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Literature DB >> 27966562

One Size Fits All?: Ethical Considerations for Examining Efficacy in First-in-Human Pluripotent Stem Cell Studies.

Michelle Gjl Habets¹, Johannes Jm van Delden¹, Sophie L Niemansburg¹, Harold L Atkins², Annelien L Bredenoord¹.

Abstract

Entities: Species

Mesh：

Year: 2016 PMID： 27966562 PMCID： PMC5167794 DOI： 10.1038/mt.2016.202

Source DB: PubMed Journal: Mol Ther ISSN： 1525-0016 Impact factor: 11.454

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26 in total

1. Assessing benefits in clinical research: why diversity in benefit assessment can be risky.

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2. Assessing risk/benefit for trials using preclinical evidence: a proposal.

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3. Stable ethics: enrolling non-treatment-refractory volunteers in novel gene transfer trials.

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5. The tragedy of translation: the case of "first use" in human embryonic stem cell research.

Authors: Jan Helge Solbakk; Laurie Zoloth
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Review 6. A clinical development paradigm for cancer vaccines and related biologics.

Authors: Axel Hoos; Giorgio Parmiani; Kristen Hege; Mario Sznol; Hans Loibner; Alexander Eggermont; Walter Urba; Brent Blumenstein; Natalie Sacks; Ulrich Keilholz; Geoffrey Nichol
Journal: J Immunother Date: 2007-01 Impact factor: 4.456

7. Lumbar intraspinal injection of neural stem cells in patients with amyotrophic lateral sclerosis: results of a phase I trial in 12 patients.

Authors: Jonathan D Glass; Nicholas M Boulis; Karl Johe; Seward B Rutkove; Thais Federici; Meraida Polak; Crystal Kelly; Eva L Feldman
Journal: Stem Cells Date: 2012-06 Impact factor: 6.277

Review 8. First-in-Man (FIM) clinical trials post-TeGenero: a review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials.

Authors: Adel Nada; John Somberg
Journal: Am J Ther Date: 2007 Nov-Dec Impact factor: 2.688