.

Stem Cells Transl Med. 2013 Jun 11;
Kleitman N, Rao MS, Owens DF

Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts. HubMed – drug


Guest Editorial: Topical drug treatment for the dental pulp: An idea whose time has come.

Quintessence Int. 2013; 44(7): 463-5
Markowitz K, Vassiliou E

HubMed – drug


Childhood and Adult Secondhand Smoke and Type 2 Diabetes in Women.

Diabetes Care. 2013 Jun 11;
Lajous M, Tondeur L, Fagherazzi G, de Lauzon-Guillain B, Boutron-Ruaualt MC, Clavel-Chapelon F

OBJECTIVEThe objective of this study was to evaluate the relationship between childhood and adult secondhand smoke and type 2 diabetes.RESEARCH DESIGN AND METHODSWe conducted a prospective cohort study among 37,343 French women from the E3N-EPIC (Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l’Education Nationale-European Prospective Investigation into Cancer and Nutrition) who never smoked and who were free of type 2 diabetes, cancer, or cardiovascular disease at baseline in 1992. Self-reported childhood secondhand smoke exposure was defined as having at least one parent who smoked. Adult secondhand smoke was defined as the sum of self-reported hours recorded at baseline of exposure to tobacco smoke from a spouse who smoked (or domestic close contact) and from outside the home.RESULTSBetween 1992 and 2007, 795 cases of incident type 2 diabetes were identified and validated through a drug reimbursement dataset and a specific questionnaire. Women with at least one parent who smoked appeared to have an 18% higher rate of type 2 diabetes than women with parents who did not smoke (age-adjusted hazard ratio 1.18 [95% CI 1.02-1.36]). Adult secondhand smoke exposure (no exposure versus ?4 h/day) was associated with an increased rate of type 2 diabetes (1.36 [1.05-1.77], P = 0.002 for trend) after adjusting for parental history of diabetes, education, body silhouette at age 8, childhood secondhand smoke exposure, physical activity, body mass index, hypertension, hypercholesterolemia, menopausal status and hormone use, alcohol intake, and processed red meat and coffee consumption.CONCLUSIONSThis prospective analysis suggests that secondhand smoke exposure in childhood and adulthood are associated with a higher rate of type 2 diabetes. HubMed – drug



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